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Disclosures: Adalja, Walensky and Woodcock report no relevant financial disclosures.
April 26, 2021
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As CDC, FDA lift pause of J&J vaccine, poll indicates ‘eroded confidence’ in shot

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Press Release.

Disclosures: Adalja, Walensky and Woodcock report no relevant financial disclosures.
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The CDC and FDA on Friday lifted a recommended pause on the Johnson & Johnson COVID-19 vaccine rollout in the United States after a panel of experts encouraged its use despite a small number of clotting events linked to the shot.

Results of a poll taken in the days before the pause was lifted indicate that the delay may have damaged the public’s perception of the vaccine, said Amesh A. Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.

J&J infographic
Source: FDA.

In the poll of 369 unvaccinated American adults conducted by The Washington Post and ABC News, just 22% of respondents said they would be willing to get the vaccine, whereas 73% said they would not and 4% did not have an opinion.

The poll was conducted from April 18-21 — in the days after the CDC and FDA recommended the pause and the CDC’s Advisory Committee on Immunization Practices (ACIP) initially said it did not have enough information to vote on whether the pause should continue. The ACIP eventually voted last Friday that use of the vaccine should resume.

Amesh A. Adalja
Rochelle P. Walensky

“The lifting of the pause was a welcome action, and I hope that the Johnson & Johnson vaccine — a critical tool in vaccinating hard-to-reach populations, not just in the U.S. but globally — resumes going into arms as soon as possible,” Adalja told Healio. “However, the poll indicates that the pause and the extremely rare clotting disorder that prompted it have eroded confidence in the vaccine. It will be important to proactively extoll how the benefits of this vaccine greatly outweigh any risks.”

The pause followed reported of six cases of cerebral venous sinus thrombosis with thrombocytopenia, or low levels of blood platelets, that occurred out of the first 6.8 million doses administered in the U.S. European regulators have recommended that a blood clot warning be added to the vaccine’s label.

“Above all else, health and safety are at the forefront of our decisions,” CDC Director Rochelle P. Walensky, MD, MPH, said in a press release. “Our vaccine safety systems are working. We identified exceptionally rare events — out of millions of doses of the Janssen COVID-19 [vaccine] administered — and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated.”

The CDC and the FDA said they determined the following after analyzing data related to the Johnson & Johnson vaccine’s potential risk for thrombosis and thrombocytopenia:

  • use of the vaccine should resume in the United States;
  • both the FDA and the CDC are confident that vaccine is safe and effective;
  • available data suggest the vaccine’s potential benefits outweigh its risk in individuals aged 18 years or older;
  • data show that the odds of thrombosis-thrombocytopenia are low, but the CDC and FDA will continue to monitor it as a risk factor; and
  • health care providers should consult the Janssen COVID-19 vaccine sheet before administering the vaccine.

“Safety is our top priority,” acting FDA commissioner Janet Woodcock, MD, said in the release. “This pause was an example of our extensive safety monitoring working as they were designed to work — identifying even these small number of cases.”

References:

Goldstein A, Clement S. The public’s concerns over the Johnson & Johnson coronavirus vaccine are widespread, Post-ABC poll finds. April 26, 2021. Accessed April 26, 2021. https://www.washingtonpost.com/health/poll-johnson-johnson-vaccine/2021/04/26/a1085b26-a3ad-11eb-a774-7b47ceb36ee8_story.html.

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