Medmonitor

The FDA granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is for use by individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu). This product will be available over-the-counter.

The FDA granted Emergency Use Authorization (EUA) to the Novavax COVID-19, Adjuvanted vaccine for individuals aged 18 and older. This vaccine is administered in two primary doses given three weeks apart. The vaccine was assessed in an ongoing randomized, blinded, placebo-controlled study involving 17,200 people. Overall, the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19. This vaccine utilizes a different technology than other COVID-19 vaccines, and was recently endorsed by the Centers for Disease Control and Prevention.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 in favor of recommending an Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine for individuals aged 18 and older. Phase 3 clinical trials with 30,000 people saw an efficacy rate of 90.4%. This vaccine requires two doses, delivered at least 21 days apart.

The FDA has limited the authorized use of the Johnson & Johnson/Janssen COVID-19 Vaccine to individuals for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals who elect to receive the Johnson & Johnson/Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine. The FDA has determined that the Johnson & Johnson/Janssen COVID-19 vaccine comes with the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration.

The FDA authorized a second booster dose of either the Pfizer or Moderna COVID-19 vaccines for individuals aged 50 and older at least four months after their first booster dose, and for immunocompromised individuals at least four months after their first booster dose. Immunocompromised individuals include those who have undergone solid organ transplants or those living with conditions considered to have an equivalent level of immunocompromise.

The FDA issued an emergency use authorization (EUA) for bebtelovimab, a monoclonal antibody, for the treatment of mild-to-moderate COVID-19 that retains activity against the omicron variant in patients weighing at least 88 pounds who are at high risk of progression to severe COVID-19. This drug is not authorized for hospitalized patients or patients who require oxygen therapy. Bebtelovimab is not a substitute for vaccination.

The FDA issued an emergency use authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis of COVID-19. This product is only authorized for individuals not currently infected with COVID-19 who were recently exposed to infected individuals. Furthermore, this authorization requires that patients either have moderate-to-severely compromised immune systems or a history of severe adverse reactions to a COVID-19 vaccine. Evusheld is not a substitute for vaccination.

The FDA issued an emergency use authorization (EUA) for Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in patients who are high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is only available via prescription and should be initiated as soon as possible after diagnosis and within five days of symptom onset. Paxlovid is not a substitute for vaccination.

The FDA issued an emergency use authorization for molnupiravir for the treatment of mild-to-moderate COVID-19 who are at high risk of progression to severe COVID-19, including hospitalization and death, and for whom alternative COVID-19 treatments are not accessible or clinically appropriate. Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Molnupiravir is not authorized for use in patients younger than 18 years of age because molnupiravir may affect bone and cartilage growth. Molnupiravir is not a substitute for vaccination.

The FDA issued emergency use authorizations for all currently available COVID-19 vaccines – Pfizer, Moderna, Johnson & Johnson – allowing all adults aged 18 and older to receive a booster dose. Individuals must complete their initial vaccine series prior to receiving a booster dose, with those who received either the Pfizer or Moderna vaccine required to wait six months after completion of vaccination, and those who received the Johnson & Johnson vaccine to wait two months after completion of vaccination.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-inc-issues-voluntary-nationwide-recall-levetiracetam-injection-usp-due-lack

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.