The European Union approved the single-shot Johnson & Johnson coronavirus vaccine on Thursday — the fourth jab to get the green light for the 27-nation bloc.
The decision offers a boost for the EU’s sluggish vaccination programme even if reports say the first J&J shipments may not arrive in European countries until April.
The European Commission formally gave the green light for the jab after the Amsterdam-based European Medicines Agency recommended approval.
“More safe and effective vaccines are coming to the market,” EU Commission President Ursula von der Leyen said in a tweet.
“We have just authorised the use of Johnson & Johnson’s vaccine in the EU…. With the number of doses we ordered, we could vaccinate up to 200 million people in the EU” with the J&J jab this year, she said.
The EU has signed a firm order for 200 million and an option for 200 million more.
As well as being the first that requires a single injection as opposed to two, the Johnson & Johnson vaccine is easier to store.
The EU has so far approved three vaccines — Pfizer-BioNTech, Moderna and AstraZeneca-Oxford. Three other vaccines are under “rolling review” by the Amsterdam-based EMA — Novavax, CureVac and Russia’s Sputnik.
The EMA gave the green light after saying clinical trials involving volunteers in the United States, South Africa and South American countries found the J&J jab was 67 percent effective at preventing people from getting Covid.
Side effects were “usually mild or moderate”, including pain at the injection site, headache, tiredness, muscle pain and nausea, and usually cleared within a couple of days, it said.
“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,” European Medicines Agency (EMA) chief Emer Cooke said in a statement.
“This is the first vaccine which can be used as a single dose.”
The J&J shot however appears less protective than Pfizer and Moderna’s regimes, which both have an efficacy of around 95 percent against all forms of Covid-19 from the classic coronavirus strain.
The EU has been struggling with a disappointing vaccination rollout that started in January and faltered because of a shortage of doses produced by the three suppliers so far.
The head of the EU’s vaccine supply task force, Thierry Breton, said on Tuesday the EU’s “bumpy” vaccine strategy should be augmented by the addition of the Johnson & Johnson jab.
Reported production shortfalls in the United States by Johnson & Johnson would not impact the EU because Brussels had made contingency plans for all vaccines, he said.
“Do not believe that because one company has a problem that overall it will jeopardise the whole programme,” said Breton, the EU’s industry commissioner.
Europe’s vaccination strategy faced fresh problems on Wednesday as Denmark, Norway and Iceland said they were temporarily suspending the use of AstraZeneca’s Covid-19 vaccine after some patients developed blood clots.
Norway and Iceland are not in the EU but are covered by the EMA.
The EMA said the vaccine was still safe for use, pending an investigation.