The American biotechnology company Moderna will officially request approval of its coronavirus vaccine to the US and European authorities today, the company announced on Monday.
Additionally, Moderna announced the results of a follow-up study, showing the vaccine is 94.1% effective in preventing infection with Covid-19, and 100% effective at preventing a serious form of the virus.
“We believe we have a vaccine with high effectiveness. We now have the data to prove it,” said Dr Tal Zaks of Moderna. “We expect to play a major role in reversing this pandemic.
Low Side Effects
Trial result shared earlier this month reported no serious illness from Covid-19 was recorded among those vaccinated, compared to 11 in the placebo group, according to the biotech release. According to Moderna, about 9-10% of those vaccinated had side effects after the second dose such as fatigue, aches and pains, or redness around the injection site.
“This is a pivotal moment in the development of our Covid-19 vaccine candidate,” said Moderna’s CEO, Stéphane Bancel at the time. “This positive interim analysis from our phase 3 trial gives us the first clinical indications that our vaccine can prevent Covid-19 disease, including the severe form.”
In Europe, the European Medicines Agency (EMA) has set up a fast-track procedure that allows it to review safety and efficacy data on vaccines as they are released, even before a formal application for authorisation is filed by the manufacturer.
Vaccinations in the European Union could begin “in the first quarter of 2021” in an “optimistic” scenario, the director of the European agency in charge of epidemics told AFP at the start of November.
This news comes hot on the heels of pharmaceuticals Pfizer and BioNTech, who already filed an application for accelerated approval of their corona vaccine with the US Food and Drug Administration (FDA). Approval for that vaccine is expected as early as mid-December.
The Brussels Times