united-states medical covid-19
When will Pfizer et. al. be liable for injuries caused by the COVID-19 vaccine?
<p>According to the <a href="https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html" rel="nofollow noreferrer">PREP act</a>, the companies developing and administering the COVID-19 vaccines cannot be sued for unintentional injuries resulting from the vaccine.  I have seen enough commercials advertising class action lawsuits for other wonder drugs that this is making me hesitant to get the vaccine.  It's bad enough to suffer some horrible side effect, but not even being able to seek compensation is just the last straw.</p>
<p>My pulmonologist believes that these protections for Pfizer et. al. only last until these vaccines get full FDA approval; once they're no longer on emergency use approval they will be open to lawsuits.  Is he correct?</p>
<p>(I'm not anti-vax like <a href="https://en.wikipedia.org/wiki/Alex_Jones" rel="nofollow noreferrer">Alex Jones</a>. I get my flu shot every year. Please don't assume anything.)</p>

<p>The other answers have addressed the letter of the question you asked, but I wanted to correct a misconception in your question statement:</p>
<blockquote>
<p>...  It's bad enough to suffer some horrible side effect, but not even being able to seek compensation is just the last straw.</p>
</blockquote>
<p>Note that under the PREP Act, you can <a href="https://www.hrsa.gov/cicp/faq" rel="noreferrer">seek compensation from the government if you are injured by a covered vaccine,</a> including (at this time) a COVID-19 vaccine:</p>
<blockquote>
<p>The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of covered countermeasures identified in and administered or used under a PREP Act declaration.  The CICP also may provide benefits to certain survivors of individuals who die as a direct result of the administration or use of such covered countermeasures.  The PREP Act declaration for medical countermeasures against COVID-19 states that the covered countermeasures are:</p>
<ol>
<li><p>any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or <strong>any vaccine manufactured, used, designed, developed, modified, licensed, or procured:</strong></p>
<p>a. <strong>to diagnose, mitigate, prevent, treat, or cure COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom; or</strong></p>
<p>b. to limit the harm that COVID–19, or the transmission of SARS–CoV–2 or a virus mutating therefrom, might otherwise cause;</p>
</li>
</ol>
</blockquote>
<p>So it is incorrect to say that you would be unable to seek compensation if you were injured by Pfizer's COVID-19 vaccine.  You would just have to seek compensation from the government rather than suing Pfizer.</p>
<p>As noted in the other answers, this protection under the PREP Act will lapse by October 1, 2024.  However, it is also entirely plausible that this vaccine will be recommended on a regular basis going forward, in which case it would end up being covered by the <a href="https://en.wikipedia.org/wiki/National_Vaccine_Injury_Compensation_Program" rel="noreferrer">National Vaccine Injury Compensation Program</a> instead.  This program is designed to protect manufacturers of vaccines that are routinely administered to children and pregnant women, the idea being that the threat of costly lawsuits might otherwise dissuade manufacturers from making such vaccines.  Your seasonal flu shot, for example, is covered under this program;  if you sustained an injury from that shot, you would be able to file a claim for benefits under this program.</p>
<p>If we end up in a situation where COVID-19 vaccines are required regularly for most people (which seems entirely plausible at this point), then I would wager that they would end up being folded into this program.</p>

<p>The protection extends until October 1, 2024 and does not depend on when the vaccine becomes fully approved by the FDA.</p>
<p>The official <a href="https://govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05484.pdf" rel="nofollow noreferrer">notice of <strong>Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID–19</strong></a> (PDF) was published in the Federal Register Vol. 85, No. 52 for Tuesday, March 17, 2020, on pages 15198 through 15203. The Declaration was effective as of February 4, 2020.</p>
<p>Section XII of the notice (on p. 15201) reads:</p>
<blockquote>
<p>The Secretary must identify, for each Covered Countermeasure, the period or periods during which liability immunity is in effect, designated by dates, milestones, or other description of events, including factors specified in the PREP Act. Section XII of the Declaration extends the effective period for different means of distribution of Covered Countermeasures through October 1, 2024.</p>
</blockquote>
<p>Section VI (on p. 15199) reads, in relevant part:</p>
<blockquote>
<p>To be a Covered Countermeasure, qualified pandemic or epidemic products or security countermeasures also must be approved or cleared under the FD&amp;C Act; licensed under the PHS Act; or authorized for emergency use under Sections 564, 564A, or 564B of the FD&amp;C Act.</p>
<p>A qualified pandemic or epidemic product also may be a Covered Countermeasure when it is subject to an exemption (that is, it is permitted to be used under an Investigational Drug Application or an Investigational Device Exemption) under the FD&amp;C Act and is the object of research for possible use for diagnosis, mitigation, prevention, treatment, or cure, or to limit harm of a pandemic or epidemic or serious or life-threatening condition caused by such a drug or device.</p>
</blockquote>
<p>The news story linked in the question includes the statement:</p>
<blockquote>
<p>The protection lasts until 2024.</p>
</blockquote>
<p>The pulmonologist  is incorrect.</p>

<p>The relevant law is <a href="https://www.law.cornell.edu/uscode/text/42/247d-6d" rel="noreferrer">42 USC 247d-6d</a>, which says that</p>
<blockquote>
<p>a covered person shall be 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...</p>
</blockquote>
<p>And <a href="https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures" rel="noreferrer">here</a> is the declaration. The law doesn't state any particular expiration, just that the immunity exists &quot;during the effective period of the declaration&quot;, so we have to see what the declaration says. Section XII, on the time period, says</p>
<blockquote>
<p>Liability immunity for Covered Countermeasures through means of
distribution, as identified in Section VII(a) of this Declaration,
other than in accordance with the public health and medical response
of the Authority Having Jurisdiction and extends through October 1,
2024.</p>
<p>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.</p>
</blockquote>
<p>FDA approval therefore has no effect on the liability question. There is incidentally another clause related to damage from the countermeasures:</p>
<blockquote>
<p>The PREP Act authorizes the Countermeasures Injury Compensation
Program (CICP) to provide benefits to certain individuals or estates
of individuals who sustain a covered serious physical injury as the
direct result of the administration or use of the Covered
Countermeasures, and benefits to certain survivors of individuals who
die as a direct result of the administration or use of the Covered
Countermeasures. The causal connection between the countermeasure and
the serious physical injury must be supported by compelling, reliable,
valid, medical and scientific evidence in order for the individual to
be considered for compensation. The CICP is administered by the Health
Resources and Services Administration, within the Department of Health
and Human Services. Information about the CICP is available at the
toll-free number 1-855-266-2427 or <a href="http://www.hrsa.gov/%E2%80%8Bcicp/%E2%80%8B" rel="noreferrer">http://www.hrsa.gov/​cicp/​</a>.</p>
</blockquote>
