- For immediate release:
Today, the United States Food and Drug Administration amended the Emergency Use Authorizations (EUA) for the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine to allow the use of a additional dose in some immunocompromised individuals, particularly, solid organ transplant recipients or those diagnosed with conditions which are considered to have an equivalent level of immunosuppression. The Centers for Disease Control and Prevention’s advisory committee on immunization practices is due to meet on Friday to discuss new clinical recommendations for people with compromised immunity. Today’s action does not apply to people who are not immunocompromised.
“The country has entered a new wave of the COVID-19 pandemic, and the FDA is particularly aware that people with immunosuppression are particularly at risk of serious illness. After a careful review of the available data, the FDA determined that this small, vulnerable group could benefit from a third dose of Pfizer-BioNTech or Moderna vaccines, ”said Acting FDA Commissioner Janet Woodcock, MD. today’s action allows doctors to strengthen immunity. in some immunocompromised people who need additional protection against COVID-19. As we have already stated, other fully vaccinated people are well protected and do not need an additional dose of COVID-19 vaccine at this time. The FDA is actively engaged in a rigorous, science-based process with our federal partners to determine if an additional dose may be required in the future. “
People who are immunocompromised in a manner similar to those who have had a solid organ transplant have a reduced ability to fight infections and other illnesses, and they are particularly vulnerable to infections, including COVID-19. The FDA has evaluated information on the use of a third dose of Pfizer-BioNTech or Moderna vaccines in these individuals and has determined that administration of third doses of the vaccine may increase protection for this population. These patients should be counseled to maintain physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised people should be vaccinated, depending on their state of health, in order to offer increased protection to their loved ones.
It is recommended that people who are immunocompromised discuss monoclonal antibody treatment options with their healthcare provider if they contract or are exposed to COVID-19. The FDA has cleared the monoclonal antibody treatments for emergency use during this public health emergency for adults and pediatric patients (aged 12 years and older weighing at least 40 kilograms or approximately 88 pounds) with positive results of direct SARS-CoV-2 viral tests, and which present a high risk of progressing to severe COVID-19 and / or hospitalization. An approved product includes use for preventive treatment (prophylaxis) after exposure to SARS-CoV-2; however, this product is not a substitute for vaccination.
The Pfizer-BioNTech COVID-19 vaccine is currently cleared for emergency use in people 12 years of age and older, and the Moderna COVID-19 vaccine is cleared for emergency use in people 18 years of age and over. more. The two vaccines are given as a series of two injections: the Pfizer-BioNTech COVID-19 vaccine is given three weeks apart and the Moderna COVID-19 vaccine is given one month apart. The authorizations of these vaccines have been changed to allow the administration of an additional dose or a third dose at least 28 days after the two-dose regimen of the same vaccine to persons 18 years of age or older (12 years of age or older for Pfizer -BioNTech) who have undergone a solid organ transplant, or who are diagnosed with conditions that are considered to have an equivalent level of immunosuppression.
The EUA modifications for the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine have been issued to Pfizer Inc. and ModernaTX Inc., respectively.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.