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Johnson & Johnson said on Tuesday it would delay the rollout of its Covid-19 vaccine in Europe and was reviewing cases of extremely rare blood clots in people after they received the shot with European health authorities.
It comes as US federal health agencies on Tuesday recommended pausing the use of the single-shot Johnson & Johnson’s Covid-19 vaccine after six women under 50 who had received it developed rare blood clots, dealing a fresh setback to efforts to tackle the pandemic.
All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalised in critical condition, the officials said.
Regulators in Europe and elsewhere are concerned about a similar issue with the AstraZeneca vaccine, leading to Ireland on Monday restricting the use of the AstraZeneca vaccine jab to people aged over 60 only. Janssen, Johnson & Johnson’s European subsidiary, is expected to administer 605,000 doses to the Republic. It is understood the first consignment of the Johnson & Johnson vaccine, some 14,000 doses had been due to arrive arrive into the State on Wednesday afternoon.
Speaking before the European announcement by Johnson &Johnson, Ireland’s acting chief medical officer Dr Ronan Glynn told Tuesday’s meeting of the Oireachtas Committee on Health that health authorities were aware of the need to maintain confidence in the vaccination programme amid concerns over two vaccines – AstraZeneca and Johnson & Johnson – being linked to rare blood clots.
He said authorities have been proactive in assessing the latest data and ensuring the public understands the rationale for decisions and that safety comes first.
Mr Glynn said the European Medicines Agency is monitoring the situation and he will be getting an update from the State’s Health Products Regulatory Authority after the committee meeting.
He said he knew there were six cases of rare blood clots in recipients of the Johnson & Johnson vaccine reported out of 7 million doses given in the US but he needed to look at further information on the issue.
White House
Nearly 7 million people in the US have received Johnson & Johnson shots so far and about 9 million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention (CDC).
The White House said the pause would not have a “significant” impact on its plan to administer about three million shots per day and a total of 200 million shots before US president Joe Biden’s 100th day in office.
Scientists with the Food and Drug Administration (FDA) and CDC will jointly examine possible links between the vaccine and the disorder and determine whether the FDA should continue to authorise use of the vaccine for all adults or limit the authorisation.
The move could substantially complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy.
Most of the vaccine supply in the US comes from two other manufacturers, Pfizer-BioNTech and Moderna, which together deliver more than 23 million doses a week of their two-shot vaccines. There have been no significant safety concerns about either of those vaccines.
But while shipments of the Johnson & Johnson vaccine have been much more limited, the Biden administration had still been counting on using hundreds of thousands of doses every week. In addition to requiring only a single dose, the vaccine is easier to ship and store than the other two, which must be stored at extremely low temperatures.
It is unclear to what degree the pause in the use of the Johnson & Johnson vaccine will set back the Biden administration’s plans to deliver enough vaccine to be able to inoculate all adults in the US by the end of May.
In the US alone, 300,000 to 600,000 people a year develop blood clots, according to CDC data. But the particular blood clotting disorder that the vaccine recipients developed, known as cerebral venous thrombosis, is extremely rare. All of the women developed the condition between six and 16 days of vaccination, and government experts are concerned that an immune system response triggered by the vaccine was the cause.
The decision is a fresh blow both to Johnson & Johnson and to the administration’s plans. Late last month, the company discovered that workers at a Baltimore plant run by its subcontractor had accidentally contaminated a batch of vaccine, forcing the firm to throw out the equivalent of 13 million to 15 million doses. That plant was supposed to take over supply of the vaccine to the US from Johnson & Johnson’s Dutch plants, which were certified by federal regulators earlier this year. – New York Times/Reuters