Commission expects 200 million doses to be delivered from second quarter of the year
The European Commission has approved EU use of a Covid-19 vaccine made by Janssen, a subsidiary of the US pharmaceutical company Johnson & Johnson, making it the fourth vaccine to gain EU-wide authorisation for use against the pandemic.
Conditional marketing approval for the vaccine was granted by the Commission on 11 March, based on a recommendation by the European Medicines Agency regulator released the same day.
The EMA said clinical trials of the vaccine in the United States, South Africa and Latin America showed that it met the agency’s criteria for efficacy, safety and quality. The trials found a 67 per cent fall in the number of symptomatic Covid-19 cases after two weeks in people who got the jab, rather than a placebo.
Johnson & Johnson’s vaccine uses a harmless virus to present a protein from SARS-Cov-2—the virus that causes Covid-19—and trigger a protective immune response. Unlike some rival products, it requires only a single dose.
The Commission said 200 million doses of the vaccine should be delivered to the EU starting in the second quarter of the year, and that an EU contract with Johnson & Johnson would enable member states to buy up to 200 million more.
“With the number of doses we ordered, we could vaccinate up to 200 million people in the EU,” Commission president, Ursula von der Leyen said, adding that the vaccine would help the bloc reach its goal of vaccinating 70 per cent of its adult population “by the end of summer”.
The EMA’s approval conditions mean that Johnson & Johnson must provide more study data to confirm that the benefits of its jab outweigh any risks.