CDC and FDA Give Green Light to Resuming Johnson & Johnson Vaccine Shots

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By Karen Brooks Harper, The Texas Tribune

April 23, 2021

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 health advisory panel recommended it be reinstated. The recommendation came 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.

Hours later, the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration lifted the pause and recommended that providers begin resuming use of the vaccine immediately, with updated information and guidelines about the clotting syndrome.

"I know this is welcome news for many, as many have wanted the Johnson & Johnson vaccine to fill an important need in vaccination efforts here and around the world," CDC Director Rochelle Walensky said in a Friday evening news conference. "In the end, this vaccine was shown to be safe and effective for the vast majority of people."

On Friday afternoon, the CDC advisory panel said that it recommends reinstatement of the shot because the benefits of vaccination far outweigh the clotting risk associated with the shot.

The vaccines will likely be available as early as Saturday, federal officials said, as providers wait for updated fact sheets from the FDA to help explain the risks to recipients.

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 that her 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 that 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 nearly1,000 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 Johnson & Johnson vaccine, lauded by many as being particularly well-suited for some of most hard-to-reach and highest-risk people, was key to Texas’ effort to fully and quickly vaccinate most of its population of 29 million people.

Unlike vaccines produced by Pfizer and Moderna, both of which require two doses to be fully effective against the virus, the Johnson & Johnson’s “one-and-done” regimen, combined with its ability to be stored for months at regular refrigeration temperatures, made it ideal for homeless people, residents of rural areas and mobile vaccination efforts.

It is also well-suited for young people whose busy social lifestyles not only contribute to community spread but also sometimes prevent them from returning reliably for a second dose, providers say.

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, up front, 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.”

This article originally appeared in The Texas Tribune at https://www.texastribune.org/2021/04/23/cdc-johnson-johnson-vaccines-texas/.