Europe approved Johnson & Johnson's single-dose COVID-19 vaccine on Thursday and is expected to be delivered in a month. The COVID-19 shot is the fourth to be endorsed for use in the European Union after vaccines from Pfizer-BioNTech, AstraZeneca-Oxford University, and Moderna, and is recommended for those over 18 years of age, the European Medicines Agency (EMA) said.
The United States, Canada and Bahrain have also approved the shot. South Africa is carrying out an expedited review.
With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens, EMA's Executive Director Emer Cooke said after the agency gave its conditional approval.
The official nod came from the European Commission shortly after, the final step to allowing its use across the bloc.
The region is having difficulty taming a spike in cases driven by a more contagious variant of the coronavirus, with countries including Italy and France imposing fresh lockdowns.
J&J Chief Scientific Officer Paul Stoffels described it as a landmark moment for the U.S. drug-maker and the world as governments struggle to control the pandemic which has crushed economies and killed more than 2.7 million.
The shot, called COVID Vaccine Janssen after the J&J unit that developed it, will help bulk up EU vaccine supplies after a faltering rollout due to delivery delays from Pfizer and AstraZeneca.
The first shipments will start in the second half of April, the company said, adding it is committed to delivering at least 200 million doses to the EU this year.
Exact volumes are not clear though and the U.S. drug-maker has told the European Union it is facing supply issues that may complicate plans to deliver the 55 million doses due in the second quarter in full.
J&J's factory in Leiden in the Netherlands and a plant in Baltimore in the United States run by Emergent BioSolutions have both been authorised by the drugs' regulator as a manufacturer of ingredients for the vaccines.
In J&J's 44,000-person global trial, the vaccine was found to be 66% effective at preventing moderate-to-severe COVID-19 four weeks after inoculation. It was 100% effective in preventing hospitalization and death due to the virus.
In its statement on Thursday, the EMA said the vaccine was found to be 67% effective two weeks after inoculation.
The side effects were usually mild or moderate and cleared within a couple of days after vaccination, it said. The most common ones were pain at the injection site, headache, tiredness, muscle pain and nausea.