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The FDA – US regulatory agency equivalent to Anvisa – approved this Friday (18) the emergency use of the Covid-19 vaccine manufactured by Moderna. The immunizer, the second approved in the country, can be applied to people over 18 years of age.
The day before, a scientific committee issued a favorable opinion on Moderna’s vaccine with 20 votes in favor and none against, with a single abstention. To start shipping in the US, the vaccine is still pending approval from the Center for Disease Control and Prevention (CENTERS FOR THE CONTROL AND PREVENTION OF DISEASES).
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President Donald Trump had reported this morning that Moderna’s vaccine was approved. However, the FDA, a necessary step, had not yet endorsed the immunizer. Following the official announcement, Trump congratulated the manufacturer on social media.
Moderna has an agreement with the United States government to administer 20 million doses by 2020 and a total of 200 million doses by the end of June 2021. The efficacy of the vaccine reaches 94%, according to phase 3 clinical studies (read more at the end of the story).
US already uses Pfizer vaccine
Nurse Sandra Lindsay received this Monday (14) doses of the Pfizer vaccine at a hospital on Long Island in New York state – Photo: Mark Lennihan / Pool via Reuters
Moderna’s vaccine was approved with the Pfizer-BioNTech immunizer already in emergency use in the US, which allowed the application of the first three million vaccines this week in the country, the most affected in the world by the pandemic.
Both the Pfizer and Moderna vaccines use mRNA (messenger ribonucleic acid) molecules to cause human cells to generate the coronavirus spike and thus prevent the coronavirus from sticking. See in the VIDEO below how it works.
The Pfizer Covid vaccine uses technology called messenger RNA; see how it works
The two companies used a slightly different formulation that resulted in different cold storage requirements: -70 ° C for Pfizer; -20 ° C for Modern.
One difference is that Moderna has applied for approval for ages 18 and over, while Pfizer is for ages 16 and over.
Moderna has applied for emergency approval for the Covid vaccine in the US – Photo: JN
The small Massachusetts-based biotech company partnered with scientists from the US National Institutes of Health to develop the vaccine. The work began in January, shortly after China shared the SARS-CoV-2 virus genome, according to France Presse.
Modern received more than $ 2.5 billion of the United States government for this project and promised to administer six million doses in a first phase.
Based on clinical trials with 30,400 volunteers, Moderna’s vaccine is 94.1% effective in preventing Covid-19 compared to placebo, with slightly better performance in young adults compared to the elderly.
The FDA found no “specific safety issues that would prevent the issuance of an emergency use permit” after reviewing all available data.
But on Thursday, Doran Fink, an FDA official, said that if this authorization was granted, it would be accompanied by a warning about possible allergic reactions.
Facilities where both vaccines are administered must ensure the availability of medical treatments for severe allergic reactions.
This is after two health professionals in Alaska and two in the UK had such reactions to the Pfizer-BioNTech vaccine. Still, these cases are rare and the immunizers have passed country-validated safety tests.
VIDEOS: News about vaccines against Covid-19
