United States vaccine manufacturer Johnson & Johnson is to pause deliveries of its single-shot Covid-19 jab in Europe pending an investigation of rare blood clot cases that have halted rollout in the US, it announced.
“We have been reviewing these cases with European health authorities,” the company said in a statement. “We have made the decision to proactively delay the rollout of our vaccine in Europe.”
Deliveries began rolling out on Monday to EU member states and the announcement is a blow to vaccination efforts, as the single-shot vaccine is a cornerstone of plans to ramp up the pace of inoculation campaigns.
Overall, the EU is due to receive 55 million doses of the vaccine by the end of June. Janssen, Johnson & Johnson’s European subsidiary accounts for 605,000, or 15 per cent of the projected 3.9 million Covid-19 vaccines doses that the Government was expecting to be delivered in April, May and June.
Roughly 7 million doses have been administered in the United States. Among these, six cases of a rare kind of blood clot, cerebral venous sinus thrombosis, was reported along with low levels of platelets.
The cases all occurred in women aged between 18 and 48, with symptoms occurring 6 to 13 days after vaccination, according to the US Food and Drug Administration (FDA).
The regulator is “recommending a pause in the use of this vaccine out of an abundance of caution,” pending a review of the cases, the FDA announced in a statement.
“This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot,” the regulator said.
“People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.”
The blood clotting conditions reported in recipients of the Johnson & Johnson vaccine in the US are the same rare condition linked to the AstraZeneca vaccine. This lead to Ireland on Monday restricting the use of the AstraZeneca vaccine jab to people aged over 60 only.
The European Medicines Agency last week began a review of a safety signal to assess reports of blood clotting in people who had received the vaccine. As deliveries only began in Europe this week, it so far has data from the rollout of the vaccine elsewhere and is in touch with the US FDA and other international regulators, the EMA said in a statement.
“EMA’s safety committee (PRAC) is investigating all the cases reported and will decide whether regulatory action is necessary,” the statement read
“It is currently not clear whether there is a causal association between vaccination with Janssen’s COVID-19 vaccine and these conditions.”
The European Commission said it was in contact with the company over the issue and that the vaccine Steering Board, made up of representatives of member states, would work to coordinate a common EU approach to the issue.
“The safety of our citizens is our absolute priority. We follow a science based approach, and hence EMA’s opinions,” the Commission said in a statement.
No doses of the vaccine had yet been given out in the EU, the statement said.
Too early to say
The chief executive of the Health Service Executive Paul Reid said that volumes of Johnson & Johnson doses to be supplied over the next couple of weeks were “relatively low” .
He said he could not comment on the situation with the Johnson & Johnson/Janssen vaccine as news of the delay in the European rollout was just breaking this afternoon.
Ireland’s acting chief medical officer Dr Ronan Glynn said it was “too early to say” what the impact of Johnson & Johnson’s decision to delay the rollout of its vaccines in Europe would mean for the State’s vaccination programme and the lifting of Covid-19 public restrictions.
Dr Glynn told an online conference that the European Medicines Agency was monitoring the situation with the Johnson & Johnson vaccines and that he would be discussing the issue with the State’s medicines regulator, the Health Products Regulatory Authority, later this afternoon.
He was speaking at the RCSI University of Medicine and Health Sciences annual conference.
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.
The State’s Health Products Regulatory Authority (HPRA) said “The EMA stressed that these reports point to a ‘safety signal’, but it is currently not clear whether there is a causal association between vaccination with COVID-19 Vaccine Janssen and these conditions.”
White House
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.
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.
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. – Additional reporting New York Times/Reuters
