Will US Pharma see legal action over COVID vaccine side effects?

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Pictured: Signe BioNTech / Courtesy, iStock, UJ Alexander

BioNTech, a German mRNA vaccine company, is facing its first lawsuit in Germany related to alleged side effects of its COVID-19 vaccine, developed in partnership with Pfizer and authorized for emergency use in 158 country, Reuters reported last week.

But in the United States, vaccine makers are protected from liability until October 2024, thanks to a provision the federal government put in place at the start of the pandemic.

Omar Ochoa, a legal expert in biopharma and related matters, told BioSpace that the move was intended to promote rapid innovation of vaccines that could change the course of the epidemic.

You tend to get all the manufacturers and distributors involved in all of these things so they can build the plane in flight.

It is impossible to say whether the rapid development of the COVID-19 vaccine was due to the PREP Act, but the first emergency use authorization for the Pfizer-BioNTech vaccine for people 16 years of age and older was issued on the 11 December 2020, less than a year after the virus reached American soil. That’s compared to the typical development time of 5 to 10 years for vaccines to reach the US market, according to Johns Hopkins University.

The new lawsuit comes amid ongoing efforts to figure out how to deal with future pandemics in the U.S. It remains to be seen whether the legal immunity given to U.S. vaccine developers this time around is in question, but Ochoa has noted that these companies are largely protected, even in the absence of such special circumstances.

Side effects of the COVID-19 vaccine

Among the adverse events cited after vaccination are cardiovascular and respiratory outcomes. The plaintiff in the German case said she had experienced pain in her upper body, swollen extremities, fatigue and trouble sleeping since vaccination as ongoing problems.

The lawsuit against BioNTech was filed on behalf of a German citizen who claims to have suffered serious adverse reactions after receiving the company’s COVID-19 vaccine. The plaintiff alleges that the vaccine caused significant health problems, which had a lasting impact on her quality of life. Specific details of the alleged side effects were not disclosed in the initial report. Under German law, the name of the plaintiffs and the specifics of the case are not public.

BioNTech has previously highlighted the safety and efficacy of its COVID-19 vaccine, noting the extensive clinical trials and rigorous regulatory approvals that preceded its release. The company also stressed the importance of monitoring and reporting adverse events to ensure the continued safety of its vaccines.

The EMA has also defended the COVID-19 vaccine, saying all the vaccinations it has approved saved nearly 20 million lives worldwide in the first year of the pandemic alone, Reuters reported.

Implications in the United States: the PREP Act

In March 2020, the Secretary of the United States Department of Health and Human Services (HHS) released the Public Preparedness and Emergency Preparedness Act (PREP) regarding COVID-19 testing, drugs, and vaccines. 19. This statement was intended to provide liability protections to various entities involved in the development, distribution and administration of COVID-19 countermeasures.

Unless a party commits willful misconduct, covered entities, including manufacturers of biopharmaceutical vaccines, enjoy immunity from suit and liability under federal and state laws for claims related to losses resulting administration or use of covered countermeasures, such as COVID-19 vaccines. The PREP Act expires Oct. 1, 2024, but for now that means Pfizer, Moderna, and Novavax, the three U.S. producers of COVID-19 vaccines, are protected by full immunity unless they willfully violate them.

Willful violations are very difficult to prove. You have to show that the company knew of a danger and proceeded anyway, Ochoa said. It is a very tough standard.

However, he added that even after the PREP Act expires, the standard for seeking damages from pharmaceutical manufacturers is incredibly high and, in practice, arduous to litigate with little chance of success.

Even when that immunity goes away, vaccine makers are largely immune anyway, in the sense that there’s this very complicated administrative procedure and process that someone has to go through first before they can sue a vaccine maker. , did he declare.

Specifically, Ochoa pointed to the National Vaccine Injury Compensation Program, which makes it difficult to file a lawsuit, let alone a winning lawsuit. The program requires an individual to present detailed medical records and claim to be seeking compensation. Additionally, the program has a backlog of cases, further lengthening the process, according to a Politico report.

Ochoa said there is no pressure in Washington to renew the PREP law at this point because the legal threshold is sufficient, as is, to assuage vaccine makers’ anxiety.

In contrast, in Germany, although vaccine manufacturers have limited liability for potential side effects resulting from their vaccines under emergency use authorizations (similar to FDA Fast Track approval), this does not relieve manufacturers of their responsibility to thoroughly assess and mitigate potential risks associated with their products.

Lisa Munger is an editor at BioSpace. You can reach her at [email protected]. Follow her on LinkedIn

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