The spokesman added: “Generally speaking, any change in a USA must be requested by the company and include data to support the requested change and would be authorized through a letter of grant or reissue of the letter of authorization, which would be posted on FDA website. “
Why it matters: If the agency fulfills the company’s request, it could help speed up the rate of vaccination in the United States – a top priority for President Joe Biden’s government and governors across the country. Biden’s team focused its efforts to control the pandemic on accelerating vaccine manufacturing and availability.
The federal government this week finalized the purchase of 100 million additional doses of Moderna and Pfizer, whose Covid-19 vaccines are the only vaccines so far authorized for use in the United States.
Background: The United States has signed contracts for 300 million doses of Moderna’s mRNA vaccine to be delivered by July.
Pfizer, which also promised 300 million vaccines, found that its vials contained enough vaccine for six doses, instead of the planned five. She sought and obtained FDA authorization for healthcare professionals to use these extra doses.
The company subsequently reduced the number of vials it planned to deliver to the United States because of the FDA decision, subject to the availability of the ultra-efficient syringes needed to extract the sixth dose.
What is the next: Moderna said that any change in the number of doses per bottle depends on the final approval of Organs regulatory agencies.
“The implementation of such changes is expected to be completed in approximately two to three months,” said the spokeswoman for Moderna.