Malone, who bills himself as having played a key role in creation of mRNA vaccines, is a prominent skeptic of the coronavirus vaccines that have been crafted using the technology. Shortly after the Food and Drug Administration fully authorized the Pfizer-BioNTech vaccine, he appeared on a program hosted by Stephen K. Bannon, a one-time adviser to former president Donald Trump, and claimed that the full authorization was a bait-and-switch game played by the FDA.
“One again the mainstream media has lied to you,” he said. “Sorry to say that. I know it’s a shock to this viewership.”
In essence, his argument was that the approved vaccine would no longer have liability protections so Pfizer would simply keep distributing in the United States the product that had been authorized for emergency use.
A similar claim was made by Robert F. Kennedy, a leading anti-vaccine campaigner.
“Licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield,” Kennedy wrote with a co-author in an Aug. 24 post. “Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could sue for damages. And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical. Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.”
These claims are false, based on a misunderstanding of the law, as Malone acknowledged after we contacted him.
“Emergency Use Authorization” (EUA) allowed the FDA to quickly approve the vaccines for distribution to millions of Americans, but that designation also spawned skepticism and vaccine hesitancy among some people. The government hopes that full authorization will ease those concerns. Full approval also means that companies, governments and the Pentagon can begin to order employees to get vaccinated as a condition of employment, as they do for other fully-authorized vaccines.
The letters issued by the FDA are obtuse and written in legalese, which make it easy for people to misunderstand them. Skeptics have focused on a footnote on page 2 of the letter to Pfizer: “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.”
But this footnote has nothing to do with liability protection, according to Pfizer and government officials.
“The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions,” said Pfizer spokesperson Sharon J. Castillo in an email. “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.”
Indeed, contrary to the claims of Malone and others, the Comirnaty vaccine has the same liability protection as the vaccine approved under the EUA. That’s because of a law known as the Public Readiness and Emergency Preparedness Act (PREP Act).
In early 2020, after the coronavirus emerged, Health and Human Services Secretary Alex Azar invoked the PREP Act to “provide liability immunity for activities related to medical countermeasures against covid-19.” So that covers all vaccines that might be produced to combat the coronavirus, whether fully authorized or not.
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.)
Claims filed under CICP for lost income are capped at $50,000 per year and unlike the VICP it does not provide any compensation for pain, suffering, emotional distress, or similar damages. Cases filed under VICP also have limitations; they are heard in the U.S. Court of Federal Claims, where there are no juries and judge decides the case.
The CICP website shows that as of Aug. 2, 686 people have alleged injuries or deaths from coronavirus vaccines but so far no countermeasure claims have received any compensation.
“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,” Castillo said. “Therefore, both Comirnaty and the Pfizer-BioNTech covid-19 vaccine receive the same liability protections as medical countermeasures against covid-19.”
“There are no liability or compensation differences between a countermeasure approved under an EUA or one that has received full FDA approval,” confirmed an HHS spokesperson.
Castillo said that as of Aug. 22, the day before the FDA authorization was announced, Pfizer had shipped more 1.3 billion doses. The company expects to produce 3 billion doses of the vaccine this year. FDA acting commissioner Janet Woodcock told reporters that the EUA version produced pre-authorization can be used interchangeably with the fully authorized version as that become more widely available.
“They are made using the same processes, and there are no differences between them in safety or effectiveness,” Castillo said.
The European Union in December approved the Comirnaty vaccine and so it already has been distributed by member states under that brand name.
Malone quickly conceded his statement on the Bannon show was wrong. “When one is doing rapid analysis on the fly, one does not always get everything right,” he told The Fact Checker. “On this particular legal liability issue I did not hunt down the details myself, and relied on comments from a third party lawyer which were not fully correct.” He said the statements we received from Pfizer and HHS “are consistent with my current understanding.”
The Pinocchio Test
As regular readers know, we generally do not award Pinocchios when a person admits error. Otherwise, this would be a Four-Pinocchio claim. Malone was too quick to embrace false information (while bashing the mainstream media at the same time). The liability protection for Comirnaty is the same as the vaccine that was previously approved under emergency authorization, so that is not a bar to distributing the fully-approved vaccine in the United States
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