The Role of the Certified Legal Nurse Consultant in COVID-19 Lawsuits

COVID-19, the coronavirus disease that originated in 2019, has created a global pandemic the size of which none of us has seen in our lifetime.

Lawsuits related to COVID-19 are one of the newest and most emerging areas of litigation. They have the potential to be one of the largest areas of litigation in your career as a CLNC® Consultant. It will pay to decide if, and how, you will participate and to start researching and marketing to law firms involved in COVID-19 litigation.

As the COVID-19 pandemic continues, it’s obvious that there will be myriad COVID-19 related lawsuits on the horizon. Thousands of COVID-19 related lawsuits have already been filed. Certified Legal Nurse Consultants are pivotal to attorneys understanding the complexities of COVID-19. As a CLNC® consultant you will want to position yourself for this new and emerging litigation which could conceivably last a decade or more.

Types of COVID-19 Lawsuits

The Certified Legal Nurse Consultant focuses on all four legal elements (duty, breach of duty, damages and causation) in medical malpractice cases. In non-medical malpractice cases, the CLNC consultant focuses primarily on damages and causation.

Medical Malpractice

These cases involve the professional negligence of a healthcare provider or the negligence of a healthcare facility. Hospitals, long term care facilities, home healthcare agencies, emergency medical services, urgent care centers and individual RNs, respiratory therapists and MDs are most vulnerable to the allegations of negligent management and treatment of COVID-19 patients or residents.

The focus is on the Certified Legal Nurse Consultant’s role. Addressing legal allegations (e.g. breach of fiduciary duty) and legal defenses (e.g. consent) are the role of the attorney and are not addressed in this article.

Possible Allegations

Allegations are asserted by the plaintiff. The allegations addressed in this medical malpractice section are examples of deviations from the Standards of Care (SOC) that the Certified Legal Nurse Consultant addresses with the attorney from a nursing or medical perspective. The plaintiff also asserts allegations that are not within the scope of the CLNC consultant’s role.

Failure to timely diagnose COVID-19.
Failure to institute appropriate nursing (medical) interventions. An example of a negligent medical intervention is negligently prescribing hydroxychloroquine for off-label use. Note, physicians are free to prescribe FDA-approved drugs for any scientifically supported use, whether on- or off-label, however they are potentially liable for adverse events from the prescribed drug, especially if there is no scientific support for off-label use.

In June 2020, the FDA revoked the emergency use authorization (EUA) for use of hydroxychloroquine to treat COVID-19 patients outside of a clinical trial. The FDA determined the drug is not effective and had the potential to cause cardiac adverse events and other serious side effects. A plaintiff attorney would use the FDA revocation of the EUA as proof of negligence if the drug was used after that date.

Another example of negligent medical intervention is a physician’s failure to order remdesivir and dexamethasone, which the plaintiff alleges are the SOC for COVID-19.
Failure to assess and perform appropriate tests and diagnostic studies. This includes the failure to assess and perform appropriate tests and diagnostic studies relevant to systemic complications of COVID-19.
Failure to respond timely and appropriately to the patient’s deteriorating condition (e.g. severe respiratory distress).
Negligent staffing and supervision. For example, a specific RN in the ICU was not experienced and qualified to treat the patient. With hospitals having to tap into surge capacity ICU beds, resources were strained and the RNs called upon to treat critical COVID-19 patients might not have been experienced and qualified.

Another example of an allegation is negligent implementation of infection control by management.
Negligent lack of preparedness. Failure to provide adequate personal protective equipment (PPE) and adequate supplies of ventilators. Lack of preparedness was a big issue in some areas (e.g. New York City) at the beginning of the pandemic and then again later in areas where COVID-19 spiked, therefore straining the healthcare system.
Failure to provide policies and procedures regarding screening, infection control, containment, use of PPE (N95 respirators, masks, eye protection, face shields, gloves and gowns, etc.) and treatment of patients with COVID-19.
Failure to provide adequate training to personnel treating possible COVID-19 infections regarding PPE, the preparedness plan, infection control and management of COVID-19.
Violated state and/or federal regulations.
Abuse and neglect.
Failure to diagnose non-COVID-19 medical issues due to physicians practicing telemedicine.

Possible Defenses

The defense will assert defenses responsive to the allegations asserted by the plaintiff, plus additional damage and causation defenses.

Adhered to recognized standards regarding diagnosis, testing, nursing and medical interventions and/or response to the patient’s deteriorating condition. An example is “The use of hydroxychloroquine was appropriate.” In July 2020, a study suggested that use of the drug in patients with minimal cardiac risk factors reduced mortality. The validity of that study is being challenged.
The SOC evolved for this new disease and were being developed in real time. There were no actual SOC at the time of the incident. For example, ventilator use for patients who are hypoxic and not in true respiratory distress was recognized as harmful to COVID-19 patients in April 2020. Some medical professionals have acknowledged they were treating the wrong disease initially and jumping to ventilators too quickly.

