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Decision on J&J one-shot dose expected on Tuesday as EMA assesses blood clot data

The rollout of the one-shot dose was paused in the United States after six rare blood clots were identified post-vaccination.

Image: Shutterstock/rafapress

A DECISION ON the future use of the Johnson & Johnson one-dose vaccine will be made later this week in Europe and the United States after health agencies paused the rollout last week following reports of rare blood clots associated with the vaccine. 

The J&J jab, which has already been widely used across America, was to start being administered in European countries, including Ireland, last week but was paused after the Food and Drugs Administration (FDA) and the Centers for Disease Control and Prevention (CDC) halted its use “out of an abundance of caution”. 

The agencies said that six people who experienced the clots were between the ages of 18 and 48, were women, and that symptoms occurred 6 to 13 days after vaccination.

The company itself has said that it will be working with authorities in both the US and Europe in regard to the reported blood clots. 

It says that it is aware of “an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals” who have received its Covid-19 vaccine. 

Johnson & Johnson later paused all deliveries to Europe as it awaits a decision on its future use. 

The European Medicines Agency (EMA) is expected to make a decision and issue its assessment of the J&J vaccine on Tuesday – The one-shot dose was approved for use in Europe in March. 

Top US infectious disease expert Dr Anthony Fauci, meanwhile, said on Sunday that he expects a decision on whether to end a US pause of the J&J vaccine by Friday. 

A US government-convened expert panel has been assessing the vaccine’s possible links to the clotting disorder with Fauci saying that by Friday “we should have an answer as to where we’re going with it. I would think that we’re not going to go beyond Friday in the extension of this pause.”

u-s-washington-d-c-hearing-covid-19 Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases. Source: Xinhua News Agency/PA Images

While saying he did not want to get ahead of the expert panel convened by CDC, Fauci noted that the clotting disorder was “an extraordinarily rare event.”

“I believe we’ll get back with it,” he said, though possibly with some restrictions or warnings on its use.

The shot has been given to some 7.2 million Americans.

Some US experts have opposed continuing the pause, fearing it might disproportionately impact vulnerable groups that are easier to reach through a single-dose vaccine that can be stored in fridges.

But most felt that given the highly serious nature of the clots, and given the abundance in the United States of other vaccines that do not have the same safety concern, further study was necessary.

CDC director Rochelle Walensky has said that the symptoms in the women suffering clotting disorders were consistent with rare side effects from the AstraZeneca vaccine seen in Europe.

Both the J&J and the AstraZeneca vaccines are based on adenovirus vector technology, as are Russia’s Sputnik V and China’s CanSino.

The clotting problem has not been linked to the Pfizer or Moderna vaccines.

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NO FEE HSE weekly update 018 HSE CEO Paul Reid Source: RollngNews.ie

In Ireland, HSE officials are keenly awaiting the EMA’s decision on Thursday as the country’s rollout continues. 

Ireland is scheduled to receive 40,800 doses of the J&J vaccine this month, and over 600,000 in total up to the end of June. The first scheduled delivery of 14,000 doses arrived in Ireland last week and the doses are being held in cold storage. 

Acting Chief Medical Officer Dr Ronan Glynn last week said it was “too early to say” what impact the decision by Johnson & Johnson to delay the European rollout will have on the State’s vaccination programme and lifting of public restrictions.

Glynn said the EMA is currently assessing the data associated with these clots and that he would be discussing the matter with the Health Products Regulatory Authority (HPRA). 

HSE CEO Paul Reid said he expects the Johnson & Johnson vaccine to be available for use in Ireland soon despite the setbacks. 

“All we know right now is that it has been withdrawn for now, paused, and we can build based on that,” he told a briefing in Dublin.

Said Reid: “What we would expect, and we will certainly hope that the Johnson & Johnson does come back within the quarter, with whatever definitions are defined by the EMA or NIAC or the organisation themselves.”

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