EU guidance on J&J jab coming next week, on Oxford/AstraZeneca later

The European Medicines Agency expects to make a recommendation about the use of the Johnson & Johnson coronavirus vaccine next week, following blood clotting concerns in the U.S., the agency said Wednesday.

 “While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects,” the agency wrote in a press release.

In a separate announcement, the agency said will also provide more information about who should receive the Oxford/AstraZeneca vaccine, following a request from Health Commissioner Stella Kyriakides last Friday for guidance.

The Johnson & Johnson vaccine has become the latest twist in the EU’s struggling vaccination campaign, as countries had expected to begin using the vaccine this week.

On Tuesday, American regulators recommended pausing the one-dose viral vector vaccine after six blood clotting issues were reported in young women. The country has used 6.8 million J&J vaccines. J&J then said it was “proactively” delaying the rollout over the concerns in the U.S.

The company also told EU countries to store the doses until EMA’s safety committee, PRAC, made an assessment, the EMA wrote in the press release.

However, to date, most EU countries have said they plan to use their doses unless told otherwise by the EMA. Some, including Belgium and the Netherlands, have decided to temporarily halt using the J&J vaccine. And Italy is considering an age restriction on the vaccine, according to La Stampa.

The agency said it’s “expediting” its J&J evaluation, but indicated that each EU country will be able to use the safety information to decide whether to use the vaccine.

“The Agency’s scientific opinions provide EU Member States with the information they need to take decisions on the use of vaccines in their national vaccination campaigns,” the agency wrote.

Guidance on AstraZeneca

Meanwhile, the agency’s human medicines committee, CHMP, will look at data on vaccination rates, infection rates, hospitalizations, morbidity and mortality, and provide an assessment to health authorities so they can put the risks of the Oxford/AstraZeneca vaccine “into the context of the benefits of ongoing vaccination campaigns,” the agency wrote today in a press release.

The committee will also provide more guidance on whether people who received the first dose of the Oxford/AstraZeneca vaccine, but fall under new age restrictions set by EU governments, should still receive a second dose.

The EMA didn’t specify when it would make an announcement, but the Commission has set a deadline of April 22.

EU regulators last week found a link between the viral vector vaccine and rare cases of blood clotting disorders, but said benefits of taking the vaccine far exceeded the risks.

Still, many EU countries set differing age restrictions on the vaccine, while Denmark announced today it will completely stop using the vaccine. Others continue to use the vaccine in all adults.

Carlo Martuscelli contributed reporting.

UPDATE: This article has been updated with the EMA’s statement about Oxford/AstraZeneca’s vaccine and the news from Belgium and the Netherlands about the Johnson & Johnson vaccine.

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email pro@politico.eu for a complimentary trial.

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