[ad_1]
Citing an urgent need to vaccinate the country quickly, a government advisory panel is recommending the nation resume injections of the Johnson & Johnson vaccine with a label warning. The panel voted 10 in favor, four opposed, with one abstention.
The next step is for the director of the Centers for Disease Control and Prevention to sign off on the recommendation. If she does as expected, J&J shots could resume within hours or days.
The panel declined to provide a specific warning to women under the age of 50 saying they should be aware of the increased risk of TSS and that they “may choose another COVID-19 vaccine” authorized in the U.S. Among the concerns is that such a specific warning could deter women from getting vaccinated.
Instead, the panel agreed it recommends the vaccine “under FDA’s Emergency Use Authorization.” As part of that plan, the FDA would provide fact sheets for health care professionals and recipients that details the risks involved and guidelines for treatment.
Following the vote, several members said they remain concerned that the public won’t necessarily read the fact sheets. Dr. Beth Bell, a member of the panel, voted in favor of the move but said it’s up to the CDC and other public health officials to educate the public.
“I am concerned that … women in this age group in particular will not be adequately informed just by the FDA,” she said.
“We really are depending on the public health agencies and the partner organizations to make sure that people actually are informed and are empowered, and that they actually get a balanced perspective,” Dr. Bell said
As federal advisers considered Friday whether Johnson & Johnson vaccine injections should resume, the Centers for Disease Control and Prevention said there were 15 confirmed reports of blood clots with low platelet counts following the J&J vaccine.
A dozen of the clots occurred in veins near the surface of the brain — a condition called “cerebral venous sinus thrombosis.”
The number of these rare reactions is more than double the six cases initially reported that prompted federal regulators to recommend a temporary suspension of the vaccine, but they arise out of the nearly 8 million J&J shots given.
Dr. Tom Shimabukuro, a member of the CDC’s task force on COVID-19 vaccines, provided the update at the Friday panel meeting to help federal regulators decide whether to resume J&J vaccinations.
Last week, the government recommended a suspension of J&J vaccinations following the initial reports of blood clotting.
On Friday, Shimabukuro told the panel that all of the 15 cases discovered were women. Most of them were in their 30s, although the age range was 18-59. Three of the women died.
Among the options weighed by the advisory panel was resuming shots with a medical warning or suggesting that certain groups of people — such as women under 50 — avoid the J&J shot.
The expert panel, which advises the Centers for Disease Control and Prevention, also had the option of determining they needed more time and more data before making a decision.
Johnson & Johnson officials on Friday urged the panel and federal regulators to agree to a label alerting patients and health care providers of risks — similar to what EU regulators did — but not restricting the availability of the vaccine.
Mathai Mammen, global head of research and development at J&J’s Janssen Pharmaceuticals, warned that limiting availability of the vaccine would hurt the world’s chances of achieving “herd immunity.”
“Janssen fully supports awareness, education, labeling. With these efforts, our goal is earlier recognition, making this event more identifiable, diagnoseable, treatable, and with improved chances of successful outcomes,” he said.
CDC Director Rochelle Walensky said Friday during a White House COVID-19 briefing that after the “risk benefit analysis” is presented, “I think the FDA and I both feel strongly and the CDC … feel strongly that we need to act swiftly after that analysis.”
“I do think that there’s plenty of people who are interested in the day-to-day vaccine if just for convenience, as well as for a single dose option,” she said.
In an emergency meeting last week, members of the advisory panel said they had too little data to make a recommendation either way, including whether younger women were more at risk. The advisers said they wanted to see if more cases emerged from the estimated 3 million people who received that vaccine in recent weeks before making a decision.
The nationwide suspension immobilized hundreds of federally run mobile clinics aimed at reaching the most vulnerable communities, leaving only nine operational.
“We’re not trying to scare anyone,” Dr. Jose Romero, chair of the Advisory Committee on Immunization Practices, told ABC News last week of the recommendation not to resume shots yet.
“We are simply trying to bring to the attention of the American public that this condition exists,” he added. “We want to reassure them, and we want to examine it and make a decision about the benefits of this.”
The disruption came at a critical time of the pandemic, with death and hospitalization rates tied to COVID-19 on the rise in nearly half the country. Health experts warned that variants of the virus were spreading more easily, impacting younger patients and that it’s critical to vaccinate the broader population quickly before new variants might take hold.
At the same time, federal regulators wanted to alert doctors and hospitals to be on the lookout for complications and to know how to treat them. Heparin, a commonly used blood thinner, appeared to worsen conditions.
ABC News’ Arielle Mitropoulos, Sasha Pezenik and Sony Salzman contributed to this report.
[ad_2]
Source link
