FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test
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.
Novavax COVID-19 Vaccine Receives EUA
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.
FDA Panel Votes in Favor of Novavax COVID-19 Vaccine – Final Decision Pending
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.
FDA Limits Authorized Use of Johnson & Johnson/Janssen COVID-19 Vaccine
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.
FDA Authorizes Second COVID-19 Booster Dose for Certain Populations
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.
FDA Authorizes New Antibody Bebtelovimab for Mild-to-Moderate COVID-19
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.
FDA Issues EUA for Antiviral Evusheld as COVID-19 Prophylaxis
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.
FDA Issues EUA for Antiviral Paxlovid to Treat COVID-19
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.
FDA Authorizes Molnupiravir for Treatment of COVID-19
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.
FDA Authorizes COVID-19 Vaccine Boosters for All Adults
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.
