CDC panel endorses use of Johnson & Johnson Covid-19 vaccine

A federal vaccine advisory panel on Friday recommended the use of Johnson & Johnson’s Covid-19 vaccine for people 18 and over, more than a week after the Biden administration called its used to be paused over a potential link to rare and severe blood clots.

The Centers for Disease Control and Prevention panel considered, but ultimately did not vote on, a recommendation to warn women under 50 of the potential risk of clotting coupled with low platelet levels.

Federal health officials called for a pause in use of the vaccine on April 13, responding to a handful of reports of the blood clotting syndrome now known as thrombosis with thrombocytopenia. Fifteen women have been diagnosed with the condition; three have died and seven are hospitalized. They are among nearly 8 million Americans who have received the J&J shot since the FDA authorized its use in March.

The panel’s recommendations are non-binding, but the Biden administration has said it will consider them in deciding whether and how to end the pause. The FDA is expected to act in the coming days, potentially adding a warning that Johnson & Johnson representatives showed at the Friday meeting and described as something the company had negotiated with the agency.

Many members of the CDC advisory committee — which includes doctors, public health experts, state leaders and federal officials — said there are distinct logistical advantages to J&J’s shot that make it important for immunizing people who are hard to reach or skeptical. The vaccine is the only option available in the U.S. that is given as one shot, and it is easier than other Covid-19 vaccines to ship and store.

CDC Director Rochelle Walensky acknowledged those points during a press briefing Friday. “I think the FDA and I both feel strongly, and the CDC feels strongly that we need to act swiftly after that analysis,” she said. “But I do think that there is plenty of people who are interested in the J&J vaccine if just for convenience as well as for a single-dose option.”

President Joe Biden’s chief medical adviser, Anthony Fauci, echoed that argument in an interview Friday on MSNBC. “People are saying they’re sorry it was paused,” Fauci said. “They can’t wait until it gets back because they’d rather have a single dose vaccine. There will be plenty of people who will prefer having a single dose vaccine.”

But others worried that a warning could put a burden on health care providers and patients themselves to understand the risks — and that in certain settings, like mass-vaccination sites, that could prove difficult.

Women under 50 appear to be at highest risk for the clotting syndrome, with seven cases per million doses of vaccine administered, according to information presented Friday by the CDC panel’s safety subgroup. The risk appears to be less than one in 7 million doses for men and women over 50.

A risk-benefit analysis conducted by agency staff found that as many as 26 cases of clotting could occur out of a projected 9.8 million J&J doses administered over the course of six months. The CDC said two of those cases could likely show up in people between ages 50 and 64, with 24 cases in those between 18 and 49.

The CDC also modeled how long it would take to vaccinate every adult American who still wants a shot, from Friday on. The agency found that vaccinating all willing adults would happen 14 days sooner if the country began giving out J&J shots at the same rate as it was before the pause.

European regulators were first to raise concerns about the J&J vaccine and clotting. The European Medicines Agency said Tuesday that it had identified a possible link, but the benefits of the shot outweighed the risks of its use. The EMA recommended that the European Union issue a general warning about clotting rather than restrict the vaccine’s use.

Biden officials in the CDC and the Food and Drug Administration then made the call to implement a pause in the shot to gather more data about the people who had developed the clotting, to identify additional cases, and to speak with health care providers about the best course of treatment. Officials were concerned about the severe blood clotting cases in part because the typical treatment for clotting — the blood thinner heparin — can make them worse.

Johnson & Johnson’s chief scientific officer, Paul Stoffels, said in a statement Friday that the company would continue to collaborate with regulators worldwide to further investigate the clotting issue.

“We are grateful to the Advisory Committee and its medical experts for the rigorous evaluation of our COVID-19 vaccine,” he said. “We will continue to collaborate with the CDC, FDA and health authorities around the world, including the European Medicines Agency and the World Health Organization, to ensure this very rare event can be identified early and treated effectively.”

Over the past week federal and state health officials have grown increasingly frustrated with the J&J pause, arguing that a prolonged halt would harm efforts to distribute Covid-19 vaccines to vulnerable populations, including the homebound and homeless. Last week, states did not receive any J&J vaccine allocations from the federal government, according to two state public health officials, and they are unsure whether they will receive any doses next week. To supplement the gap, the Biden administration has ramped up delivery of the Pfizer and Moderna vaccines.

Health experts continue to worry about the long-term impacts of the pause, particularly around vaccine hesitancy.

“I have been a little frustrated with the extension of the pause,” said Ashish Jha, dean of Brown University’s School of Public Health, referring to the CDC panel’s decision last week not to defer a recommendation on the shot. “It sends a global signal that somehow we’re keeping the good stuff for us and sending out everything else for other people. I don’t think that’s actually correct. I don’t think J&J is an inferior vaccine. And it makes global vaccinations so much harder because it leads into a narrative that will build vaccine hesitancy globally.”

