A day before a Centers for Disease Control and Prevention (CDC) committee is set to meet regarding the Johnson & Johnson COVID-19 vaccine, the agency’s director said she is "really hopeful" that the one-shot jab "can be used again soon."
Speaking to TODAY, Dr. Rochelle Walensky, whose agency along with the FDA recommended a pause in the vaccine’s rollout after six cases of a rare blood clot occurred in the more than 7 million vaccine recipients, said the agency will "need to make a decision quickly" regarding its use.
A day after the agencies recommended the pause, the Advisory Committee on Immunizations Practices (ACIP) decided to extend it in order to allow for more time to review the data and for patients to report possible reactions.
Walensky had previously said in a White House briefing this week that the agency had only received a "handful" of possible reports, and that they were now working to verify whether those instances qualified as a case.
The committee is tasked with deciding whether to issue new guidance regarding the jab days after a European Union panel said the unusual blood clots and low platelets should be listed as very rare side effects of the vaccine. The European Medicines Agency (EMA) safety committee (PRAC) said that "based on the currently available evidence, specific risk factors have not been confirmed."
The PRAC review was based on the six cases reported in the U.S., a seventh that involved a clot that occurred outside the brain, and an eighth that involved a male during clinical trials but could not be associated to the shot at that time. Johnson & Johnson had proactively halted the rollout in Europe after the FDA and CDC recommended the U.S. pause.
The EU panel also noted that "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."
In the U.S., critics said the pause would contribute to vaccine hesitancy, and said it would put hard-to-reach communities at further risk of the virus as the vaccine was being deployed to these populations through mobile units and pop-up clinics due to easy storage requirements and the convenience of one dose versus having to schedule a second. However, proponents of the pause said that continuing to use the jab in those hard-to-reach populations would also add hurdles when trying to monitor for adverse reactions and make it difficult to provide emergency care should one arise.
Federal health authorities have spent the week applauding the decision to pause the rollout and said it’s a sign that the safety monitoring systems in the U.S. are working.
"The fact that following the EUA, we have continued to follow very carefully any possibility of adverse events, I believe, is the other side of the coin of hesitancy," Dr. Anthony Fauci, the nation’s leading infectious disease expert, said. "It should reinforce in those individuals how we take safety so seriously, so as opposed to looking at this as a negative safety issue, it could be looked at as a positive issue, where they know that when we let a vaccine be available and give it a go-ahead to be put into the arms of the American people, we do it with a considerable degree of confidence as to its safety. So when I get asked questions about whether or not this has set us back, from a hesitancy standpoint, I give the opposite of that."