Pfizer is still providing Virginia distributors the Pfizer-BioNTech COVID-19 vaccine allowed by the FDA under the Emergency Use Authorization (EUA), not the Comirnaty-labeled vaccine that was fully approved by the FDA in August. Pfizer says it will use up its existing stock of vaccine made under the earlier label before distributing the new version.
“The FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and, according to the FDA labeling, can be used interchangeably to provide the COVID-19 vaccination series,” a Pfizer statement provided to The Virginia Star said. “The Pfizer-BioNTech COVID-19 EUA labeled product will still be shipped and usable until its expiry date, as long as authorized frozen storage conditions have been maintained.”
A spokesperson for Sentara Healthcare told The Star that the Virginia Department of Health (VDH) provides the vaccines to the health network, and that the network can’t pick which label of the vaccine they receive, but only specify that they want more Pfizer vaccines (or Moderna.)
A spokesperson for CVS Pharmacies told The Star, “As a member of the Federal Pharmacy Partnership, we receive direct distributions of the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older from the Federal Government for use in vaccinating the public in locations that carry this vaccine.”
The Ohio Star reported that the vaccines are legally distinct, and reported that attorney Robert Barnes said, “You have less legal rights and fewer legal remedies when you take an EUA drug than a biologic licensed drug. This directly impacts the legal rights of all Americans.”
University of Virginia Professor of Law Margaret Riley teaches topics including food and drug law, health law, and regulation of clinical research. She said, “There is no substantive difference between the EUA authorized vaccine and the approved vaccine for an individual receiving the vaccine.”
Liability Protections for COVID-19 Vaccine Providers
Riley told The Virginia Star, “First and foremost, the formulations are identical. So, for any individual receiving the vaccine, they are getting the identical vaccine put into their arm. The liability schemes are also still identical – both the approved branded Comirnaty and the Pfizer product authorized under the EUA (again, substantively identical products) are subject to the Countermeasures Injury Compensation Program (CICP) – the liability scheme provided by the PREP ACT.”
According to a Congressional Research Service (CRS) report, the February 2020 Prep Act Declaration protects manufacturers, distributors, and health care providers from legal liability for losses related to administration and use of covered COVID-19 countermeasures. The CICP covers vaccinations, medications, and other recommended tools to fight health threats including COVID-19, Ebola, and Zika.
The CICP is the payer of last resort in a compensation program for those seriously injured or killed from the result of a covered countermeasure. Riley said the CICP doesn’t cover non-economic damages, and is under exclusive federal jurisdiction.
“CICP compensation is limited to eligible individuals, such as persons injured by countermeasures or their survivors. CICP only provides compensation for death or ‘serious physical injuries,’ that is, injuries that warrant hospitalization or lead to a significant loss of function or disability. Thus, individuals who experience only minor side effects from a COVID–19 vaccine – such as soreness, headache, or fatigue – would not be eligible for CICP compensation,” the report states.
“As of November 1, 2021, the CICP has not compensated any COVID-19 countermeasures claims. Three COVID-19 countermeasures have been denied compensation because the standard of proof for causation was not met and/or a covered injury was not sustained. One COVID-19 claim has been determined eligible for compensation and is pending a review of eligible expenses,” the CICP page states.
Riley said that in the future, COVID-19 vaccines might move to the National Vaccine Injury Compensation Program (NVICP), but that probably won’t happen soon.
She explained, “In a nutshell, the NVICP assumes a lot more experience with the vaccines. So we know what types of reactions are more likely, and the liability scheme is designed to reflect that. It sets up a no-fault scheme that allows for relatively easy (albeit capped) compensation – you can still go outside the system.”
Under the NVICP, vaccine manufacturers can be found liable for injuries from vaccines, according to the CRS report.
Riley said that there’s no substantive difference between the EUA-authorized Pfizer vaccine and the FDA-approved Pfizer vaccine.
In Virginia, organizations including universities and workplaces are mandating a COVID-19 vaccine. Some school districts are requiring students involved in sports to be COVID-19 vaccinated or tested regularly. Federally, a requirement for large employers to mandate the vaccine is working its way through the courts. Virginia Governor-elect Glenn Youngkin has said that while he’s pro-vaccine, he’s anti-mandate – but has also expressed an intention to allow local authorities to make decisions.
Riley said, “I think it is accurate to say that there is no real legal problem with organizations distributing one or the other version. Ethically, they should be distributing them to mitigate waste – that means using the ones more likely to expire first (either because of use or expiration dates). I don’t think mandates play any role.”
The VDH did not respond to multiple requests for comment.
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Eric Burk is a reporter at The Virginia Star and The Star News Network. Email tips to [email protected].
Photo “Comirnaty” by Prefeitura de Olinda. CC BY 2.0.