EU drug agency discounts any link between vaccine and clots
The finding from the European Medicines Agency could open the way for European countries that had suspended the use of the vaccine over the past week to resume dispensing the shots.
The head of the EMA, Emer Cooke said Thursday that the agency “cannot rule out definitively a link” between rare types of blood clots and the vaccine, however, and experts recommend raising awareness among doctors and recipients of possible risks.
EMA recommended adding a description of these cases to the vaccine leaflets so health workers and patients would be aware of these rare blood clots.
But Cooke also said: “Our scientific position is that is that this vaccine is a safe and effective option to protect citizens against COVID-19. It demonstrated that at least 60% efficacy in clinical trials and preventing coronavirus disease. And in fact, the real-world evidence suggests that the effectiveness could be even higher than that.”
Numerous European countries had suspended use of the vaccine over the past week amid concerns over blood clots in a few dozen of the millions of people vaccinated with the formula across the continent.
The world awaited the results Thursday of an initial European investigation into whether AstraZeneca’s COVID-19 vaccine is linked to blood clots reported in a small number of people who received the shot.
Concerns over the clotting led more than a dozen European countries, including Germany, France, Italy and Spain, to suspend use of the 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 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, 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.
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 U.S. authorization for its vaccine. The U.S. 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.
The German government defended its decision to suspend use of the vaccine, saying it was based on expert advice. Government spokeswoman Ulrike Demmer said Wednesday that the move could “strengthen trust” in the vaccines.
“Concerns are taken seriously and examined. And as soon as these concerns are cleared up, a vaccine can be used again without hesitation,” she said.
Germany will rely on the EMA decision for how to proceed, Health Ministry spokesman Hanno Kautz said. Other countries including France have also indicated they will follow the advice issued Thursday.
Clinical trials are typically done in tens of thousands of participants. As a result, extremely rare side effects often aren’t detected until vaccines are used in many millions of people, long after they have reached the market.
For example, it took nearly a year after vaccination campaigns began against the 2009 swine flu pandemic for European officials to notice an increase in narcolepsy in children and teenagers who got the GlaxoSmithKline vaccine.
“It’s right to investigate any potential signals of problems, but you can do that while you continue immunization,” said Michael Head, a senior research fellow in global health at the University of Southampton. “If we pause the vaccine rollout every time there’s a possible signal, it won’t be much of a rollout.”
Head cautioned that there are costs to going slowly: The longer the coronavirus is allowed to circulate widely, the more chance it has to mutate into a deadlier version.
“People may well be more hesitant to take an AstraZeneca vaccine when immunization resumes,” he said. “And this is at a time when we need to stop the virus circulating to the reduce the chances of further variants emerging.”