,

A federal vaccine advisory panel on Friday recommended the use of Johnson & Johnson’s Covid-19 vaccine for people 18 and over, more than a week after the Biden administration called its used to be paused over a potential link to rare and severe blood clots.

The Centers for Disease Control and Prevention panel considered, but ultimately did not vote on, a recommendation to warn women under 50 of the potential risk of clotting coupled with low platelet levels.

Federal health officials called for a pause in use of the vaccine on April 13, responding to a handful of reports of the blood clotting syndrome now known as thrombosis with thrombocytopenia. Fifteen women have been diagnosed with the condition; three have died and seven are hospitalized. They are among nearly 8 million Americans who have received the J&J shot since the FDA authorized its use in March.

The panel’s recommendations are non-binding, but the Biden administration has said it will consider them in deciding whether and how to end the pause. The FDA is expected to act in the coming days, potentially adding a warning that Johnson & Johnson representatives showed at the Friday meeting and described as something the company had negotiated with the agency.

Many members of the CDC advisory committee — which includes doctors, public health experts, state leaders and federal officials — said there are distinct logistical advantages to J&J’s shot that make it important for immunizing people who are hard to reach or skeptical. The vaccine is the only option available in the U.S. that is given as one shot, and it is easier than other Covid-19 vaccines to ship and store.

CDC Director Rochelle Walensky acknowledged those points during a press briefing Friday. “I think the FDA and I both feel strongly, and the CDC feels strongly that we need to act swiftly after that analysis,” she said. “But I do think that there is plenty of people who are interested in the J&J vaccine if just for convenience as well as for a single-dose option.”

President Joe Biden’s chief medical adviser, Anthony Fauci, echoed that argument in an interview Friday on MSNBC. “People are saying they’re sorry it was paused,” Fauci said. “They can’t wait until it gets back because they’d rather have a single dose vaccine. There will be plenty of people who will prefer having a single dose vaccine.”

But others worried that a warning could put a burden on health care providers and patients themselves to understand the risks — and that in certain settings, like mass-vaccination sites, that could prove difficult.

Women under 50 appear to be at highest risk for the clotting syndrome, with seven cases per million doses of vaccine administered, according to information presented Friday by the CDC panel’s safety subgroup. The risk appears to be less than one in 7 million doses for men and women over 50.

A risk-benefit analysis conducted by agency staff found that as many as 26 cases of clotting could occur out of a projected 9.8 million J&J doses administered over the course of six months. The CDC said two of those cases could likely show up in people between ages 50 and 64, with 24 cases in those between 18 and 49.

The CDC also modeled how long it would take to vaccinate every adult American who still wants a shot, from Friday on. The agency found that vaccinating all willing adults would happen 14 days sooner if the country began giving out J&J shots at the same rate as it was before the pause.

European regulators were first to raise concerns about the J&J vaccine and clotting. The European Medicines Agency said Tuesday that it had identified a possible link, but the benefits of the shot outweighed the risks of its use. The EMA recommended that the European Union issue a general warning about clotting rather than restrict the vaccine’s use.

Biden officials in the CDC and the Food and Drug Administration then made the call to implement a pause in the shot to gather more data about the people who had developed the clotting, to identify additional cases, and to speak with health care providers about the best course of treatment. Officials were concerned about the severe blood clotting cases in part because the typical treatment for clotting — the blood thinner heparin — can make them worse.

Johnson & Johnson’s chief scientific officer, Paul Stoffels, said in a statement Friday that the company would continue to collaborate with regulators worldwide to further investigate the clotting issue.

“We are grateful to the Advisory Committee and its medical experts for the rigorous evaluation of our COVID-19 vaccine,” he said. “We will continue to collaborate with the CDC, FDA and health authorities around the world, including the European Medicines Agency and the World Health Organization, to ensure this very rare event can be identified early and treated effectively.”

Over the past week federal and state health officials have grown increasingly frustrated with the J&J pause, arguing that a prolonged halt would harm efforts to distribute Covid-19 vaccines to vulnerable populations, including the homebound and homeless. Last week, states did not receive any J&J vaccine allocations from the federal government, according to two state public health officials, and they are unsure whether they will receive any doses next week. To supplement the gap, the Biden administration has ramped up delivery of the Pfizer and Moderna vaccines.

Health experts continue to worry about the long-term impacts of the pause, particularly around vaccine hesitancy.

“I have been a little frustrated with the extension of the pause,” said Ashish Jha, dean of Brown University’s School of Public Health, referring to the CDC panel’s decision last week not to defer a recommendation on the shot. “It sends a global signal that somehow we’re keeping the good stuff for us and sending out everything else for other people. I don’t think that’s actually correct. I don’t think J&J is an inferior vaccine. And it makes global vaccinations so much harder because it leads into a narrative that will build vaccine hesitancy globally.”

Leave a Reply