In April 2020, remdesivir was considered the Standard of Care (SOC). In June 2020, a trial reported that dexamethasone (steroid) reduced death rates by approximately one third among severe COVID-19 patients. This is not surprising considering that COVID-19 causes inflammation and catastrophic systemic issues. A physician treating a severe COVID-19 patient in July 2020 had a more accurate understanding of COVID-19 than one treating the same patient in March 2020 and would therefore be held to higher or different standards. For example, a defense of a physician in March 2020 would be that remdesivir and dexamethasone were not the SOC at the time of the incident. An additional defense related to remdesivir is the unavailability of the drug due to a supply shortage.
Adhered to crisis standards of care (CSC) implemented by the state government. CSC are based on the substantial change in usual healthcare operations and the level of care it is possible to deliver in the absence of necessary equipment, ICU beds, medications, personnel or experience. CSC might apply to the peak of the pandemic in New York City v to a city with a controlled number of cases and available resources.
Reliance upon junk science and/or no scientific support for allegations. For example, use of convalescent plasma in July 2020 was still investigational and there is no proven safety and effectiveness at this time. If the plaintiff asserts the physician was negligent for failing to administer convalescent plasma, the defense would argue there is no scientific support for this allegation.
The RNs and MDs on the frontlines are the heroes of the COVID-19 pandemic. They risked their own lives and potentially the lives of their families. Because jurors might not be willing to hold healthcare providers accountable for negligent actions, plaintiff attorneys may prefer to pursue healthcare facilities for systemic issues rather than sue the heroes on the frontlines for individual negligence.
Reliance upon an immunity defense. Possible state immunity granted to some (e.g. out-of-state volunteers, retired professionals) or all healthcare providers treating COVID-19 patients. Some states have granted immunity to long term care facilities. If immunity applies, the plaintiff would have to prove gross negligence or intentional misconduct, both of which are difficult to prove.
Staffing and supervision were consistent with the recognized SOC.
Was adequately prepared. Or the lack of preparedness and shortage of PPE is not the fault of the provider and/or facility given the magnitude of the pandemic and the global emergency. No one could have been prepared. If anyone is at fault, it is the state and federal governments and the CDC who failed the healthcare system and the American public.
Did have adequate policies and procedures given the magnitude of the pandemic and the global emergency and continued to update in real time.
Did provide adequate training for personnel given the magnitude of the pandemic and the global emergency and continued to update in real time.
Adhered to state and federal regulations.
No proof of abuse or neglect.
Limited or no damages.
The actions did not cause the patient’s death or injuries. For example, the defense will argue that the death or injuries are acceptable side effects of COVID-19 and were not preventable due to the severity of COVID-19 at the time of presentation. Additional causation defenses include that the plaintiff had preexisting conditions which made him high risk and/or that the plaintiff was also negligent (comparative negligence). For example, the plaintiff delayed seeking treatment. Finally, the defense might argue that the damages are acceptable complications of treatment necessary to save the patient’s life.

It’s important for the Certified Legal Nurse Consultant to address both allegations and defenses when consulting for either plaintiff or defense attorneys.

General Negligence

These cases can involve a wide range of negligence claims against a variety of businesses, corporations and individuals.

Examples of corporations that will potentially face COVID-19 litigation include long term care facilities (e.g. nursing homes and assisted living facilities), airlines, cruise lines, ride share companies, hotels and casinos. Day care centers, gyms, nail and hair salons, bars and restaurants are also potential defendants. Businesses that remained open or failed to cancel events during the public health crisis are also at risk.

Examples of individuals include employees of long term care facilities, massage therapists, chiropractors, hair stylists and other personal service providers.

Individuals are also potentially liable for negligently transmitting the virus after notice of infection. Once a person has been diagnosed as infected, it’s arguable that they have a duty to self-quarantine from family, friends, coworkers, clients and the public at large.

Possible Allegations

Failure to properly screen employees for COVID-19.
Failure to inform customers of possible exposure to COVID-19.
Failure to provide PPE.
Failure to provide safe air quality.
Failure to implement safety policies such as social distancing, mask requirements, workplace sanitation, etc.
Failure to cleanse and sanitize the workplace. Surface transmission is low risk compared to the risk of airborne transmission. The Certified Legal Nurse Consultant might steer the attorney away from this allegation toward more effective allegations related to air quality, mask requirements and social distancing.
Failure to implement state or federal regulations. For example, a long term care facility may be sued for failing to implement infection control regulations. A long term care facility may be sued for elder abuse resulting from failure to adhere to state and federal regulations regarding hiring, retention and supervision of employees. The plaintiff attorney wants elder abuse to be a management issue, not a case about an individual employee.
For long term care facilities, also refer to Medical Malpractice allegations.

Possible Defenses

Did provide adequate and appropriate protection for clients through screening, informing customers of possible exposure, PPE, safe air quality and safety policies and procedures.
Adhered to state and federal regulations (e.g. no proof of abuse and neglect).
Reliance upon junk science and/or no scientific support for allegations.
Limited or no damages.
Did not cause the plaintiff to contract COVID-19. Given that the incubation period is up to 14 days, it will be difficult to prove when and where the plaintiff contracted COVID-19. If someone gets symptoms 13 days after exposure, a lot could have happened in those 13 days.

Causation will be easier to prove when a large number of individuals are infected (e.g. nursing home residents, staff and visitors, cruise ship passengers, hotel guests and casino visitors) than a single case.
The actions did not cause the patient’s death or injuries. The defense will also potentially argue that the incident did not cause the alleged death or injuries. Damages are due to the severity of COVID-19 at the time of presentation, preexisting conditions which made the patient high risk and/or comparative negligence (e.g. Plaintiff delayed seeking treatment.).
Plaintiff signed a waiver agreeing not to sue. Whether waivers will hold up in court is unknown at the time of this writing. Government waivers (e.g. attending legislative session or hearing) are likely to be upheld, while private event waivers (e.g. campaign rallies, concerts, sporting events, auto races, conventions, exhibitions, etc.) may face stricter scrutiny.
For long term care facilities, also refer to Medical Malpractice defenses.

Products Liability

These cases involve injury as a result of a defective product. There are a large number of products related to COVID-19 that are already known to be defective. Examples include defective COVID-19 virus tests with high false negative rates, defective COVID-19 antibody tests with false positive rates, defective hand sanitizers and defective and counterfeit PPE. Ultimately there will be vaccines and potentially there could be issues of effectiveness and deaths or serious side effects resulting from vaccines.

