What’s concerning is that the vaccine manufacturers, who have not had the time for human trials, have received a green signal for fall.
Let’s explore the details of the news with Ehline Law and our personal injury attorneys.
The Biden Administration is pushing for a booster campaign to start in September, putting a lot of heat on mRNA vaccine-makers Pfizer and Moderna.
The new covid vaccines have only been tested on mice without going through human trials. It is a risky bet for the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention, relying on mice trials and similar vaccine human trial data.The original vaccines went through human clinical trials at the NIAID’s vaccine research center before being available to the public.
The Covid-19 vaccine campaign in the United States was met with people who accepted the vaccine and the “anti-vaxxer,” who started their own social media campaign against the horrors of vaccination.
A few death cases arising from health complications after receiving vaccines further cemented anti-vaxxers’ narrative and lowered public trust, especially for booster doses.
Federal Health officials hope the new boosters would provide stronger protection than the current booster doses while targeting the original strain. However, the lack of human trial data means that the FDA does not know whether the new vaccines will be more effective than the current or the health impact they may have on the vaccinated.
Many experts believe that the FDA’s decision to move forward without conducting human trials is risky. If the booster doses do not work as intended, it could be a severe dent in public trust.
According to Dr. Celine Gounder, an infectious disease specialist, there is no reason to believe that the new vaccines might be unsafe. However, he remains skeptical whether it will be better than the current vaccines.
Barouch, the Johnson & Johnson vaccine maker, reported their boosters only had a marginal improvement in immune response over the original vaccine.
It is important to remember that the FDA authorized the first version of mRNA vaccines after assessing safety and efficacy data based on the thousands of human trials conducted. The new mRNA vaccines would target the original strain and BA.4 and BA.5 omicron subvariants.
Supporters of this controversial move believe that vaccine manufacturers have had a lot of experience in the past two years to deem the new vaccines safe without the need for human data.
Dr. Ofer Levy, infectious disease specialist and an advisor to the FDA, argued that the death rate from coronavirus is more likely to jump during fall and winter. By implementing this approach, the FDA can prevent the severe disease from spreading.
The urgency of rolling out the new vaccines arises from the concern of the nation’s top health executives.
Heather Scobie, a CDC epidemiologist, spoke about how deaths and hospitalizations in the country have risen again. He stated that the omicron variant continues to mutate into more transmissible subvariants capable of avoiding the protection offered by original vaccines.
Because of rapid mutations, concerns arise about the waning effectiveness of the older vaccines, which could lead to an increase in hospitalizations and deaths, especially with how people will spend most of their time indoors during winters, an environment for the virus to spread swiftly.
Not everyone believes that the decision made by the FDA to roll out vaccines after only conducting mice trials would benefit the country.
John Moore, an immunologist at Weill Cornell Medicine, finds it bizarre that the FDA is relying on animal studies as these are not predictive of the effects of the vaccine in humans.
According to Moore, the FDA is just making guesswork rather than basing its decision on analysis and consultation with experts.
Deepta Bhattacharya, an immunobiologist, takes a somewhat logical approach to the argument.
Speaking with NPR, he stated that health officials now understand vaccine development and how to work with them. Bhattacharya further said that flu vaccine manufacturers change their vaccine each year to match the latest strain but do not conduct yearly trials; the same is the case with Covid vaccines now. Researchers are handling it just like they would any flu vaccine.
Dr. Peter Marks, responsible for heading the FDA department that reviews vaccines, backed the organization stating it is confident and has the experience to predict the effectiveness of the vaccines from available data using animal testing and without clinical trials.
The two mRNA vaccine manufacturers, Pfizer and Moderna, initially focused on developing a vaccine with original spike protein targeting the omicron variant BA.1, responsible for many hospitalizations and deaths in the winter of 2021.
The rapid evolution of the Covid virus has made it challenging for manufacturers to keep up with it. By the time the mRNA vaccine manufacturers decided to ready the vaccines, more transmissible subvariants had driven the BA.1 booster out of prevalence.
The FDA requested the manufacturers to focus on targeting omicron BA.5, the latest dominant subvariant.
Such a decision did not allow mRNA vaccine manufacturers enough time to carry out clinical trials for their bivalent vaccines if they were to roll out the vaccines by fall to help prevent hospitalizations and deaths.
In 2005, the president of the United States signed the Public Readiness and Emergency Preparedness Act or PREP Act which provides legal protection to manufacturers and distributors of vaccines in the country, unless in the event of willful misconduct. It was a way to expedite vaccine development for infectious diseases.
Under PREP Act, there is no party you can blame in the US court of law. Simply put, you cannot sue the manufacturer or distributor for your vaccine side effects.
What about the government? Can you sue them then, as many are also concerned about whether or not they can sue the Food and Drug Administration for side effects as they authorized the release of the vaccine without human clinical trials?
Because of sovereign immunity, you cannot sue the FDA as well!
Many businesses are making it mandatory for all their employees to get the covid-19 vaccine. Employers legally have the right to impose such a requirement on their employees, which means you cannot pursue legal action against your employers for any side effects of the vaccine you were “forced” into taking.
Workers can seek protection under anti-discrimination laws such as the Americans with Disabilities Act, which exempts workers from getting a vaccine if it violates their “sincerely held” religious beliefs.
In cases where an employee suffers severe side effects from a work-mandated Covid vaccine, they may be able to apply through the workers’ compensation program, treating the side effects as a work-related injury. Still, there are significant limits on the FDA authorization of damages one can recover.
That said, governments have provided a way to recover some damages if anything were to go wrong following immunization to both the original strain and Omicron BA.1. Under the PERP Act, Countermeasures Injury Compensation Program allows eligible individuals to recover benefits up to a specific limit based upon their human data and how it affected their human cells. After all, it’s all mouse data!
However, it can be challenging to recover under the program as the bar for evidence is relatively high, which can be an obstacle for those affected by Covid vaccine side effects as compelling evidence how it will infect cells is not available early on.
In some cases, it may be easier to recover compensation under the workers’ compensation program if you contract side effects. To know more about your rights, contact us at (833) LETS-SUE for a free consultation with our legal experts.