- The Washington Times - Wednesday, April 14, 2021

A federal panel said Wednesday it wants to gather more data on extremely rare blood clots tied to the Johnson & Johnson vaccine and see if new cases arise from recent shots, likely prolonging the U.S. pause in deploying the one-dose option against COVID-19.

The decision by the Advisory Committee on Immunization Practices, a panel of independent experts that helps the Centers for Disease Control and Prevention devise vaccine policy, comes after six women experienced clots out of nearly 7 million shots put into arms. One of the women died.

Members decided not to vote on any recommendations to amend the use of the one-shot vaccine. They will reconvene in a week to 10 days.

Some members said the existence of two-dose alternatives from Pfizer-BioNTech and Moderna, which have accounted for 95% of American shots so far, allows them to be more cautious and thoughtful about how to proceed. However, others said putting the efficient option from J&J on the shelf will cause harm, both tangibly and in public perception.

“Not making a decision is tantamount to making a decision,” said Nirav D. Shah, director of the Maine Center for Disease Control and Prevention.



Administration officials said Wednesday they paused the J&J vaccine because they needed to decide if it is risky for certain populations. They also wanted doctors to be on the lookout for more cases and understand how to treat these extremely rare clots, which are marked by a drop in platelets and cannot be treated with heparin, a common drug for other blood clots.

“It is important for health care workers to know the treatment of these clots is different than our current standard of care,” said CDC Director Rochelle Walensky.

All six clotting cases occurred in White women between ages 18 and 48. A 45-year-old died and a 48-year-old is in serious condition in Nebraska.

Officials said the pattern is “very similar” to clotting tied to the AstraZeneca vaccine in Europe, which also uses an adenovirus vector but isn’t identical to J&J’s version.

A representative from Johnson & Johnson’s pharmaceutical arm, Janssen, told ACIP it supports broadcasting the signs and symptoms of this “very rare event” so recipients can self-monitor and seek help if needed.

Officials say recipients should contact a doctor if they feel severe headaches, abdominal pain, leg pain, or shortness of breath.

J&J’s vaccine was entering the mix of U.S. options after production stumbles, enthusing governors. The company is trying to ramp up manufacturing but the clotting issue is President Biden’s first major public-facing challenge in the rollout.

Whether he overcomes it quickly will depend in part on whether the CDC and FDA can find ways around the concerns about blood clots.

For now, states and counties are working to reschedule J&J appointments or offer recipients the initial dose of Pfizer-BioNTech or Moderna vaccines.

Officials are trying to get 70% to 90% of the population immunized against the coronavirus. They said the alert-system is working, so people who are leery should see it as a positive.

“It should reinforce in those individuals how we take safety so seriously,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

White House COVID-19 coordinator Jeff Zients said the U.S. is averaging 3.3 million shots per day — up from 3 million per day a week ago.

“In the very short term, we do expect some impact on daily averages as sites and appointments transition from Johnson & Johnson to Moderna and Pfizer vaccines,” he said. “However, I want to be clear that we have more than enough Pfizer and Moderna vaccine supply to continue or even accelerate the current pace of vaccinations and meet the president’s goal of 200 million shots by his 100th day in office.”

The mRNA vaccines require two doses weeks apart, however, so it takes a longer time for someone to be considered “fully vaccinated” under those versions than J&J’s one-and-done type.

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