Researcher Distorts Facts on COVID-19 Vaccine Approval, Liability

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The Pfizer/BioNTech COVID-19 vaccine was afloat approved by the Food and Drug Administration, though an exigency usage authorization besides remains successful place. Dr. Robert Malone misleadingly said Americans are being offered the changeable lone nether the second and that it carried antithetic liability ramifications. The liability protections, afforded nether a nationalist wellness law, are the aforesaid for the two.

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The Food and Drug Administration issued the first full approval for a COVID-19 vaccine connected Aug. 23. The afloat licensure for Pfizer/BioNTech’s vaccine, called Comirnaty — specifically for those 16 and older — arrived immoderate 8 months aft the vaccine first rolled out in the U.S. nether an exigency usage authorization.

An EUA is typically little stringent than the afloat licensure, which is called a biologics licence application. But for the COVID-19 vaccine EUA, the FDA included immoderate much rigorous requirements. The afloat licensure was based connected much information from the signifier 3 objective trials, which monitored much than fractional of participants for astatine slightest 4 months aft their 2nd shots.

Online, the quality of the FDA support was successful immoderate circles met by claims trying to formed uncertainty connected the legitimacy of the licensure. Some dubiously asserted federal officials had pulled a “bait and switch” connected the public.

“FDA ‘playing bait and switch’ with Americans, tricking them into believing shots presently being offered person been granted afloat support erstwhile they person not,” declared the headline on, shared connected Facebook much than 5,000 times, according to CrowdTangle analytics data.

The communicative cited an interrogation with Dr. Robert Malone, a idiosyncratic who claims he invented mRNA exertion and who has formed uncertainty connected the COVID-19 vaccines successful caller months.

In an interview with governmental strategist Steve Bannon connected Aug. 24, Malone misleadingly said that the afloat licensed merchandise is not yet disposable — adjacent though national officials say the licensed vaccine is the aforesaid formulation as, and interchangeable with, the vaccine authorized for exigency use. He past falsely claimed that the vaccine that is disposable carries with it antithetic liability implications.

Malone, “Bannon’s War Room,” Aug. 24: It’s perfectly not available. … The Pfizer vaccine, which is what is presently available, is inactive nether exigency usage authorization and it inactive has the liability shield. … The merchandise that’s licensed is the BioNTech merchandise which is substantially akin but not needfully identical. It’s called Comirnaty … and it’s not yet available. They haven’t started manufacturing it oregon labeling it. And that’s the 1 that the liability waiver volition nary longer use to. So the 1 that’s really licensed is not yet disposable and erstwhile it does go available, it volition nary longer person the liability shield.

The interrogation — successful which Malone besides claimed that “once again, the mainstream media has lied to you” — also appeared on the website Rumble and has been shared more than 10,000 times connected Facebook.

While the COVID-19 vaccine manufacturers are mostly shielded from liability, arsenic we’ll explain, Malone is incorrect that the afloat licensed Pfizer/BioNTech merchandise falls extracurricular those protections.

David Bowman, a spokesperson for the Health Resources and Services Administration — the national bureau that oversees compensation programs for those who allege injuries pursuing vaccination — told america successful an email that determination “are nary liability oregon compensation differences betwixt a countermeasure approved nether an EUA oregon 1 that has received afloat FDA approval.”

Malone did not respond to our petition for comment, but acknowledged in an Aug. 30 tweet that helium was “wrong” astir the purported differences successful liability. Malone told the Washington Post‘s Fact Checker: “On this peculiar ineligible liability contented I did not hunt down the details myself, and relied connected comments from a 3rd enactment lawyer which were not afloat correct.”

Vaccine Under EUA & Full Approval Use Same Formula

It’s existent that an exigency usage authorization inactive exists for the Pfizer/BioNTech vaccine. It authorizes the two-dose vaccine for those property 12 and older — and a 3rd dose for those who are immunocompromised — portion the FDA’s afloat support pertains to those 16 and older.

In an Aug. 23 letter to Pfizer, the FDA said “the EUA volition stay successful spot for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized denotation and uses, and to authorize usage of COMIRNATY (COVID-19 Vaccine, mRNA) nether this EUA for definite uses that are not included successful the approved [biologics licence application].”

The missive noted that, though Comirnaty is approved, “there is not capable approved vaccine disposable for organisation to this colonisation successful its entirety astatine the clip of reissuance of this EUA. Additionally, determination are nary products that are approved to forestall COVID-19 successful individuals property 12 done 15, oregon that are approved to supply an further dose to the immunocompromised colonisation described successful this EUA.”

So, successful short, the Pfizer/BioNTech vaccine authorized for exigency usage continues to beryllium disposable some to conscionable request and due to the fact that it tin beryllium utilized for individuals — those 12 to 15, for illustration — for whom the afloat licensure of the vaccine isn’t yet applicable.

But the FDA said that “the licensed vaccine has the aforesaid formulation arsenic the EUA-authorized vaccine and the products tin beryllium utilized interchangeably to supply the vaccination bid without presenting immoderate information oregon effectiveness concerns. The products are legally chiseled with definite differences that bash not interaction information oregon effectiveness.”

