J&J single-dose Covid-19 vaccine approved by EU drug regulator

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

The J&J vaccine has the potential to significantly enhance vaccination actions over time. It can be stored in refrigerators instead of freezers, making it easier to store and distribute that some already approved vaccines and recipients only need one dose instead of the two administered for other vaccines, often separated by many weeks.

Trials found that the J&J vaccine had a large impact on the prevention of serious disease, but was 67% effective overall when moderate cases were included. Side effects used to be mild or moderate, the EMA said.

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

“Now, as we await a decision on the use of our single-dose Covid-19 vaccine in the European Union, we are confident that the Johnson & Johnson vaccine will be a critical tool in combating this pandemic,” said Paul Stoffels. , scientific director of the company.

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

The company has agreed to supply 200 million doses to the EU this year and the EU has the option to buy another 200 million. The company said last week that it was confident it would meet its full-year goal.

On Wednesday, President Biden said J&J had agreed to provide the United States with an additional 100 million doses during the second half of this year, in addition to the 100 million it already had to deliver. To overcome manufacturing difficulties, the White House helped negotiate an agreement between J&J and longtime competitor Merck & Co., in which Merck would help produce the J&J vaccine.

The EU and the United States began talks this week to make sure they do not block vital vaccine ingredients that are exported from each other. An executive order issued last month by Biden had raised concerns in Europe that some vaccine materials, including doses of J&J destined for the EU, could be blocked for US exports.

The White House on Wednesday tried to dispel those concerns.

“The main priority of the Biden administration is to save lives and end the pandemic. The United States has not imposed a ban on vaccine exports or their contributions, “said an expert on exporting administrations.” All vaccine manufacturers in the U.S. are free to export their products as long as they comply with the terms of the its contracts with the United States government “.

Unlike the United States and the United Kingdom, the EU has exported more than 34 million doses of vaccine to 31 countries outside the bloc since late January, but slow deployment in Europe has caused the EU to allow its members to ban some exports. Last week, this happened for the first time, when Italy blocked the delivery of AstraZeneca doses to Australia.

On Thursday, the EU said it would extend by 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. So far, four of the vaccines have been approved, from J&J, AstraZeneca PLC, Pfizer Inc.

and Modern Inc.

The EU vaccination campaign has been hampered by the late signing of contracts, delivery problems and difficulties in distributing vaccines in some Member States. At the moment, the vaccination rate in the EU is well below that of the US and the UK

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

With deaths from Covid-19 high even in countries like Germany, which performed well during the first wave of coronavirus, much of Europe has been closed for months, affecting the already troubled economy of the region. and provoking 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 vaccine delivery double approximately every month since January and expects 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 a month in the second quarter, keeping the bloc on track to vaccinate 70% of the adult population in late summer.

Doubts remain about these figures, as the EU continues to have trouble blocking the promised vaccines.

AstraZeneca is expected to supply the EU with only half of the original expectations of 80 million vaccines during the first quarter and there are intense discussions between the company and the European Commission about how much AstraZeneca will reach 180 million in the second quarter.

The J&J shot was not as effective in studies as Pfizer and Moderna’s Covid-19 vaccines.

U.S. health officials said the vaccine showed preliminary signs, according to J&J, of slowing the spread of the virus among asymptomatic people. They have been an important source of transmission.

Europe has been hit since the start of the pandemic, and as of March 4, official figures showed more than 547,000 people dying from the disease and more than 22 million sick in EU countries and their fellow members. of the wider European economic space.

The most deadly and contagious British variant of coronavirus has spread widely across the continent in recent weeks, causing stubbornly high levels of infection, hospitalizations and deaths in many countries.

—Sabrina Siddiqui contributed to this article.

Write to Laurence Norman to [email protected]