While the emerging COVID-19 vaccines promise to provide at least 90 percent effectiveness against the virus, vaccine makers are making sure they too enjoy immunity.
Even though taxpayers gladly shoveled $2.5 billion to develop the Moderna vaccine, and the federal government is spending $27 billion of your tax dollars to fund the Biomedical Advanced Research and Development Authority, BARDA, as drug makers rush a COVID-19 vaccine to market don’t expect your financial contribution to the effort to buy you any goodwill.
Pfizer and Moderna have made sure you cannot sue if you suffer severe Covid vaccine side effects.
AstraZeneca has also reportedly sought and received immunity from civil liability in the European Union. The Intercept reports that the trade group, Vaccines Europe is seeking an “exemption from civil liability” due to the “unprecedented public health and economic crisis.”
Under the federal PREP Act, lawyers have secured total immunity from liability for Big Pharma just in case something goes terribly wrong with the vaccine. Big Pharma “cannot be sued for money damages in court” over any efforts to fight the novel virus, whether a vaccine, a therapeutic, or any respiratory device.
We’ve already heard of side effects. People with a history of allergic reactions to vaccines are warned not to take the COVID shot after there have been several reports of anaphylaxis in the U.S. and UK that required an immediate injection by an Epi Pen.
With an estimated 120 vaccines in some stage of development, the potential downsides are magnified exponentially. The PREP Act effectively bars anyone who believes they have been harmed by a COVID-19 fighting vaccine.
PREP (the Public Readiness and Emergency Preparedness Act) was updated in April after being invoked by HHS in February when it was clear that COVID-19 was here to stay. The Act empowered director, Alex Azar to provide legal immunity to the companies making the vaccine or anything considered critical to the public during a pandemic, unless there is “willful misconduct” by the company. That is a high standard sought by defendants because it is so difficult to meet.
The drug giants will enjoy that protection until 2024.
For the last decade, the Countermeasures Injury Compensation Program (CICP) was intended to provide compensation for any serious injury resulting from countermeasures the government may take during a health emergency whether vaccine, medication, device, or a public health emergency.
Zika, Ebola, Anthrax and now COVID-19 are all considered covered countermeasure threats. The injured or their survivors are supposed to be covered.
With a death benefit capped at $370,000 for the surviving family members, and up to $50,000 a year for unreimbursed lost wages and medical expenses, the program sounds good. But it is more talk than action. Of the 499 filed claims, only 29 have been paid.
Blanket immunity is rarely granted pharmaceutical companies, with some exceptions. In 1976, the swine flu makers had immunity from civil litigation. Mutual Pharmaceuticals was granted immunity from liability in 2013 when the U.S. Supreme Court decided federal preemption offered protection to Big Pharma since it was an FDA-approved drug.
And if you were told as a condition of employment you have to be immunized, your employer is off the hook as well. The U.S. Food and Drug Administration, as do most states, enjoys sovereign immunity. “You can’t sue the king” is a remnant of British law before the American Revolution.
What could go wrong?
The Pfizer and Moderna vaccines were developed four to five times faster than vaccines are usually created due to the threat by COVID-19. That means the lengthy and expensive clinical trials were cut short during the eight-month development time.
Pfizer’s CEO Dr. Albert Bourla told CNBC that “This is a vaccine that was developed without cutting corners” and that it was approved by authorities around the world. CNBC reports that the shortest time to develop a vaccine previously was for mumps and that took four years back in 1967.
Because it requires an ultra-cold temperature during handling and transport (-100 °F (-73 °C) Pfizer makes a point of saying its vaccine is free of thimerosal, the controversial mercury-based preservative thought to be linked to childhood autism. Thimerosol is being phased out of all vaccines even though the Centers for Disease Control and Prevention (CDC) insists it’s safe.
The Pfizer vaccine contains no other preservative, according to the company (there are no microchips either).
Newly emerging are variations of COVID-19, as the virus mutates in order to survive, adding a layer of complexity to the immunity question.
Employers may be asking whether they can be sued for requiring employees to be immunized. Yes, requiring a vaccine can be a requirement of employers. Under the Americans with Disabilities Act, workers may be exempted from taking a vaccine if there is a medical reason or a sincerely held religious belief.
Any injuries may have to be addressed by workers’ compensation as an on-the-job injury.
If you are seeking compensation, don’t count on the Countermeasures Injury Compensation Program (CICP), a last-ditch government program managed under HHS. It provides benefits to employees who suffered work-related injuries.
Providing up to $50,000 a year for lost wages and medical expenses, it is capped at $370,376 if a COVID vaccine is fatal. In the last 10 years, of 499 claims, only 29 have been paid, providing more than $6 million. There is a one-year statute of limitations.
Individuals typically injured by vaccines have, in the past, been routed through the National Vaccine Injury Compensation Program (VICP), also known as vaccine court. Its record shows it pays about 70% of claims from 16 routine vaccines over the last decade totaling about $4.4 billion since it began in 1988. The statute of limitations there is three years.
So far, the COVID-19 vaccine is not on its list of covered vaccines.
CNBC: You can’t sue Pfizer or Moderna if you have severe Covid vaccine side effects. The government likely won’t compensate you for damages either.