Johnson & Johnson says it has negotiated Covid-19 vaccine warning label with FDA

Johnson & Johnson says it has negotiated Covid-19 vaccine warning label with FDA

April 23, 2021

Johnson & Johnson said Friday that it has negotiated a warning label for its Covid-19 vaccine to make health care providers aware of a potentially increased risk of rare but severe blood clots and low platelet counts.

The vaccine maker revealed the warning text, which it said the Food and Drug Administration had agreed to, during a presentation Friday before a Centers for Disease Control and Prevention vaccine advisory panel.

Neither the FDA nor CDC, which called for a nationwide pause in use of the shot on April 13, has said they will adopt a warning label. The CDC panel — the Advisory Committee on Immunization Practices — is set to vote later Friday on its recommendations for use of the J&J shot. The Biden administration has said it will take the panel’s findings into account as it decides on a way forward.

Earlier in the day, members of the CDC panel heard that two more people have died from the blood clotting syndrome now dubbed thrombosis with thrombocytopenia.

That brings the total known deaths to three, among nearly 8 million Americans who have received the shot. Seven more people are hospitalized — including four in intensive care — and five have been discharged home, members of the CDC panel’s safety workgroup found Thursday, according to slides posted online.

The warning label that J&J said it negotiated with FDA notes an increased risk of the rare clotting syndrome, particularly among adult women younger than 49 years old. The label text lays out treatment recommendations such as avoiding common blood clot medicine heparin, which can worsen this unusual type of clot.

The CDC panel is meeting for the second time in 10 days to examine the potential connection between the J&J vaccine and the unusual clotting. It is possible that the panel could vote to lift the pause entirely as long as the warning label is added.

Agency staff presented a risk-benefit analysis that found 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.

When the CDC committee first met last week to examine the safety concerns around the J&J shot, and whether the administration should restrict eligibility for the vaccine, members decided they did not have enough information to make any recommendations.

The presentation prepared by the CDC panel’s safety subgroup says that the risk of the clotting syndrome appears to be highest for women under 50, at seven per million doses. The risk appears to be less than one in 7 million doses for men and women over 50, the subgroup’s slides said.

So far, 15 cases have been confirmed in people ages 18 to 59, all of them women, according to another presentation delivered Friday to the broader CDC panel. The median age of those affected was 37.

The full committee is expected to vote Friday on its recommendations for use of the vaccine. It is possible that the committee will recommend a warning label be added to the vaccine or suggest its use should be restricted by age, sex or both factors.

Biden administration officials have previously said they would look to the CDC’s advisory panel for guidance on lifting the pause in the shot, and they are expected to make a final decision soon.

“I think the FDA and I both feel strongly, and the CDC feels strongly that we need to act swiftly after that analysis,” CDC Director Rochelle Walensky told reporters in a press briefing Friday. “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.”

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 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.

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 advisory panel’s move not to make a recommendation on the shot last week. “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.”

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