Tags: J&J Vaccine Covid Liability
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The Food and Drug Administration asked states on Tuesday to temporarily halt using Johnson & Johnson’s Covid-19 vaccine “out of an abundance of caution” after six women in the U.S. developed a rare blood-clotting disorder. This highlights one question – what if – and this is the biggest of ifs- the vaccines turns out to be harmful? Who, if anyone, would be liable?
- The announcement was made after six people in the U.S. developed a rare blood-clotting disorder – that is 0.000000086% of people who’ve had the J&J vaccine.
- The FDA said the recommendation is “out of an abundance of caution.”
- The cases occurred in women ages 18 to 48, with symptoms developing six to 13 days after they received the shot.
- The European Medicines Agency (“EMA”) has also initiated a review on possible cases of blood clots linked to the J&J vaccine.
- Under the PREP Act, companies like Pfizer and Moderna have total immunity from liability if something unintentionally goes wrong with their vaccines.
Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution.
— U.S. FDA (@US_FDA) April 13, 2021
“Right now, these adverse events appear to be extremely rare,” the FDA said in a joint statement with the Centers for Disease Control and Prevention. “COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”
After the news, first reported by The New York Times, shares of J&J were down 2.4% in premarket trading Tuesday.
The CDC will convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to further review the cases, federal health regulators said Tuesday. The FDA is also investigating the cases.
“Right now, these adverse events appear to be extremely rare.” the FDA said.
of people who've had the J&J vaccine developed blood clots
0
%
I have yet to see a *single* headline noting how many out of 6.8 million Johnson and Johnson recipients — of which I am one — developed blood clots.
— Rodericka Applewhaite ? (@Rodericka) April 13, 2021
(6. The answer is 6. Total. Over months of distribution.)
I am begging editors to be responsible here.
J&J said in a statement that “no clear causal relationship” has been identified between the blood clots and the vaccine, adding it is working closely with regulators to assess the data.
As part of its application for emergency use authorization, J&J submitted its Covid vaccine data to the FDA in February, and no specific concerns were identified according to the agency.
It’s unclear how the pause will impact J&J’s goal to deliver 100 million doses to the U.S. by the end of May. Nearly 7 million people in the United States have received J&J shots so far.
The question of vaccine liability
While public health officials say there’s no doubt that refusing a COVID vaccine is far more dangerous than taking it, the liability question does remain important.
Usually, drug manufacturers are liable for the safety of their products, and they spend many years developing and testing their products. However, this is not how things work in a pandemic: here the Covid vaccines have been developed in less than a year and quickly received emergency use authorizations.
The United States has granted those companies immunity from liability if something unintentionally goes wrong with their vaccines. You also can’t sue the FDA for authorizing the vaccine for emergency use, nor can you hold your employer accountable if they require the vaccine as a condition of employment.
Back in February 2020, the Trump Administration invoked the PREP Act, which gives vaccine manufacturers and distributors four years of legal protection, unless willful misconduct can be proved. Then, the burden of proof is on the claimant to show willful misconduct – a very high threshold.
The American Congress created a fund specifically to help cover lost wages and out-of-pocket medical expenses for people who have been irreparably harmed by a “covered countermeasure,” such as a vaccine.
Immunity helps lower the cost of the immunizations
The legal immunity granted to pharmaceutical companies doesn’t just guard them against lawsuits. It helps lower the cost of the immunizations. The manufacturers would probably charge the government a higher price per person per dose if they could be sued easily over an emergency use of their vaccine.
In the European Union, the question of clear compensation mechanisms for the side effects of vaccines has not been fully answered. Although it has been announced that pharmaceutical companies will not be exempted from the general safety requirements for medicines, specific answers to questions on the liability of manufacturers are often not provided on the grounds of the confidentiality of contracts.
In the absence of a common approach to compensation for vaccine side effects, some Member States have already taken national measures (e.g., a ‘no-fault’ compensation model), but such provisions seem fragmented at EU level.
Opinion: A vaccine pause will cost lives
Just as the coronavirus pandemic appears to be setting off a new wave of infections, the United States have paused the rollout of the J&J vaccine.The news came as European countries were getting ready to roll out their first doses.
The White House said the pause would not have a “significant” impact on its plan to administer about three million shots per day, but some experts believe the damage to public confidence will be long-lasting and result in unnecessary deaths.
In the European Union, the temporarily suspension of the Oxford-AstraZeneca vaccine rollout had deepen consequences. “I have no doubt that Europeans have died because of some of these decisions,” said Professor Harnden, who is an expert in primary care at the University of Oxford.
“I think this is a very low risk issue, even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about,” Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email to Reuters.
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