Feds lift pause on J&J vaccine
FDA, CDC say benefits of the shot outweigh risks; safety warning added
Federal health officials have lifted their suspension of the Johnson & Johnson vaccine, clearing the way for immediate resumption of one-shot inoculations. But will people feel safe using it?
The decision by the U.S. Food and Drug Administration and Centers for Disease Control and Prevention on Friday afternoon came after an influential committee of the CDC endorsed the vaccine, saying the benefits outweigh the rare risk of dangerous blood clots.
Rather than continuing to pause its use, authorities are updating the “patient information sheet” given to consumers at vaccination sites, which describes the very small but elevated risk observed in women under the age of 50.
“This is a serious adverse event, and we need to continue to be sure that awareness is raised,” said Dr. Grace Lee, a Stanford University pediatrics professor and member of the CDC’s Advisory Committee on Immunization Practices.
Because of its one-dose regimen and simpler storage requirements, the Johnson & Johnson vaccine has been considered an important tool in vaccinating hard-to-reach and mobile populations, such as homeless people and migrant farmworkers, even though manufacturing problems have led to short
supplies. But after weeks of alarming publicity, Friday’s decision may not be enough to restore that role.
The Todec Legal Center, which has been vaccinating farmworkers in the Inland Empire, will move slowly and cautiously when it comes to reintroducing the shot, Director Luz Gallegos said. “It’s just that there’s a lot of mistrust with that vaccine right now,” she said.
It’s also unclear whether renewed access to Johnson & Johnson shots will make a meaningful impact in the Bay Area’s broader vaccination strategy. Several counties hit a turning point recently and no longer are struggling to meet demand, even without Johnson & Johnson’s product. Santa Clara, Contra Costa and Marin counties all had appointments go unbooked this week.
“Regarding vaccine supply in Santa Clara County, we now have plentiful supply. We have lots of Pfizer and lots of Moderna,” said Dr. Sara Cody, Santa Clara County health officer. San Mateo County has 1,220 Johnson & Johnson doses on hand, waiting for the green light. Likewise, San Francisco has 700 doses of J&J on the shelf, ready for use.
Use of the Johnson & Johnson vaccine was paused 11 days ago by the CDC and FDA after six cases of a rare health problem — severe stroke-like blood clots, accompanied by low platelet counts, called thrombosis with thrombocytopenia syndrome or TTS — among the 6.8 million people who have received the Johnson & Johnson vaccine.
Since then, authorities have found nine additional cases of the syndrome in people vaccinated with the product. Of the 15 total cases, 13 were in women between the ages of 18 and 49, and two were in women over age 49. No cases were found in men.
Three women have died, and seven are still hospitalized, with four needing intensive care. The median age is 37 years, with symptoms appearing six to 15 days after inoculation. There are no identifiable predispositions, other than gender or age, that were linked to this complication.
The news of new cases, while tragic, was better than feared, said Stanford’s Lee. “The last 11 days have been reassuring in that we haven’t identified hundreds of more cases,” she said, “despite enhanced awareness across the U.S.”
The risk to this subgroup — women of childbearing age — is only 1 in 143,000, according to data presented at the Friday meeting. But these women are also at very low risk of dying of COVID-19. By being vaccinated, they are largely protecting others, said Dr. Sarah Long, a professor of pediatrics at Drexel University College of Medicine.
The CDC committee made its decision on a 10 to 4 vote, with one abstention. Those opposing the proposal sought to include an explicit warning about the syndrome in the committee’s recommendation.
Starting Friday, the vaccine’s “fact sheet” includes this information: “Blood clots involving blood vessels in the brain, abdomen and legs along with low levels of platelets, have occurred in some people who have received the COVID-19 vaccine.”
Officials in Santa Clara County plan to put that warning online, so people see it when they’re making their appointment, said County Executive Jeff Smith. That way, if they want to avoid Johnson & Johnson, the county can direct them to a clinic offering the other shots.
But that won’t work for walk-up sites, where appointments aren’t required and staff don’t stock multiple types of vaccines, because they don’t want to risk wasting doses.
“That will be challenging,” Smith said, of giving people options at walkup sites. “I don’t know how we’re going to do that.”
The suspension of the vaccine had threatened protection of other groups: homeless or incarcerated people, migrant workers, college students and people who are homebound and can’t travel to get two doses of the Moderna and Pfizer vaccines.
San Francisco’s COVID Command Center issued a statement saying that it plans to resume the use of the J&J vaccine in clinical settings, once safety reviews are completed. It will make it clear on its website which vaccines are available.
Some providers aren’t so sure J&J will be accepted.
“The question is, will the community like it and will they support it? Because it doesn’t do you any good to have it and then people don’t want it or use it,” said Reymundo Espinoza, CEO of Gardner Health Services in Santa Clara County.
After news broke of the Johnson & Johnson safety concerns, Espinoza saw a noticeable decline in demand — even for Pfizer and Moderna vaccines. The health center plans to again start vaccinating unhoused people in San Jose and low-income residents in Gilroy, but it likely will take a few weeks.
The vaccine is very protective against the virus, with clinical trial data showing 66.7% efficacy against symptomatic illness, 93% efficacy against hospitalization and 100% protection against severe illness and death.
You should seek medical attention right away if you have any of the following symptoms one to three weeks after receiving the J&J vaccine: shortness of breath, chest pain, leg swelling, persistent abdominal pain, severe and persistent headaches or blurred vision and easy bruising or tiny blood spots under the skin beyond the site of the injection.