Moderna Vaccine Gets FDA Go-ahead
The second vaccine to be granted emergency use authorization in the US could begin distribution within hours
The COVID-19 vaccine developed by biotech firm Moderna and the National Institutes of Health has become the second vaccine to be granted emergency use authorization by the Food and Drug Administration.
The approval comes hours after an independent panel of health advisors Thursday voted 20-0 with one abstention to recommend the agency grant an emergency use authorization for the Moderna product. It’s the second COVID-19 vaccine to be issued an EUA in the past week.
On Dec. 11 the agency cleared a vaccine developed by Pfizer and German biotech firm BioNTech for emergency use in the US. That vaccine is currently being given to front line medical workers and elder care patients at facilities around the country.
With the go-ahead from the FDA, shipments of 5.9 million doses of Moderna’s coronavirus vaccine will begin this weekend, according to Health and Human Services Secretary Alex Azar. In all, Azar said the US government has purchased 200 million doses, enough to inoculate 100 million Americans in the two-shot protocol.
The Moderna vaccine is based on the same mRNA technology as the Pfizer-BioNTech vaccine. In large-scale clinical trials both vaccines were shown to be around 95 percent effective in protecting against the SAR-CoV-2 virus which causes COVID-19. The trials did not uncover any major safety concerns with either vaccine and side effects were characterized as typically mild to moderate, such as fever, fatigue and muscle aches.
The Pfizer-BioNTech vaccine was first approved for emergency use in the UK, and since then a number of countries have followed suit, including Chile, Costa Rica, Ecuador, Kuwait, Mexico, Panama and Singapore, while Canada, Saudi Arabia and Bahrain have given the vaccine full approval.
A third vaccine candidate from a collaboration of Astrazeneca and Oxford University, has also returned favorable results in clinical trials. So far, the makers have not filed for any emergency use authorizations.
The New York Times reports 18 vaccine candidates are currently in late-stage large scale clinical trials worldwide and seven have been approved either for limited or widespread use in different countries.
In a recent survey, over half of consumers asked say the availability of an effective vaccine is key to assuring them it would be safe to travel again.
