Johnson & Johnson is essentially protected under a 2005 federal law from liability for any damage or death resulting from its COVID-19 vaccine, whose distribution was halted on Tuesday, experts say.
Healthcare professionals, including manufacturers, have immunity from liability under the 2005 Public Emergency Preparedness Act and the Emergency Preparedness Act's program for countermeasures. The law came into force on February 4, 2020, when the then Minister of Health Alex Azar declared COVID-19 as an emergency for public health.
The Centers for Disease Control and the Federal Drug Administration said Tuesday in a joint statement that they have reported six cases in the United States of a "rare and severe" type of blood clot in individuals who received the J&J vaccine, of more than 6.8 million as it has been administered since Monday.
All six cases occurred among women between the ages of 1
The agency said it was pausing to use the vaccine "out of an abundance of caution" until their review processes were complete.
New Brunswick, New Jersey-based J&J said in a statement that they are reviewing these cases with European health authorities and have decided to delay the vaccine's deployment in Europe.
The statement states, “We have worked closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the general public.
The PREP Act, which has been invoked several times before, gives manufacturers immunity and authorizes a fund to provide compensation for physical injury or death caused by vaccines, drugs or medical devices.
Renée Gentry, director of the Vaccine Injury Clinic at George Washington University in Washington, says that vaccine manufacturers "really have no" responsibility under the Countermeasures Program.
The program is limited and provides out-of-pocket costs and lost wages, she said. Claims are filed with the U.S. Department of Health and Human Services.
The clinic's former head, Peter Meyers, a professor emeritus at George Washington University Law School, said the only narrow exception to the PREP Act is if it was intentional.
"It is a very bad compensation program" whose intention was to get manufacturers' help in dealing with health pandemics, he said. Before COVID, more than 400 claims have been placed within the program, of which more than 90% were rejected by HHS, Meyers said. Catalog