Why Pfizer And Moderna Can’t Be Sued For Covid Vaccine Side Effects

You’re looking at video of Sandra Lindsay, an intensive care nurse, receiving the first vaccination at Long Island Jewish Medical Center in New York. The U.S. began vaccinating the population against the coronavirus in December of 2020. The goal is to get the Covid vaccine to every person in the U.S. who wants one. But survey data shows that nearly 40% of the U.S. population doesn’t want it.

Widespread mistrust might have something to do with the fact that if anything goes wrong with the vaccine, the drug makers that produce them aren’t responsible. This is a remarkable circumstance. It’s certainly not like anything anybody’s ever seen before. That means that companies like Pfizer and Moderna have total immunity against lawsuits related to injuries resulting from taking the Covid vaccines. Meanwhile, employers are legally allowed to require employees to get immunized against the virus. Requiring a vaccine is a health and safety work rule and employers can do that. Ultimately, if we want any chance and returning to life is normal, mass vaccination is going to be critical. So how do you convince the public to take a vaccine made in record time, using technology that’s never before been licensed? And is anyone to blame if something goes wrong? Frontrunners Pfizer and Moderna built their Covid vaccines with a new kind of technology that’s never before been licensed in the U.S. Typically a vaccine puts a weakened or inactivated virus into our bodies to trigger an immune response.

But the coronavirus vaccine relies on messenger RNA, which contains a piece of genetic code with instructions for our body. The mRNA tells our cells to make a protein. The same protein that’s a spike on top of the actual Coronavirus. This is what triggers the immune response to Covid-19, which then produces antibodies. Those antibodies are what ultimately protect us from getting infected if we ever encounter the real thing. Both companies have said that taking their vaccines could result in side effects similar to mild covid symptoms like muscle pain, chills and a headache. Even those side effects of the vaccine resemble Covid-19 symptoms, it’s impossible to contract the coronavirus from the vaccine because the mRNA vaccines that Pfizer and Moderna are making don’t use the live virus. I experienced stiffness pain in my left arm where I had gotten the vaccine, but it was mild. The second dose was a different story for Batalvi.

After the injection, I had the same side effects as the first. So the localized pain, stiffness, there was a little bit worse. More significant symptoms presented that evening. I had developed a low grade fever and stuff associated with that. So the fatigue had worsened. I had gotten chills. Other trial participants from both the Pfizer and Moderna studies have reported similar issues after the second shot. One Pfizer trial participant told CNBC that after the booster shot, he woke up with chills, shaking so hard he cracked a tooth. For him, it hurt to even just lay in his bed sheet. But this kind of reaction isn’t the norm. Both of these vaccines are about 95% effective, but it’s still unclear how long this protection lasts, which is what worries some doctors more than the potential for any sort of long-term side effects. There is a concern that once the initial response against the vaccine wanes, that we might see more disease.

And that is why all the Phase 3 clinical trials against Covid continue to run, even after demonstrating the early efficacy. One major benefit of the mRNA technology is how quickly it can be developed. And that is one of the reasons why the messenger RNA technology was sort of first in line right after knowing the virus’ genetic sequence. But the Covid vaccine’s faster manufacturing timeline is part of what has been fueling widespread fear that it’s unsafe to get the shot.

Experts, however, say the process was no less rigorous than usual. A lot of the steps that would occur in sequence in the past, has been occurring in parallel during Covid, but they were not eliminated in terms of determining the safety of the vaccine. The FDA may have cleared the Pfizer/BioNTech vaccine for emergency use. But mass adoption? It’s not guaranteed. Roughly 4 in 10 Americans say they would “definitely or probably not” get a vaccine.

While this is lower than it was two months ago, to achieve herd immunity, experts say that about 70% of the population needs to be vaccinated or have natural antibodies. Central to closing the trust gap is a robust and reliable national education campaign. The Department of Health and Human Services is slated to spend $250 million in taxpayer money on this effort. But this push by the federal government to educate the public has been plagued by controversy.

For everything from allegedly trying to politicize the message, to concern over the lengthy delay and rolling out the targeted messaging that was promised. At least 15 states told NBC News in early December, they weren’t waiting for the HHS campaign. Instead, they launched their own communication campaigns to expedite the message. The private sector is also playing a big role. It’s everyone’s responsibility. And what we do know is that pharmacy and pharmacists are actually in everyone’s community. We have pharmacists who are within 5 miles of probably 90% of Americans. Really, pharmacists are up there as one of the most trusted health care professionals. And the survey recently said that 3 of 4 Americans basically said they trust pharmacists to administer their Covid-19 vaccine. Closing the Covid vaccine trust gap will prove especially difficult in communities of color, which have been hit hardest by the pandemic. Black Americans, for example, are dying from Covid-19 it almost 3 times the rate of White Americans in the U.S.

