Moderna’s vaccine has become the second approved Coronavirus vaccine after Pfizer-BioNTech. The green light was granted by the U.S. Food and Drug Administration (FDA) advisory panel on Thursday (Dec 17). The 20-0 with one abstention decision, delivered by the FDA’s Vaccines and Related Biological Products Advisory Committee, came exactly 1-week after Pfizer got its approval.

 

Dr. Michael Kurilla, the only member who did not vote yes, explains his decision to abstain – “In the midst of a pandemic and with limited vaccine supply, a blanket statement for individuals for 18 years and older is just too broad. I’m not convinced for all of those age groups the benefits do actually outweigh the risk.”

 

Both Pfizer and Moderna’s vaccines are built based on genetic material called “mRNA” or messenger RNA vaccines – a new technology that’s never before been licensed in the U.S. These vaccines are not like a normal flu vaccine. However, Pfizer and Moderna have claimed effectiveness of 95% and 94.5% respectively. Both vaccines have side effects, of course.

Now that there are two Covid-19 vaccines approved by the FDA, can you actually sue Pfizer or Moderna or even the government if you suffer severe side effects after taking the jab? Unfortunately, you will take the vaccine at your own risk. That means you can’t sue the pharmaceutical companies, let alone the U.S. federal government in a U.S. court of law.

 

If you can’t sue Pfizer, Moderna or the U.S. government, common sense says you can’t sue your own non-U.S. government (assuming you do not reside in America). The reason you can’t sue the American drug makers is because the U.S. government has granted them “immunity from liability” – if something unintentionally goes wrong with their vaccines.

 

On April 8, 2020, the U.S. Department of Health and Human Services (HHS) Secretary Alex Azar issued an emergency declaration allowing pharmacists to become so-called covered persons under the PREP Act and allowing them to procure, dispense, and administer the Coronavirus disease 2019 (COVID- 19) vaccine when it becomes commercially available without risk of liability.

The 2005 law, when invoked by the HHS Secretary Alex, was meant to provide legal protection to companies involved in the development, manufacture, testing, distribution, administration, and use of critical medical supplies, such as vaccines and treatments, unless there is “willful misconduct” by the company.

 

Under Trump administration, the scope of the PREP Act (Public Readiness and Emergency Preparedness Act) was expanded on 3 Dec, 2020 to include Covid-19. The official amendment means vaccines developed by companies like Pfizer and its German partner BioNTech, of which they claim to be safe and effective, are shielded from any liability.

 

It’s worth noting that the approvals granted by the FDA are under EUA (Emergency Use Authorizations) – NOT a “full approval”. Unlike a full approval for other vaccines, which had gone through extensive testing and trials to be able to produce more data, FDA allows Pfizer and Moderna’s Covid-19 vaccines to be used while the agency continues to evaluate data.

Therefore, you can’t sue the FDA for authorizing a vaccine for “emergency use”. Because the immunity granted to pharmaceutical companies under the PREP Act will last until 1 Oct, 2024, neither Moderna nor Pfizer can be sued for money damages in court for the next 4 years. It also provides sufficient time for the FDA and the drug makers to collect data from the “guinea pigs”.

 

Another reason you can’t sue the FDA, which is a U.S. government agency since 1906, is because FDA enjoys sovereign immunity. That means even if the Coronavirus vaccines were not approved under EUA, you still can’t sue the FDA – even if the agency has wrongly approved the vaccines. It was like sovereign or diplomatic immunity enjoyed by foreign embassies and consulates.

 

Interestingly, the principle of sovereign immunity in the U.S. law was inherited from the English common law legal maxim “rex non potest peccare” – meaning “the King can do no wrong”. This refers to the British law before the American Revolution (1765-1783), triggered from tensions between Great Britain’s 13 North American colonies and the colonial government, which represented the British crown.

To be fair to the drug makers, it was not their idea in the first place to rush the vaccine in record time. It was the Trump administration’s ambitious “Operation Warp Speed” to create a vaccine for the virus by the end of the year, even though experts warned that at least 18 months is needed to do so. The fastest vaccine developed to date has been for mumps, and that took 4 years.

 

In comparison, Pfizer’s Covid-19 vaccine was developed and cleared for emergency use in mind-boggling 8 months. This is the reason why even Americans do not trust vaccines developed by their own companies. According to a recent Gallup survey, many Americans – especially people of colour – are still skeptical about getting a Covid-19 vaccine.

