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CDC vaccine panel unexpectedly delays Johnson & Johnson vaccine decision

While many members of the committee – which include public health experts, scientists and doctors – said they needed more information before making a call, others expressed frustration over the damage. that the lingering uncertainty would do to public confidence and immunization efforts among underserved populations.

“We’re in a position where not making a decision is making a decision,” said Nirav Shah, who heads the Maine public health agency and represents the Association of State and Territorial Health Officials.

The panel is not yet sure when it will meet again, but leaders said it could take more than a week to convene a new session. Senior health officials in the Biden administration had said on Monday that the break for the J&J vaccine could last for days or even weeks. It is not clear whether the CDC committee’s delay in making recommendations will delay the federal government’s timeline in deciding how to move forward with the vaccine.

The CDC and the FDA on Tuesday recommended suspending the use of millions of doses of J&J while they investigate possible links between the six confirmed cases of clots and the vaccine. Officials pointed out that these clots are cause for concern in part because the typical treatment for coagulation – the anticoagulant heparin – can make them worse.

All known cases have occurred in women aged 18 to 48. One of the women died and another is still in serious condition. But CDC officials said it might be difficult to implement gender-based limits rather than age restrictions. Several European countries have used this approach for a similar vaccine manufactured by AstraZeneca which may also be linked to coagulation problems.

The CDC committee, known as the Immunization Practices Advisory Committee, not only reviews the six reported cases of clots in J&J recipients, but examines whether the risk from using the vaccine outweighs benefits.

The J&J vaccine is convenient to administer because it only requires one dose and can be stored in the refrigerator. But CDC officials noted that the country has an adequate supply of safe and effective vaccines from Pfizer and Moderna. These injections use mRNA technology, while the vaccines from Johnson & Johnson and AstraZeneca are based on adenoviruses.

“The decision isn’t necessarily whether to get a Janssen vaccine versus whether you remain at risk for Covid-19,” CDC official Sara Oliver said, referring to the J&J division doing the shooting. “The decision may be receiving one Janssen vaccine versus receiving another mRNA vaccine.”

Pfizer and Moderna have each pledged 300 million doses to the United States by this summer. Pfizer said on Tuesday it was ahead of the production schedule and could deliver all of those plans by mid-July.

The United States can easily use these two vaccines to vaccinate its adult population, according to Jeff Zients, the White House’s Covid-19 response coordinator. But J&J is expected to play a bigger role in the country’s immunization plans by the end of spring, especially as the United States moves towards immunizing children and considers the potential need for booster vaccines in the future. the months or years to come.

Members of the CDC vaccine panel argued that an extended J&J vaccine hiatus could hamper efforts to equitably distribute Covid-19 vaccines. Members said the shooting was essential in reaching vulnerable populations, including those confined to their homes and the homeless.

Aran Maree, who heads the Janssen World Medical Organization, said the company determined that four of the women who developed clots, known as cerebral venous sinus thrombosis or CVST, had low platelet counts. Three of the patients had other blockages, including in the portal vein of the abdomen.

Maree said another case of coagulation has been reported but specific details are pending. There have also been two other cases of CVST reported in two different clinical trials, he said.

Neither the company nor the regulators know if any of the known cases of coagulation involved people who were pregnant or postpartum, but one person was taking birth control pills.

Maree said five of the reported cases – one in a clinical trial and four after vaccination – were treated with the anticoagulant heparin. While heparin is commonly used to treat typical blood clots, scientists say the drug may exacerbate the type of clots being studied for links to the J&J vaccine.

The Food and Drug Administration J & J’s authorized single-dose vaccine for emergency use in late March. At the time, he noted concerns about blood clots in some of the trial volunteers, but said there was not enough data to link to the vaccine. Although many people who developed clots in the trial had underlying health issues, a 25-year-old man with no previous conditions had a severe case. The FDA has advised providers to monitor whether more blood clots are occurring in the general population to learn more about the potential risks.



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