European nations to resume AstraZeneca use

Vaccine ‘safe, effective,’ regulator says, but rare blood clot link possible

BERLIN — Europe’s medical regulator said Thursday that AstraZeneca’s vaccine was “safe and effective,” but that it could not rule out a link to highly unusual types of blood clots and said a warning would be added to the product.

Many of the countries in Europe that had paused the use of the Oxford-AstraZeneca vaccine — including Germany, France, Italy and Spain — announced that they would resume Friday or early next week. Ireland said it would announce its decision Friday, and Sweden said it would next week.

“If it was me, I would be vaccinated tomorrow,” said Emer Cooke, the head of the European Medicines Agency. “But I would want to know if anything happened to me after vaccination, what I should do about it, and that’s what we’re saying today.”

In addition to the warning, the agency said it would conduct outreach to health-care providers and the public about the signs and symptoms to watch for.

The suspensions of the AstraZeneca vaccine have split both the scientific community and the countries in Europe, with some continuing their vaccination campaigns as others warn that the extremely unusual and deadly nature of blood clots detected, even if in small numbers, warrant caution.

Norwegian experts said Thursday that their investigations into three cases of unusual clots among health workers there, one of whom died, found they were likely caused by an immune response to the vaccine.

Even with the European regulator reiterating that the benefits far outweigh the risks, experts say the damage has been done, with trust in the vaccine already diminished. The pause comes as several European countries warn they are at the beginning of a third wave of the pandemic, with an already slow pace of vaccinations and new more contagious variants spreading rapidly.

The potential ramifications stretch much further than the continent. Easier to store and handle than other products on the market, the offering from AstraZeneca, which developers have said will be distributed on a not-for-profit basis, is a major tool in the fight against the spread of the coronavirus in developing countries.

AstraZeneca has said that the 37 blood clotting incidents reported among the 17 million shots given in Europe are far lower than to be expected in the normal population, and the World Health Organization has said it continues to think that the benefits outweigh the risks.

Experts from the EMA agreed on both counts, but said their investigation was focused on a small number of normally extremely rare brain clots that have been reported in countries, including Germany and Norway, following vaccinations, including in younger people and notably among women.

Their panel said the vaccine “may be associated with” those cases, which include 18 incidents of a rare brain clot known as cerebral venous sinus thrombosis, three of which were reported in the United Kingdom. It’s a kind of stroke that can be deadly.

There have also been seven cases of an unusual condition in which blood clots form in vessels throughout the body. While such symptoms may be linked to the coronavirus itself, “we still feel that we see sufficient information to include a warning,” said Sabine Straus, head of the EMA’s safety committee.

She said that “younger women” seemed to be notably affected, but that it was too early to issue specific guidance, and the agency is looking into whether there could be increased risk for people on contraceptive pills. Women on the pill are already at a higher risk of the rare clots in the brain.

In Britain, where 11 million shots have been administered, almost double the amount across the entire European Union, the medical regulator continues to urge people to get their vaccines.

June Raine, the chief executive of the Medicines and Healthcare Products Regulatory Agency, Britain’s counterpart to the EMA, said they had received a “very small number” of reports of “an extremely rare form of blood clot” in the brain along with lower levels of platelets following vaccination, but that such events could occur among those who haven’t been vaccinated, or those who have coronavirus.

“While we continue to investigate these cases, as a precautionary measure we would advise anyone with a headache that lasts for more than 4 days after vaccination, or bruising beyond the site of vaccination after a few days, to seek medical attention,” she said in a statement on Thursday.

Concerns were first triggered in Austria in early March. As the country vaccinated medical workers, a 46-year-old nurse died of multiple blood clots. Austria suspended use of that batch as a precaution.

Last week, Europe’s regulator said that it found no evidence of a causal link with the vaccine in those cases, and it maintains that there is no problem with a specific batch.