ainitfunny
Saved, to glorify God.
Barrons
www.barrons.com
CORONAVIRUS
Serious Vaccine Side Effects Are Rare. Compensation for Those Injuries Shouldn’t Be.
By Arthur L. Caplan and Dorit R. Reiss
Updated Sept. 17, 2021 8:45 am ET / Original Sept. 17, 2021 5:30 am ET
Nurses prepare doses of the Pfizer Vaccine for patients.
Lauren DeCicca/Getty Images
About the authors: Arthur L. Caplan is professor of bioethics and the founding head of New York University School of Medicine’s Division of Medical Ethics. Dorit R. Reiss is a professor of law, James Edgar Hervey ’50 chair of litigation, at the University of California Hastings College of Law.
As we see Covid-19 cases and deaths rising, many states, cities, and now the federal government are reaching for vaccine mandates. Even where the political climate is unfriendly to mandates, governments are, rightly, trying to increase Covid-19 vaccines rates.
Covid-19 vaccines are extremely effective, and very safe. They are an essential part of controlling the pandemic. But the other side of their use is that the extremely rare cases of severe harms from the vaccines deserve to be fully, quickly, and generously compensated. A nation that demands vaccination owes that to anyone who is harmed. It’s the right thing, and it’s good policy.
Covid-19 vaccines are currently covered by a declaration under the Public Readiness and Emergency Preparedness Act that protects manufacturers of any Covid-19 related products from liability, with very narrow exceptions. The liability protections are there for a reason: During an emergency, we want products on the market fast, and liability protections can allow companies to move forward on products faster than they could otherwise.
Vaccine safety review normally involves multiple rounds of increasingly large trials that monitor patients for months to ensure there are no unexpected side effects. Vaccine trials enroll more subjects than drug studies and seek diversity of subjects. This takes time, during which there is no vaccine to prevent the disease. Vaccines are held to that high bar because they are given to many healthy people, and it is a particular ethical problem to make a healthy person sick.
But in the midst of an outbreak or pandemic, there is good reason to move faster. Many people who are healthy now are likely to become sick in the absence of vaccine. In an emergency, the risk-benefit calculation may be different than in usual times: Waiting can carry heavy risks. At its peak, Covid killed thousands of people each day in the United States. Where normally regulators would consider a 1:10,000 risk of severe harm in vaccines unacceptable, when thousands are dying each day, we may not be willing to wait to be sure there is no such risk.
But the other side of protecting manufacturers from liability should be providing compensation to those harmed. For vaccines, that’s even more crucial. Vaccines fill two purposes: They protect the individual directly, and they also protect the public by reducing transmission of a virus (or bacteria) and reducing disease for the entire community. People who take the vaccine are contributing to public health (while also benefiting themselves). The people who suffer very rare cases of injury should not be left to bear the costs alone for a public good.
Hundreds of millions of doses of Covid-19 have been administered in the U.S. without serious side effects. But there have been very rare cases of harm: severe blood clots from the Johnson & Johnson vaccine, myocarditis in young adults from the mRNA vaccines. While exceedingly uncommon, those harms have a dramatic impact on the families involved. They should be financially compensated—fast and generously.
But the program the United States provides under the PREP Act is not generous. Quite the opposite. The Countermeasures Injury Compensation Program has a high bar for proving causation, requiring “compelling, reliable, valid, medical and scientific evidence.” It is a program of last resort, not paying if there are other sources of compensation. It is hard to use. It does not cover lawyer fees.
And we have an alternative. The Vaccine Injury Compensation Program has a much lower burden of proof, covers lawyer fees and litigation costs, and has a history of making careful decisions.
However, in order to move Covid-19 vaccines cases to the VICP, legislation is needed that will, among other things, create an excise tax on the vaccines to cover the cost. Right now, cases alleging harm from COVID-19 vaccines cannot reach the VICP; the narrower countermeasures program is their only forum.
Congress can and should move Covid-19 vaccines under the VICP. It’s the right thing to do: The rare families who suffered severe impact from Covid-19 vaccines should not be left to bear the costs alone, since vaccinating helps all of us. These families deserve to have their costs covered. It’s good policy: It can give people more confidence in vaccinating, knowing that in the unlikely case that something happens, there will be compensation. It’s an important complement to rapidly increasing the use of mandates. If work or access to higher education depends on being vaccinated, our government should compensate the rare cases of harm. And, not unimportantly, it will take away an anti-vaccine talking point.
Congress should act now to place Covid-19 vaccines under the VICP.
Guest commentaries like this one are written by authors outside the Barron’s and MarketWatch newsroom. They reflect the perspective and opinions of the authors. Submit commentary proposals and other feedback to ideas@barrons.com.
Serious Vaccine Side Effects Are Rare. Compensation for Those Injuries Shouldn’t Be.
