Moderna’s COVID-19 vaccine has received full approval from the Food and Drug Administration (FDA) for use in adults in the U.S., the company announced Monday.
Spikevax, as it has been named, is the second Covid vaccine to receive full approval from the FDA, joining Pfizer’s Comirnaty. It was previously used on an emergency use authorization basis.
Full approval means the shot will still be available for use once the Covid-related state of emergency ends – which could be sometime this year. It also means the shot is being given an official stamp of approval from regulators that it is safe and effective over a long period of time.
The shot is among the most effective in the world against the virus and is the second most commonly used shot in the U.S.
It has been used to fully vaccinate 204 million Americans, and has been used as a booster shot 38.4 million times.
The Moderna COVID-19 vaccine has received full approval for use in adults from the FDA. It is the second vaccine to receive approval in the U.S., joining the Pfizer show (file photo)
‘Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death,’ Moderna CEO Stephane Bancel said in a statement.
‘The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved.’
The FDA decision was based on a Phase 3 study using data from real world recipients of the vaccine while it was in its emergency use phase.
Only the first two shots of Moderna’s vaccine have received approval, and the booster shot remains available of the emergency use basis only.
The company also plans to release an Omicron-specific shot in the near future that will become available under emergency use authorization as well.
‘The FDA’s approval of (the vaccine) is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19,’ FDA Acting Commissioner Janet Woodcock said in a statement.
The initial regimen received its first authorization in December 2020, shortly after Pfizer’s shot did.
The one-shot Johnson & Johnson vaccine still has not received FDA approval, and has been phased out by some vaccine providers due to its lower efficacy and durability compared to its peers.
Approval for the Moderna shot comes as Covid cases are starting to fall nationwide, with some already looking forward to life post-pandemic.
The U.S. has recorded a 28 percent drop in daily cases over the past seven days, with states along the east coast that were hard struck by Omicron now recording sharp case declines.
This signals that the pandemic may end, and with it, pandemic related emergency declarations as well.
Because the Moderna vaccine was previously only approved on the basis of the pandemic-related emergency, it would become unavailable should the pandemic end.
With this new approval, though, it is now permanently approved for use across the United States.
‘Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants,’ Dr Peter Marks, one of the FDA’s top vaccine regulators, said.
‘The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.’