Possible Allegations

Design defect – the entire line of products is defective. For example, the entire line of a specific antibody test produced by a specific manufacturer is only 50% accurate and therefore defective.
Manufacturing defect – a single product in the line of products is defective. For example, a specific antibody test is generally 95% accurate, but one batch of the antibody test is only 50% accurate.
Failure to warn of defects, foreseeable risks or known defects. For example, there is a failure to warn that an antibody test has a 20% inaccuracy rate. That inaccuracy rate may be acceptable given the pandemic, as long as a warning is provided.
Fraudulent misrepresentation for holding out that a product meets standards, which it does not. For example, an N95 respirator does not meet the NIOSH filtration standards of filtering at least 95% of airborne particles.

Possible Defenses

The product is not defective (design or manufacturing). In a pandemic, a higher inaccuracy percentage of COVID-19 and antibody tests will be accepted than would be outside of a pandemic.
Appropriate warnings were given and/or not indicated.
All representations were accurate based on what was known at the time.
Reliance upon junk science and/or no scientific support for allegations.
Immunity defenses for manufacturers of vaccines, testing and treatment products. If applicable, immunity defenses would probably only apply to FDA approved products and drugs.

Title 42 of the U.S. Code protects vaccine manufacturers from liability for state lawsuits for injuries from vaccines. The U.S. Supreme Court has upheld the National Childhood Vaccine Injury Act (NCVIA), which preempts all design defect claims against vaccine manufacturers. The National Vaccine Injury Compensation Program (NVICP), compensates parties injured by vaccines on a no-fault basis which limits damages. Given these hurdles, it is unlikely that there will be large-scale litigation over vaccine-related deaths or injuries.
Limited or no damages.
The product did not cause the patient’s COVID-19 infection. The plaintiff contracted COVID-19 from another cause. It will be difficult to prove when and where the plaintiff contracted COVID-19. The defense will also potentially argue that the product did not cause the alleged death or injuries. Damages are due to the severity of COVID-19 at the time of presentation, preexisting conditions which made the patient high risk and/or comparative negligence (e.g. Plaintiff delayed seeking treatment.).

Workers’ Compensation

These cases involve job-related injuries. Workers’ compensation laws vary from state to state. Whether contracting COVID-19 from work-related activities is compensable will vary from state to state. If applicable, workers’ compensation applies to any worker (healthcare providers and other ancillary workers, meatpacking plant employees, flight attendants, office workers, etc.) who can prove they contracted COVID-19 at work.

If an employer is workers’ compensation insured, this system is usually the employee’s sole remedy. In some states employees can sue employers outside of workers’ compensation if the employee can prove an intentional act or gross negligence on the part of the employer, both of which are difficult to prove.

Proof of fault is not required. The employee has to prove that they contracted COVID-19 on the job. Some states have already enacted legislation providing a presumption of causation, while others may treat COVID-19 as a common disease of life like a cold or flu and, therefore, not compensable.

Possible Defenses

Limited or no damages.
In some states the plaintiff will have to prove that the actual COVID-19 infection occurred on the job site and not elsewhere. With America’s return to work, commuting, traveling, restaurants, bars, beaches, gyms, worship services, casinos and general disregard for wearing masks and social distancing, proving causation could be a difficult hurdle.

Workplace Safety

These cases involve lawsuits by employees or unions against employers seeking injunctive relief from employers to ensure a safe working environment. Plaintiffs may include almost any worker (healthcare providers and other ancillary workers, meatpacking plant employees, flight attendants, office workers, etc.).

Possible Allegations

Failure to properly screen employees for COVID-19.
Failure to inform employees of possible exposure to COVID-19 in the workplace.
Failure to provide PPE.
Failure to provide safe air quality.
Failure to implement safety policies such as social distancing, mask requirements, workplace sanitation, etc.
Failure to cleanse and sanitize the workplace.
Failure to implement state or federal regulations.

Possible Defenses

Adhered to standards and regulations and did provide adequate and appropriate protection for employees through screening, informing employees of possible exposure, PPE, safe air quality and safety policies and procedures.
The lack of preparedness and shortage of PPE is not the fault of the employer given the magnitude of the pandemic and global emergency.

Wrongful Termination, Employment Discrimination and Constructive Discharge

Healthcare providers and other relevant workers may sue employers for wrongful termination for insisting on adequate PPE, reporting employer/employee misconduct or unsafe working conditions or wearing their own PPE against company policy.

Employment discrimination can take place when employees are terminated, passed over for promotion or not hired based on age, sex, race/ethnicity or disability, etc.

Constructive discharge cases involve employees forced to quit their jobs due to intolerable workplace conditions. For example, when bars first opened, many of them were out of control regarding crowd size, lack of social distancing and failure to wear masks. Security staff, bartenders and other service staff may have been forced to quit their job due to intolerable workplace conditions.

Intentional Torts

These cases could include assault, battery and intentional infliction of emotional distress for volitional acts that intend to bring about actual or threatened transmission of COVID-19. For example, a non-masker intentionally coughs in an employee’s face for insisting the customer wear a mask.

Criminal

These cases involve acts that society has deemed contrary to the public good. According to the CDC, transmission of HIV and STDs has been criminalized to varying degrees in at least 34 states. It’s possible that COVID-19 may receive similar treatment if the person knows they have COVID-19 and acts without regard for the safety and well-being of others. As of the date of this article, there are no states that criminalize transmission of COVID-19, but there are states that do criminalize threats of transmission of COVID-19.

