Johnson & Johnson is essentially protected under a 2005 federal law against liability for injury or death resulting from its COVID-19 vaccine, the distribution of which was halted on Tuesday, experts said.
Healthcare providers, including manufacturers, enjoy tort immunity under the countermeasures compensation program of the Public Preparedness and Emergency Preparedness Act 2005. The law came into effect on February 4, 2020, when then Health and Human Services Secretary Alex Azar declared COVID-19 a public health emergency.
The Centers for Disease Control and the Federal Drug Administration said in a joint statement Tuesday that there had been six reported U.S. cases of a “rare and severe” type of blood clot in people who received the J&J vaccine, over more of 6.8 million people. it was administered from Monday.
All six cases occurred in women aged 18 to 48, with symptoms appearing six to 13 days after vaccination.
The agency said it was suspending use of the vaccine “out of caution” until their review processes are complete.
J&J, based in New Brunswick, New Jersey, said in a statement that it is reviewing these cases with European health authorities and has decided to proactively delay the deployment of the vaccine in Europe.
The statement said, “We are working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.”
The PREP law, which has been invoked several times before, grants immunity to manufacturers and authorizes a fund to compensate for bodily injury or death caused by vaccines, drugs or medical devices.
RenÃ©e Gentry, director of the Vaccine Injury Litigation Clinic at George Washington University in Washington, said vaccine producers “don’t really” have any responsibility under the countermeasures program.
The program is limited and takes care of personal expenses and lost wages, she said. Claims are filed with the US Department of Health and Human Services.
Former clinic director Peter Meyers, who is professor emeritus at George Washington University Law School, said the only narrow exception to the PREP law was if there was willful misconduct.
âThis is a very poor compensation programâ intended to enlist the help of manufacturers to deal with health pandemics, he said. Before COVID, just over 400 claims were filed under the program, more than 90% of which were dismissed by the HHS, Meyers said.