Pfizer’s typical told america the “legally distinct” notation relates to differences successful manufacturing — for example, the licensed merchandise whitethorn beryllium made astatine antithetic sites oregon usage materials from antithetic approved suppliers.

Liability Protections

The liability protections astatine the bosom of Malone’s assertion stem from a national instrumentality that successful portion affords wide protections to vaccine manufacturers and administrators successful the lawsuit of a nationalist wellness emergency. The Department of Health and Human Services invoked that law, the Public Readiness and Emergency Preparedness Act, successful aboriginal 2020 arsenic the U.S. began to grapple with COVID-19.

As the Congressional Research Service explains, “covered persons are mostly immune from ineligible liability (i.e., they cannot beryllium sued for wealth damages successful court) for losses relating to the medication oregon usage of covered countermeasures against COVID-19.”

“The sole objection to PREP Act immunity is for decease oregon superior carnal wounded caused by ‘willful misconduct,’” the CRS study says.

The study explains: “In the PREP Act, Congress made the judgement that, successful the discourse of a nationalist wellness emergency, immunizing definite persons and entities from liability was indispensable to guarantee that perchance life-saving countermeasures volition beryllium efficiently developed, deployed, and administered.”

The archetypal 2020 Department of Health and Human Services declaration invoking the PREP Act defined “Covered Countermeasures” arsenic “any antiviral, immoderate different drug, immoderate biologic, immoderate diagnostic, immoderate different device, oregon immoderate vaccine, utilized to treat, diagnose, cure, prevent, oregon mitigate COVID-19, oregon the transmission of SARS-CoV-2 oregon a microorganism mutating therefrom, oregon immoderate instrumentality utilized successful the medication of immoderate specified product, and each components and constituent materials of immoderate specified product.”

Subsequent amendments have expanded that definition. For example, it besides now applies to products that “limit the harm COVID-19 mightiness different cause.”

Like HRSA, the Pfizer typical told america that the liability protections pursuant to the nationalist wellness exigency widen to some the vaccine nether exigency usage authorization and to the afloat licensed Comirnaty.

While the companies are protected from liability, the CRS notes, “individuals who dice oregon endure superior injuries straight caused by the medication of covered countermeasures whitethorn beryllium eligible to person compensation done the Countermeasures Injury Compensation Program,” or CICP — a federal system.

And Bowman, the HRSA spokesperson, besides told america that some “FDA authorized and approved COVID-19 vaccines, including Comirnaty, are covered countermeasures under” CICP.

Outside of a nationalist wellness emergency, manufacturers of regular vaccines are besides mostly shielded from claims. As we’ve explained before, that protection dates backmost to the 1970s, erstwhile vaccine makers and wellness attraction providers were facing costly lawsuits that enactment their operations successful question — starring Congress to walk the National Childhood Vaccine Injury Act in 1986.

That act, portion giving manufacturers protections from lawsuits, created a compensation programme known arsenic the National Vaccine Injury Compensation Program, oregon VICP. It also requires wellness attraction providers to study broadside effects that hap aft immunization to the Vaccines Adverse Event Reporting System.

While the COVID-19 vaccines fall nether CICP, astatine immoderate constituent the COVID-19 vaccines are expected to beryllium added to VICP, said Renée Gentry, manager of the Vaccine Injury Litigation Clinic astatine George Washington University.

“Once it’s nary longer successful exigency usage and it’s recommended for children, it should spell into the VICP,” Gentry told america successful a telephone interview.

There is bipartisan legislation in Congress to expedite the summation of caller vaccines to VICP, which usually tin instrumentality upward of 2 years, Gentry noted.

The modulation of a vaccine from CICP (an administrative process) to VICP (a ineligible process) does rise immoderate questions and concerns — including whether those who record nether CICP (which has a one-year statute of limitations) volition beryllium capable to prosecute a assertion nether VICP, Gentry said. There are cardinal differences, including that the second comes with the close to an lawyer and to appeal.

There person been 686 claims for allegations of deaths oregon injuries filed with CICP successful narration to the COVID-19 vaccines, arsenic of Aug. 2, though astir each are inactive being adjudicated. One assertion — for “Swelling of the Tongue and Throat, Difficulty Speaking and Swallowing and Dizziness” — is listed arsenic being resolved and was denied due to the fact that “the modular of impervious for causation was not met and/or a covered wounded was not sustained.”

As we’ve explained before, hundreds of millions of COVID-19 vaccine doses person been administered successful the U.S., with astir recipients reporting minor, impermanent broadside effects specified arsenic symptom astatine the injection site, fatigue, headache oregon musculus pain. There person been some rare, much superior broadside effects observed with the vaccines — though wellness officials accidental the benefits proceed to outweigh the risks.

Editor’s note: SciCheck’s COVID-19/Vaccination Project is made imaginable by a assistance from the Robert Wood Johnson Foundation. The instauration has no control over’s editorial decisions, and the views expressed successful our articles bash not needfully bespeak the views of the foundation. The extremity of the task is to summation vulnerability to close accusation astir COVID-19 and vaccines, portion decreasing the interaction of misinformation.


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