Pictured: BioNTech sign/Courtesy, iStock, U.J. Alexander
BioNTech, a German company specializing in mRNA-based vaccines, 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 countries, Reuters reported last week.
But in the U.S., vaccine makers are protected from any such liability until October 2024, thanks to a provision the federal government put forth at the start of the pandemic.
Omar Ochoa, a legal expert in biopharma and related cases, told BioSpace that the move was meant to promote the rapid innovation of vaccines that could change the course of the outbreak.
“You tend to incentivize to assure all the manufacturers and the distributors that would have to be involved in all of these things so they can build the plane as its flying.”
Whether the speed of the COVID-19 vaccine development was due to the PREP Act is impossible to say, but the first emergency use authorization for the Pfizer-BioNTech vaccine for individuals 16 years of age and older was issued on Dec. 11, 2020—less than a year after the virus reached U.S. soil. That’s compared to the typical 5 to 10 years of development time for vaccines to reach the U.S. market, according to Johns Hopkins University.
The new lawsuit comes amidst ongoing efforts to ideate how to deal with future pandemics in the U.S. Whether the legal immunity granted to U.S. vaccine developers this time around comes under question remains to be seen, but Ochoa noted that these companies are largely protected, even in the absence of such special circumstances.
COVID-19 Vaccine Side Effects
Amongst cited adverse events after vaccination include cardiovascular and respiratory outcomes. The plaintiff in the German case said she had experienced upper-body pain, swollen extremities, fatigue and disordered sleep since vaccination as ongoing issues.
The lawsuit brought against BioNTech was filed on behalf of a German citizen who claims to have experienced severe adverse reactions after receiving the company’s COVID-19 vaccine. The plaintiff alleges that the vaccine caused significant health issues, which have had a lasting impact on her quality of life. The specific details of the alleged side effects were not disclosed in the initial report. Under German law, the plaintiff’s name and the specificities of the case are not public.
BioNTech has previously emphasized the safety and efficacy of its COVID-19 vaccine, highlighting the extensive clinical trials and rigorous regulatory approvals that preceded its distribution. The company has also stressed the importance of monitoring and reporting adverse events to ensure the ongoing safety of its vaccines.
The EMA has similarly defended the COVID-19 vaccine, saying that all of the immunizations it approved saved almost 20 million lives globally in the first year of the pandemic alone, Reuters reported.
U.S. Implications: The PREP Act
In March 2020, the U.S. Department of Health and Human Services (HHS) secretary issued the Public Readiness and Emergency Preparedness (PREP) Act pertaining to COVID-19 tests, drugs and vaccines. This declaration aimed to provide liability protections to various entities involved in the development, distribution and administration of COVID-19 countermeasures.
Unless a party engages in willful misconduct, covered entities—including biopharma vaccine manufacturers—are granted immunity from lawsuits and liability under federal and state law for claims related to losses resulting from the administration or use of covered countermeasures, such as COVID-19 vaccines. The PREP Act sunsets on Oct. 1, 2024, but for now, this means that Pfizer, Moderna and Novavax—the three U.S.-based producers of COVID-19 vaccines—are protected by complete immunity, except in the case of a willful violation.
“Willful violations are very hard to prove. You have to show that the company knew about some danger and proceeded anyway,” Ochoa said. “It’s a very hard standard.”
However, he added that even after the PREP Act expires, the standard for seeking damages from pharma manufacturers is incredibly high and, practically speaking, arduous to litigate with little chance of success.
“Even when this immunity goes away, the vaccine manufacturers are largely immune anyway, in the sense that there’s this very complicated administrative proceeding and process that somebody has to go through first before they can ever sue a vaccine manufacturer,” he said.
Specifically, Ochoa pointed to the National Vaccine Injury Compensation Program, which makes filing a suit difficult, much less a winning one. The program requires an individual to detailed medical records and claims to seek compensation. Additionally, the program has a backlog of cases, drawing out the process further, according to a report by Politico.
Ochoa said there isn’t a push in Washington to renew the PREP Act at this point because the legal threshold is sufficient, as is, to quell anxiety on the part of vaccine manufacturers.
By contrast, in Germany, though vaccine manufacturers have limited liability for potential side effects resulting from their vaccines under emergency use authorizations (similar to FDA’s Fast Track approval), this doesn’t absolve manufacturers of their responsibility to thoroughly assess and mitigate potential risks associated with their products.
Lisa Munger is a senior editor at BioSpace. You can reach her at lisa.munger@biospace.com. Follow her on LinkedIn
