JOHNSON & JOHNSON vaccine OK to use in EU.

Move gives bloc four vaccine options as it struggles with inoculation rollout

LONDON — The European Medicines Agency on Thursday gave the green light to Johnson & Johnson’s one-dose coronavirus vaccine, handing the European Union’s 27 nations a fourth vaccine to try to speed up the bloc’s much-criticized vaccination rollout.

The EU medicines regulator advised that the vaccine be cleared for use in all adults over 18 “after a thorough evaluation” of Johnson & Johnson’s data found the vaccine met the criteria for efficacy, safety and quality.

“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,” said Emer Cooke, the agency’s executive director.

The European Medicines Agency has already recommended covid-19 vaccines made by Pfizer-BioNTech, Moderna and AstraZeneca — but all of those vaccines require two doses, several weeks apart. Production delays have also plagued all three vaccine manufacturers.

In its statement Thursday, the agency said the Johnson & Johnson vaccine was about 67% effective. The most common side effects were pain at the injection site, headache, tiredness, muscle pain and nausea.

The European Commission quickly granted a conditional marketing authorization to the vaccine.

“The entry on the market of the [Johnson & Johnson] vaccine ensures that we have access to a total of up to 1.8 billion doses of approved vaccines from different technology platforms,” Health Commissioner Stella Kyriakides said.

The U.S. Food and Drug Administration gave an emergency authorization to the Johnson & Johnson shot in late February. Health experts hope that having a onedose vaccine will speed efforts to immunize the world against covid-19, especially given the recent infection spikes in Europe driven by worrying new variants.

The EU has struggled to quickly roll out shots and immunize its most vulnerable citizens. It ranks far behind countries including Israel, Britain, Chile and the U.S.

Johnson & Johnson said it has committed to providing the EU with its pre-ordered 200 million doses starting in the second quarter.

EU figures show that the 27-nation bloc has allowed the export of well over 34 million doses of covid-19 vaccines over the past weeks.

The EU said more than 9.1 million doses were exported to the United Kingdom alone, at a time when diplomatic tensions rose over vaccine exports and the implementation of the Brexit divorce agreement.

The figures show that even if the EU is accused of “vaccine nationalism” by checking some exports, only one shipment of a quarter-million doses was effectively held back. The exports are almost as high as the roughly 45 million doses that have been distributed within the EU as of last week

In the wake of rumors that doses that should have stayed in the bloc had been siphoned off, the EU instituted a special export transparency system late in January to make sure companies with delivery commitments to the EU would not ship them elsewhere. On Thursday, the system was extended until the end of June.

The bloc has contract commitments with six companies for 2.6 billion doses for a population of 450 million, and has openly clashed with one — AstraZeneca — after the company said its first-quarter promises of 80 million doses would in reality amount to less than half as many due to what it called technical issues.

Meanwhile, Danish and Norwegian authorities said Thursday that they have temporarily suspended the AstraZeneca vaccine, citing concerns over a possible association with blot clots, even as the EU’s regulator found no evidence that the vaccine is unsafe.

“We are engaged in the largest and most important vaccination rollout in Danish history. And right now, we need all the vaccine doses we can get,” said Soren Brostrom, director of the Danish National Board of Health, in a statement Thursday. “It is, therefore, not an easy decision to pause vaccination with one of the vaccines. However, because we vaccinate so many people, we also need to react with due diligence when we learn of possible and severe side effects.”

Danish authorities said that one death in Denmark is being investigated.

Concerns were first prompted by a case in Austria of a person who was diagnosed with blood clots and died 10 days after vaccination. At least three other people who received AstraZeneca vaccines from the same batch also developed serious conditions, the European Medicines Agency said Wednesday.

But the agency concluded there “is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine.”