Moderna Inc has teamed up with Pfizer Inc to apply to the FDA to issue an emergency use authorization for its injection. Both vaccines are more than 90% effective, according to preliminary results from clinical trials.
“Moderna’s data for the emergency use authorization request for mRNA-1273 has been submitted to the US FDA,” Moderna said in a tweet.
Meanwhile, US Vice President Mike Pence told governors on Monday that distribution of a coronavirus vaccine could begin in the third week of December, indicating that US regulators will approve. quickly an emergency clearance for the first injections.
“We strongly believe that the vaccine distribution process could begin the week of December 14,” Pence told governors, according to a summary of the call provided by the office of Washington Governor Jay Inslee.
An FDA advisory panel is scheduled to meet Dec. 10 to discuss vaccines. Azar told governors that distribution could begin within 24 hours of regulatory approval.
Results from a late-stage study by Moderna showed that its covid vaccine was 94.1% effective without serious safety concerns.
The FDA will decide on emergency use authorizations (EUA) after the assessors make their recommendations.
Moderna, which also plans to seek European approval, reported that the efficacy of its vaccine was consistent based on age, race, ethnicity and gender demographics, as well as being 100% successful in preventing severe cases of the disease it has killed. almost 1.5 million people worldwide.
“We think we have a vaccine that is very effective. Now we have the data to prove it,” said Moderna’s chief medical officer, Tal Zaks. “We hope to play an important role in reversing this pandemic.”
Moderna said it was on track to have about 20 million doses of its vaccine ready to ship to the United States by the end of 2020, enough to inoculate 10 million people.
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