Texas health officials on Friday told vaccine providers across the state that they could resume using the one-dose COVID-19 Johnson & Johnson vaccine in all adult recipients after a federal advisory panel recommended that it be reinstated. The recommendation comes 11 days after use of that particular vaccine was paused over a small number of reports of a rare but serious clotting side effect in recipients.
On Friday afternoon, the CDC advisory panel said that the benefits of vaccination far outweigh the clotting risk associated with the shot. The U.S. Centers for Disease Control and Prevention was expected to offer its official guidance mirroring the panel’s recommendations later Friday.
The news comes a day after state health officials said that a Texas woman who received the Johnson & Johnson vaccine had been hospitalized with blood clots and whose condition was being investigated by the CDC as potentially connected to the vaccine. No other details were released.
CDC officials Friday reported 15 total cases reported of the clotting syndrome connected to the vaccines – all in women, mostly in those under 50. Three of them died. Nearly 8 million doses of the Johnson & Johnson vaccine have been administered nationwide.
Some 616,000 Johnson & Johnson doses had been administered in Texas before the vaccine’s use was paused 11 days ago, said Imelda Garcia, associate commissioner of the Texas Department of State Health Services.
Texas health officials said Friday that with the new recommendations, more doses are expected to be made available to the state as early as the weekend and those doses will be allocated as soon as providers place their orders with the state. Meanwhile, more than 700,00 first doses of Pfizer and Moderna vaccines will go to nearly 1,000 providers in 129 Texas counties next week, officials said.
More than 16.8 million doses of vaccine have been administered in Texas, with almost 10.5 million people receiving at least one dose, and about 7 million – about a third of all Texans ages 16 and older – are now fully vaccinated. Some 48,000 Texans have died of COVID-19.
The CDC panel on Friday grappled with whether to include language in its recommendation warning women under age 50 that the Johnson & Johnson vaccine poses an increased risk to their age group of the clotting syndrome and that they have other vaccine options.
“This is an age group that is not at risk, that is getting this vaccine predominantly to save other people’s lives and morbidity, not their own, 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,” said Dr. Sarah Long, a panelist and professor of pediatrics at Drexel University College of Medicine in Philadelphia. “But I am very sorry that we haven’t chosen to put, upfront, the knowledge that we have that this … is almost certainly related to the vaccine and there are [other] options.”
Neither the Pfizer nor Moderna two-dose regimens have been connected to the clotting side effect, CDC officials said Friday.
Ultimately, the panel voted 10-4 to leave out the warning, with most on the panel agreeing that it could be confusing and that providers can inform recipients of the side effect. The new information that will be added to the vaccine’s emergency use authorization approved by the U.S. Food and Drug Administration.
Panelists said they would continue to monitor the vaccines and their side effects, encourage reporting and awareness, and be ready to adjust their recommendations if information changes.
“The [Johnson & Johnson] vaccine can be reinstituted and should be reinstituted,” said Dr. Jose Romero, Arkansas Secretary of Health and chairman of the advisory panel. “I acknowledge, as does everyone else, that these events are rare, but they are serious. … It is our responsibility as clinicians to make sure that women understand this risk and when possible that they have an alternative.”
Reinstating the vaccine could result in between 26 and 45 total clotting cases over nearly 10 million doses anticipated, but prevent up to 2,500 hospitalizations and up to 1,400 deaths, a CDC official said during the panel meeting on Friday.
Panelists decided on Friday that resuming the Johnson & Johnson vaccine for the entire U.S. adult population – as opposed to segments of it – would have far more benefits than risks.
Panelists and CDC officials also said that stopping it would disproportionately affect people experiencing homelessness, homebound people, people living in rural and hard-to-reach areas, lower-income people, and those who are incarcerated – particularly vulnerable populations whose lack of access to the two-dose Pfizer and Moderna vaccines makes them especially good candidates for the easily stored, one-dose shot.
“Perfect should never be the enemy of the good,” said Dr. Jason Goldman, assistant professor of clinical biomedical science at Florida Atlantic University, a nonvoting panel member. “To not continue use of the vaccine would be detrimental to the overall vaccine program in preventing tremendous amounts of deaths, hospitalizations, and ICU care.”