Medmonitor

The FDA amended the emergency use authorization (EUA) for both the Pfizer and Moderna COVID-19 vaccines to allow for an additional dose in certain immunocompromised individuals, specifically organ transplant recipients, or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. According to the CDC, emerging data suggest some people with moderately to severely compromised immune systems do not always build the same level of immunity compared to people who are not immunocompromised. People who are immunocompromised in a manner similar to those who have undergone solid organ transplantation have a reduced ability to fight infections and other diseases, and they are especially vulnerable to infections, including COVID-19, and the administration of a third vaccine dose may increase protection in this population.

The FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in patients weighing at least 40 kilograms (about 88 pounds) with COVID-19 who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

In April, the FDA and the CDC announced that six women experienced rare and severe blood clots after receiving the Johnson & Johnson COVID-19 vaccine. As of April 12, 2021, more than 6.8 million doses of this specific vaccine have been administered, making the occurrence of these blood clots rare. The CDC and FDA reviewed these cases, recommending a pause in the use of this vaccine, but following a safety review, the FDA and CDC determined that the use of the Johnson & Johnson COVID-19 vaccine should be resumed. Current data shows that the vaccine’s known and potential benefits outweigh risks and that the chance of these blood clots occurring is very low.

As of early March, three COVID-19 vaccines received emergency use authorization (EUAs) from the FDA. In
December, the Pfizer/BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine received EUAs, and in late
February the Johnson & Johnson/Janssen COVID-19 vaccine received an EUA. Both the Pfizer/BioNTech and Moderna vaccines require two separate doses, while the Johnson & Johnson/Janssen vaccine requires only a single dose. EUAs are not an FDA approval; EUAs are authorizations for non-FDA-approved drugs when no other effective alternatives are available, and the benefits appear to outweigh the risk.

The FDA alerted clinical laboratory staff and healthcare providers that genetic variants of COVID-19 may lead to false negative results in certain diagnostic tests. This alert applies to all molecular COVID-19 tests, though the FDA continues to monitor the effect of different variants on molecular tests. Negative test results should be considered in combination with clinical observations, patient history, and epidemiological information. Retesting may be considered when patients display symptoms but test negative.

In November of 2020, the FDA issued an emergency use authorization (EUA) for bamlanivimab, an investigational monoclonal antibody designed to block the coronavirus’ attachment and entry into human cells, for the treatment of mild-to-moderate COVID-19. However, in April of 2021, the FDA revoked that EUA. Based on ongoing analysis of emerging scientific data, viral variants of COVID-19 were found to be resistant to bamlanivimab, and with no testing technologies available to allow healthcare providers to test individual patients for COVID-19 variants, the potential benefits of using the drug no longer outweighed the risks.