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The way I understand this CNBC video https://youtu.be/nJbd402xj0Q, Pfiser could not be sued because the covid vaccine was not FDA approved. This is how i understand it.

Now that the Pfiser covid vaccine is FDA approved, does Pfiser has any responsibility for side effects? Pfiser was FDA approved on August 23.

Question: if a patient got both doses before August 23, is this patient not covered for any side effect?

Question: if a patient got the first dose before August 23, BUT the second dose after August 23, is this patient partially insured for the side effect?

Question: if a patient got both doses after August 23, is this patient fully insured?

If there are proven side effect 3 or more years down the road, then how does this FDA approval change plaintiffs chances to win a lawsuit?

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  • Thanks but this question was asked BEFORE the FDA approval. My question, is how does the FDA approval make any difference in terms of liability
    – user39725
    Commented Aug 30, 2021 at 0:25
  • 1
    That question asked whether the situation would change when approval was granted. Two of the three answers explained that approval would make no difference.
    – Nate Eldredge
    Commented Aug 30, 2021 at 0:34
  • Please edit the question to limit it to a specific problem with enough detail to identify an adequate answer.
    – Community Bot
    Commented Aug 30, 2021 at 11:23
  • As asked, the question is of interest only to anti-vaxxers and to Pfizer itself. The interesting question: Is there someone who I can make pay if I take the vaccine and suffer from side effects, and who is it?
    – gnasher729
    Commented Aug 30, 2021 at 14:15

2 Answers 2

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CNBC's explanation is simply wrong. The law says that a vaccine manufacturer is

immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure if a declaration under subsection (b) has been issued

and there was a declaration under subsection (b). This immunity is not conditioned either way by being approved, indeed the declaration states

To be a Covered Countermeasure, qualified pandemic or epidemic products or security countermeasures also must be approved or cleared under the FD&C Act; licensed under the PHS Act; or authorized for emergency use under Sections 564, 564A, or 564B of the FD&C Act

The liability immunity is not perpetual, the declaration says:

Liability immunity for Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction begins with a Declaration and lasts through (1) the final day the emergency Declaration is in effect, or (2) October 1, 2024, whichever occurs first.

That doesn't mean that there can't be another declaration in the future.

Immunity of a manufacturer to liability is not related to a patient being "covered". There are other ways in which a patient could be "covered". One of them is the Countermeasures Injury Compensation Program and the other is the National Vaccine Injury Compensation Program, which presently redirects you to CICP.

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In the US, no. Under the Public Readiness and Emergency Preparedness Act, the Secretary of Health and Human Services can grant immunity for "covered countermeasures" against actual or potential public health emergencies. This immunity can apply to manufacturers, distributors, planners, and people who prescribe, dispense, and administer covered countermeasures. The only exception is for willful misconduct. The HHS Secretary has issued one of these declarations for COVID vaccines, so Pfizer continues to be immune under the PREP Act.

A PREP Act declaration triggers a federal compensation program for injuries: the Countermeasures Injury Compensation Program This is similar in concept to the National Vaccine Injury Compensation Program used for childhood vaccines, although there are some differences in the fine print. This compensation is paid by the federal government out of a congressional appropriation.

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