FDA Advisory Committee Recommends Moderna’s COVID-19 Vaccine for Emergency UseBy
An advisory committee of the US Food and Drug Administration (FDA) met on Thursday of this week (December 17, 2020) to discuss the request by Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, for emergency use authorization for its COVID-19 vaccine candidate, mRNA-1273 and recommended emergency use authorization for the vaccine.
FDA advisory committees provide non-binding recommendations. The FDA will now take the advisory committee’s recommendation into consideration in making a final decision on approval or authorization. Under an emergency use authorization, the FDA has the authority to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions during a declared public health emergency when there are no adequate, approved, and available alternatives.
The full FDA will now consider the request for emergency use authorization, which is expected shortly. “Following today’s [Decembe 17, 2020] positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” said FDA Commissioner Stephen Hahn in a December 17, 2020 statement. “The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”
In advance of the FDA’s Vaccines and Related Biological Products Advisory Committee public meeting, the FDA posted online materials. Additionally, The FDA posted a briefing document, in which the agency saying that “the two-dose vaccination regimen was highly effective in preventing PCR-confirmed COVID-19.” The company had filed a request for emergency use authorization with the FDA late last month (November 2020).
In a separate development, the US government has exercised its option to purchase an additional 100 million doses of mRNA-1273 to bring its confirmed order commitment to 200 million doses.
Of the first 100 million doses purchased by the US government, approximately 20 million doses will be delivered by the end of December 2020 (as reported on December 11, 2020) and the balance will be delivered in the first quarter of 2021. The new order of 100 million doses will be delivered in the second quarter of 2021. These deliveries are subject, in each case, to receipt of an emergency use authorization from the FDA for the vaccine.
Under the agreement, Moderna will continue to use its US-based manufacturing infrastructure to supply mRNA-1273 to the US government. As part of Operation Warp Speed, a US government initiative to speed the development of treatments and vaccines for COVID-19, the US government has the option to purchase up to an additional 300 million doses of mRNA-1273 from Moderna.
Moderna has also concluded an agreement with the Ministry of Health of Singapore to supply mRNA-1273.
In total, Moderna has confirmed the following supply agreements of committed orders totaling more than 390 million doses: (1) US: 200 million doses with an option for an additional 300 million doses; (2) European Union: 80 million doses with an option for an additional 80 million doses; (3) Japan: 50 million doses; (4) Canada: 40 million doses with an option for an additional 16 million doses; (5) Switzerland: 7.5 million doses; (6) the UK: 7 million doses; (7) Israel: 6 million doses; (8) Qatar, undisclosed amount; (9) other countries, which have placed orders and have not been disclosed.
Moderna is working with the US Centers for Disease Control and Prevention, Operation Warp Speed, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations and approvals.
Source: Moderna (advisory committee recommendation), US Food and Drug Administration (December 17, 2020 statement) US Food and Drug Administration (briefing documents), Moderna (US supply), and Moderna (Singapore supply)