The world awaited the results Thursday of an initial European investigation into whether AstraZeneca’s vaccine for the coronavirus disease 2019 is linked to blood clots reported in a small number of people who received the shot.
Concerns over the clotting led to more than a dozen European countries to suspend use of AstraZeneca vaccine over the past week, even though the company and international health agencies said there was no indication the shots were to blame and recommended continuing with the vaccinations.
The European Union (EU) drug regulator’s expert committee was expected to report its analysis Thursday, including whether any new precautions should be taken, such as adding warnings to the product.
Clots that form in the arms, legs or elsewhere can break free and travel to the heart, brain or lungs, causing strokes, heart attacks or other deadly blockages.
While many countries have continued to use the AstraZeneca vaccine, there are concerns the debate could seriously undermine confidence in the shot, which is key to efforts to vaccinate the world’s population, especially in poorer countries.
In Europe, where there is a choice of vaccines, the safety questions have complicated an already slow rollout across the 27-nation EU at a critical moment when infections are rising at an alarming rate again in many countries, in part because of mutant versions of the coronavirus.
“We are worried that there may be an effect on the trust of the vaccines,” Emer Cooke, executive director of the European Medicines Agency (EMA), acknowledged this week. “But our job is to make sure that the products that we authorize are safe and we can be trusted by the European citizens.”
Blood clots have been reported in at least 37 people, and at least four deaths among them have been recorded, out of the 17 million who have received at least one dose of the AstraZeneca vaccine in Europe.
WHO BACKS ASTRAZENECA
Both the EMA and the World Health Organization have said that there is no evidence to suggest the vaccine was responsible and that the benefits of immunization far outweigh the potentially small risk. The drugmaker likewise said it found no increased risk of clots.
AstraZeneca is expected to apply in the coming weeks for US authorization for its vaccine. The US now relies on vaccines from Pfizer, Moderna and Johnson & Johnson.
On Thursday, ahead of the EMA’s announcement, Britain’s drug regulatory agency said there is no sign AstraZeneca’s vaccine causes clots, and it urged people to continue getting the shot. Britain was not among the countries that suspended use of the vaccine.
The pause in vaccinations with AstraZeneca’s formula comes as tens of thousands of new daily cases have prompted new lockdown measures in Italy, caused hospitalizations in France to spike and led German officials to announce a third surge of Covid-19 has begun.
In yet another setback, British officials said Thursday that the country is facing a shortfall in vaccine deliveries that may delay the start of shots for people under 50 in the coming weeks.
Figures from the European Centers for Disease Prevention and Control this week show there are about 7 million unused doses of the AstraZeneca across the EU.