J & J’s single dose of Covid-19 vaccine approved by the EU drug regulator

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

The J&J vaccine has the potential to significantly boost vaccination coverage 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 only need one dose instead of the two given for other vaccines , often many weeks apart.

Studies showed that J & J’s vaccine had a major impact on the prevention of serious illness, but was overall 67% effective 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 illness.

“As we await a decision on the use of our single-dose Covid-19 vaccine in the European Union, we remain convinced that the Johnson & Johnson vaccine will prove to be a critical tool to combat this pandemic,” said Paul Stoffels, the company’s Chief Scientific Officer.

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

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

On Wednesday, President Biden said J&J had agreed to give the US an additional 100 million doses in the second half of this year, on top of the 100 million it would already deliver. To overcome manufacturing issues, 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 US started talks this week to make sure they don’t block exports of essential vaccine ingredients to each other. An executive order issued by Mr Biden last month had raised concerns in Europe that some vaccine materials, possibly including J&J doses intended for the EU, could be blocked from US exports.

The White House tried to address those concerns on Wednesday.

“The Biden administration’s top priority is to save lives and end the pandemic. The US has not banned the export of vaccines or their inputs, ”said an export expert. “All vaccine manufacturers in the US are free to export their products, while also complying with the terms of their contracts with the US government.”

Unlike the US and UK, the EU has exported more than 34 million doses of vaccine to 31 countries outside the bloc since late January, but the slow rollout within Europe has prompted the EU to allow its members to ban some exports. This happened for the first time last week when Italy blocked the supply of AstraZeneca doses to Australia.

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

The EU signed contracts with J&J in October, one of six vaccine deals 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’s vaccination campaign was hampered by late signing of contracts, delivery problems and difficulties in distributing the vaccines in some Member States. For now, vaccination coverage in the EU is well below that in the US and UK

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

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

The European Commission, the EU’s executive arm, has seen about double the supply of vaccines every month since January, and is expecting about 50 million this month, officials say. European Commission President Ursula von der Leyen said this week that she expects the EU to receive 100 million vaccines per month in the second quarter, keeping the bloc on track to its goal of 70 % of the adult population to be vaccinated.

Doubts remain about these figures, as the EU continues to struggle to commit to the promised vaccines.

AstraZeneca will deliver only half of its 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 about how much of its 180 million target for the second quarter AstraZeneca will meet.

The injection of J & J was not as effective in studies as the Covid-19 vaccines from Pfizer and Moderna.

Health authorities in the US said the vaccine showed preliminary signs, according to J&J, of reducing the spread of the virus among people who do not show symptoms. They have been an important source of transmission.

Europe was hit by the pandemic early on, and as of March 4, official data showed that more than 547,000 people died from the disease and more than 22 million people were sick in EU countries and their fellow members of the wider European Economic Area.

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

—Sabrina Siddiqui contributed to this article.

Write to Laurence Norman at [email protected]