[ad_1]
Moderna’s vaccine has become the second approved Coronavirus vaccine according to Pfizer-BioNTech. The green light was granted by the U.S. Advisory panel to the Food and Drug Administration (FDA) on Thursday (December 17). The 20-0 decision with one abstention, issued by the FDA’s Advisory Committee on Vaccines and Related Biologics, came exactly one week after Pfizer got its approval.
Dr Michael Kurilla, the only member who did not vote in favor, explains his decision to abstain: “In the midst of a pandemic and with a limited supply of vaccines, a blanket statement for people over 18 is too broad. I am not convinced for all those age groups, the benefits outweigh the risk. “
Both Pfizer and Moderna vaccines are built from genetic material called “mRNA” or messenger RNA vaccines, a new technology that has never been licensed in the US before.S. These vaccines are not like a regular flu vaccine. However, Pfizer and Moderna have claimed 95% and 94% effectiveness.5% respectively. Both vaccines have side effects, Of course.
Now that there are two FDA-approved Covid-19 vaccines, can you really sue Pfizer or Moderna or even the government if you suffer serious side effects after getting the vaccine? Unfortunately, you will take the vaccine in your own risk. That means you can’t sue the drug companies, much less the United States.S. federal government in the U.S. Justice Court.
If you cannot sue Pfizer, Moderna or the U.S. government, common sense says you can’t sue your own government (assuming you do not reside in the United States). The reason you can’t sue American drug manufacturers is because the U.S. the government has granted them “Immunity from liability” – if something accidentally goes wrong with your shots.
April 8, 2020, USA Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a emergency Statement that allows pharmacists to become the so-called people covered by the PREP Act and that allows them to acquire, dispense and administer the vaccine against the Coronavirus disease 2019 (COVID-19) when it is commercially available without risk of liability.
The 2005 law, when invoked by HHS Secretary Alex, was intended 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” on the part of the company.
Under the Trump administration, the scope of the PREP Law (Public Preparedness and Emergency Preparedness Act) was expanded on December 3, 2020 to include Covid-19. The official amendment means that vaccines developed by companies like Pfizer and its German partner BioNTech, which they claim to be safe and effective, are protected from liability.
It is worth noting that the approvals given by the FDA are under the US (Emergency Use Authorizations), NOT a “Full approval.” Unlike a full approval for other vaccines, which underwent extensive testing and trials in order to produce more data, the FDA allows Pfizer and Moderna’s Covid-19 vaccines to be used while the agency continues to evaluate the data.
Therefore, you cannot sue the FDA for authorizing a vaccine for “emergency use.” Because the immunity granted to pharmaceutical companies under the PREP Act will last until October 1, 2024, neither Moderna nor Pfizer can be sued for money damages in court for next 4 years. It also provides sufficient time for the FDA and drug manufacturers to collect data on “guinea pigs.”
Another reason you can’t sue the FDA, which is a government agency since 1906, it is because the FDA enjoys sovereign immunity. That means that even if the coronavirus vaccines were not approved by the US, you still cannot sue the FDA, even if the agency has wrongly approved the vaccines. It was like the sovereign or diplomatic immunity enjoyed by foreign embassies and consulates.
Interestingly, the principle of sovereign immunity in the United States.S. the law was inherited from the English common law legal maxim “rex non potest peccare”, which means “The King can do nothing wrong”. This refers to the British law before the American Revolution (1765-1783), caused by tensions between the 13 North American colonies of Great Britain and the colonial government, which represented the British crown.
In fairness to drug makers, it wasn’t their idea in the first place rush the vaccine in record time. The Trump administration’s ambitious “Operation Warp Speed” was to create a vaccine for the virus before the end of the year, despite experts warning that it takes at least 18 months to do so. The fastest vaccine developed to date has been for mumps, and that took 4 years.
By comparison, Pfizer’s Covid-19 vaccine was developed and approved for emergency use in a mind-blowing 8 months. This is why even Americans do not trust vaccines developed by their own companies. According to a recent Gallup poll, many Americans, especially people of color, still skeptical about getting a Covid-19 vaccine.
The latest data, based on a survey conducted from October 19 to November 1, shows that 42% of Americans deny Getting a Vaccine – A significant challenge ahead of the government’s plan to achieve mass public compliance. Another survey by the Pew Research Center similarly shows that 4 in 10 Americans say they would not get the Covid-19 vaccine.
The main reason was the “Urgent chronology” for the development of the Covid vaccine, 37% of Americans said they would not receive the vaccine. Another 26% say they want to wait to confirm that the vaccine is safe. About 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% of Americans revealed that they want to wait to see how effective the vaccine will be. This group is perhaps the smartest, expecting others to be the guinea pig First. Although companies like Pfizer insist that “no corners have been cut,” the huge trust gap suggests that people were smarter than playing with their lives.
The statutory immunity granted to pharmaceutical companies was also necessary to help reduce the cost of the immunization program. If the government doesn’t protect drug makers from potential lawsuits, not only will they not be able to develop a vaccine in just eight months, but they will also charge a fee. highest price or a premium per dose to cover the risk of being sued.
In short, it can be said that the granting of coronavirus vaccines to be used by the general public at this stage can be seen as an experiment on Lab rats (that’s you). Still, there is a way to recover some damages if something goes terribly wrong with the vaccine. The same PREP Act that provides legal immunity to drug manufacturers has a program called CICP.
CICP (Countermeasures Injury Compensation Program) is an HHS program that provides benefits to individuals who suffer serious injuries as a result of the administration or use of a covered countermeasure. However, it is extremely hard to win. Of the 499 claims submitted, CICP has cleared only 29 claims (5% success rate) in the last 10 years for a total amount of more than $ 6 million.
To make matters worse, CICP was designed to provide compensation to eligible individuals who suffer serious injuries, such as those from H1N1, smallpox, botulism, or anthrax vaccines – something they would never get anyway. The program provides up to US $ 50,000 per year in unreimbursed lost wages, or in the event of death: only US $ 365,670.
Obviously, suffering side effects as a result of receiving the Covid-19 vaccines is almost impossible to justify under the CICP program. Proving that an injury is a direct result of the coronavirus vaccine is already difficult. To make matters worse, any claim must be made within the 1 year period or 12 months upon receiving the vaccine. But what if the side effects or injury appear after 1 year?
The alternative could be to claim for injuries caused by the Covid vaccine through another HHS program called the National Vaccine Injury Compensation Program (VICP). The success rate is around 70% and since 1998 the VICP has paid a staggering $ 4.4 billion in total compensation. But there is a big problem: Covid-19 vaccines are
TWITTER FINANCE
.
[ad_2]