Individuals, online resellers and companies may also be criminally prosecuted for fraudulently deceiving the public regarding representations of quality and/or effectiveness of products such as masks, other PPE, supplements, alternative therapy remedies, etc. For example, a Chinese company faces federal charges for selling fake N95 respirators to American healthcare facilities.

Businesses could be charged for refusing to close when mandated by law.

Criminal cases also include elder abuse in long term care facilities.

Miscellaneous

There are additional potential and actual lawsuits relevant to COVID-19:

Lawsuits against the federal, state and local governments for negligently handling COVID-19 (arguably unlikely to be successful). For example, there is a lawsuit against one state’s department of health over nursing home inspection procedures in a nursing home that had a large number of residents infected with COVID-19.
Lawsuits against the federal, state and local governments for required business closures during the pandemic.
Actions by regulatory agencies against corporations for failing to adhere to regulations.
Lawsuits by businesses against insurance companies for economic losses due to COVID-19.
Lawsuits (class actions) against China for negligently failing to contain COVID-19.
Lawsuits for failing to comply with state, local or business mask policies. Examples include airline passengers placed on “do not fly” lists and customers barred from business establishments or public events.
Lawsuits brought under the Americans with Disabilities Act (ADA) by parties with asthma or other disabilities who cannot wear a mask and parties refused reasonable accommodations due to disabilities.
Lawsuits involving exemptions from mandatory COVID-19 vaccines due to medical exemptions and religious, personal, moral or other beliefs.
Lawsuits regarding failure to provide leave under either the Family and Medical Leave Act (FMLA) or Families First Coronavirus Response Act (FFCRA) where applicable.

What Interested CLNC® Consultants Should Do

Lawsuits related to COVID-19 are one of the newest and most emerging areas of litigation. They have the potential to be one of the largest areas of litigation in your career as a CLNC Consultant. It will pay to decide if, and how, you will participate and to start researching and marketing to law firms involved in COVID-19 litigation.

Certified Legal Nurse Consultants: Go to Part 2 of The Role of the Certified Legal Nurse Consultant in COVID-19 Lawsuits to learn more about the specific services Certified Legal Nurse Consultants provide and factors that will affect COVID-19 litigation. Go also to the presentation How to Market to Attorneys Handling COVID-19 Cases.

Updates

Click here for more FDA updates

3/14/23 – FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age

The U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in children 6 months through 4 years of age at least 2 months after completion of primary vaccination with three doses of the monovalent (single strain) Pfizer-BioNTech COVID-19 Vaccine.

The amendments are as follows:

Children 6 months through 4 years of age who completed their three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine more than two months ago are now eligible to receive a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
Since December 2022, children 6 months through 4 years of age who receive the first two doses with monovalent Pfizer-BioNTech COVID-19 Vaccine should complete their three-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. These children in this age group are not eligible for a booster dose of a bivalent vaccine at this time and are expected to have protection against the most serious COVID-19 outcomes. This authorization is for those children 6 months through 4 years of age who completed their 3-dose primary vaccination series with the monovalent Pfizer-BioNTech COVID-19 Vaccine, before the Pfizer-BioNTech COVID-19 Vaccine, Bivalent was authorized to provide the third dose in the 3-dose primary series.
The Pfizer-BioNTech COVID-19 Vaccine, Bivalent includes an mRNA component corresponding to the original virus strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component corresponding to the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.

The amendment to the EUA was issued to Pfizer Inc.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-bivalent-pfizer-biontech-covid-19-vaccine-booster-dose

12/08/22 – FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age

The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to 6 months of age.

The amendments are as follows:

Children 6 months through 5 years of age who received the original (monovalent) Moderna COVID-19 Vaccine are eligible to receive a single booster of the updated (bivalent) Moderna COVID-19 Vaccine two months after completing a primary series with the monovalent Moderna COVID-19 Vaccine.
Children 6 months through 4 years of age who have not yet begun their three-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine or have not yet received the third dose of their primary series will now receive the updated (bivalent) Pfizer-BioNTech COVID-19 vaccine as the third dose in their primary series following two doses of the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine.
Children 6 months through 4 years of age who have already completed their three-dose primary series with the original (monovalent) Pfizer-BioNTech COVID-19 Vaccine will not be eligible for a booster dose of an updated bivalent vaccine at this time. Children in this age group who already completed their primary series would still be expected to have protection against the most serious outcomes from the omicron variant.
The Moderna and Pfizer-BioNTech bivalent COVID-19 vaccines include an mRNA component corresponding to the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component corresponding to the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.
Individuals who receive the updated (bivalent) vaccines may experience similar side effects reported by individuals who received previous doses of the original (monovalent) mRNA COVID-19 vaccines.
The fact sheets for both bivalent COVID-19 vaccines for recipients and caregivers and for healthcare providers include information about the potential side effects, as well as the risks of myocarditis and pericarditis.

Moderna COVID-19 Vaccine, Bivalent

The monovalent Moderna COVID-19 Vaccine is authorized as a two-dose primary series in individuals six months of age and older and as a third primary series dose for individuals 6 months of age and older who have been determined to have certain kinds of immunocompromise. With this authorization, the Moderna COVID-19 Vaccine, Bivalent is now authorized for administration in individuals 6 months through 5 years of age as a single booster dose at least 2 months after completion of primary vaccination with the monovalent Moderna COVID-19 Vaccine. The Moderna COVID-19 Vaccine, Bivalent is also authorized for use in individuals 6 years and older as a single booster dose at least two months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine, or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

Pfizer-BioNTech COVID-19 Vaccine, Bivalent

With this authorization, children 6 months through 4 years of age who have not yet received the third dose of the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine will now receive the Pfizer-BioNTech COVID-19 Vaccine, Bivalent as the third dose of the primary series. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is also authorized for administration in individuals 5 years of age and older as a single booster dose at least two months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine, or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

With this action, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use as the third dose of the three-dose primary series in children 6 months through 4 years of age. The monovalent Pfizer-BioNTech COVID-19 Vaccine remains authorized for administration as the first two doses of the three-dose primary series in individuals 6 months through 4 years of age, as a two-dose primary series for individuals 5 years of age and older, and as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise.

