A popular reason anti-vaxxers are using for avoiding availing themselves of the Pfizer vaccine aimed at protecting them from COVI-19 got the fact-check treatment from the Washington Post on Monday.
On Aug. 24, Dr. Robert Malone, who bills himself as one of the researchers behind mRNA vaccines, told Steve Bannon on his War Room podcast,that the vaccine in question lacks liability protection.
According to the Post's Glenn Kessler, Malone told Bannon, "The little trick that they have done here: They have issued two separate letters for two separate vaccines. The Pfizer vaccine which is currently available is still under emergency use authorization and it still has the liability shield … The product that's licensed … it's called Comirnaty. … that's the one that liability waiver will no longer apply to."
As Kessler reports, that claim is simply not true, and that it is also being shared by anti-vax proponent Robert F. Kennedy who recently wrote, "Licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield."
Kessler began by noting that Emergency Use Authorizations (EUA) are one way the government uses to bring much-needed help to the public, and in the case of the Pfizer vaccine, the terms for use are detailed with FDA noting, "The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness."
That, Kessler asserts, is what opponents of the vaccine are basing their misinformation on -- which a Pfizer spokesperson has debunked.
In an email, Pfizer spokesperson Sharon J. Castillo wrote, "The statement that the products are 'legally distinct with certain differences' refers to the differences in manufacturing information included in the respective regulatory submissions."
Castillo added, "Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers. FDA closely reviews all manufacturing steps, and has found explicitly that the EUA and BLA [biologics license application] products are equivalent."
Kessler wrote this where the law known as the Public Readiness and Emergency Preparedness Act (PREP Act) comes into play.
"The PREP Act designation means that claims related to coronavirus vaccines are covered by the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP), which was set up to handle vaccine lawsuits<," he wrote. "In other words, a person cannot sue a manufacturer for an injury caused by a vaccine or other product listed as a countermeasure, but they can seek compensation from CICP filing a claim. The intent of the law is to urge manufacturers to quickly gear up to combat a possible pandemic without fear of lawsuits. (There is an exception in the law if a person can prove 'willful misconduct' by a manufacturer.)
Castillo confirmed that, explaining, "The liability protections afforded under the PREP Act are tied to the declared public health emergency and not whether the vaccine is sold under an EUA. Therefore, both Comirnaty and the Pfizer-BioNTech covid-19 vaccine receive the same liability protections as medical countermeasures against covid-19."
You can read more here and see Malone on War Room below:
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