- The Washington Times - Tuesday, April 20, 2021

Unusual blood clots should be listed as “very rare” side effects of the Johnson & Johnson vaccine, European regulators said Tuesday, swiftly replicating the warning it put on a similar vaccine while the U.S. waits days for federal advisers to plot a way forward.

The European Medicines Agency recommended the warning after it considered eight cases and one death among the 7 million U.S. recipients of the single-shot vaccine known as the “Janssen” version, after the J&J division that produced it. It determined there was a “possible link” between the clots and the vaccine.

“Health care professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination,” the regulators said, before highlighting the importance of the vaccine. 

“COVID-19 is associated with a risk of hospitalization and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects,” the EMA said.

The EU approved J&J’s vaccine in mid-March but the company delayed its European rollout as the U.S. cases came to light. 

J&J said it will update its label and resume shipments to the EU, Norway and Iceland following the regulators’ decision.

“We appreciate the rigorous review of the [EMA safety committee] and share the goal of raising awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment,” said Paul Stoffels, chief scientific officer at J&J. “We strongly believe in the positive benefits of our single-shot, easily transportable COVID-19 vaccine to help protect the health of people everywhere and reach communities in need globally.”

The EMA’s decision is akin to one it made previously to guide the use of the AstraZeneca vaccine for COVID-19 after reports of similar clots. Both vaccines use an inactivated virus, or adenovirus vector, but are not identical.

Scientists theorize the vaccine triggers an immune response in some people that causes an unusual instance of clotting combined with low platelet levels.

Federal advisers to the Centers for Disease Control and Prevention are scheduled to meet Friday to determine whether the J&J rollout should continue in the U.S., perhaps with specific recommendations for certain groups. Most of the rare clots have occurred in women 18 to 49.

The U.S. halted the vaccine’s use while the CDC’s Advisory Committee on Immunization Practices and Food and Drug Administration decide if there is a way forward or if the pause should continue.

ACIP debated the clotting reports in a meeting last week but punted on a decision, extending the pause after advisers said they had to learn more and reconvene on April 23.

Former Food and Drug Commissioner Scott Gottlieb said the situation is putting the CDC in a “new and challenging role of judging a safety question,” so the FDA should be taking the lead.

“The discomfort of the CDC’s advisers seemed evident at an emergency meeting convened last week. The panel adjourned without a decision,” Dr. Gottlieb wrote in an op-ed for The Wall Street Journal. “We need a thorough, predictable process to assess emerging data on vaccines and advise doctors on their benefits and risks. That’s the FDA’s historical mandate. Putting the issue before the CDC confused the process and slowed the decision.”

The CDC’s ACIP played a key role in determining that health workers and then other essential workers and seniors should receive the COVID-19 vaccines first under a massive rollout that is relying on emergency-use authorizations from the FDA.

Experts said the FDA will make the final decision on whether to proceed with the J&J shot but that ACIP’s recommendations will help to guide their decision.

Requiring one dose instead of two, the J&J version appealed to people who wanted a one-and-done experience and governors looking to reach homebound people, the homeless or others who would have difficulty scheduling a second shot. 

The J&J vaccine was approved months after other versions, however, and suffered from production issues. It has accounted for less than 5% of the 212 million COVID-19 shots administered in the U.S. so far.

Federal health officials insist they have enough supply of messenger-RNA alternatives from Pfizer-BioNTech and Moderna to administer over 3 million shots per day and make sure everyone who wants the vaccine can make an appointment.

“We remain confident in our ability to meet the needs that we feel will be out there in the public by the end of May,” said White House press secretary Jen Psaki.

Ms. Psaki said there will be enough supply for every U.S. adult, period, by the end of July — even without J&J.

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