The Food and Drug Administration’s (FDA) recent approval of the messenger RNA COVID-19 vaccine Comirnaty has prompted a wave of vaccine mandates across the country, yet individuals who happen to suffer serious side effects won’t be able to file a lawsuit against the producer of the vaccine, according to lawyers.
Comirnaty was fully approved on Aug. 23 for people 16 and older. However, the fact sheet for recipients and caregivers states that the vaccine is “also authorized under EUA [emergency use authorization]” for children aged 12 to 15 and for those in the same adolescent population requiring a third dose.
The Pfizer-BioNTech COVID-19 vaccine administered in the United States since December 2020 still remains under EUA for adolescents 12 to 15 years of age and for adolescents needing the third booster shot. The FDA also issued the vaccine EUA for people 16 and older.
“Additionally, for logistical reasons, the EUA will continue to cover the use of the Pfizer-BioNTech COVID-19 vaccine in individuals 16 years of age and older; this use is also now approved,” the FDA website states in a question and answer section for Comirnaty as of Aug. 27.
Representatives for the FDA didn’t respond to a request for comment by press time.
Vaccines and other products under emergency use are considered investigational and can’t be mandated according to U.S. law. But once a vaccine is granted full FDA approval, employers and school districts can require it and physicians may prescribe it off-label.
Mark Sadaka, a medical litigations lawyer who has handled more than 175 vaccination cases, said full federal approval of the Pfizer-BioNTech vaccine doesn’t change the immunity status afforded to the vaccine manufacturer, so lawsuits can’t be filed if an individual has a severe reaction to the shot.
“The government encourages the production of vaccinations and medications used to fight a pandemic like COVID-19 by protecting the companies making them from lawsuits,” Sadaka told The Epoch Times via email. “In fact, the government has already labeled any future COVID-19 vaccine as a ‘countermeasure.’”
According to the Health Resource and Services Administration (HRSA), a countermeasure is a “vaccination, medication, device, or other item recommended to diagnose, prevent, or treat a declared pandemic, epidemic, or security threat.”
COVID-19 vaccines, including Comirnaty, are covered under the Countermeasures Injury Compensation Program (CICP). Under amendments made to the 2005 Public Readiness and Emergency Preparedness (PREP) Act, COVID-19 vaccine manufacturers, providers, distributors, and program planners are immune from lawsuits related to vaccine injuries and death, unless it can be shown that there was willful misconduct in the production of the vaccine by the company.
John Howie, a trial lawyer focused on vaccine and personal injury, said the CICP is “the only remedy available to those who are injured by the vaccination.” The program was set up in 2010 and run by the HRSA, which is part of the Department of Health and Human Services (HHS).
“The damages are limited to: 1) a death benefit for those who die; 2) lost wages; and 3) medical bills not paid by insurance,” Howie told The Epoch Times in an email.
People have one year “from the date that the covered countermeasure was received” to file a claim.
“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.
“There is no transparency like a true judicial process. There is no provision for attorney’s fees, thus making it difficult for any injured individual to even retain a lawyer. Any appeals are handled by [three] people hand-selected by HHS to review the claim.”
From 2010 to Aug. 2, 2,186 claims have been filed with the CICP, of which 1,693 are for COVID-19 countermeasures. None of the COVID-19 claims have been approved for payment, and some lawyers aren’t optimistic that any will be, since the vaccine is still new and data continue being collected.
Only 29 of the 2,186 claims have been paid, totaling more than $6 million. All but one of the 29 claims were mostly for Guillain-Barré syndrome, a rare neurological disorder that can cause muscle weakness and paralysis, from the H1N1 vaccine. Ten more claims were approved but were ineligible for payment.
An HRSA spokesperson said the agency has yet to develop a list of covered adverse events from COVID-19 vaccines.
“An injury table for COVID-19 medical countermeasures will be developed when there is sufficient data to meet the ‘compelling, reliable, valid, medical, and scientific evidence’ standard,” Christy Choi, deputy director of HRSA, wrote in an email to The Epoch Times. “When a table is developed, it is published in the Federal Register, with an opportunity for public comment, and is posted on the CICP website.”
The Centers for Disease Control and Prevention stated that the COVID-19 vaccines are safe and effective and “will continue to undergo the most intensive safety monitoring in U.S. history.”
Ugur Sahin, chief executive officer of BioNTech, said the “full approval by the FDA underlines the vaccine’s high efficacy and favorable safety profile,” noting that “our companies have shipped more than 1 billion doses worldwide, and we will continue to work tirelessly to broaden the access to our vaccine and to be prepared for potential emerging escape variants.”
Howie, who was also a former member of the Advisory Commission on Childhood Vaccines, said the only way for COVID-19 vaccine-injured people to receive compensation is to add the approved vaccine to the National Vaccine Injury Compensation Program, also known as the vaccine court. It was created in 1988 as a no-fault system to compensate individuals injured by a vaccine (listed on the vaccine table) fairly, quickly, and efficiently.
“Until the COVID vaccines are added to the National Vaccine Injury Compensation Program [NVICP], the remedies for those who are injured are generally nonexistent. And, it will take an act of Congress—literally—for the COVID vaccines to become covered under the NVICP,” Howie said.
The compensation program is funded by a 75 cent excise tax that’s charged to each vaccine administered by the provider, who later sends the money to the vaccine court fund. Since the inception of the program, more than $4 billion (pdf) have been paid out.
Sadaka claimed that with the liability protection offered to vaccine companies, “there is no incentive to disclose safety risks of countermeasures outside of the simple goodwill of the large corporations that sell the product,” noting that “rare side effects are often swept under the rug in favor of profit.”
The FDA says vaccines that are approved “undergo the agency’s standard process for reviewing the quality, safety, and effectiveness of medical products” and that it “conducts its own analyses of the information in the BLA [biologics license application] to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.”
Some experts are questioning the FDA’s quick approval of the vaccine, a process that normally takes years. The approval was based on six months of safety data of the vaccine’s phase 3 trial, where many of the participants in the control group have been unblinded.
“Vaccines are usually made by first showing that they are safe and effective in experimental animals. Once this is established, the vaccine becomes an Investigational New Drug (IND), and the company is given an IND license to further study the safety and effectiveness of the vaccine in adults, and eventually, children,” the Children’s Hospital of Philadelphia website reads.
“Again, these trials can take years, giving companies ample time to provide the FDA with proof of long-term safety and effectiveness.”
In its licensing process, the FDA bypassed the external advisory committee that usually reviews and comments on the agency’s decision in the approval process, saying that the application met the agency’s requirements.
“We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion,” the FDA wrote in its approval letter to BioNTech.
However, Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said the public can rest assured of the agency’s decision to approve the Pfizer-BioNTech vaccine.
“We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines,” Marks said. “The public and the medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
Pfizer said it plans to seek full approval of a third dose of Comirnaty in people 16 and older when results from its phase 3 trial evaluating the booster dose are released. The vaccine company will also seek licensure of Comirnaty for adolescents 12 to 15 years “once the required data out to six months of data after the second vaccine dose are available.”
According to the FDA, the emergency authorized Pfizer-BioNTech COVID-19 and the approved Comirnaty “have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns.”
“Providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine,” the FDA stated.
Currently, no doses of Comirnaty are available in the United States like they are in Europe. The FDA directed The Epoch Times to the CDC when asked about when Comirnaty will be available to Americans. The CDC didn’t respond to requests for comment by press time.