Johnson & Johnson COVID-19 vaccine pause extended, CDC committee wants more time to review

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A Centers for Disease Control and Prevention (CDC) committee did not hold a vote regarding guidance on Johnson & Johnson’s COVID-19 vaccine Wednesday after federal officials recommended a pause in the rollout. The Advisory Committee on Immunization Practices (ACIP) met one day after the FDA and CDC recommended the pause over concern of six instances of a rare, severe blood clot in over 6.8 million vaccine recipients.

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The ACIP had been tasked with discussing two questions:

Does ACIP have enough information to make interim age or risk factor-based recommendations for use of the Janssen vaccine?

What recommendation does ACIP feel is appropriate today given current available information for use of the Janssen vaccine?

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Many committee members felt there was insufficient data to make an evidence-based decision on Wednesday. Several unknowns include the true background incidence of cerebral venous sinus thrombosis (CVST) with low platelet count, specific risk factors, ability to compare thrombotic cases post-vaccination between AstraZeneca and J&J vaccines, and true incidence of cases specific to J&J vaccine recipients.

Officials emphasized the extended pause did not indicate increased concern but instead an attempt to better characterize the risk.

The cases under review involved six females between ages 18 and 48, whose serious adverse events occurred within six to 13 days of vaccination. Most of them experienced headaches, and one of the women died while another is in critical condition.

The instances have been described as “extremely rare” by the FDA, and the agencies recommended the pause Tuesday “out of an abundance of caution” partly due to how the blood clots must be treated. There have been no such reported cases of CVST with low platelet count in nearly 200 million vaccinations between Moderna and Pfizer.

The committee said that by Friday it would determine when to next meet and discuss the data. 

Fox News’ Alexandria Hein contributed to this report.

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