J&J Covid-19 single dose vaccine approved by 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 strengthen vaccination initiatives over time. It can be kept in refrigerators instead of freezers, making it easier to store and distribute than some approved vaccines, and recipients need only one dose instead of the two administered for other vaccines, usually several weeks apart.

Clinical trials found that the J&J vaccine had a high impact in preventing serious illnesses, but was 67% effective overall when moderate cases were included. Side effects were generally mild or moderate, said the EMA.

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

“Now, pending a decision on the use of our Covid-19 single dose vaccine in the European Union, we remain confident that the Johnson & Johnson vaccine will prove to be a critical tool to combat this pandemic,” said Paul Stoffels, the scientific director from the company.

Despite the approval, doubts remain about how quickly J&J will start distributing vaccines on a large scale after manufacturing problems in the US. This week, EU officials said they were hopeful that the company would meet its target of delivering 55 million doses in the EU for the second quarter and that they would have a more complete picture after the EMA approval decision.

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

On Wednesday, President Biden said that J&J had agreed to supply the US with 100 million additional doses in the second half of this year, in addition to the 100 million that it was about 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 the J&J vaccine.

The EU and the US began talks this week to ensure that they do not block the export of vital ingredients for vaccines. An executive order issued by Biden last month raised concerns in Europe that some vaccine materials, potentially including doses of J&J destined for the EU, could be blocked for export from the United States.

The White House on Wednesday tried to allay those concerns.

“The Biden government’s top priority is to save lives and end the pandemic. The United States has not banned the export of vaccines or their inputs, ”said a government export expert. “All vaccine manufacturers in the United States are free to export their products and, at the same time, comply with the terms of their contracts with the United States government.”

Unlike the United States and the United Kingdom, the EU has exported more than 34 million doses of vaccines to 31 countries outside the bloc since the end of January, but the slow launch in Europe has prompted the EU to allow its members to ban some exports. Last week, this happened for the first time, when Italy blocked 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 of 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’s vaccination campaign has been hampered by delays in signing contracts, delivery problems and difficulties in the distribution of vaccines in some member states. For now, the vaccination rate in the EU is well below that of the USA and the UK

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

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

The European Commission, the EU’s executive arm, has seen vaccine delivery nearly double 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 target to vaccinate 70% of the adult population by the end of the summer.

There are still doubts about these figures, as the EU continues to face problems in securing the promised vaccines.

AstraZeneca is expected to supply only half of 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 about how much of its target of 180 million for the second quarter, AstraZeneca will achieve.

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

Health officials in the United States said the vaccine showed preliminary signs, according to J&J, of containing the spread of the virus among people who have no symptoms. They have been a significant source of transmission.

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

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

—Sabrina Siddiqui contributed to this article.

Write to Laurence Norman at [email protected]