On Aug. 23, 2021, the U.S. Food and Drug Administration (FDA) gave full approval to a Biologics License Application (BLA) submitted by BioNTech Manufacturing GmbH of Mainz, Germany on May 18, 2021 for a biologic drug called COVID Vaccine, mRNA. The FDA gave permission to BioNTech to label the product “Comirnaty” and market it in 2.0 milliliter (mL) glass vials, in packages of 25 and 195 vials.1
According to the FDA:
Comirnaty is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.2
The FDA states that Comirnaty has the same formulation as the experimental mRNA biologic produced by Pfizer and known as the “Pfizer-BioNTech COVID-19 Vaccine” or by its research name “BNT162b2.” The Pfizer-BioNTech COVID-19 Vaccine has been marketed and sold jointly by Pfizer and BioNTech since it received Emergency Use Authorization (EUA) from the FDA on Dec. 11, 2020.3
EUA for Pfizer-BioNTech COVID-19 Vaccine Reissued
The FDA reissued its letter of authorization for the Pfizer-BioNTech COVID-19 Vaccine on Dec. 23, 2020; Feb. 25, 2021; May 10, 2021; June 25, 2021 and Aug. 12, 2021. On the same day the FDA approved Comirnaty, the agency once again reissued its letter of authorization Pfizer-BioNTech COVID-19 Vaccine “in its entirety with revisions incorporated to clarify that the EUA will remain in place” for that product.4
In its Aug. 23 letter to Pfizer notifying the company of the reissuance of the EUA for the Pfizer-BioNTech COVID-19 Vaccine, FDA stated:
Pfizer-BioNTech COVID‑19 Vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series.4
The FDA’s letter to Pfizer also stated clearly that the Pfizer-BioNTech COVID-19 Vaccine has “not been approved or licensed by FDA, but has been authorized for emergency use by FDA… “4
Comirnaty and Pfizer-BioNTech COVID-19 Vaccine are Similar But Separate Products
It is a little confusing but, essentially, the FDA is saying that Comirnaty and the Pfizer-BioNTech COVID-19 Vaccine have the same ingredients, the same recipe and are manufactured based on the same “processes and procedures.” While the FDA states that the two products are identical and may be used interchangeably, the FDA also declares that these two products are “legally distinct” without disclosing information or explaining how these products are legally distinct.4
Comirnaty, which is given as two injections into the arm at least 21 days apart, has been marketed in European Union (EU) since it received conditional market authorization from the European Medicines Agency (EMA) on Dec. 21, 2020. According to the EMA, the most common side effects of Comirnaty include “pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever.”5 The government of India has decided against granting emergency authorization for Comirnaty for use in that country. On Feb. 3, 2021, India’s COVID-19 Subject Expert Committee (SEC) rejected an EUA application for Comirnaty. The SEC reportedly cited “serious adverse events including anaphylaxis and palsy as well as the companies’ lack of safety and immunogenicity studies in the Indian population.”6
Full Liability Shield for Pfizer-BioNTech COVID-19 Vaccine and Comirnaty
By the FDA issuing a license to a Comirnaty and granting it EUA status on the same day, the FDA has created uncertainty surrounding liability for Comirnaty. Many are wondering whether Comirnaty has a different liability status than other EUA products now that it is licensed by the FDA. Under the PREP Act, Covered Countermeasures have liability protection except in cases of willful misconduct and any qualifying claims for serious injury or death as a result of the administration of an EUA product are heard by the Countermeasures Injury Compensation Program (CICP).7
On Dec. 3, 2020, a Fourth Amendment to the Prep Act declaration was issued which clearly states that a countermeasure that is licensed, approved, cleared or authorized by the FDA in response to COVID-19 will fall under PREP Act for purposes of liability.7
The day after the FDA licensed and provided EUA status to Comirnaty, as well as reissuing the EUA status for the experimental Pfizer-BioNTech COVID-19 Vaccine, the National Vaccine Information Center (NVIC) contacted the U.S. Health Resources and Services Administration (HRSA) to seek clarification about the legal liability of Comirnaty. HRSA administers the Vaccine Injury Compensation Program (VICP) that awards compensation for injuries arising from routinely recommended vaccines for children and pregnant women, and the Countermeasures Injury Compensation Program (CICP) that awards compensation for vaccine injuries sustained by vaccines that are in use as countermeasures and have EUA status.