That’s part of why federal health officials have talked about giving priority access to the vaccine to people of color. But there is an overwhelming resistance to inoculation. A survey released at the end of November 2020, found that only 14% of Black Americans “mostly or completely trust” a Covid vaccine will be safe and 18 % trust that it will be effective in shielding them from the Coronavirus. We’ve had continued mistrust because of people who have been frankly abused within the health care system. Not treated respectfully, not approaching a culturally competent manner, denied access to care. Experts say the memory of the Tuskegee Syphilis Experiment has also fueled suspicion. For 40 years, starting in 1932, the U.S. Public Health Service used Black men to conduct a study of the progression of the lethal Syphilis disease. And because of racism, overt racism and even microinsults that have occurred to people of color in the health system. You know, people developed a degree of mistrust. Combating this narrative may take a more targeted approach.

The National Medical Association, of which Benjamin is a member, is convening a group of Black doctors for an expert task force that will independently assess the safety and efficacy of Covid-19 vaccines. We know that patients trust their doctors, and many of the surveys have shown that if their physician recommends it, they are much more likely to take the vaccine. If you suffer severe side effects after getting the vaccine, there’s basically no one to blame in a U.S. court of law. Take the vaccine makers. Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act in February of 2020, which protects the makers of Covid products such as vaccines and treatments from legal action. This protection lasts until 2024. Essentially, in order to encourage companies to get into the space, to develop vaccines for the good of the public, for public health. The government comes up with a program which immunizes those companies from liability for any injuries or damages caused by taking the vaccine.

That means for the next four years, companies like Pfizer and Moderna can’t be sued for money damages in court over injuries related to the administration or use of products to treat or protect against Covid-19. But drug makers, like Pfizer, continue to reassure the public no shortcuts were taken. This vaccine is getting approved by all authorities in the world, so that should say something to them. Pfizer and Moderna did not return CNBC’s request for comment on their legal protections. But remember, it was the FDA that actually cleared the vaccine for use. So does the federal government bear any responsibility? You can’t sue the FDA for approving or disapproving a drug, that’s part of its sovereign immunity.

Sovereign immunity traces back to British law before the American Revolution. You couldn’t sue the king. The U.S. adopted that same principle. There are limited exceptions, but legal experts say they don’t provide a viable legal path to hold the government responsible for a Covid vaccine injury. And the workplace now introduces a unique set of legal challenges related to the vaccine. Once the FDA upgrades its emergency authorization to a full approval in a few months from now, there’s speculation that employers could require staff to get inoculated. The clients of mine that are most interested in making a mandatory vaccine a condition of employment are brick and mortar operations that have a lot of foot traffic from their customers. They view it as a selling point. Look, you can come to our business location and it’s safe because all employees have been vaccinated.

That’s particularly important for restaurants, bars, gyms and salons. While this is in part a PR tactic, it is also legally within an employer’s rights to roll out this kind of requirement. Requiring a vaccine is a health and safety work rule and employers can do that. Now, some employees could apply to be exempt from a blanket requirement. If a workforce is unionized, the collective bargaining agreement may require negotiating with the union before mandating a vaccine. Anti-Discrimination laws also provide some protections, but legal experts say that if an employee is forced to get a vaccine and suffers a debilitating injury from it, claims would be routed through workers compensation programs and treated as an on the job injury. So if you’re looking for accountability, you’re probably going to have to use other accountability tools beside the court. If you’re looking for compensation, you should use a government compensation program. The National Vaccine Injury Compensation Program, better known by the name “Vaccine Court”, is relatively easy to use and generous in terms of what it’s willing to pay out to those who are eligible.

But because the Covid vaccine has not yet been recommended for routine administration to pregnant women or children, it doesn’t qualify. Another program, and the only real pool of cash available to those harmed by the Covid vaccine is a fund attached to the PREP Act. The so-called Countermeasures Injury Compensation Program has been around for a decade, but experts specializing in vaccine law say it’s a lot more difficult to navigate. The problem with the PREP Act is that it’s attached to a government compensation program that’s very hard to use, where the bar for compensation is very high.

Since the program began 10 years ago, the CICP has only compensated 29 claims, totaling more than $6 million. If a case for compensation through the CICP is successful however, the program provides up to $50,000/year for reimbursed lost wages and any out-of-pocket medical expenses. It won’t cover legal fees nor anything to compensate for pain and or suffering. It’s also capped at the death benefit of $370,376, which is the most that a surviving family member receives in the event that a Covid vaccine proves to be fatal.

There’s also a strict one year statute, meaning that all claims have to be filed within 12 months of getting the vaccine. People who are harmed by Covid-19 vaccine deserve to be compensated. Compensated fast and generously. The PREP Act doesn’t do that. The HRSA declined CNBC’s request for an interview. Reiss says the best fix is to change the rulebook of the National Vaccine Injury Compensation Program. An easy solution is to say: “Anyone harmed by the Covid-19 vaccine is compensated under that program. But that will require legislative change.

Should that legislative change happen, lawyers tell CNBC that there usually is a retroactive provision once a new vaccine is added to the VICP. That would be good news for those injured by the Covid vaccine, who would then have access to a much larger pool of cash that has a better track record for rewarding compensation. But for now, it remains to be seen whether Congress will actually make the change, meaning that compensation options are limited. I’m hoping people don’t look at this and say: “Heck, I’m limited in what I can recover in the event of a serious injury or the event of any injury.

So I’m not going to take it or it’s not overreaching by the government whatsoever. It’s the government doing what it should be doing, which is protecting the public health, generally..

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