FDA Drug Approvals, Infectious Disease — 2022 Midyear Review

August 24, 2022

COVID-19 vaccine, adjuvanted (Novavax)

The FDA granted emergency use authorization for COVID-19 vaccine, adjuvanted for prevention of coronavirus disease 2019 (COVID-19) infection in adults. It is a more traditionally manufactured vaccine that contains a purified full-length protein subunit (rS). An immune response to the rS protein is elicited, which protects against COVID-19. It also contains an adjuvant (ie, saponin-based Matrix-MTM) to enhance immune response and stimulate high levels of neutralizing antibodies.

Approval was based on the PREVENT-19 phase 3 clinical trial in the United States and Mexico, which demonstrated overall efficacy of 90.4% (P<0.001). Results showed 77 cases of symptomatic COVID-19 disease that investigators observed in trial participants from January 25 through April 30, 2021. There were 63 cases among 9,868 participants who received placebo and 14 cases among 19,714 participants who received the investigational vaccine. Of the 63 COVID-19 cases in the placebo group, investigators classified 10 as moderate and 4 as severe. There were no cases of moderate or severe disease in the investigational vaccine group. It is important to note that the study was conducted before the delta and omicron variants were circulating. N Engl J Med. 2022 Feb 10;386:531-543

Spikevax (COVID-19 vaccine, mRNA-Moderna)

COVID-19 vaccine, mRNA-Moderna is the second mRNA vaccine to gain full approval from the FDA for a 2-dose primary series. It is approved for adults aged 18 years and older.

Approval was based on analysis of follow-up safety and effectiveness data from the data that supported the emergency use that was granted in December 2020. The updated analyses to determine effectiveness included 14,287 vaccine recipients and 14,164 placebo recipients 18 years of age and older who did not have evidence of SARS-CoV-2 infection prior to receiving the first dose. The data used for the analyses were accrued before the Omicron variant emerged. These data demonstrated that the vaccine was 93% effective in preventing COVID-19, with 55 cases of COVID-19 occurring in the vaccine group and 744 COVID-19 cases in the placebo group. The vaccine was also 98% effective in preventing severe disease. N Engl J Med 2021 Nov 4;38519:1774-1785

The emergency use authorization remains in effect for heterologous and homologous booster doses, and also for a third dose as part of the primary series for severely immunocompromised adults.

COVID-19 Approvals & Emergency Use Authorizations

Olumiant (baricitinib) – New indication approved by the FDA for treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). EUA for this indication remains in place for pediatric patients aged 2 years and older.


mRNA COVID-19 vaccines

  • CDC interim recommendations for vaccine regimens in individuals aged 6 months and older, including additional doses for immunosuppressed individuals, adults aged 50 years and older, and otherwise healthy individuals.

  • CDC interim recommendations also states that an 8-week interval may be optimal for some people aged 12 years and older, especially for males aged 12-39 years, because of the small risk of myocarditis associated with mRNA COVID-19 vaccines.

COVID-19 vaccine, mRNA-Pfizer

  • EUA extended to include children aged 6 months through 4 years (previously authorized for 5 years and older).

  • Full approval granted for adolescents aged 12 years and older.

COVID-19 vaccine, mRNA (Moderna)

  • FDA granted emergency use to prevent COVID-19 in children aged 6 months through 17 years.

COVID-19 vaccine, viral vector-Janssen

  • Use limited to adults for whom other FDA-authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, or for those who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine


Veklury (remdesivir) – Full approval gained for adults and children to allow outpatient infusions for treatment of COVID-19. The indication includes adults and children who are aged 28 days and older (weighing at least 3 kg), who require hospitalization, or who are not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

Monoclonal antibodies

Two monoclonal antibodies are available in the United States. Bebtelovimab is used for postexposure prophylaxis in patients at high risk for progression to severe COVID-19 (or for whom other COVID-19 treatment options are not available or are not clinically appropriate). Tixagevimab plus cilgavimab is used for preexposure prophylaxis for individuals who are moderately to severely immunocompromised because of a medical condition or treatments and would otherwise not mount a sufficient immune response to a vaccine (also for those with confirmed severe allergy to the vaccines).

Other monoclonal antibodies (ie, sotrovimab, bamlanivimab/etesevimab, casirivimab/imdevimab) previously used for postexposure prevention are no longer being distributed because of decreased efficacy against omicron variants.

Bebtelovimab – EUA issued for treatment (ie, postexposure prophylaxis) of mild-to-moderate COVID-19 in adults and pediatric patients aged 12 years and older who weigh 40 kg or more and are at high risk for progressing to severe disease.

Evusheld (tixagevimab and cilgavimab) – EUA revised for preexposure prophylaxis of COVID-19 with an increased dose of tixagevimab 300 mg IM and cilgavimab 300 mg IM administered as separate, consecutive IM injections. Patients who have already received the previously authorized dose (150 mg of tixagevimab and 150 mg of cilgavimab) should receive an additional dose of 150 mg of tixagevimab and 150 mg of cilgavimab as soon as possible to raise their monoclonal antibody levels to those expected for patients receiving the higher dose.

Other infectious disease approvals

Triumeq, Triumeq PD (abacavir/dolutegravir/lamivudine) – Indication for HIV treatment expanded to include children weighing at least 10 kg; additionally, a tablet for suspension approved for precise dosing in those weighing <25 kg.

Cabenuva (cabotegravir/rilpivirine) – New dosage regimen (every 2 months) approved for HIV-1 treatment; additionally, indication for HIV treatment expanded to include adolescents aged 12 years and older who weigh at least 35 kg; additionally, lead-in oral therapy is now optional.

TPOXX (tecovirimat) – New IV formulation approved to treat smallpox in individuals unable to swallow capsules.


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