- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) for Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting. In general, advisory committees include a chair, members with scientific and public health expertise, and a consumer and industry representative. Additional members with specific expertise may be added for individual meetings as needed. The members of the VRBPAC are independent, scientific and public health experts from around the country who provide advice to the agency, which may include advice on the safety and effectiveness data submitted in the EUA request. However, final decisions on whether to authorize the vaccine for emergency use are made by the FDA.
- The FDA is alerting health care professionals and compounders of potential risks associated with compounding remdesivir drug products. The FDA cautions against compounding remdesivir drug products. The agency recommends health care providers utilize the FDA-approved drug for patients who are prescribed remdesivir. Compounded drugs are not FDA-approved. This means the FDA does not verify the safety, effectiveness, or quality of compounded drugs. Compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug.
- On Feb. 4, the FDA revised the Letter of Authorization for COVID-19 convalescent plasma to limit the authorization to the use of high titer COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19 early in the disease course and to those hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response. Data indicates that plasma with low levels of antibodies may not be effective in treating COVID-19. The revision was based upon data from new clinical trials analyzed or reported since the original EUA was issued in August 2020.
- On Feb. 4, the FDA issued a statement noting that as part of its commitment to a public and transparent process, the FDA is developing guidances for diagnostic, therapeutic and vaccine developers to help guide ongoing medical product development as they evaluate the impact of COVID-19 variants on their products.
- Testing updates:
- As of today, 322 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 239 molecular tests and sample collection devices, 69 antibody tests, and 14 antigen tests. There are 35 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Lindsey O’Keefe