The excellent news — that the EU would begin utilizing Johnson & Johnson’s one-shot vaccine this week — lasted barely greater than 24 hours.
The U.S. on Tuesday beneficial suspending the vaccine after six experiences of blood clots. Shortly after, the American firm introduced it might “proactively delay” its European rollout.
The primary deliveries of the one-dose adenovirus vaccine set to reach within the EU this week have been initially cheered as the antidote to the bloc’s sluggish vaccination campaigns. However now the shot is wanting extra just like the Oxford/AstraZeneca jab, which has been affected by supply delays and security issues within the EU.
“It’s a setback, however higher to be protected than sorry,” one EU official mentioned. However an EU diplomat mentioned the announcement was not “excellent news.”
“We noticed what occurred with AstraZeneca,” he added.
It isn’t but clear whether or not the international locations that have already got their first bins of J&J vaccines will use them regardless of the corporate’s warning. However the announcement Tuesday prompted concern that capitals will once more take totally different approaches, simply as they’ve performed with the Oxford/AstraZeneca jab. In that case, the patchwork of nationwide responses on age cut-offs has prompted the Fee and the Portuguese presidency of the Council to push for a extra harmonized strategy on who ought to get the vaccine.
Alessio D’amato, well being counselor within the Italian area of Lazio, mentioned {that a} “fast, clear, definitive resolution, with out hesitation and uncertainty” is required on the J&J vaccine. “We should keep away from doing what has been performed with the AstraZeneca vaccine,” he mentioned, as quoted in la Repubblica. “The authorities ought to communicate with one voice.”
Up to now, most international locations — even those who exercised excessive warning over the Oxford/AstraZeneca jab — have indicated they are going to nonetheless go ahead with the J&J vaccine. Belgium, for instance, has 36,000 doses and plans to make use of them except the European Medicines Company says in any other case. Portugal additionally mentioned it was too early to pause the vaccine.
Different international locations, like Spain, that weren’t set to obtain their first doses of the vaccine till Wednesday have but to announce their resolution.
One issue affecting international locations’ selections, mentioned the EU diplomat, is how a lot they ordered of every jab. The EU is about to obtain by the tip of June 55 million J&J doses, which have been supplied to every nation based mostly on their inhabitants measurement. However some international locations ordered much less of the dear mRNA vaccines and extra of the cheaper viral vector jabs like Oxford/AstraZeneca and J&J.
One value checklist printed accidentally in December confirmed EU international locations spent $8.50 for these photographs, in comparison with mRNA photographs, which initially value EU international locations as much as $18 a bit.
For these international locations that didn’t order sufficient of the mRNA vaccines, Tuesday’s information “is a large deal,” the diplomat mentioned. He predicted, nonetheless, that those who purchased extra of Oxford/AstraZeneca “will proceed to make use of AstraZeneca,” and those who purchased extra Johnson & Johnson “will proceed to make use of J&J.”
What we all know thus far
European regulators have but to suggest in opposition to utilizing the J&J vaccine. However all eyes at the moment are on the protection report that the EMA launched on Friday to research circumstances of blood clots linked to vaccination.
“It’s at present not clear whether or not there’s a causal affiliation between vaccination with COVID-19 Vaccine Janssen and these situations,” the EMA wrote in an announcement. It added that its security committee, PRAC, “is investigating these circumstances and can determine whether or not regulatory motion could also be needed.”
The EMA did not say how lengthy it might take to make an evaluation. However in a tweet, Well being Commissioner Stella Kyriakides known as on the regulator to maintain an “open line” with its U.S. counterparts, on the grounds that “vaccine security is all the time paramount.”
The U.Okay., in the meantime, remains to be anticipating its regulator to approve the vaccine imminently, in keeping with British media.
The pause could not final lengthy within the U.S, with the appearing Meals and Drug Administration Commissioner Janet Woodcock saying Tuesday that the delay might be for “a matter of days.”
Anthony Fauci, President Joe Biden’s chief medical adviser, mentioned Tuesday mentioned it might be weeks, though “it’s going to be extra like days to weeks, somewhat than weeks to months.” Behind closed doorways, the Biden administration is getting ready for a doubtlessly prolonged suspension.
The advice from American regulators was based mostly on six circumstances of blood clots mixed with low platelets all in girls between the ages of 18 and 48. That quantities to a tiny fraction of the 6.Eight million vaccinations given in complete within the U.S.
“It’s plainly apparent to us already that what we’re seeing with the [J&J] vaccine appears to be like similar to what was being seen with the AstraZeneca vaccine,” mentioned FDA’s prime vaccine regulator, Peter Marks. That vaccine is just being utilized in older populations in quite a few EU international locations.
The U.S. authorities mentioned the pause gained’t have a large influence on vaccinations within the nation, because the vaccine “makes up lower than 5 p.c of the recorded photographs in arms in america thus far,” White Home COVID-19 response coordinator Jeff Zients mentioned in an announcement.
However in contrast to the U.S., the EU is banking on these vaccines to offer a much-needed increase to the bloc’s vaccination campaigns. “It solely takes one vaccination to attain ample safety, so the vaccine will massively speed up the tempo within the EU,” German MEP Peter Liese wrote in an announcement Monday after the corporate started shipments to EU international locations and earlier than Tuesday’s announcement.
Nonetheless, the majority of the EU’s doses within the second quarter will come from BioNTech/Pfizer, which is anticipated to offer 200 million photographs. Moderna ought to ship one other 35 million. In the meantime, AstraZeneca appears to be like prone to solely present 70 million doses of the 180 million it initially deliberate to offer the EU within the second quarter, in keeping with a second EU diplomat. That comes on prime of a large shortfall of round 70 million doses within the first quarter.
Nonetheless, if all the pieces runs as deliberate, Liese wrote in that Monday assertion, the Fee’s aim of vaccinating 70 p.c of adults by the tip of the summer time “may be achieved as early as mid-July, and if issues go properly, each European citizen can already be supplied vaccination by mid-summer.”
The primary EU diplomat mentioned that issues might work out for the EU regardless of the information. So long as the EU will get its 55 million J&J doses this quarter, a short-term pause won’t be that unhealthy, he mentioned.
Preliminary deliveries of the J&J vaccine have been already fairly small initially, he famous, including that the majority of doses are anticipated beginning in Might. But when the pause continues longer than days or perhaps weeks, he warned, it’s “doubtlessly an enormous blow.”
Carlo Martuscelli and Helen Collis contributed reporting.
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