FDAnews
www.fdanews.com/articles/201190-us-vaccine-supply-deals-with-pfizerbiontech-moderna-likely-to-be-fulfilled-within-months

U.S. Vaccine Supply Deals With Pfizer/BioNTech, Moderna Likely to be Fulfilled Within Months

February 3, 2021

As the U.S. impatiently awaits delivery of many more millions of doses of the two currently authorized COVID-19 vaccines, Pfizer/BioNTech and Moderna said they are confident that they can fully deliver what’s been ordered to date in the next few months — and that they have shipped around 59.4 million doses so far.

The U.S., with a population of approximately 330 million, will have received enough of Pfizer/BioNTech’s and Moderna’s two-dose vaccines to inoculate nearly two-thirds of its population by summer, if the companies deliver on time.

Coupled with Johnson & Johnson’s (J&J) commitment to deliver 100 million shots of its single-dose vaccine by June, the U.S. could stand well equipped, at least in terms of numbers of doses, to inoculate nearly the entire population by the end of the second quarter, if all goes to plan on the manufacturing side. Fears linger, however, that vaccines may need to be modified to protect against mutating strains of coronavirus that could pose a threat to current vaccines.

The country could soon see substantial doses of J&J’s highly anticipated single-dose vaccine as the company is expected to file for Emergency Use Authorization (EUA) early this month.

J&J has not supplied any doses yet but would do so shortly after earning an EUA for its single-dose inoculation. The drugmaker struck an approximately $1 billion deal with the U.S. last summer to supply 100 million doses and has said it is on track to fully deliver those by June (DID, Jan. 28). The contract includes a provision to purchase up to 200 million more extra shots.

Likewise, AstraZeneca’s vaccine has not yet been authorized in the U.S. and looks even farther away from potentially getting an EUA than J&J’s candidate; it’s speculated that it could be authorized around the end of March. The drugmaker, whose vaccine encountered delays and questions that have significantly pushed back its regulatory filing with the FDA, reached a $1.2 billion contract with HHS last May that includes a commitment to provide 300 million doses (DID, May 22, 2020).

Pfizer, which looks like it will be the first to fulfil its vaccine supply contract with the U.S. government, has delivered 29 million doses as of Jan. 31. The drugmaker revealed during an investor call that it now plans to deliver its full 200 million vaccine dose order by the end of May, two months earlier than it previously expected.

Originally on the hook for 100 million doses, Pfizer and the U.S. government reached an agreement near the end of 2020 that secured an additional 100 million doses of vaccine for the U.S. for $1.95 billion (DID, Dec. 28, 2020), a deal identical to the one reached in July 2020. The latest deal also leaves the door open to purchase 400 million additional doses if needed.

The final shipment of Moderna’s vaccine supply deal with the U.S. — 200 million shots — will likely be delivered by the end of the second quarter at the latest, with half of the doses arriving by the end of March, the company said. Moderna had supplied 30.4 million doses to the federal government as of Jan. 26 and, per its contract, the U.S. is eligible to buy up to 300 million more. HHS’ Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense have jointly given the company approximately $3.2 billion to expand manufacturing capacity and deliver vaccine doses. — James Miessler