A simple principle: Anyone legitimately harmed by a vaccine should be compensated swiftly and generously. That's not how it works right now, write Arthur L. Caplan and Dorit R. Reiss.
Serious Vaccine Side Effects Are Rare. Compensation for Those Injuries Shouldn’t Be.
By Arthur L. Caplan and Dorit R. Reiss
Updated Sept. 17, 2021 8:45 am ET / Original Sept. 17, 2021 5:30 am ET
Nurses prepare doses of the Pfizer Vaccine for patients.
Lauren DeCicca/Getty Images
About the authors: Arthur L. Caplan is professor of bioethics and the founding head of New York University School of Medicine’s Division of Medical Ethics. Dorit R. Reiss is a professor of law, James Edgar Hervey ’50 chair of litigation, at the University of California Hastings College of Law.
As we see Covid-19 cases and deaths rising, many states, cities, and now the federal government are reaching for vaccine mandates. Even where the political climate is unfriendly to mandates, governments are, rightly, trying to increase Covid-19 vaccines rates.
Covid-19 vaccines are extremely effective, and very safe. They are an essential part of controlling the pandemic. But the other side of their use is that the extremely rare cases of severe harms from the vaccines deserve to be fully, quickly, and generously compensated. A nation that demands vaccination owes that to anyone who is harmed. It’s the right thing, and it’s good policy.
Covid-19 vaccines are currently covered by a declaration under the Public Readiness and Emergency Preparedness Act that protects manufacturers of any Covid-19 related products from liability, with very narrow exceptions. The liability protections are there for a reason: During an emergency, we want products on the market fast, and liability protections can allow companies to move forward on products faster than they could otherwise.
Vaccine safety review normally involves multiple rounds of increasingly large trials that monitor patients for months to ensure there are no unexpected side effects. Vaccine trials enroll more subjects than drug studies and seek diversity of subjects. This takes time, during which there is no vaccine to prevent the disease. Vaccines are held to that high bar because they are given to many healthy people, and it is a particular ethical problem to make a healthy person sick.
But in the midst of an outbreak or pandemic, there is good reason to move faster. Many people who are healthy now are likely to become sick in the absence of vaccine. In an emergency, the risk-benefit calculation may be different than in usual times: Waiting can carry heavy risks. At its peak, Covid killed thousands of people each day in the United States. Where normally regulators would consider a 1:10,000 risk of severe harm in vaccines unacceptable, when thousands are dying each day, we may not be willing to wait to be sure there is no such risk.
But the other side of protecting manufacturers from liability should be providing compensation to those harmed. For vaccines, that’s even more crucial. Vaccines fill two purposes: They protect the individual directly, and they also protect the public by reducing transmission of a virus (or bacteria) and reducing disease for the entire community. People who take the vaccine are contributing to public health (while also benefiting themselves). The people who suffer very rare cases of injury should not be left to bear the costs alone for a public good.
Hundreds of millions of doses of Covid-19 have been administered in the U.S. without serious side effects. But there have been very rare cases of harm: severe blood clots from the Johnson & Johnson vaccine, myocarditis in young adults from the mRNA vaccines. While exceedingly uncommon, those harms have a dramatic impact on the families involved. They should be financially compensated—fast and generously.
But the program the United States provides under the PREP Act is not generous. Quite the opposite. The Countermeasures Injury Compensation Program has a high bar for proving causation, requiring “compelling, reliable, valid, medical and scientific evidence.” It is a program of last resort, not paying if there are other sources of compensation. It is hard to use. It does not cover lawyer fees.
And we have an alternative. The Vaccine Injury Compensation Program has a much lower burden of proof, covers lawyer fees and litigation costs, and has a history of making careful decisions.
However, in order to move Covid-19 vaccines cases to the VICP, legislation is needed that will, among other things, create an excise tax on the vaccines to cover the cost. Right now, cases alleging harm from COVID-19 vaccines cannot reach the VICP; the narrower countermeasures program is their only forum.
Congress can and should move Covid-19 vaccines under the VICP. It’s the right thing to do: The rare families who suffered severe impact from Covid-19 vaccines should not be left to bear the costs alone, since vaccinating helps all of us. These families deserve to have their costs covered. It’s good policy: It can give people more confidence in vaccinating, knowing that in the unlikely case that something happens, there will be compensation. It’s an important complement to rapidly increasing the use of mandates. If work or access to higher education depends on being vaccinated, our government should compensate the rare cases of harm. And, not unimportantly, it will take away an anti-vaccine talking point.
Congress should act now to place Covid-19 vaccines under the VICP.
Guest commentaries like this one are written by authors outside the Barron’s and MarketWatch newsroom. They reflect the perspective and opinions of the authors. Submit commentary proposals and other feedback to ideas@barrons.com.
Last edited:
