EU approves J&J vaccine but faces wait to get doses – POLITICO



European regulators have been criticized for not approving vaccines quickly enough. Now it seems they’re moving faster than the vaccine makers.

The first deliveries of the newly approved Johnson & Johnson vaccine won’t arrive until mid-April at the earliest, the American company confirmed Thursday — the same day that the European Medicines Agency, followed by the European Commission, signed off on the jab.

EU diplomats fear deliveries could come even later amid rumors that the EU’s doses, which have to be put into vials in the U.S., could be stopped by the American government. The fact that the company still hasn’t sent its delivery schedule has also made EU countries uneasy.

Johnson & Johnson becoming the EU’s fourth approved vaccine in just four months should be a success story. Instead, Thursday’s announcement added little relief to the seemingly endless barrage of bad news about the bloc’s vaccination campaigns. The latest is Denmark’s decision to completely stop using the Oxford/AstraZeneca vaccine for two weeks due to concerns that it causes blood clotting issues.

A host of other EU countries — including Austria, Estonia, Italy, Latvia, Lithuania and Luxembourg — have already suspended specific batches of the vaccine over similar concerns, even though European regulators say there’s no indication that the vaccine caused problems.

The national moves pile on top of new data showing that AstraZeneca has delivered slightly more than 11 million doses to the EU as of March 7 — less than one-third of even the company’s lowest projections for the first quarter.

Ireland’s deputy prime minister and trade minister, Leo Varadkar, blasted the drug maker Thursday, noting the country had planned to inoculate 1.7 million people, a third of its population, by the end of March. But delays in receiving orders mean the country is unlikely to achieve even half of that goal — meaning a national lockdown begun in late December is likely to last until May.

Irish Health Minister Stephen Donnelly told lawmakers Thursday that he couldn’t offer new vaccination targets because of AstraZeneca’s “unacceptable unreliability.” The company had repeatedly extended delivery dates “often at the last minute” and, on one occasion, three times within one week, he added.

Meanwhile, Health Commissioner Stella Kyriakides hailed the approval of the Johnson & Johnson vaccine and also promised to push vaccine producers to meet their commitments.

“A single dose vaccine can make a difference in the speed of rollout,” she said in a statement.

“We will continue to work tirelessly to support vaccine producers and ensure they deliver doses, as agreed in our contracts,” she also said.

The Commission is also trying to challenge the narrative that it’s engaging in vaccine nationalism after blocking an Oxford/AstraZeneca shipment headed for Italy last week. The EU formally decided on Thursday to extend the requirement that companies must get national approval before exporting vaccine doses — despite calls to implement a full export ban on vaccines. 

Commission figures disclosed to EU diplomats showed that, since March 9, the EU has allowed the export of more than 34 million vaccines to wealthy countries, including more than 9 million to the U.K. and more than 953,000 to the U.S. 

But simultaneously, the Commission is getting flak for allowing any exports of those doses amid a vaccine shortage in the bloc.

Alan Kelly, leader of Ireland’s opposition Labour Party, said the Commission is as much to blame as the drug maker, accusing its leaders of lacking backbone when confronting AstraZeneca chiefs and permitting millions of vaccine doses to be exported outside the EU.

Winter is ending

However, the Commission claims there is good news on the horizon. The EU has received more than 54 million doses so far, and Commission President Ursula von der Leyen said this should double to 100 million doses in April alone. The EMA also has three other vaccines — from CureVac, Novavax and Sputnik — under rolling reviews, a process to speed up vaccine approvals.

Another potential boost is that the Johnson & Johnson vaccine requires a single shot and can be stored in normal refrigeration, making it easier to use than the three vaccines the EU currently has. 

European regulators also found that that the single-shot vaccine was 67 percent effective in preventing COVID-19 cases, citing large-scale trials with more than 44,000 participants. The American company will still have to provide additional information, including further studies showing how well the vaccine protects against new variants. 

However, there’s evidence that, like other coronavirus vaccines, Johnson & Johnson’s shot could be less effective in combating new variants. A trial in South Africa produced a lower efficacy rate of 57 percent compared to a trial in the U.S., which boasted a 72 percent efficacy rate. Researchers said it’s likely that the lower efficacy rate from the South African arm of the trial is related to the more transmissible South African variant that was circulating at the time. 

Still, the vaccine’s South African trial provided stronger efficacy results than Oxford/AstraZeneca’s two-dose viral vector vaccine, which was found to be 10 percent effective against the variant in its own South African study from February. Although the Oxford/AstraZeneca trial wasn’t conclusive because it only included 2,000 people, the results prompted South Africa to stop using that vaccine. 

South Africa is now administering Johnson & Johnson’s vaccine to health care workers as part of an extension of its clinical trial. 

Ashleigh Furlong, Shawn Pogatchnik and 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. 



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