Johnson & Johnson COVID vaccine use in US should resume, CDC panel recommends

Written by on April 23, 2021


Oregon well being officers stated Thursday that federal officers are investigating the demise of a girl in her 50s who developed a uncommon blood clot and low platelets inside two weeks of receiving the Johnson & Johnson vaccine in opposition to COVID-19. (April 22) AP Home

The pause on the Johnson & Johnson COVID-19 vaccine ought to be lifted, an skilled advisory committee to the Facilities for Illness Management and Prevention stated Friday.

The advice by the CDC committee, referred to as the Advisory Committee on Immunization Practices, must be accredited by the CDC and the Meals and Drug Administration earlier than turning into official authorities coverage. 

The FDA is predicted to make an announcement later Friday concerning warnings it could add to the vaccine’s authorization. The CDC would then design public communication supplies associated to the change.

The committee spent six hours Friday discussing the right way to deal with the rare side effect.

“This can be a critical opposed occasion. We have to proceed to make sure that consciousness is raised,” stated member Dr. Grace Lee, a pediatrician on the Lucile Packard Youngsters’s Hospital and Stanford College Faculty of Medication, who supported the measure. “However I additionally assume that we have now to return out with a transparent suggestion.”

CDC employees reported there have been 15 circumstances of the weird dysfunction, amongst 7.89 million doses of the J&J vaccine delivered in america. All the circumstances have been in girls, apart from one man within the medical trial.

The uncommon situation features a mixture of blood clots, many in uncommon places such because the mind or stomach, and low ranges of platelets, which assist wounds heal. It has been dubbed thrombosis with thrombocytopenia syndrome or TTS.

The bizarre facet impact, seen six to 14 days after receiving the J&J vaccine, appears to most frequently strike girls underneath age 50. 

Comparable uncommon occasions have been seen amongst British and European recipients of a unique COVID-19 vaccine, made by AstraZeneca and Oxford College, which makes use of the same supply system as J&J’s photographs. The AstraZeneca-Oxford vaccine, which isn’t obtainable in america, additionally appears to strike girls greater than males, although of a wider age vary. 

The impact has not been seen with the 2 different vaccines approved to be used within the U.S., by Pfizer-BioNTech and Moderna, which have to date been given to about 130 million People.

Resuming the usage of the J&J vaccine in america would forestall 1,435 deaths from COVID-19 and a pair of,236 admissions to hospital intensive care items, in response to a CDC evaluation. It may trigger roughly 24 circumstances of TTS, a CDC staffer stated. 

Three of the 15 identified sufferers have died, roughly 20% of these identified with TTS to date; an extra 5 individuals could be prone to die if use of the vaccine have been resumed, in response to a CDC evaluation. 

The J&J vaccine has been common for some individuals as a result of it solely requires a single shot. 

“Eradicating a vaccine that may be given as a single dose, which is a choice for Latinos in our group, could be a detriment,” stated Dr. José Romero, chair of the committee and director of the Arkansas Division of Well being.

The J&J shot has been particularly common to be used in difficult-to-reach populations, akin to individuals experiencing homelessness, the homebound, incarcerated people and school college students.

“We actually do depend upon this ‘one dose and also you’re completed’ vaccine with simple storage” to achieve at-risk populations, stated Dr. Sandra Fryhofer, a professor of drugs at Emory College Faculty of Medication and liaison to the committee.

​People additionally wish to have some selection about which vaccine they obtain, stated Dr. Beth Bell, a professor of world well being on the College of Washington.

“This can be a time once we want choices and adaptability,” she stated.

The United States stays in the midst of a COVID-19 outbreak and so wants these choices now, she famous. However suggestions may change as extra details about the dangers and advantages of vaccines turns into obtainable.

A number of panel members praised the CDC for recognizing and appearing on the protection concern so rapidly.

The FDA and the CDC first beneficial the pause on April 13 after a number of studies of the uncommon blood clotting situation confirmed up within the CDC’s vaccine monitoring system.

Last Wednesday the advisory committee determined the pause ought to proceed till not less than Friday because the CDC gathered extra data on the situation and extra circumstances may doubtlessly be recognized. At the moment, there have been eight identified circumstances of the situation. 

It was very reassuring that so few further circumstances have been recognized since, stated Dr. Grace Lee, a professor of pediatrics at Stanford College Faculty of Medication.

“The final 11 days for me have been reassuring in that we haven’t recognized a whole bunch of extra circumstances regardless of enhanced focus, which was my fear final week,” she stated. “Final week I might have made a unique choice than I might this week.”

TTS is so uncommon that the skilled testifying earlier than the CDC panel stated he’d by no means seen it earlier than.

Dr. Michael Streiff, a hematologist on the Johns Hopkins College Faculty of Medication, stated it occurred in about 1 out of 100,000-250,000 recipients of both the J&J or AstraZeneca-Oxford vaccines.

Thrombocytopenia happens when somebody has fewer than 150,000 platelets, also referred to as thrombocytes, per microliter of blood. Harmful inside bleeding can happen with platelet counts under 10,000, a determine reached by most of the sufferers with TTS. Such extreme thrombocytopenia may cause deadly bleeding into the mind.

Many of the blood clots, additionally referred to as thromboses, occurred within the mind, although a number of have been within the stomach.

Public well being officers have warned that anybody who develops a extreme headache or leg or stomach ache every week or two after vaccination with the J&J vaccine ought to search fast consideration.

This facet impact is completely different from preliminary reactions to a vaccine, which begin a day or two after a shot and are short-lasting.

Streiff additionally beneficial that these sufferers not be given heparin, a drug generally used to fight blood clots, as it could exacerbate signs. Not one of the three TTS sufferers who died obtained heparin, however six got the drug earlier than the pause.

General, the committee determined the advantages of the J&J vaccine nonetheless outweigh the possibility of this very uncommon facet impact.

COVID-19 itself causes 200 individuals to be hospitalized and results in 30 deaths out of each million People, CDC numbers present, in comparison with 15 hospitalizations and three  deaths out of greater than 7 million who obtained the J&J vaccine.

“The overwhelming threat profit right here is ‘Get the vaccine you may get,’” stated Dr. Robert Gluckman, chief medical officer of Windfall Well being Plans, a well being community in Oregon.

Contact Elizabeth Weise at and Karen Weintraub at kweintraub@usatoday.

Well being and affected person security protection at USA TODAY is made attainable partially by a grant from the Masimo Basis for Ethics, Innovation and Competitors in Healthcare. The Masimo Basis doesn’t present editorial enter.

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