As Coronavirus cases continue to spike all over the country, two vaccine companies have announced promising early results for their respective products. On November 9, 2020, Pfizer Inc. and BioNTech SE announced that their vaccine candidate against COVID-19 was “found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection . . . “¹  At the same time, they also announced that a submission for an Emergency Use Authorization (EUA) to the Food and Drug Administration was planned for after “the required safety milestone is achieved, which is currently expected to occur in the third week of November.”²   Only a week after Pfizer’s announcement, Moderna, Inc. also announced that its COVID-19 vaccine met its primary efficacy endpoint in the first Interim Analysis of the Phase 3 study data, showing that the vaccine is 94.5% effective.³  The company noted in its press release that it intended to submit for an EUA with FDA in the coming weeks and that it “expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months.”⁴

While these are both promising developments, questions remain over whether the EUA process is appropriate for a vaccine candidate, particularly given the speed at which these products are being developed, and the perceived lack of transparency when it comes to FDA’s decision-making during the EUA process.⁵  To date, the FDA has been careful when it comes to the authorization of therapeutics to treat or prevent COVID-19 and has required that sponsors conduct clinical trials prior to seeking authorization for their products under an EUA.  FDA has only issued seven EUAs for drugs and biological products, if we count the one issued for hydroxychloroquine, which was subsequently withdrawn after it was determined that the product was “unlikely effective in treating COVID-19 for the authorized uses in the EUA.”⁶  Conversely, FDA has authorized more than 280 diagnostic tests since the beginning of the pandemic.⁷  

Despite this seemingly careful approach to therapeutics, there have been reports that some members of FDA’s Vaccine and Related Biological Products Advisory Committee, have “questioned whether the FDA has set the bar for a vaccine high enough.”⁸  According to FDA’s Guidance, “Emergency Use Authorization for Vaccines to Prevent COVID-19,” for a vaccine which “there is adequate manufacturing information to ensure its quality and consistency, issuance of an EUA would require a determination by FDA that the vaccine’s benefits outweigh the risks based on data from at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling matter.”⁹  Given that it had previously taken years for manufacturers to develop a vaccine, it may be too early for FDA to be able to determine that the benefits of any COVID-19 vaccine will outweigh any “known and potential risks,” partly because we do not yet know what the potential long-term effects are for the vaccine candidates currently being studied.

Given the current state of the pandemic, and the high likelihood that FDA will review at least one EUA submission for a vaccine candidate before the end of the year, on November 17, 2020, FDA announced “additional steps to increased transparency regarding [its] review of the scientific information supporting the issuance of or revisions to an [EUA] to promote public confidence in FDA’s scientific process and the appropriate use of authorized products,” especially any potential COVID-19 vaccines.¹⁰  The agency noted that its goal is to be “as transparent as possible” about the scientific basis for recommending that a drug or biological product be authorized for emergency use.  To that end, FDA plans to do the following:

• When a CDER-regulated or CBER-regulated product is authorized, [FDA] intends to the extent appropriate and permitted by law to make public the Center’s review of the scientific data and information supporting [the agency’s] recommendation to issue the EUA.
• When an EUA is revised, [FDA] also intends to make public the Center’s review of the scientific data and information supporting [the agency’s] recommendations to revise the EUA.¹¹

While the agency intends to disclose as much data as possible to the public, FDA did note that it will redact certain information that is exempted from disclosure under the Freedom of Information Act (FOIA), such as trade secrets and other information “identified by the requestors that is exempt under FOIA.”¹² Thus, the amount of information disclosed could be very little unless the requestor “consents to the release of information that is exempt under FOIA.”¹³

At this point, it is unclear whether this attempt at transparency will be sufficient to promote an adequate level of “public confidence in FDA’s scientific review process” for any of the vaccine candidates that appear to close to being able to request an EUA from the agency, and which are so urgently needed in the United States.  The bottom line is that FDA has a monumental task ahead, no matter how transparent the agency is when issuing an EUA for a COVID-19 vaccine.

[1] See Press Release, titled “Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study,” available at https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against.

[2] Id.

[3] Press Release, titled, “Moderna’s COVID-19 Vaccine Candidate Meets Its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study,” available at https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy.

[4] Id.

[5] See “BIO: A lack of transparency could threaten confidence in the vaccine development process,” available at https://www.biopharma-reporter.com/Article/2020/10/05/BIO-A-lack-of-transparency-could-threaten-confidence-in-the-vaccine-development-process

[6] See FDA’s list of EUAs for Drugs and Biological Products available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs/. 

[7] See FDA Coronavirus (COVID-19) Update: November 16, 2020, available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-november-16-2020.

[8] See Opinion from MIT Technology Review, titled, “Covid-19 vaccines shouldn’t get emergency-use authorization,”   available at https://www.technologyreview.com/2020/11/13/1012098/covid-19-vaccines-fda-emergency-use-authorization-opinion/.

[9] Available at https://www.fda.gov/media/142749/download.

[10] See CDER and CBER Emergency Use Authorization Transparency, available at https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap; see also, COVID-19 Update:  FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs, available at https://www.fda.gov/news-events/press-announcements/covid-19-update-fdas-ongoing-commitment-transparency-covid-19-euas

[11] Id.

[12] Id.

[13] Id.