The spokesman added: ‘In general, any changes to an EUA should be requested by the company, and it should contain data that supports the requested change and will be authorized via a grant letter or reissue of the authorization letter, which is submitted to the FDA website will be posted. . “
Why it matters: If the agency approves the company’s request, it could help speed up vaccination in the US – a top priority for President Joe Biden’s government and governors across the country. Biden’s team has focused their efforts to bring the pandemic under control, speeding up the manufacture and availability of vaccines.
The federal government this week finalized the purchase of 100 million additional doses of Moderna and Pfizer, whose Covid-19 vaccines are so far the only ones allowed for US use.
Background: The US has signed contracts for 300 million doses of Moderna’s mRNA vaccine to be delivered by July.
Pfizer, which also promised 300 million shots, discovered that the vials contained enough vaccine for six doses instead of the planned five. It sought FDA authorization for healthcare providers to use the extra doses.
The company later reduced the number of vials it intended to deliver to the United States due to the FDA ruling, depending on the availability of the ultra-efficient syringes needed to withdraw a sixth dose.
What’s next: Moderna said that any change in the number of doses per vial depends on the final approval of the regulators.
“The implementation of such changes is expected to be completed within about two to three months,” the Moderna spokesperson said.