Washington: A panel of medical experts reaffirmed their support for Johnson & Johnson’s Covid-19 vaccine, setting the stage for regulators to allow use of the shot to resume after a pause to study rare, severe blood clots in some recipients.
The Advisory Committee on Immunization Practices voted 10 to 4, with one abstention, to back the vaccine, opening the way for the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration to lift the hold on the shot. Regulators put dosing on hold 10 days ago to gather more information about the side effect.
The agencies could decide to resume use as soon as Friday evening. The FDA will include a warning statement with the shot about the risk of clots, which have primarily been seen in young women. Panelists split over whether to give clearer guidelines, ultimately deciding to stick to recommending the vaccine to everyone 18 and older with the addition of the new FDA language.
“It’s our responsibility as clinicians to make sure women understand this risk and, when possible, that they have an alternative at the same site where you’re administering the vaccine,” the panel’s chair Jose Romero said following the vote.
More than than 8 million Americans have been given J&J’s vaccine. The panel reviewed evidence from 15 women who suffered the rare side effect, which involves abnormal clotting along with low platelets, a key component of blood coagulation. Three died, while seven remain hospitalized and five were discharged.
Thirteen of the women were under the age of 50, according to a presentation to the panel, and 12 of the 15 cases involved rare brain blood clots. As of April 21, about 4 million women in the U.S. had received the J&J vaccine.
J&J said in a statement that it’s grateful to the panel for the “rigorous evaluation” of its vaccine. The company said it will continue working with health agencies around the world to ensure the clots can be identified early and treated effectively.
Plenty of interest
CDC Director Rochelle Walensky said Friday that many people would still want a J&J shot. Unlike two-dose vaccines developed by Pfizer Inc. and Moderna Inc., J&J’s coronavirus vaccine requires a single shot and can be kept in refrigerators, making it a preferred tool for those who interact less frequently with the health system, or live in hard-to-reach places.
“I do think that there’s plenty of people who are interested in the J&J vaccine if just for convenience as well as for a single-dose option,” Walensky said.
The agency has been doing risk-benefit analysis, she said, including looking at who would prefer the J&J vaccine or wouldn’t be able to access others. The CDC and the Food and Drug Administration “feel strongly that we need to act swiftly after that analysis,” Walensky said.
Panelists wrestled with whether the benefits of J&J’s vaccine — preventing hospitalization and death — outweigh the risk of developing a clot. One of the most commonly cited concerns about keeping J&J’s vaccine sidelined was the disproportionate impact on vulnerable communities, including the homeless. Many state and local health departments were using J&J’s vaccine, which requires only one dose and is easier to store than other available Covid-19 vaccines, to reach these groups.
Sarah Long, a Drexel University College of Medicine pediatrician who voted against the recommendation, says she didn’t object to resuming use of the vaccine, but to the lack of guidance.
“I am very sorry that we haven’t chosen to put up front the knowledge that we have,” she said during the meeting, “that this is unique, it’s clustered, that it’s almost certainly related to the vaccine.”
Praise for decision
While the cases reviewed Friday suggest the blood clots are most common in young women, panelists warned the clots may still occur in men. One man in J&J’s clinical trial developed a clot. And two of the 15 cases recorded thus far occurred in women over 50, raising the possibility that the syndrome can also appear in older people.
European Union regulators have already decided to move forward with J&J’s vaccine, and Friday issued an analysis showing that the benefits of AstraZeneca Plc’s vaccine, also linked to clotting, outweigh its risks. The European Medicines Agency said the blood clots should be listed as a very rare side effect of J&J’s vaccine so doctors and people who receive it can be aware of the symptoms.
Mario Ramirez, an emergency medicine doctor who served in the Department of Health and Human Services’ Office of Pandemic and Emerging Threats during the Obama administration, praised the advisors’ decision.
“All medicines, even ones that we use commonly, have side effects,” he said. “The way forward is to help inform people about the risk based on the information we have right now.” – Bloomberg