Lawyers say Pfizer and BioNTech still immune from lawsuits despite full vaccine approval
09/01/2021 // Ramon Tomey // Views

Vaccine lawyers have said people who suffer serious side effects after getting the Pfizer/BioNTech vaccine cannot sue for damages. The comments by the lawyers came amid the Food and Drug Administration's (FDA) full approval of the Pfizer/BioNTech coronavirus vaccine called Comirnaty. The Aug. 23 full approval did not extend to its use on children 12 to 15 years old and its use as a booster shot.

Comirnaty's full approval led to many private and public entities mandating COVID-19 vaccination. However, Pfizer and its German partner BioNTech remained immune from any lawsuits filed as a result of serious side effects. Medical litigations lawyer Mark Sadaka said Comirnaty's approval did not affect the immunity afforded to the two firms.

Sadaka said in an email: "The [federal] government encourages the production of vaccinations and medications used to fight a pandemic like COVID-19 by protecting the companies making them from lawsuits. In fact, [it] has already labeled any future COVID-19 vaccine as a 'countermeasure.'"

The Health Resources and Services Administration (HRSA) defined a countermeasure as a "vaccination, medication, device or other item recommended to diagnose, prevent or treat a declared pandemic, epidemic or security threat." HRSA Deputy Director Christy Choi said in an email that Comirnaty and other COVID-19 vaccines are covered by the Countermeasures Injury Compensation Program (CICP).

The CICP was established in 2010 and operated by the HRSA, an agency under the Department of Health and Human Services (HHS). Under the CICP, people are given one year "from the date that the covered countermeasure was received" to file a claim. This meant that vaccinated people have one year since their vaccination to file for any injury claims through the program.


Vaccine and personal injury lawyer John Howie said the CICP is "the only remedy available to those who are injured by the vaccination." However, he continued that the damages awarded by the CICP are limited to a death benefit for those who die, medical bills not paid by insurance and lost wages. (Related: Every death caused by Covid vaccines will be blamed on "Covid".)

Americans injured by a fast-tracked COVID-19 vaccine have no recourse

Despite the CICP's existence, Howie lamented its different deficiencies. "I call it a 'feel good' program. We like to say we have it because it makes people feel better. But when you dig into it, it is a joke," he said.

The lawyer pointed out the CICP's lack of transparency and lack of provision for attorney's fees, with the latter "making it difficult for any injured individual to even retain a lawyer." Howie also pointed out that appeals were handled by only three individuals selected by HHS.

Howie ultimately remarked that the only way for those injured by COVID-19 vaccines to receive payment is for the shots to be added to the National Vaccine Injury Compensation Program (NVICP). The program was created in 1988 to compensate individuals injured by certain vaccines fairly, quickly and efficiently. The NVICP had paid out more than $4 billion since its establishment.

"Until the [COVID-19] vaccines are added to the [NVICP], the remedies for those who are injured are generally non-existence. And it will take an act of Congress – literally – for the [COVID-19] vaccines to become covered under the NVICP," Howie said.

Sadaka meanwhile said "there is no incentive to disclose safety risks of countermeasures outside of the simple goodwill of the large corporations that sell the product," given the liability protection offered to vaccine makers. He added: "Rare side effects are often swept under the rug in favor of profit." (Related: Italy launches manslaughter case after AstraZeneca's coronavirus vaccine kills teacher.)

Furthermore, the 2005 Public Readiness and Emergency Preparedness (PREP) Act protected vaccine manufacturers from any lawsuits related to vaccine injuries and death. However, this immunity did not apply if "willful misconduct" in the process of vaccine manufacture could be proven. CNBC reported back in December 2020 that former HHS Secretary Alex Azar invoked the PREP Act to protect vaccine makers such as Pfizer and Moderna from lawsuits. The same article added that the February 2020 declaration by Azar will last until 2024.

On the other hand, Choi said the HSRA has yet to develop a list of adverse events from COVID-19 vaccines that are eligible for claims. "An injury table for COVID-19 medical countermeasures will be developed when there is sufficient data to meet the 'compelling, reliable [and] valid medical and scientific evidence' standard," she said. has more articles about the dangers of vaccines.

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