The FDA on Saturday voted 20-0 to approve Moderna’s request for emergency clearance, giving the company permission to start shipping millions of doses of its COVID vaccine to healthcare facilities and nursing homes.
Most healthcare providers will receive the vaccine on Monday, says US Army General Gustave Perna, and at least 4,000 locations received the vaccine within 24 hours of FDA approval.
“The transparency around our review of the Moderna COVID-19 vaccine should assure the public that this vaccine met the FDA’s rigorous standards for quality, safety, and efficacy,” explains FDA Commissioner Stephen Hahn. “As with any decision made by the FDA, this authorization was guided solely by science and data.”
Nursing homes, healthcare facilities, and pharmacies have already begun administering Pfizer’s COVID vaccine, which earned FDA approval last week.
As it stands, we are on track to fulfill the Trump Administration’s ambitious goal to vaccine 24 million Americans by mid-January and up to 100 million by the end of February if a majority of Americans agree to receive the vaccine.
Both COVID vaccines require two doses administered several weeks apart and are believed to be more than 90% effective. Most recipients can expect mild side effects, but there have been reports of serious allergic reactions.
“It is known that one of the components that are present in both of the vaccines, polyethylene glycol, can be associated uncommonly with allergic reactions,” explains Peter Marks, a doctor with the FDA. “But what we’re learning now is perhaps those allergic reactions could be somewhat more common than the highly uncommon that we thought.”
The increased risk of allergic reaction threatens to exacerbate the widespread apprehension surrounding COVID vaccines.
According to Dr. Anthony Fauci, at least 75% of the population must receive the vaccine in order to achieve “herd immunity.” Polls conducted in mid-November suggest that up to 50% of Americans may decide against receiving the vaccine.