Fauci expects Johnson & Johnson COVID-19 vaccine will 'get back on track' soon

America’s leading infectious disease expert Dr. Anthony Fauci told Reuters Thursday he hopes federal health authorities can reach a conclusion on the Johnson & Johnson COVID-19 vaccine "quickly and get back on track." 

Fauci’s comments came a day after a Centers for Disease Control and Prevention (CDC) committee did not hold a vote regarding guidance on the jab. The Food and Drug Administration together with the CDC issued a recommended pause on the J&J COVID-19 vaccine Tuesday after six cases of a rare, severe blood clot were reported amid a backdrop of over 6.8 million recipients. 

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Many committee members felt there was insufficient data to make an evidence-based decision. 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.

"I hope they make the conclusion of this quickly and get back on track, I hope so, and I believe they will," Fauci said. 

Committee members had emphasized the extended pause did not indicate increased concern but instead an attempt to better characterize the risk. The committee said that by Friday it would determine when to next meet and discuss the data. 

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This week, Fauci has repeatedly said the FDA and CDC’s decision to pause the J&J vaccine indicates the agencies "take safety really very seriously."

He reiterated that while there is concern a prolonged pause could give rise to vaccine hesitancy, people who feel reluctant or hesitant to receive jabs should feel confident the product is safe if and when federal health authorities give it the greenlight.

The cases under the CDC committee’s 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. A seventh case has since come to light, though this instance did not occur in the brain, as the other six did, sparking further questions about what evidence the committee needs to consider. 

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There have been no such reported cases of the rare but serious clotting issue called cerebral venous sinus thrombosis (CVST) with low platelet count in nearly 200 million vaccinations between Moderna and Pfizer.

"I believe that ultimately it will get back on track," Fauci told Reuters. "I hope it does, but you know, from what I’ve seen, I believe that it will."