EU regulator reviews AstraZeneca lap and blood clot links

LONDON (AP) – The world on Thursday awaited the outcome of an initial European investigation into whether there is evidence that the AstraZeneca coronavirus vaccine is linked to blood clots reported in small numbers of recipients of the shot.

Concerns about the coagulation have led to more than a dozen European countries stopping the use of the vaccine in the past week, although the company and international health agencies have said there is no indication that the vaccine is causing the coagulation and recommend that continue with the vaccination.

The European Union’s expert committee on medicine regulators is expected to report its analysis on Thursday, including whether new precautions should be taken regarding the vaccine.

Although many countries still use the vaccine, there are concerns that the debate could seriously undermine confidence in the shot, which is key to efforts to vaccinate the world population, especially in poorer countries. Even in Europe, where countries have a choice of vaccines, it has complicated an already slow rollout at a time when infections are on the rise again in many countries.

The head of the European Medicines Agency said this week that the drug regulator’s priority is to confirm that the product is safe and that he will consider a range of actions, including the addition of additional warnings to the vaccine.

“We are concerned that there may be an effect on the confidence of the vaccines,” said Emer Cooke, chief executive officer. “But our job is to make sure that the products we approve are safe and that we can be trusted by European citizens.”

Blood clots were reported in 37 people among the 17 million who received at least one dose of the AstraZeneca vaccine in Europe. Both the EMA and the World Health Organization have said there is no evidence that the vaccine is responsible and that the benefits of immunization far outweigh the potential low risk. The drugmaker said after a careful review of the COVID-19 vaccination data, he found no evidence of any increased risk of blood clots in any age group or gender in any country.

The interruption of the vaccinations with the shot comes because tens of thousands of new daily cases caused new closure measures in Italy, which increased hospitalizations in France and caused German officials to announce that a third surge of COVID-19 had begun.

In Britain, which has vaccinated the most vulnerable, officials said on Wednesday that the number of people receiving their first dose of COVID-19 vaccine from April would be ‘significantly limited’ due to a decline in the country’s vaccine supply. .

A letter to local health leaders said they should expect a “significant decrease in the weekly supply available from manufacturers” from the week of March 29. The reduction will continue for four weeks.

According to figures from European Centers for Disease Prevention and Control this week, there are around 7 million unused AstraZeneca vaccines in the EU with 27 countries.

The German government defends its decision to suspend the use of the vaccine, saying it is based on the advice of experts.

Government spokeswoman Ulrike Demmer said on Wednesday that the move could boost confidence in the vaccines.

“Concern is taken seriously and investigated. “Once these problems are resolved, a vaccine can be used again without hesitation,” she said.

But some experts have expressed concern that the opposite could happen: that public and dramatic suspensions could already lead to widespread skepticism about vaccines being developed in record time.

Germany’s Ministry of Health spokesman Hanno Kautz will rely on the EMA decision on how to proceed. Other countries, including France, have also indicated they will follow the advice issued on Thursday.

If vaccines are widely distributed, scientists expect serious health problems and deaths to be reported simply because tens of millions of people receive the shots. It can be difficult to determine if the vaccine is to blame, especially since the COVID-19 vaccination campaigns are currently focusing on vulnerable people who have other health problems.

But because there is no long-term data on the COVID-19 vaccines, any possible signal of problems needs to be thoroughly investigated.

Because clinical trials are only performed on tens of thousands of people, extremely rare side effects are often not detected until many millions of people have been vaccinated long after they have been licensed.

For example, it took almost a year after vaccinations against the swine flu pandemic began in 2009 that European officials noticed an increase in narcolepsy in children and teenagers who received the GlaxoSmithKline vaccine.

“It’s okay to investigate potential signals of problems, but you can do it while you continue the vaccination,” said Michael Head, a senior research fellow in global health at the University of Southampton. “If we interrupt the explosion of the vaccine every time there is a possible signal, it will not be much.”

Chief warned that there are costs involved in going slow: the longer the coronavirus is allowed to spread widely, the more likely it is to turn into a more deadly version.

“People may be more reluctant to take a vaccine against AstraZeneca when vaccination resumes,” he said. “And this is at a time when we need to stop the virus circulating to reduce the chance of further variants.”

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Jordans reports from Berlin.

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