Medmonitor

Gilead Sciences Inc issued a recall of two lots of Veklury (remdesivir) injections due to the presence of glass particulates. Remdesivir is indicated for the treatment of severe COVID-19 that requires hospitalization. The administration of an injectable product containing glass particulates may result in local irritation or swelling. If the particulates reach the blood vessels it can travel to various organs and block vessels in the heart, lungs, or brain, which can cause stroke and death. The lots impacted at 2141001-1A and 2141002-1A.

The FDA updated the emergency use authorization (EUA) for the combined administration of bamlanivimab and etesevimab – two monoclonal antibodies – to include emergency use as a post-exposure prophylaxis (prevention) for COVID-19 patients aged 12 or older who are at high risk of progression to severe COVID-19. These drugs can only be administered as a prophylaxis for COVID-19 if patients are not fully vaccinated or are not expected to mount an adequate immune response to complete COVID-19 vaccination, including for example, immunocompromised patients. Post-exposure prophylaxis is not a substitute for vaccination against COVID-19.

The FDA has expanded the emergency use authorizations (EUAs) for the Moderna and Johnson & Johnson COVID-19 vaccines to allow for the use of a single booster dose among certain populations. The Moderna vaccine may now be administered at least six months after completion of the primary vaccine series to individuals 65 years of age and older, individuals 18-64 years of age at high risk of severe COVID-19, and individuals 18-64 years of age with frequent institutional or occupational exposure to COVID-19. The Johnson & Johnson vaccine may be administered at least two months after completion of the single-dose primary regimen to any individual aged 18 or older. Furthermore, the FDA clarified that after finishing an initial vaccination regimen, individuals may mix and match which vaccine they use for a booster dose.

The White House announced plans to make COVID-19 boosters available for all adults starting the week of September 20th. Boosters could only be administered eight months after an individual’s second dose of the Pfizer or Moderna vaccine. In essence, during the initial start of booster administration, only healthcare workers, nursing home residents, and other early receivers of the vaccine would be eligible. The White House’s decision coincides with recommendations from the Department of Health and Human Services (HHS) and the CDC. 

The FDA officially approved the Pfizer-BioNTech COVID-19 vaccine in late August. This is the first FDA-approved vaccine for the prevention of COVID-19 and potentially serious outcomes including hospitalization and death. Prior to this approval, COVID-19 vaccines had only received emergency use authorization (EUAs) – declarations that circumstances exist to justify the emergency use of drugs that have not been FDA-approved, particularly when no effective alternatives are available. Full FDA approval means that a drug has undergone the FDA’s full standard process for reviewing the quality, safety, and effectiveness of medical products. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

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.