The authorization of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for administration as the third dose of a three-dose primary series following two doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age is supported by the FDA’s previous analyses of the effectiveness of primary vaccination with the monovalent Pfizer-BioNTech COVID-19 Vaccine in individuals 16 years of age and older and individuals 6 months through 4 years of age, and previous analyses of immune response data in adults greater than 55 years of age who had received a two-dose primary series and one booster dose with the monovalent Pfizer-BioNTech COVID-19 Vaccine and a second booster dose with the investigational Pfizer-BioNTech bivalent COVID-19 vaccine (original and omicron BA.1).

The amendments to the EUAs were issued to Moderna TX Inc. and Pfizer Inc.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-updated-bivalent-covid-19-vaccines-children-down-6-months

11/30/22 – FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region

The U.S. Food and Drug Administration announced the monoclonal antibody bebtelovimab is no longer authorized for emergency use in the U.S. because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1., according to data included in the Health Care Provider Fact Sheet.

Data from the Centers for Disease Control and Prevention estimates that the combined proportion of COVID-19 cases caused by the Omicron BQ.1 and BQ.1.1 subvariants to be above 68% nationally and data shows a sustained trend of increasing prevalence across all regions. Given that a COVID-19 infection is likely to be caused by a non-susceptible SARS-CoV-2 variant, and consistent with the terms and conditions of the Emergency Use Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time.

Health care providers should use other approved or authorized products that are expected to retain activity against BQ.1 and BQ.1.1 as they choose appropriate treatment options for patients, which include the following:

Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.

In addition, COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies is authorized for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment, in inpatient or outpatient settings.

For more information related to the therapeutic management of non-hospitalized patients with mild-to-moderate COVID-19, refer to the NIH COVID-19 Treatment Guidelines and the COVID-19 Treatment Guidelines Panel’s update on bebtelovimab.

10/12/22 – FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups

The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups. The Moderna COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to six years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for administration at least two months following completion of primary or booster vaccination in children down to five years of age.

These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant. The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.

With this authorization, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as a booster dose for individuals five through 11 years of age. Both the Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine continue to be authorized for primary series administration in individuals six months of age and older.

The fact sheets for both of the bivalent COVID-19 vaccines for recipients and caregivers and for healthcare providers include information about potential side effects, as well as the risks of myocarditis and pericarditis.

The amendments to the EUAs were issued to Moderna TX Inc. and Pfizer Inc.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-bivalent-covid-19-vaccines

8/31/22 – FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines, referred to as “updated boosters,” contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.

The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.

The Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent contain mRNA from the SARS-CoV-2 virus. The mRNA in these vaccines is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.

The FDA has also revised the EUA of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to remove the use of the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines for booster administration for individuals 18 years of age and older and 12 years of age and older, respectively. These monovalent vaccines continue to be authorized for use for administration of a primary series for individuals 6 months of age and older as described in the letters of authorization. The Pfizer-BioNTech COVID-19 Vaccine remains authorized for administration of a single booster dose for individuals 5 through 11 years of age at least five months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine.

The amendments to the EUAs were issued to Moderna TX Inc. and Pfizer Inc.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use

7/13/22 – FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.

The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual. The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile.

In clinical trial participants, the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19. In a subset of participants 65 years of age and older, the vaccine was 78.6% effective. The clinical trial was conducted prior to the emergence of delta and omicron variants.

The FDA also expects Novavax Inc. to continue their clinical trials to obtain additional safety and effectiveness data and pursue approval (licensure). The EUA was issued to Novavax Inc.

6/17/22 – FDA Authorized Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

The U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.

For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.

For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older.

The Moderna COVID-19 Vaccine is administered as a primary series of two doses, one month apart, to individuals 6 months through 17 years of age. The vaccine is also authorized to provide a third primary series dose at least one month following the second dose for individuals in this age group who have been determined to have certain kinds of immunocompromise.

The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of three doses in which the initial two doses are administered three weeks apart followed by a third dose administered at least eight weeks after the second dose in individuals 6 months through 4 years of age.

The EUA amendment for the Moderna COVID-19 Vaccine was issued to ModernaTX Inc. and the EUA amendment for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-and-pfizer-biontech-covid-19-vaccines-children

05/17/22 – FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

The U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.

On Jan. 3, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to individuals 12 through 15 years of age after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. This action expands the use of a single booster dose of the vaccine for administration to individuals 5 through 11 years age at least five months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine. The FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 years of age and older and has approved Comirnaty (COVID-19 Vaccine, mRNA) for use in individuals 16 years of age and older.

“The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations. The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups.”

The amendment to the EUA was granted to Pfizer Inc.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-vaccine-booster-dose

05/05/22 – FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

The U.S. Food and Drug Administration has limited the authorized use of the Janssen COVID-19 Vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.

Key Points:

After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine.
The FDA has determined that the known and potential benefits of the vaccine for the prevention of COVID-19 outweigh the known and potential risks for individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and for individuals 18 years of age and older who elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.
The Fact Sheet for Healthcare Providers Administering Vaccine now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS. Additionally, information on the revision to the authorized use of the vaccine and updated information on this risk of blood clots with low levels of blood platelets has been added to the Fact Sheet for Recipients and Caregivers.

