J&J’s Single-Dose Covid-19 Vaccine Approved by EU Drug Regulator

BRUSSELS—The single-shot Covid-19 vaccine from Johnson & Johnson was cleared for use by the European Union’s drug agency on Thursday, but the regulator’s approval appears unlikely to immediately accelerate Europe’s lagging vaccine rollout.

The European Medicines Agency said that the J&J vaccine is safe and effective against Covid-19, paving the way for EU authorities to formally authorize its use later Thursday. Distribution is set to begin in the second quarter.

The EMA’s decision to recommend authorization of the J&J vaccine follows U.S. approval late last month.

The J&J vaccine has the potential to significantly bolster vaccination drives over time. It can be kept in refrigerators instead of freezers, making it easier to store and distribute than some vaccines already approved, and recipients need only one dose rather than the two administered for other vaccines, often many weeks apart.

Trials found J&J’s vaccine had a high impact in preventing serious illness but was 67% effective overall when moderate cases were included. Side effects were usually mild or moderate, the EMA said.

In a statement, J&J said the data also showed 85% efficacy in preventing cases of serious disease.

“Now, as we await a decision on the use of our single-dose Covid-19 vaccine in the European Union, we remain confident that the Johnson & Johnson vaccine will prove a critical tool for fighting this pandemic,” said Paul Stoffels, the company’s chief scientific officer.

Despite the approval, questions persist about how quickly J&J will start delivering vaccines on a large scale, following manufacturing problems in the U.S. This week, EU officials said they were hopeful the company would meet its second-quarter EU distribution target of 55 million doses and that they would get a fuller picture after the EMA’s approval decision.

The company has agreed to provide the EU with 200 million doses this year, and the EU has the option of buying another 200 million. The company said last week it was confident it would meet its full-year target.

On Wednesday, President Biden said J&J had agreed to provide the U.S. an additional 100 million doses in the second half of this year, on top of the 100 million it was already due to deliver. To overcome manufacturing difficulties, the White House helped negotiate an agreement between J&J and longtime competitor Merck & Co., in which Merck will help produce J&J’s vaccine.

The EU and the U.S. started talks this week on ensuring that they don’t block vital vaccine ingredients from export to each other. An executive order Mr. Biden issued last month had raised concerns in Europe that some vaccine materials, potentially including J&J doses intended for the EU, could be blocked from U.S. export.

The White House on Wednesday sought to dispel those concerns.

“The Biden administration’s top priority is saving lives and ending the pandemic. The U.S. has not imposed a ban on the export of vaccines or their inputs,” an administration expert on exports said. “All vaccine manufacturers in the U.S. are free to export their products while also fulfilling the terms of their contracts with the U.S. government.”

Unlike the U.S. and the U.K., the EU has exported over 34 million vaccine doses to 31 countries outside the bloc since late January, but the slow rollout within Europe prompted the EU to permit its members to ban some exports. Last week, that happened for the first time, when Italy blocked the delivery of AstraZeneca doses to Australia.

On Thursday, the EU said it would extend until the end of June the mechanism that allows member states to ban export vaccines.

The EU signed contracts with J&J in October, one of six vaccine agreements the bloc has signed so far. To date, four of the vaccines have been approved, from J&J, AstraZeneca PLC, Pfizer Inc. and Moderna Inc.

The EU vaccination campaign has been hampered by late signing of contracts, delivery problems and difficulties distributing the vaccines in some member states. For now, the vaccination rate in the EU is well below those in the U.S. and U.K.

In France, Germany and Italy, less than 8% of people have received their first dose, according to Wednesday’s daily data from the European Center for Disease Prevention and Control.

With Covid-19 deaths high even in countries like Germany, which performed well during the first wave of coronavirus, much of Europe has been in lockdown for months, hitting the region’s already troubled economy and drawing protests in some countries. On Wednesday, German Chancellor Angela Merkel warned that her country faces three tough months ahead.

The European Commission, the EU’s executive arm, has seen delivery of vaccines roughly double each month since January and is expecting around 50 million this month, officials say. European Commission President Ursula von der Leyen said this week she expects the EU to receive 100 million vaccines a month in the second quarter, keeping the bloc on target for its goal of vaccinating 70% of the adult population by the end of the summer.

Doubts remain about these figures, as the EU continues to face trouble locking in promised vaccines.

AstraZeneca is set to supply only half the original expectation of 80 million vaccines to the EU in the first quarter, and there are intense discussions between the company and the European Commission over how much of its 180 million second-quarter target AstraZeneca will meet.

J&J’s shot wasn’t as effective in studies as Covid-19 vaccines from Pfizer and Moderna.

Health authorities in the U.S. said the vaccine showed preliminary signs, according to J&J, of curbing spread of the virus among people who don’t show symptoms. They have been a significant source of transmission.

Europe was hit early on in the pandemic and as of March 4, official data showed more than 547,000 people killed by the disease and more than 22 million sickened in EU countries and their fellow members of the broader European Economic Area.

The deadlier and more contagious British variant of the coronavirus has spread broadly across the continent in recent weeks, leading to stubbornly high levels of infection, hospitalizations and deaths in many countries.

Write to Laurence Norman at [email protected]

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