Vaccine production in focus as Moderna, Pfizer await FDA decision.
U.S. health officials expect 100 million Americans could be vaccinated against COVID-19 by the end of February. Meeting that goal, though, will require near-perfect production from Pfizer and Moderna, both of which are now awaiting a Food and Drug Administration decision on approval of their coronavirus shots.
Moncef Slaoui, a leader of the U.S.' Operation Warp Speed, this week said he anticipates 20 million people being vaccinated in December, another 30 million in January and 50 million in February, assuming both vaccines are approved for emergency use as expected.
Both Pfizer's and Moderna's vaccines are given as two shots, meaning some 200 million doses would be needed to meet Slaoui's target — an ambitious number even as both companies rapidly ramp up production. On Thursday, Moderna reaffirmed its expectation of producing 20 million doses for the U.S. by the end of the year, and said it could make between 85 million and 100 million for U.S. use between January and March.
With Pfizer's and Moderna's vaccines proving highly protective against COVID-19 in large clinical trials, planning to roll out and distribute the two shots throughout the U.S. has kicked into high gear.
The vaccines are expected to be authorized shortly after FDA advisory committees review them — meetings are scheduled Dec. 10 for Pfizer's candidate and Dec. 17 for Moderna's — although the agency still needs to review the companies' data and reach its decision. Both companies have been working feverishly to manufacture the hundreds of millions of doses that will be needed, but supplies will be extremely limited in the months following any authorization.
U.S. officials expect nearly 20 million doses — 6.4 million from Pfizer and its partner BioNTech, and 12.5 million doses from Moderna — will available within the first week following an authorization. Beyond that, however, projections are more uncertain, and meeting Slaoui's target will still be a challenge.
Worries spiked Thursday when a The Wall Street Journal report detailed some of the difficulties Pfizer and BioNTech encountered in speeding manufacturing, which led the companies in early November to cut their 2020 production target to 50 million from an initial goal of 100 million set earlier this year.
Scale up of raw material took "longer than expected," a Pfizer spokesperson said in an emailed statement. The companies still expect to produce as many as 1.3 billion doses for use globally in 2021. Pfizer and BioNTech have not specified exactly how many doses of the first 50 million this year would go to the U.S.
Availability of raw materials is also a key limitation for Moderna. At an event hosted by Evercore ISI last month, company CEO Bancel said the "swing factor" in whether Moderna can produce 500 million doses next year or 1 billion is the amount of raw materials received from suppliers.
Even with available supply, vaccination schedules may stretch the timelines offered by Slaoui and other U.S. health officials.
The two doses of Pfizer and BioNTech's vaccine are given three weeks apart, while Moderna's two shots are given four weeks apart. So, even if both vaccines are approved immediately after their respective advisory committee meetings on Dec. 10 and Dec. 17, it's unlikely that many, or any, individuals will have received their second shot by the end of the year.
Author: Ned Pagliarulo
Published: https://www.biopharmadive.com/news/vaccine-production-in-focus-as-moderna-pfizer-await-fda-decision/591649/