WASHINGTON, DC–December 17th, 2020–The COVID-19 vaccine developed by pharmaceutical giant Pfizer and German firm BioNTech was approved by the US Food and Drug Administration on 11 December.
The US Food and Drug Administration (FDA) on Friday authorized a Moderna coronavirus vaccine for emergency use, allowing the vaccine to be distributed in the US for use by individuals who are 18 years or older.
Today, FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of #COVID19 caused by SARS-CoV-2. The emergency use authorization allows the vaccine to be distributed in the U.S for use in individuals 18 years and older. https://t.co/w4BQVg0n2G pic.twitter.com/cw5JwYqxsh
— U.S. FDA (@US_FDA) December 19, 2020
“With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day”, said FDA Commissioner Stephen M. Hahn. “Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited timeframe while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA”.
According to the FDA, the Moderna vaccine “has met the statutory criteria for issuance of an EUA”, as the potential benefits outweigh the known risks.
“Today’s authorization demonstrates our steadfast commitment to the health of the American people, with the assurance that our scientific standards and the integrity of our review process have been maintained”, said Peter Marks, the director of the FDA’s Centre for Biologics Evaluation and Research.
US President Donald Trump took to Twitter to mark the authorization of the Moderna vaccine in America in an uncharacteristically modest post.
Congratulations, the Moderna vaccine is now available!
— Donald J. Trump (@realDonaldTrump) December 19, 2020
Earlier in December, the FDA issued an emergency use authorization for another coronavirus vaccine developed in partnership by the pharmaceutical giant Pfizer and German firm BioNTech.
After the authorization, several US political figures, including Vice President Mike Pence, Speaker of the House Nancy Pelosi, and US Senate Majority Leader Mitch McConnell, publicly received shots of the Pfizer vaccine. President-elect Joe Biden announced that he would take the vaccine on Monday.
Moderna’s shot is expected to be used in harder-to-reach locations, such as rural hospitals. The vaccine needs to be stored and shipped frozen, but does not require the ultra-cold temperatures of the Pfizer/BioNTech shot.
Once thawed, the Moderna vaccine can be kept at typical refrigerator temperatures. It is administered in two shots 28 days apart.
Moderna said it would deliver approximately 20 million doses to the U.S. government this year and expected to have between 100 million and 125 million in the first quarter of next year, with 85-100 million of those for the United States.
No information is yet available over whether the Moderna vaccine will be distributed in the Caribbean.
“While a number of vaccine candidates are under consideration, no vaccine has been approved for distribution across our region yet,” Dr. Carissa Etienne, the director of the Pan American Health Organization, the regional branch of the World Health Organization, said Wednesday during a remote briefing from Washington.
Still, in anticipation of a vaccine rollout, PAHO this week is convening health ministers from across the region in an extraordinary session. It is calling on member nations to prepare for the purchasing and distribution of a COVID-19 vaccine, and to prioritize who will be first in line.