Vaccine manufacturers Pfizer and BioNTech will be submitting for approval for emergency use authorization for their COVID-19 vaccines from the US Food and Drug Administration (FDA,) the companies said in a statement.
The vaccine candidate will be the first to seek emergency use status in the United States.
Pfizer and Biotech said in a statement that they hope to see their vaccine be potentially available by mid-to-late December.
Pfizer announced on November 9 that their vaccine was 90 percent successful in stage three clinical trials, which involved over 43,000 volunteers.
The clinical trials showed that Pfizer and its German partner BioNTech's vaccine had no serious safety concerns, and was extremely effective in preventing COVID-19 in older recipients.
"Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential," Albert Bourla, Pfizer CEO said in the statement.
“Filing for Emergency Use Authorization in the US is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
“We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”
Competing biotech company Moderna also plans to apply for FDA emergency use authorization. Moderna said their vaccine was nearly 95 percent effective, and can be stored at a warmer temperature than that of Pfizer.
"We have a plan in place that the moment that the FDA concludes that that vaccine is safe and effective, we have a system in place to begin within 24 hours to ship that to hospitals and health care officials and 24 hours after that injecting that vaccine into Americans," said Vice President Mike Pence on Thursday.
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