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.

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.

Representatives for the FDA didn’t respond to a request for comment by press time.

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.”

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.

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.”

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.

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.”

“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.

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.