- Joe Biden extends protection for Pfizer and Moderna against COVID-19 vaccine lawsuits until 2029
- The protection has been extended on the understanding that the coronavirus may become uncontrollable within the next few years
- Victims of vaccine side effects will continue to be unlikely to receive compensation
- Are COVID-19 vaccines safe?
Joe Biden extends protection for Pfizer and Moderna against COVID-19 vaccine lawsuits until 2029
The administration of outgoing US President Joe Biden has quietly extended a pandemic-era provision that protects COVID-19 vaccine makers such as Pfizer and Moderna from any legal action for health problems or deaths caused by the vaccine. Manufacturers will be protected until 2029.
This measure, based on the Public Preparedness and Emergency Preparedness Act (PREP Act), ensures that vaccine developers, healthcare workers, and hospitals remain protected from legal consequences in the event of a claim for damages due to possible vaccine side effects.
In fact, the PREP Act itself was enacted in 2005 as a tool for public health emergencies. Its purpose is to ensure that individuals and organizations supposedly acting solely in the interest of public health are protected from legal action for health damages. The Act provides legal protection for companies and professionals who implement (i.e. manufacture, sell, give to patients, etc.) public health measures such as vaccines, antivirals or other therapies to contain large-scale outbreaks or pandemics[1].
At the start of the COVID-19 pandemic in 2020, US Health and Human Services (HHS) head Alex Azar activated this long-standing act to speed up the development of experimental, never-before-used vaccines. He also wanted to protect pharmaceutical companies, healthcare workers and hospitals from potential lawsuits once the drugs have been developed and used for mass vaccination.
Without this protection, manufacturers could have feared legal repercussions, which would have slowed down the vaccine development process. The PREP Act protected:
- Pharmaceutical companies (e.g. Pfizer, Moderna and Novavax);
- Healthcare professionals (doctors, nurses, pharmacists and other medical staff);
- Hospitals and health facilities that provide COVID-19 vaccines or other medical supplies to fight the pandemic.
The protection has been extended on the understanding that the coronavirus may become uncontrollable within the next few years
Although the current rates of COVID-19 cases and hospitalizations are the lowest since the start of the pandemic, the Biden administration is not concerned. This decision is based on the assertion that there is still a "credible threat" that the COVID-19 pandemic could spread again over the next four years and become uncontrollable[2].
HHS officials believe this measure is necessary to ensure that vaccine production, supply, and vaccination processes continue even during an unexpected outbreak. According to HHS, the main rationale behind the decision is to ensure that pharmaceutical companies are not deterred from developing new vaccines.
The argument is that although the COVID-19 pandemic is currently under control, the situation could change very quickly if new strains of the virus emerge. HHS officials said:
"We have determined that COVID-19 could become such an emergency again in the future, so we are amending this act to be prepared and to mitigate potential risks."
This decision has been met with mixed reviews, especially from the incoming Donald Trump administration, which has already nominated a prominent vaccine skeptic, Robert F. Kennedy Jr., to head HHS. Mr Kennedy Jr. has long been a critic of the indiscriminate use of vaccines and has been active in holding vaccine manufacturers accountable for the side effects of vaccines.
Victims of vaccine side effects will continue to be unlikely to receive compensation
In addition, some Americans are also outraged by the Biden administration's decision to extend protection for vaccine manufacturers until 2029. Some people who claim to have suffered serious health damage after vaccinations now feel abandoned and unable to get justice. Others claim that the decision was taken too quietly, without any wider debate.
However, while the PREP Act protects vaccine manufacturers from lawsuits, individuals who have suffered serious health problems caused by vaccines still have access to compensation through special programs. However, this option is very limited.
If a person's health has been affected by the COVID-19 vaccines, he or she can apply to a special injury compensation program (CICP) in the USA. This program is designed to compensate people who claim to have been injured as a result of certain medical interventions, such as vaccines, treatments, or antiviral drugs. However, the CICP works differently from the Vaccine Injury Compensation Program (VICP), which covers other standard vaccines.
The CICP reimbursement program has been heavily criticized because, unlike the VICP, it has no upfront budget and limited payments. In addition, to be reimbursed, it is necessary to prove that the injury was directly linked to the vaccine, which is often challenging to do.
The protection of the PREP Act does not apply only to cases where individuals or companies act deliberately irresponsibly or intentionally ignore medical advice. This is known as "willful misconduct". If it is proven that a person acted deliberately to harm a patient or disregarded safety protocols, he or she may be held legally liable. However, proving this is also difficult, so pharmaceutical companies and medical professionals remain immune.
Of course, the pharmacists themselves are happy with the current situation. For example, Dr Michael Hogue, CEO of the American Pharmacists Association, said that the decision "will continue to save lives and reduce healthcare costs, especially in rural and underserved areas where the local pharmacy may be the only healthcare provider for many miles".
Are COVID-19 vaccines safe?
COVID-19 vaccines, from their inception to the present day, are generally described as being exceptionally safe and effective. However, over time, more and more information has become available, both on the potentially serious side effects and on the fact that the vaccines have not been as effective as expected.
According to the CDD, one in 200,000 vaccinated patients develops allergic reactions or heart problems.
People can develop health problems such as myocarditis and pericarditis (heart muscle inflammation). Postural Orthostatic Tachycardia Syndrome (POTS), which was experienced by Karoline Stancik, a 24-year-old National Guard specialist, has also been cited as an exceptional side effect. She said she had three minor heart attacks after the vaccine and now lives with a pacemaker.
According to official US data, more than 13,000 claims have been submitted to HHS so far for side effects caused by COVID-19 vaccines. Of these, as many as 10 000 are still pending review. This shows that the system is facing a heavy workload and that the processes are extremely slow. As of 2020, only about 3,000 cases have been reviewed.
77 reminds us that, as Mr. Biden's term of office draws to a close, he is resorting to a variety of questionable and criticized actions. For example, although the politician had previously sworn that his son would be tried per US law and that he would not interfere in the whole process, Biden recently pardoned his own son, who was on trial for illegal weapons and drugs.
