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Moderna, a US pharmaceutical company that is developing a vaccine against Covid-19, announced that it requested authorization for the emergency use of its immunizer from the FDA, the US regulatory agency equivalent to Brazil’s Anvisa.
The FDA said it had scheduled a meeting of its vaccine committee to discuss Moderna’s application on Dec. 17.
According to the New York Times, if approved, as early as December 21, the first Americans may be receiving this vaccine.
Medical vials and syringes are seen in front of Moderna’s logo – Photo: REUTERS / Dado Ruvic / Illustration / File Photo
The company also plans to apply for authorization for emergency use in Europe.
The drugmaker said complete results from an end-stage study show its vaccine was 94.1% effective, without serious safety concerns. “The effectiveness of the severe Covid-19 vaccine was 100%,” Moderna says.
Moderna’s most recent effectiveness result is slightly lower than an interim analysis published on November 16, with an effectiveness of 94.5%. According to Tal Zaks, medical director of the pharmaceutical company, the difference is not statistically significant.
Farmacêutica Moderna says its vaccine is 94.5% effective against Covid-19
The phase 3 study, known as the COVE study, involved more than 30,000 participants.
This second analysis was based on 196 cases: 185 were participants in the placebo group and 11 in the group that received the vaccine. The only people who became seriously ill (30 participants, including one who died) received the placebo.
“This positive primary analysis confirms the ability of our vaccine to prevent Covid-19 with an effectiveness of 94.1% and, most importantly, its ability to prevent severe Covid-19. We believe that our vaccine will provide a powerful new tool that can change the course of this pandemic and help prevent serious illness, hospitalizations and deaths, ”said Stéphane Bancel, CEO of Moderna.
Independent consultants from the Food and Drug Administration (equivalent to the US Anvisa) will meet on December 17 to review the Moderna trial data and make a recommendation to the FDA.
There is still no contract with the federal government or with the Brazilian states for the acquisition of Moderna vaccine.
Understand how Covid vaccine tests work
How the 3 phases work
When testing a vaccine, usually divided into phases 1, 2, and 3, scientists attempt to identify serious adverse effects and whether immunization can induce an immune response (that is, a response from the body’s defense system).
- STAGES: Why Phase 3 Clinical Trials Are Essential to Your Success and Safety
Phase 1 trials generally involve dozens of volunteers; those of phase 2, hundreds; and phase 3, thousands. These phases are generally carried out separately, but due to the urgency of the pandemic, several companies have taken more than one step at the same time.
- TYPES: The 4 types of vaccines against Covid and what remains to be ready
Before testing in humans, vaccines are tested in animals, usually mice and then monkeys.