NVIC received clarification from HRSA on Aug. 26, 2021, which stated:
Your question relates to which Program provides coverage, the CICP or the Vaccine Injury Compensation Program (VICP), for injuries alleged to have been caused by the newly licensed Pfizer COVID-19 vaccine.
As noted, the COVID-19 vaccines currently authorized through Food and Drug Administration (FDA) Emergency Use Authorizations or approved by the FDA are covered countermeasures under the Public Readiness and Emergency Preparedness Act and, therefore, individuals who allege injury as a result of the administration or use of such vaccines are eligible to apply for benefits under the CICP. Full FDA approval of the Pfizer COVID-19 vaccine does not remove its coverage from the CICP or provide coverage under the VICP.
HRSA’s response affirms findings in a report issued by the Congressional Research Service7 and federal law,8 which note that the FDA may grant EUA status to licensed products. As such, under the 2005 Public Readiness and Preparedness Act, “entities and individuals involved in the development, manufacture, testing, distribution, administration, and use” EUA-approved COVID-19 vaccines are immune from liability.
Accordingly, it appears that Comirnaty, despite being licensed and approved by the FDA, remains under EUA status and is considered a Covered Countermeasure under the PREP Act and any claims for injuries arising from its use will be covered by the CICP.
Lack of Transparency in FDA Licensure of Comirnaty and Public Access to Data
The FDA’s actions of licensing Comirnaty, determining that its use is interchangeable with the experimental Pfizer-BioNTech COVID-19 Vaccine, and granting it EUA status was all done on the same day and was accomplished without convening the FDA’s federal advisory panel to evaluate the data generated since their last meeting in December 2020.
The failure of the FDA to hold a public meeting of the Vaccine and Related Biological Products Advisory Committee (VRBPAC) prior to approving BioNTech’s Comirnaty deprived the committee of the opportunity to provide independent oversight and exercising their duty to make recommendations to the FDA based on their review and evaluation of the safety and efficacy data, including post-marketing surveillance safety and efficacy data as it relates to circulating COVID-19 variants.
On Aug. 30, NVIC requested that the FDA release data to the public that would have been released to VRBPAC, disclose what was meant by stating that the two products were legally distinct, and the impact of the interchangeability of these vaccines.
Notably, without a release of data from the FDA in this regard, it is unknown if the FDA’s June 2020 Guidance for Industry document, Development and Licensure of Vaccines to Prevent COVID-19, in which the FDA recommended that vaccine manufacturers be required to meet a minimal primary efficacy endpoint of at least 50 percent in preventing severe COVID-19 disease is currently being met.9 At the time of publication of this article, the FDA had yet to respond to NVIC’s request.10
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Click here to view References:
1 U.S. Food and Drug Administration. Approval Letter – Comirnaty. Aug. 23, 2021.
2 FDA. Comirnaty. Aug. 24, 2021.
3 Press release. FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine. FDA Dec. 11, 2020.
4 FDA. Letter of Authorization (reissued). Aug. 23, 2021.
5 European Medicines Agency. EMA recommends first COVID-19 vaccine for authorisation in the EU Share. Dec. 21, 2020.
6 Taylor NP. Asia-Pacific Roundup: India rejects Comirnaty EUA. Regulatory Affairs Professionals Society Feb. 9, 2021.
7 Congressional Research Service. The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures. Mar. 19, 2021.
8 21 U.S. Code § 360bbb–3(a)(2)(B) – Authorization for medical products for use in emergencies – Approval Status of Product. Cornell Law School.
9 U.S. Department of Health and Human Services – Food and Drug Administration (DHHS – FDA). Statistical Considerations. Development and Licensure of Vaccines to Prevent COVID-19 – Guidance for Industry. FDA June 2020; Pg 14.
10 National Vaccine Information Center. Letter to RADM Denise M. Hinton, Chief Scientist. Aug. 30, 2021.