[ad_1]
The Johnson & Johnson vaccine is expected to get the green light Thursday from the European Medicines Agency, but don’t expect the news to put a spring in the EU’s vaccination step.
The drugmaker’s coronavirus vaccine, which has already been approved and used in the U.S. and boasts a 66 percent efficacy rate, can stay in a normal fridge for three months and requires just one shot. The Commission has secured 200 million doses, with the option to purchase another 200 million.
The catch: Even assuming the EMA gives the thumbs up, the company won’t deliver its first doses to EU countries until April 1 at the earliest — and even that’s not looking likely.
Unlike BioNTech/Pfizer, which began shipping its mRNA vaccines just days after EU approval, Johnson & Johnson has not committed to any shipments until the second quarter of the year — meaning at least a three-week lag between the EU’s approval and Johnson & Johnson’s first deliveries.
German MEP Peter Liese said Wednesday that the first doses might not even arrive until mid-April, adding: “It’s already a problem.” An EU diplomat said it might not even be until end of April.
The looming supply issues from Johnson & Johnson are only compounding the EU’s serious shortage of shots, and the frustration Europeans feel as they watch the U.K. and the U.S. speed ahead and they largely keep doses for themselves.
The European Commission has borne the brunt of much of this frustration. Officials repeat the message that spring is coming, and with it many more vaccines. But the EU will have to wait weeks before there are any signs of April showers.
So far, the EU has received more than 50 million doses of vaccines in total. Commission President Ursula von der Leyen said this will double to 100 million in April. The Commission also announced BioNTech/Pfizer would step up and deliver 4 million more doses in the next two weeks, ahead of schedule, for the countries currently hit hardest by coronavirus.
If all goes according to plan, the EU should get around 570 million doses by the end of the second quarter: Around 300 million will come from BioNTech/Pfizer, 35 million from Moderna, 180 million from AstraZeneca and 55 million from Johnson & Johnson. It’s also likely more vaccines will be approved in the coming months, as the EMA has rolling reviews of Novavax, CureVac and Sputnik vaccines.
But there are already concerns about Johnson & Johnson’s deliveries. EU diplomats previously raised concerns that Johnson & Johnson’s drug substance has to be sent to the U.S. for fill-finish.
As of Wednesday, the company had not sent delivery schedules to EU countries, according to two EU diplomats, one of whom worried that it was because the company’s deliveries could be stopped by the U.S.
“The Commission is trying really hard. [Internal Market Commissioner Thierry] Breton goes everywhere, [Ursula von der Leyen] calls [U.S. President Joe] Biden, etc.,” the diplomat said. “We certainly do not have any concrete plans, only hope in the end; we just have hope.”
But Johnson & Johnson isn’t the only company facing supply hurdles. The second diplomat said delivery schedules are a “top concern” for all member states because almost no producers are meeting their deliveries — “especially AZ.”
So far, AstraZeneca has only delivered 10 percent of its promised doses, and EU officials are highly skeptical the British-Swedish company will reach its second quarter projections. There are also concerns that AstraZeneca is using an extra producer in the U.S. to make up for part of its EU shortage.
Moderna saw shortages throughout February, although it maintains it will deliver 10 million doses by the end of March.
Some like Liese want the EU to get tough, saying it’s time to implement a full-on vaccine export ban rather than the current “transparency and authorization mechanism” it has in place, which has allowed more than 34 million doses to leave the bloc for wealthy countries through March 9, according to Commission figures presented to EU diplomats.
The issue is getting more fraught. The EU and U.K. have spent the past 24 hours fighting over comments from Council President Charles Michel that the U.K. and U.S. have “imposed an outright ban on the export of vaccines or vaccine components produced on their territory.”
The U.K. has not in fact done that, but its contracts and early investment in the Oxford/AstraZeneca secured the country many of the company’s doses — even many of those made in the bloc — all while the EU faces massive shortages.
However, the U.K. depends on Pfizer’s Belgian plant to supply the country’s BioNTech/Pfizer doses. The EU approved the delivery of more than 9 million vaccines to the U.K. from the end of January until the beginning of March — one quarter of the vaccines exported in that time frame, according to those figures presented to EU diplomats.
The U.S., meanwhile, received more than 950,000 doses from the EU. In December, former U.S. President Donald Trump signed an executive order saying vaccine producers must supply the U.S. first with vaccines.
Internal Market Commissioner Thierry Breton said on Tuesday that he was in contact with his U.S. counterpart, Jeffrey Zients, on Monday.
“We have a lot of supply chains that are totally interlinked between Europe and U.S.,” Breton said.
The two will now talk each day to discuss how they can “smooth the process” of sending vaccine materials like lipids or filters quickly between one another. But Liese warns the good relationship with the U.S. won’t necessarily last.
“[U.S. President Joe] Biden is behaving like Trump,” Liese said. “We should clearly speak out that this is not the way how we see international cooperation. Europe serves the world; the U.K. and United States serve themselves — that is not how we see international cooperation.”
David M. Herszenhorn contributed reporting.
This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.
[ad_2]
Source link
