US biotech firm Moderna has announced that it will file requests for authorization of its Covid-19 vaccine in the United States and Europe on Monday, after full results confirmed a high efficacy estimated at 94.1%.
“Moderna plans today to request EUA [Emergency Use Authorization] from the US FDA [Food and Drug Administration],” Moderna said in a statement, adding that it will also “apply for a conditional marketing authorisation with the European Medicines Agency.”
The US, the country worst affected by the virus, hopes to start COVID-19 vaccinations on around 20 million people by this yearâs end.
On November 16, Moderna had announced that its experimental vaccine against COVID-19 was 94.5% effective, according to early results from a clinical trial with more than 30,000 participants.
Interim safety analysis of their data shows there have been no significant safety concerns. Side effects were mild or moderate and short-lived, according to researchers. They included pain at the injection site and, after the second dose, fatigue, muscle pain and headaches.
Modernaâs vaccine uses mRNA (messenger RNA) technology. This is an experimental method where RNA, genetic material from the virus, is used to produce antigens that would allow the body to fight the SARS-CoV-2 virus.