 

The latest data, based on a survey conducted from Oct 19 to Nov 1, shows 42% of Americans refuse to get a vaccine – a significant challenge ahead of the government’s plan in achieving mass public compliance. Another survey done by the Pew Research Centre similarly shows 4 in 10 Americans say they would not get the Covid-19 vaccine jab.

The top reason was the “rush timeline” for the development of the Covid vaccine, said 37% of the Americans who would not get the vaccine. Another 26% say they want to wait to confirm the vaccine is safe. Some 15% cite other reasons, including the belief that vaccination is not necessary. An additional 12% said they don’t trust vaccines in general.

 

At least 10% Americans revealed they want to wait to see how effective the vaccine will be. This group is perhaps the smartest – waiting for others to be the guinea pig first. Even though companies like Pfizer insists “no corners have been cut”, the huge trust gap suggests that people were smarter than to gamble with their lives.

 

The legal immunity granted to pharmaceutical companies was also necessary to help lower the cost of the immunization program. If the government does not protect the drug makers from potential lawsuits, not only will they not be able to develop a vaccine as quickly as eight months, but also will charge a higher price or a premium per dose to cater for risk of being sued.

In a nutshell, you can say the granting of the Coronavirus vaccines to be used by the general public at this stage can be considered as an experiment on lab rats (that’s you). Still, there is a way to recover some damages should something go terribly wrong with the vaccine. The same PREP Act that provides legal immunity to drug makers has a program called CICP.

 

CICP (Countermeasures Injury Compensation Program) is a program under HHS that provides benefits to individuals who are seriously injured as a result of the administration or use of a covered countermeasure. However, it’s extremely hard to win. Of the 499 claims filed, the CICP has compensated only 29 claims (5% success rate) in the past 10 years for a total amount of more than US$6 million.

 

To make matters worse, CICP was designed to provide compensation to eligible individuals who suffer serious injury, such as those from H1N1, smallpox, botulism or anthrax vaccines – something that you would never get anyway. The program provides up to US$50,000 per year in unreimbursed lost wages, or in the case of death – only US$365,670.

Obviously, suffering side effects as a result of getting Covid-19 vaccines is near to impossible to justify under the CICP program. It is already difficult to prove an injury is a direct result of the Coronavirus vaccine. To make it worse, any claim must be made within 1 year period or 12 months upon receiving the vaccine. But what if the side effects or injury appears after 1 year?

 

The alternative could be to claim for Covid vaccine injuries through another program under the HHS called the National Vaccine Injury Compensation Program (VICP). The success rate is about 70% and since 1998, the VICP has paid a jaw-dropping US$4.4 billion in total compensation. But there’s one huge problem – Covid-19 vaccines are not in the VICP list.

 

Other Articles That May Interest You …

• The FDA Says Pfizer Vaccine Is Safe & Effective – But There’re Many Horror Stories, Including Allergy Warning
• Here’s Why You Should Not Rush To Get A Covid-19 Vaccine – Even After Britain Approved Pfizer Vaccine
• Mistake Or Cheating? – AstraZeneca-Oxford Admits Manufacturing Error In Its Vaccine Effectiveness Results
• AstraZeneca-Oxford Vaccine Shows 62% To 90% Effectiveness – Here’s Why This Could Be The Best Bet For Everyone
• Moderna Reveals Covid Vaccine – Here’s How This 94.5% Effective Vaccine Differs From Pfizer’s Vaccine
• Coronavirus – Here’s How China Is Back To Normal While The U.S. And Europe Are Getting From Bad To Worse
• Russia Reveals “Sputnik V” – But Scientists Condemn The Coronavirus Vaccine As Risky, Dangerous & Could Backfire
• 3 Coronavirus Variants Discovered – Surprisingly, “Type-A” Found In Americans, Wuhan’s Type-B And Type-C In Europe
• The World Is Working On 20 Coronavirus Vaccines – But It Could Take Up To 18 Months
• China Appears To Be Winning The Coronavirus War, And Other Countries Are Studying How The Chinese Did It
• Arabs Conspiracy Theories – Coronavirus Is The U.S. & Israel Biological Warfare To Cripple China’s Economy & Reputation

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December 18th, 2020 by financetwitter

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