FDA ends pause on J & J vaccine for COVID, but with warning to women
The Food and Drug Administration ended its suspension of the Johnson & Johnson COVID-19 vaccine late Friday, allowing it to be restarted across the United States. But reports of very rare blood clots among women may make the vaccine-hesitant less likely to roll up their sleeves.
The FDA decision Friday evening followed a recommendation earlier in the day by the The Advisory Committee on Immunization Practices, which advises the U.S. Centers for Disease Control and Prevention. That panel voted 10-4 to recommend resumption of the vaccine, known for its flexibility in getting to hard-to-reach populations.
But the vaccine must now carry a label about its potential risks.
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“We will start using it again, yes, but I think we will be facing a lot of questions,” Velma Hendershott, president and CEO of the InterCare Community Health Network, said Friday afternoon after the CDC panel's recommendation.
“Those who had that borderline hesitancy will tilt toward the ‘I-think-I’ll-wait-this-out,’” predicted Hendershott, whose organization serves southwest Michigan communities, including an estimated 8,000 agricultural workers.
Questions about the vaccine erupted just as Michigan was entering a new, more difficult phase of distribution — as demand for coronavirus vaccines slowed, and many providers said they had exhausted their waiting lists.
The J & J vaccine was temporarily shelved April 13, after federal authorities warned of rare reports of women developing blood clots up to two weeks after receiving the shots.
Health officials immediately sought to reassure the public after the pause was announced, noting that the half-dozen or so cases were out of more than 6.8 million doses of the vaccine that have been given in the U.S. to that point. The committee heard of additional cases Friday, bringing the total up to 15, according to news reports.
Though the clotting disorders are rare, they warranted further study, which means that the pause was actually “testament to the system working,” Nick Derusha, president of the Michigan Association of Local Public Health, said at the time the vaccine was paused.
The Johnson & Johnson vaccine’s role in Michigan’s race toward herd immunity has been small in numbers, making up less than 4 percent of vaccines administered in Michigan at the time of the pause. The predominant vaccines against COVID in Michigan and elsewhere are the two-dose vaccines produced by Pfizer and Moderna.
But J & J’s value was in its “one-dose-and-done” flexibility to reach Michiganders for whom a return trip for a second dose was less than secure, said Mike Snyder, health officer for the Public Health of Delta & Menominee Counties, which uses Moderna in its clinics and passed its J & J allocations to local doctors.
Additionally, the J & J vaccine can be more easily stored than its Moderna and Pfizer counterparts, which must remain frozen. It’s also packaged in five-dose vials rather than its ten-dose vials of its counterparts, making it less likely for small providers like a family doctor to waste doses once a package is opened.
The single-dose has been more valuable in reaching homebound seniors, as well as migrant workers, the homeless, those passing through the Soo Locks on hulking lake freighters, and residents on Michigan’s smallest islands.
Michigan hospitals had also offered the vaccine to patients at discharge, said John Karasinski, spokesperson for the Michigan Health & Hospital Association.
At the Community Health and Social Services, or CHASS, Center in southwest Detroit, CEO Dr. Felix Valbuena said Friday that its staff would no longer will order the J & J vaccine.
Valbuena said the clinic already faced questions over the J & J vaccine’s efficacy as well as some religious objections. (The vaccine was developed using a cell line derived from a fetus in 1985.)
Additionally, callers wanted administrative staff to advise on which vaccine would be best, tying up clinical staff as well. The clinic now will order the two-dose Moderna vaccine only, cutting down on time and confusion, Valbuena said.
“Vaccine supply now is just not going to be an issue,” he said as availability of COVID vaccines catches up with demand. “If we didn’t have access to Moderna, maybe the decision would be different.”
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