Examples of individuals who may still receive the Janssen COVID-19 Vaccine include: individuals who experienced an anaphylactic reaction after receipt of an mRNA COVID-19 vaccine, individuals who have personal concerns with receiving mRNA vaccines and would otherwise not receive a COVID-19 vaccine and individuals who would remain unvaccinated for COVID-19 due to limited access to mRNA COVID-19 vaccines.

The revised EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-limits-use-janssen-covid-19-vaccine-certain-individuals

03/29/22 – FDA Approves Second COVID-19 Vaccine

The U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people 50 years of age and older as well as certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns.

The agency amended the emergency use authorizations as follows:

A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
A second booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered to individuals 12 years of age and older with certain kinds of immunocompromise at least 4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.
A second booster dose of the Moderna COVID-19 Vaccine may be administered at least 4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals 18 years of age and older with the same certain kinds of immunocompromise.

This action applies only to the Pfizer-BioNTech and Moderna COVID-19 vaccines and the authorization of a single booster dose for other age groups with these vaccines remains unchanged. The agency will continue to evaluate data and information as it becomes available when considering the potential use of a second booster dose in other age groups.

The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty can be used to provide the authorized booster dose(s). Similarly, the FDA-authorized Moderna COVID-19 Vaccine and the FDA-approved Spikevax are authorized to provide the authorized booster dose(s).

The amendments to the EUAs to include a second booster dose for these populations were granted to Pfizer Inc. and ModernaTX Inc.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and

01/31/22 – FDA Approves Second COVID-19 Vaccine

The U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine, and will be marketed as Spikevax, for the prevention of COVID-19 in individuals 18 years of age and older. The vaccine has been available under emergency use authorization (EUA) for individuals 18 years of age and older since Dec. 18, 2020.

Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series. Moderna COVID-19 Vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine. It is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. The vaccine was 98% effective in preventing severe disease.

The FDA granted this application Priority Review. The approval was granted to ModernaTX, Inc. The amendment to the EUA was granted to Pfizer Inc.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-key-action-approving-second-covid-19-vaccine

01/03/22 – FDA Expands Use of Pfizer-BioNTech Covid-19 Vaccine

The U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to:

Expand the use of a single booster dose to include use in individuals 12 through 15 years of age.
Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.
Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.

The FDA’s action expands the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to include its use in individuals as young as 12 years of age. The FDA has determined that the protective health benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death, outweigh the potential risks in individuals 12 through 15 years of age.

Also, the booster interval has been updated to five months for people 12 years of age and older with the FDA authorizing the use of a single booster dose five months after completion of the primary vaccination series of the Pfizer-BioNTech COVID-19 Vaccine. While this action applies only to the Pfizer-BioNTech COVID-19 Vaccine, the FDA states it will continue to review data concerning all available vaccines and will provide additional updates as appropriate.

Additionally, a third primary series dose has now been authorized for certain immunocompromised children ages 5 through 11 who have undergone solid organ transplantation, or who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise and who may not respond adequately to the two-dose primary vaccination series.

The FDA previously authorized a third primary series dose for use as part of the primary immunization series in individuals 12 years and older. The potential effectiveness of an additional dose in children 5 through 11 years of age was extrapolated from data in adults.

The FDA has stated that children 5 through 11 years of age who are fully vaccinated and are not immunocompromised do not need a third dose at this time, but the FDA will continue to review information and communicate with the public if data emerges suggesting booster doses are needed for this pediatric population.

The amendment to the EUA was granted to Pfizer Inc. Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-multiple-actions-expand-use-pfizer-biontech-covid-19-vaccine

12/23/21 – FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth. It is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in patients hospitalized due to COVID-19 because benefit of treatment has not been observed in people when treatment started after hospitalization due to COVID-19.

Molnupiravir is a medication that works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. Molnupiravir is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules. Molnupiravir is not authorized for use for longer than five consecutive days.

Based on findings from animal reproduction studies, molnupiravir may cause fetal harm when administered to pregnant individuals. Therefore, molnupiravir is not recommended for use during pregnancy. Molnupiravir is only authorized to be prescribed to a pregnant individual after the prescribing healthcare provider has determined that the benefits of being treated with molnupiravir would outweigh the risks for that individual patient and after the prescribing health care provider has communicated the known and potential benefits and the potential risks of using molnupiravir during pregnancy to the pregnant individual. Females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for four days after the final dose. Males of reproductive potential who are sexually active with females of childbearing potential are advised to use a reliable method of birth control correctly and consistently during treatment with molnupiravir and for at least three months after the final dose.

Under the EUA, fact sheets that provide important information about using molnupiravir in the treatment of COVID-19 as authorized must be made available to healthcare providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects and information about who is able to prescribe molnupiravir. Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain

12/22/21 – FDA Authorizes First Oral Antiviral for Treatment of COVID-19

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19. Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets. Paxlovid is not authorized for use for longer than five consecutive days.

Possible side effects of Paxlovid include impaired sense of taste, diarrhea, high blood pressure and muscle aches. Using Paxlovid at the same time as certain other drugs may result in potentially significant drug interactions. Using Paxlovid in people with uncontrolled or undiagnosed HIV-1 infection may lead to HIV-1 drug resistance. Ritonavir may cause liver damage, so caution should be exercised when giving Paxlovid to patients with preexisting liver diseases, liver enzyme abnormalities or liver inflammation. Because Paxlovid works, in part, by inhibiting a group of enzymes that break down certain drugs, Paxlovid is contraindicated with certain drugs that are highly dependent on those enzymes for metabolism and for which elevated concentrations of certain drugs are associated with serious and/or life-threatening reactions. Paxlovid is also contraindicated with drugs that, conversely, strongly induce those same enzymes, leading to the faster breakdown of nirmatrelvir or ritonavir, as reduced concentrations of nirmatrelvir or ritonavir may be associated with potentially losing virologic response and developing viral resistance. Paxlovid cannot be started immediately after discontinuing such medications because the effects of those medications remain after discontinuation.

