OK for Moderna’s COVID Vaccine Could Come Today
A panel of experts advising the FDA voted 20-1 (with 1 abstention) to tell the FDA that it should grant an emergency use authorization to Moderna's COVID-19 vaccine.
A special advisory panel of experts to the US Food and Drug Administration (FDA) voted yesterday that the agency should grant emergency use authorization (EUA) to Moderna’s coronavirus disease 2019 (COVID-19) vaccine. In light of the speedy approval that the FDA granted to Pfizer/BioNTech’s COVID-19 vaccine last week—coming the day after the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) urged an EUA for that product—the approval for Moderna’s product could very well come today. Millions of doses of the Pfizer/BioNTech vaccine were shipped to hundreds of distribution sites around the country this week.
Infection Control Today®’s sister publication, Contagion®, followed the deliberations by VRBPAC throughout the day yesterday right up until the time when the panel announced that it approved the EUA in a 20-0 vote, with one abstention.
As Contagion® reports “the 1 abstention stated that he was uncomfortable with the wording of the voting question. He expressed his concern that in the midst of a pandemic, a blanket statement like ‘18 years or older’ is too broad, and that it could be interpreted as full approval in the minds of the general public. He said that he wasn’t sure if the benefits of the vaccine do in fact outweigh the risks.”
The messenger RNA (mRNA) vaccine was created in collaboration between Moderna and investigators from the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID). The phase 3 trial data was evaluated in the full-day meeting.
The ongoing randomized, stratified, observer-blind, placebo-controlled study has included 30,351 participants who were randomized 1:1 to receive intramuscular injections of either 100 μg of mRNA-1273 or a placebo. The vaccine was administered in 2 doses given 28 days apart in adults who were 18 years of age or older.
- The participants were stratified by age and health risk into 3 groups:
- 18 to <65 years of age and not at risk for progression to severe COVID-19
- 18 to <65 years of age and at risk for progression to severe COVID-19
- ≥65 years of age
The latter 2 groups constituted 41.4% of the study population. The risk for progression to severe was based on underlying comorbidities, including diabetes, chronic lung disease, severe obesity, significant cardiovascular disease, liver disease, or infection with HIV.
Included in the study were 24,907 (82.1%) participants who were considered to be at occupational risk for acquiring the SARS-CoV-2 infection, of whom 7613 (25.1%) were healthcare workers.
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