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On December 2, 2020, the U.K. became the first Western nation to approve the use of Pfizer/BioNTech’s COVID-19 (SARS-CoV-2) vaccine for mass inoculation. As pressure mounts on U.S. regulators to follow suit, the next 30 days will mark a

As the U.K. Approves its First COVID-19 Vaccine, What’s Next for the U.S.?

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On December 2, 2020, the <a target="_blank" href="https://www.nytimes.com/2020/12/02/world/europe/pfizer-coronavirus-vaccine-approved-uk.html">U.K. became the first Western nation</a> to approve the use of Pfizer/BioNTech’s COVID-19 (SARS-CoV-2) vaccine for mass inoculation. As pressure mounts on U.S. regulators to follow suit, the next 30 days will mark a crucial period in the U.S. Food and Drug Administration’s (FDA) timeline for vaccine authorization.In <a href="https://lifesciences.mofo.com/topics/FDA-establishes-clear-requirements-for-COVID-19-Vaccine.html">June</a> of this year, the FDA outlined its <a target="_blank" href="https://www.fda.gov/media/139638/download">guidance</a> on the licensure of COVID-19 vaccines. Of particular note was the decision that, unlike the U.K., whose chief regulatory agency created an accelerated pathway of approval for COVID-19 vaccines, the U.S. would not establish an equivalent specialized process. However, the FDA confirmed that developers could use existing frameworks to request <a target="_blank" href="https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained">Emergency Use Authorization (EUA)</a> for their vaccine candidates, which must still satisfy strict safety and efficacy criteria before they can be made available to the general public.To date, the FDA has received EUA requests for two different COVID-19 vaccine candidates. The first application was submitted jointly by Pfizer, a U.S. pharmaceutical powerhouse, and BioNTech, a smaller German firm, on November 20, 2020. The second request was made by Moderna, a biotechnology company based in Cambridge, MA, some 10 days later. From a research and development perspective, these two frontrunner candidates have sparked considerable interest, not least because both vaccines make use of relatively new mRNA vaccine technologies and both claim to offer close to 95% efficacy (per the data released by <a target="_blank" href="https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine">Pfizer</a>/BioNTech and <a target="_blank" href="https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-primary-efficacy-analysis-phase-3-cove-study">Moderna</a>). However, now that the first requests for EUA have been submitted, attention is turning once again to the FDA, whose much-anticipated authorization will trigger the beginning of a massive public health effort to inoculate Americans against a virus that, according to <a target="_blank" href="https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html?name=styln-coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&impression_id=47cd05b1-3595-11eb-bee5-156f6ea8992c&variant=1_Show">The New York Times</a>, has infected almost 14 million people nationwide. To that end, the coming weeks will see a number of events that may bring the reality of widespread immunization against the novel coronavirus even closer.After Pfizer and BioNTech submitted their request for EUA on November 20, 2020, the FDA announced that it would schedule a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), which is made up of scientific and public health experts from across the United States, on <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccine">December 10</a>. In a similar fashion, Moderna’s request for EUA, which was submitted on November 30, will be discussed in a meeting of the VRBPAC on <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-second-covid-19-vaccine">December 17</a>. The intent is that the FDA will use the time period between the submission of a given EUA request and the subsequent committee meeting to evaluate the information and data provided in the EUA application such that, by the date of the meeting, all parties are prepared for a rigorous (and public) discussion of the vaccine candidate’s suitability for EUA. Importantly, though the VRBPAC will provide advice to the FDA concerning the vaccine candidate’s safety and efficacy, the final decision as to whether or not to grant EUA lies solely with the FDA.In light of the highly promising efficacy data released by both Pfizer/BioNTech and Moderna, and the recent approval of the former’s vaccine candidate in the U.K., questions are being asked about what will happen if the FDA authorizes the Pfizer/BioNTech vaccine after the committee meeting on December 10. In one <a target="_blank" href="https://thehill.com/homenews/news/527408-cdc-director-covid-19-vaccine-will-be-rolled-out-second-week-in-december">scenario</a> outlined by Robert Redfield, the director of the Centers for Disease Control and Prevention (CDC), authorization of the vaccine could happen in the days following the December 10 meeting. Should this occur, the first Americans may be vaccinated by mid-December. In contrast, Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, has <a target="_blank" href="https://www.youtube.com/watch?v=F2RC09YNEjs&feature=emb_logo">signaled</a> that a more realistic timeline for mass vaccine rollout is “a matter of weeks.”In any case, though uncertainties remain over exactly when a vaccine will become publicly available, there is an increasingly clear indication of who will be first in line to receive it. In a <a target="_blank" href="https://www.cdc.gov/vaccines/acip/meetings/slides-2020-12.html">December 1 meeting</a>, the CDC’s Advisory Committee on Immunization Practices (ACIP) <a target="_blank" href="https://www.cdc.gov/vaccines/acip/recommendations.html">voted 13 to 1</a> to endorse a proposal of prioritizing the vaccination of healthcare workers and elderly people living in long-term care facilities. Next, the vaccine will be offered to “essential workers,” such as school staff, police, and grocery workers, and then more broadly to those aged 65 or over and those who have high-risk medical conditions. Following the ACIP’s endorsement of the prioritization proposal, the CDC must confirm whether they agree with the committee’s recommendation, at which point the decision passes to individual states to determine if and how they will implement the agreed proposals. Indeed, though there are many factors still at play in predicting a mass-inoculation timeline, Moncef Slaoui, Chief Science Adviser for Operation Warp Speed, <a target="_blank" href="https://www.washingtonpost.com/video/washington-post-live/the-path-forward-combating-covid-19/2020/12/01/cacf8d2e-3319-42d4-a06a-44ad0ed21166_video.html">announced on Tuesday</a> that he believes that all Americans will have access to a COVID-19 vaccine by June 2021.For continuous coverage of the Coronavirus, please visit our <a href="/special-content/coronavirus">COVID-19 Resource Center</a>, which provides multidisciplinary guidance to help you face these developing issues.In addition, please follow Morrison & Foerster’s <a href="https://lifesciences.mofo.com/" target="_blank">Life Sciences</a> blog to stay informed as we continue to report on FDA’s evolving role in the medical product industry.

As the U.K. Approves its First COVID-19 Vaccine, What’s Next for the U.S.?

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