Under the EUA, fact sheets that provide important information about using Paxlovid in the treatment of COVID-19 as authorized must be made available to healthcare providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects, drug interactions and information about who is able to prescribe Paxlovid. Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

11/19/21 – FDA Expands Eligibility for COVID-19 Vaccine Boosters

The U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.

Prior to this authorization, a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines was authorized for administration to individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19 and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. This action expands the use of booster doses of both vaccines to include all individuals 18 years of age and older at least six months after completion of the primary vaccination series of the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine or at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.

The amendments to the EUAs were granted to ModernaTX Inc. and Pfizer Inc. Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-covid-19-vaccine-boosters

10/29/21 – FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

The U.S. Food and Drug Administration (FDA) authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age.

The Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms).

The FDA determined the Pfizer vaccine has met the criteria for emergency use authorization. Based on the totality of scientific evidence available, the known and potential benefits of the Pfizer-BioNTech COVID-19 vaccine in individuals down to 5 years of age outweigh the known and potential risks. Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age

10/20/21 – FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

The U.S. Food and Drug Administration (FDA) took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:

The use of a single booster dose of the Moderna COVID-19 Vaccine that may be administered at least 6 months after completion of the primary series to individuals:

65 years of age and older
18 through 64 years of age at high risk of severe COVID-19
18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2

The use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.

The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose is approved for eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.

Additionally, a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.

The Moderna COVID-19 single booster dose is half of the dose that is administered for a primary series dose and is administered at least six months after completion of a primary series of the vaccine.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-additional-actions-use-booster-dose-covid-19-vaccines

9/22/21 – FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19

The U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:

Individuals 65 years of age and older;
Individuals 18 through 64 years of age at high risk of severe COVID-19; and
Individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

The authorization applies only to the Pfizer-BioNTech COVID-19 Vaccine, also known as Comirnaty (COVID-19 Vaccine, mRNA), which was approved by the FDA on August 23, 2021, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

The FDA has determined that based on the totality of the available scientific evidence, a booster dose of Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 and that the known and potential benefits of a booster dose outweigh the known and potential risks in the populations that the FDA is authorizing for use. The booster dose is authorized for administration to these individuals at least six months following completion of their primary series and may be given at any point after that time.

The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine is the same formulation as the FDA-approved Comirnaty and the vaccines may be used interchangeably.

Since December 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA for individuals 16 years of age and older. The authorization was expanded on May 10, 2021 to include those 12 through 15 years of age, and again on August 12, 2021 to include the use of a third dose of a three-dose primary series in certain immunocompromised individuals 12 years of age and older.

The amendment to the EUA to include a single booster dose was granted to Pfizer Inc. Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations

8/23/21 – FDA Approves Pfizer-BioNTech COVID-19 Vaccine

The U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine is also available under an emergency use authorization (EUA) which includes individuals 12 through 15 years of age and the administration of a third dose in certain immunocompromised individuals. Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under an EUA in individuals 16 years of age and older. The authorization was expanded to include those 12 through 15 years of age on May 10, 2021.

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The FDA states that mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the original EUA vaccine and is administered as a series of two doses, three weeks apart. Based on clinical trial results, the vaccine was 91% effective in preventing COVID-19 disease.

The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

2/27/21 – FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

The Janssen COVID-19 Vaccine is administered as a single dose and is manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

The vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination. At this time, data are not available to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person. The EUA for the Janssen COVID-19 Vaccine was issued to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

12/18/20 – FDA Authorizes Second COVID-19 Vaccine

The U.S. Food and Drug Administration issued a second emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

The Moderna COVID-19 Vaccine is administered as a series of two doses, one month apart and contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

The vaccine was 94.1% effective in preventing COVID-19 disease among clinical trial participants. At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person. The EUA for the Moderna COVID-19 Vaccine was issued to ModernaTX, Inc. Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

12/11/20 – FDA Authorizes First COVID-19 Vaccine

The U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

The Pfizer-BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart and contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

The vaccine was 95% effective in preventing COVID-19 disease among the clinical trial participants. At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person. The EUA for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc.

Additional information can be found in the FDA’s statement located at https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19

11/21/20 – FDA Authorizes Second Monoclonal Antibody Treatment of COVID-19

The U.S. Food and Drug Administration issued a limited emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions. Casirivimab and imdevimab must be administered together by intravenous (IV) infusion and are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Casirivimab and imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. The EUA was issued to Regeneron Pharmaceuticals Inc.

11/09/20 – FDA Authorizes First Monoclonal Antibody Treatment of COVID-19

The U.S. Food and Drug Administration issued a limited emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions. Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells. The EUA was issued to Eli Lilly and Company.

10/22/20 – FDA Update: Remdesivir Approved as First Treatment for COVID-19

U.S. Food and Drug Administration (FDA) approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 88 pounds for treatment of COVID-19 requiring hospitalization. Approval is limited to administration in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

The approval does not include the entire population that had been authorized to use Veklury under the Emergency Use Authorization (EUA) originally issued on May 1, 2020 and amended on August 28, 2020. Clinical trials assessing the safety and efficacy of Veklury in pediatric patient populations are ongoing.

