Infectious Disease

The CDC Advisory Group says they need more information about the J&J vaccine

April 14, 2021

2 min read

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ACIP.

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Adalja, Shimabukuro and Talbot do not report any relevant financial information.

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A CDC advisory committee said Wednesday that it needed more information before deciding whether to change its recommendation for Johnson & Johnson’s COVID-19 vaccine.

The Advisory Committee on Immunization Practices (ACIP) met the day after US health officials recommended halting the adoption of the Johnson & Johnson vaccine while experts are reviewing six reported cases of rare coagulation events in people who received the vaccine.

Johnson and Johnson COVID vaccine

A CDC advisory committee said it needed more information on a number of rare blood clots before it could vote on whether to change its recommendation for the Johnson & Johnson COVID-19 vaccine.
Source: Adobe Stock.

The six cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia or low platelet levels occurred out of the first 6.8 million doses of the one-shot vaccine administered in the US on April 12, according to the CDC and FDA. On Tuesday one of the people died and another was in critical condition.

All six cases occurred in women between the ages of 18 and 48 who experienced symptoms 6 to 13 days after receiving the vaccine, which is approved for use in the United States aged 18 and over. No specific risk factors have been identified for these events. The true background incidence of CVST with thrombocytopenia remains unknown, an ACIP working group said at the meeting on Wednesday.

Amesh A. Adalja

The ACIP considered several options, including recommending that vaccinations with the Johnson & Johnson shot be fully resumed in all adults or that they be resumed only in some populations, e.g. B. in adults over 50 years of age or only in men. It was also considered formally recommending that the pause be extended for more information, but it was ultimately decided not to hold any vote and the pause remained.

Several concerns were addressed about a formal vote to extend the break, including that it could potentially deter people from receiving the vaccine, interrupt ongoing studies, or hinder the availability of the vaccine in countries with limited supplies.

Instead, the ACIP decided to meet again to discuss the matter within a week or so. It also has a pre-scheduled meeting on May 5th.

ACIP member Helen Keipp Talbot, MD, An associate professor of medicine at Vanderbilt University Medical Center said the US is in a “fortunate position” to await more information about the vaccine.

“We have very good, proven alternatives in which we don’t see any safety signals,” said Talbot. “We can be much more careful and thoughtful and follow the old motto” do nothing “.”

During the hour-long meeting, ACIP reviewed the six US cases and more than 100 similar events in Europe and the UK in people who had received another vaccine made by AstraZeneca. It heard from Johnson & Johnson representatives about the documented events, as well as two cases of CVST that occurred in a Phase 3 clinical trial last year – one in a male participant aged 25 who had received the vaccine. and one in a 24-year-old old woman who was in the placebo arm of the study.

The Johnson & Johnson and AstraZeneca vaccines both use a modified adenovirus – a human vector in the Johnson & Johnson vaccine and a chimpanzee vector in the AstraZeneca vaccine – and experts have said that the similar clotting pattern could suggest it might be a problem in connection with the acts type of vaccine.

“It remains the case, however, that the risk-benefit ratio is strongly favored [these vaccines] and I worry that these decisions will result in a huge number of Johnson & Johnson vaccine rejections and a relegation to the second tier. “ Amesh A. Adalja, MD, A senior scholar at the Johns Hopkins Center for Health Safety, Healio said Tuesday after the break was announced.

In a presentation on Wednesday the CDC Tom Shimabukuro, MD, MPH, A “relatively rough analysis” found that the observed rate of CVST after vaccination with the Johnson & Johnson vaccine appeared to be at least three times what would be expected based on the background rates in women aged 20 to 50 years.

In another presentation, Johnson & Johnson reported data from U.S. claims and electronic health record databases showing that the background incidence rate of CVST in women ages 18 to 34 is 2.64 per 100,000 person-years, which is higher than any other group.

The US cases were reported through the Vaccine Adverse Event Reporting System. In Europe, regulators have recommended listing “unusual blood clots with low platelets” as a “very rare side effect” of the AstraZeneca vaccine, which is not approved in the US

Beth Bell, MD, The chairman of the ACIP’s COVID-19 Vaccines Working Group noted on Wednesday that more than 160 coagulation events had occurred in Europe and the UK following vaccination with the AstraZeneca vaccine

The Johnson & Johnson vaccine is also approved in Europe, although doses have not yet been dispensed and the drug maker announced Tuesday that its introduction there has been delayed.

No cases of CVST have been reported in people who received either of the other two US-approved vaccines – the messenger RNA vaccines made by Pfizer-BioNTech and Moderna. According to the CDC, more than 180 million doses of these vaccines have been given in the United States

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