- For immediate release:
The US Food and Drug Administration today announced the following actions taken in its ongoing effort to respond to the COVID-19 pandemic:
- The FDA has scheduled a meeting of its Vaccine and Related Biological Products Advisory Committee (VRBPAC) for February 26, 2021, to discuss Janssen Biotech Inc.’s application for emergency use authorization (USA) for a COVID-19 vaccine. FDA intends to make supporting materials available to the public, including the meeting agenda and committee list, no later than two business days before the meeting. In general, advisory committees include a chairperson, members with scientific and public health experience and a representative from the consumer and industry. Additional members with specific experience can be added for individual meetings as needed. VRBPAC members are independent, scientific and public health experts from across the country who advise the agency, which may include advice on safety and efficacy data presented in the EUA application. However, the final decisions on whether to authorize the vaccine for emergency use are made by the FDA.
- The FDA is warning healthcare professionals and drug manufacturers about the potential risks associated with the composition of remdesivir. The FDA warns against the composition of remdesivir drugs. The agency recommends that healthcare professionals use the drug approved by the FDA for patients receiving remdesivir. Compound drugs are not approved by the FDA. This means that the FDA does not verify the safety, efficacy or quality of the drugs being handled. Compound drugs should only be used on patients whose medical needs cannot be met by an FDA approved drug.
- On February 4, the FDA revised the Letter of Authorization for convalescent plasma COVID-19 to limit authorization to the use of high-grade COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19 early in the course of the disease and for those hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response. The data indicate that plasma with low levels of antibodies may not be effective in the treatment of COVID-19. The review was based on data from new clinical trials analyzed or reported since the original USA was issued in August 2020.
- On February 4, the FDA issued a statement noting that, as part of its commitment to a public and transparent process, the FDA is developing guidelines for diagnostic, therapeutic and vaccine developers to help guide the continued development of medical products throughout assess the impact of COVID 19 variants on its products.
- Testing updates:
- As of today, 322 tests and sample collection devices are authorized by the FDA under emergency use authorization (EUAs). This includes 239 molecular tests and sample collection devices, 69 antibody tests and 14 antigen tests. There are 35 molecular permits that can be used with samples collected at home. There is a home molecular prescription test, a home antigen prescription test and an over-the-counter home antigen test (OTC).
The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the security and protection of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation and for the regulation of tobacco products.
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