J&J’s Second Act Creates New Challenge for Immunization Effort
(Bloomberg) -- For Americans wary of the Johnson & Johnson Covid-19 vaccine as it returns to use after the investigation of a potentially deadly side effect, health experts have a message: The system worked.
A recommended hold on the vaccine was lifted on Friday by the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration after a 10-day review of rare and serious blood clots in some people who had received the shot.
The small risk of clots from the shot is far outweighed by its protection against the coronavirus, an advisory panel said. In the next six months, the shot could prevent some 1,435 Covid deaths and 2,236 hospitalizations, compared with a projected 26 possible clot cases, according to a presentation by the CDC.
The scientific scrutiny of the clots and the public deliberations by regulators should put people more at ease, some health officials say.
“This was the safety system working exactly as it should,” said Dave Chokshi, New York City’s health commissioner.
However, the pause has converged with a slowdown in the U.S. immunization campaign. Many people who were most eager to get vaccinated have been, and there is worry that J&J’s issues could make it harder to convince holdouts to roll up their sleeves.
While more than 41% of people in the U.S. had received at least one vaccine dose through Saturday, and more than a quarter had been fully vaccinated, according to the Bloomberg Vaccine Tracker, the daily average rate of shots has declined over the past week.
As critical as it is to get the U.S. population immunized, the J&J side effect complicates the message about vaccination’s benefits. To reach the uncertain, a more tailored message is likely to be needed. The idea that the system worked might not comfort those who question how the system functions.
“There’s not a one-size fits all approach in a country of 350 million,” said Ezekiel Emanuel, a medical ethics and health policy professor at the University of Pennsylvania.
Despite signs that the pause eroded interest in the J&J vaccine, its single-dose simplicity has made it a sought-after option for those who don’t want to deal with two injections, according to public-health experts and care providers. The other two U.S.-authorized vaccines, from Moderna Inc. and Pfizer Inc.-BioNTech SE, require two shots several weeks apart.
Nearly 10 million doses of J&J’s vaccine across the U.S. were ready to be used as of Friday, according to CDC data.
“Most patients are going to say give it to me,” said Umair Shah, secretary of the Washington State Department of Health. When use of the J&J shot was paused, some people in the Pacific Northwest state asked to be added to a wait list so they could get it as soon as it was available again, he said.
Other states have seen high interest in the J&J shot despite the clotting concerns.
On Saturday, hours after the halt lifted, people with vaccine appointments at the Indianapolis Motor Speedway were offered a choice between the J&J and Pfizer vaccines. By the end of the day, the site had given 2,515 J&J shots, or 83% of the roughly 3,000 total doses administered.
“I’m hoping as we get through this weekend and we start seeing no further concerns people realize it’s still a very safe vaccine, the messaging continues to improve, that our appointments go back up to where we would like to see them,” said Mary Kay Foster, a nurse and Indiana University Health mass vaccination co-lead.
Still, some people at the Indianapolis site remained wary of the J&J shot, particularly women who opted to get the Pfizer shot instead.
Health officials say that the overall risk to women from the vaccine is very small. All 15 cases of the clotting condition, thrombosis with thrombocytopenia syndrome, were seen in women, and 13 were under the age of 50 -- amounting to 7 cases per million doses for women under 50, according to the CDC.
Representatives from the American College of Obstetricians and Gynecologists said J&J’s vaccine remains an important option for women to protect themselves against Covid-19.
“Some of my patients really benefit by having a single-dose vaccine option, and Covid-19 remains a very serious threat to both my pregnant and nonpregnant patients,” said Linda Eckert, professor of obstetrics and gynecology at the University of Washington and ACOG’s liaison to the CDC advisory panel that reviewed J&J’s vaccine.
Women often play the role of primary caregiver in a family and want to be well-informed to feel confident about medical decisions, according to Kathryn Schubert, president and chief executive officer of the Society for Women’s Health Research. Health-care providers should help reassure them on the choice they go with, Schubert said. Risks and benefits should be “clearly discussed and weighed in a way that is not perpetuating anxiety.”
Annabelle de St. Maurice, assistant professor of pediatrics in the division of infectious diseases at University of California at Los Angeles and co-chief infection prevention officer at UCLA Health, isn’t worried by the clotting risk. She said members of her family have received the shot.
Foster, of Indiana University Health, said her 24-year-old daughter is scheduled to get it on Thursday. “As long as people know what the risk factors are and make an informed decision that works for them,” Foster said, adding that people should feel comfortable taking the vaccine.
U.S. health officials should also signal confidence in the J&J vaccine to the international community, said Emanuel, who advised President Joe Biden’s Covid transition team.
Soaring caseloads in countries such as Brazil and India have raised fears that vaccinations may not be able to keep pace with fast-spreading variants.
J&J’s shot can be stored in a refrigerator rather than ultra-cold freezers needed to house the messenger RNA shots made by Moderna and Pfizer, and it costs just $10, a fraction of the cost of its competitors in the U.S. That and its single-shot dosing regimen make it a potentially powerful tool for battling outbreaks in countries that lack resources and sophisticated health infrastructure.
“We should tout to the international community how transparent we were, that all the data was on the table,” said Emanuel, who disagreed with the pause. “That’s our greatest strength as a country. We put the data out there like good scientists, we look at it, and we have different perspectives. We must focus on transparency.”
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