The approval of Veklury was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19. The complete text of the FDA’s statement can be found at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

10/9/20 – NIH Update: Therapeutic Management of Patients with COVID-19

NIH published updated guidelines for therapeutic management of patients with COVID-19. Protocols for pharmacologic management and treatment are broken down by disease severity as follows:

Not hospitalized or hospitalized but does not require supplemental oxygen,
Hospitalized and requires supplemental oxygen,
Hospitalized and requires oxygen delivery through a high-flow device or noninvasive ventilation, and
Hospitalized and requires invasive mechanical ventilation or ECMO.

You can download the updated guidelines at: https://www.covid19treatmentguidelines.nih.gov/therapeutic-management/

9/1/20 – COVID-19 Treatment Guidelines Panel at the National Institutes of Health (NIH) Issues Statement on the Emergency Use Authorization of Convalescent Plasma for Treatment of COVID-19

The COVID-19 Treatment Guidelines Panel at the National Institutes of Health (NIH) issued a statement on the Food and Drug Administration’s (FDA) Emergency Use Authorization of Convalescent Plasma for the Treatment of COVID-19 stating, “There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19” The statement further emphasized, “Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19.” It also reinforced the FDA’s August 23, 2020 recommendation that randomized control trials are needed to determine whether convalescent plasma is effective and safe for treatment of COVID-19. Finally, NIH attached a footnote stating, “The criteria for issuance of an EUA are not the same as the standards for FDA approval. There are currently no FDA-approved therapies for the treatment of COVID-19.” Additional information can be found in the NIH’s statement located at https://www.covid19treatmentguidelines.nih.gov/statement-on-convalescent-plasma-eua/

8/28/20 – FDA Update: Emergency Use Authorization for Veklury (remdesivir) Broadened to Include All Hospitalized Patients for Treatment of COVID-19

U.S. Food and Drug Administration broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.

This expands the May 2020, EUA that authorized Veklury for the treatment of hospitalized adult and pediatric patients with severe COVID-19. As noted in the initial issuance of the EUA, the emergency use of Veklury was limited to those patients with severe disease, which was defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.

The FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients. The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses. The complete text of the FDA’s statement can be found at: https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-broadens-emergency-use-authorization-veklury-remdesivir-include-all-hospitalized

8/23/20 – FDA Issues Emergency Use Authorization (EUA) for Convalescent Plasma as Potential COVID–19 Treatment

The U.S. Food and Drug Administration (FDA) issued an EUA for investigational use of COVID-19 Convalescent Plasma (CCP) for treatment of COVID-19 in hospitalized patients. The FDA decision memorandum states “CCP may be effective in the treatment of COVID-19 and it is reasonable to believe the known and potential benefits of CCP outweigh the known and potential risks.” Randomized control trials will be required to show definitive evidence of safety and efficacy. Usage limitations and additional information can be found in the FDA’s decision memorandum located at https://www.fda.gov/media/141480/download.

Back to Legal Nurse Consultant Job Resources

Learn How You Can Earn Up to $150/hr as a CLNC^® Consultant

Call for More Information

Free Information Packet

Get your FREE info packet and book on legal nurse consulting.

713.942.2200

Download catalog

Download

Need Tuition Assistance?

We’ve partnered with Sallie Mae to provide financial options.

Financing

Types of COVID-19 Lawsuits

Medical Malpractice

Possible Allegations

Possible Defenses

General Negligence

Possible Allegations

Possible Defenses

Products Liability

Possible Allegations

Possible Defenses

Workers’ Compensation

Possible Defenses

Workplace Safety

Possible Allegations

Possible Defenses

Wrongful Termination, Employment Discrimination and Constructive Discharge

Intentional Torts

Criminal

Miscellaneous

What Interested CLNC® Consultants Should Do

Updates

3/14/23 – FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of Age

12/08/22 – FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of Age

11/30/22 – FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region

10/12/22 – FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups

8/31/22 – FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose

7/13/22 – FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted

6/17/22 – FDA Authorized Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

05/17/22 – FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years

05/05/22 – FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

03/29/22 – FDA Approves Second COVID-19 Vaccine

01/31/22 – FDA Approves Second COVID-19 Vaccine

01/03/22 – FDA Expands Use of Pfizer-BioNTech Covid-19 Vaccine

12/23/21 – FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults

12/22/21 – FDA Authorizes First Oral Antiviral for Treatment of COVID-19

11/19/21 – FDA Expands Eligibility for COVID-19 Vaccine Boosters

10/29/21 – FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

10/20/21 – FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines

9/22/21 – FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19

8/23/21 – FDA Approves Pfizer-BioNTech COVID-19 Vaccine

2/27/21 – FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

12/18/20 – FDA Authorizes Second COVID-19 Vaccine

12/11/20 – FDA Authorizes First COVID-19 Vaccine

11/21/20 – FDA Authorizes Second Monoclonal Antibody Treatment of COVID-19

11/09/20 – FDA Authorizes First Monoclonal Antibody Treatment of COVID-19

10/22/20 – FDA Update: Remdesivir Approved as First Treatment for COVID-19

10/9/20 – NIH Update: Therapeutic Management of Patients with COVID-19

9/1/20 – COVID-19 Treatment Guidelines Panel at the National Institutes of Health (NIH) Issues Statement on the Emergency Use Authorization of Convalescent Plasma for Treatment of COVID-19

8/28/20 – FDA Update: Emergency Use Authorization for Veklury (remdesivir) Broadened to Include All Hospitalized Patients for Treatment of COVID-19

8/23/20 – FDA Issues Emergency Use Authorization (EUA) for Convalescent Plasma as Potential COVID–19 Treatment

Learn How You Can Earn Up to $150/hr as a CLNC® Consultant

Call for More Information

Download catalog

Need Tuition Assistance?

Questions? Talk to a Career Advisor.

Learn How You Can Earn Up to $150/hr as a CLNC^® Consultant