US lifts pause, allowing Johnson & Johnson COVID-19 vaccinations to resume
U.S. health officials have lifted an 11-day pause on Johnson & Johnson vaccinations following a recommendation by an expert panel.
Panel members said it’s critical that younger women be told about that risk so they can decide if they’d rather choose another vaccine.
The CDC and Food and Drug Administration agreed. European regulators earlier this week made a similar decision, deciding the clot risk was small enough to allow the rollout of J&J’s shot.
Out of nearly 8 million people vaccinated before the U.S. suspended J&J’s shot, health officials uncovered 15 cases of a highly unusual kind of blood clot, three of them fatal.
All were women, most younger than 50.
But advisers to the Centers for Disease Control and Prevention said Friday the vaccine’s benefits outweigh that serious but small risk, especially against a virus that’s still infecting tens of thousands of Americans every day. The government will rapidly weigh that recommendation in deciding the next steps.
After a 10-to-4 vote, the CDC advisory committee agreed to move ahead with the one-dose vaccine.
But experts on both sides of the issue agree there needs to be more awareness and education of the one-and-done shot’s dangerous side effects.
“I am concerned that the consumers and women in this age group in particular will not be adequately informed by the FDA EUA fact sheet,” said Dr. Beth Bell, who voted yes.
Dr. Sarah Long, who voted no, said the age group susceptive to the clots are getting the vaccine to try and help others.
“This is an age group that is most at risk that is getting this vaccine predominantly to save other people’s lives and morbidity, not their own,” Long said. “And I think we have a responsibility to be certain that they know this and if they choose to be vaccinated with this anyhow, we want to respect that choice.”
Johnson & Johnson said these are rare events and the benefits outweigh the risks.
“We could expect that if 1 million people in the United States were vaccinated with the J&J single-shot vaccine, there would be over 2,000 fewer deaths and 6,000 fewer COVID-related hospitalizations,” said Dr. Joanne Waldstreicher, Johnson & Johnson Chief Medical Officer.
It would also result in two more cases of the dangerous side effects, but Johnson & Johnson said more education on the condition and labeling could help.