Doctors respond when EU countries suspend the shot

A health worker prepares a syringe containing the AstraZeneca Covid-19 dose at Coria City Hospital, Spain.

Gustavo Valiente | SOPA images | LightRocket via Getty Images

LONDON – Health experts say they are disappointed and confused by the flurry of suspensions of the coronavirus vaccine developed by AstraZeneca and the University of Oxford, warning that there is not enough data yet to justify these decisions.

Sweden and Latvia joined a fast-growing list of European countries on Tuesday that are suspending the use of the vaccine as a precautionary measure after reports of blood clots. Germany, France, Italy and Spain said on Monday they would all stop administering the shot.

Other countries, such as Austria, have temporarily discontinued certain batches of the Oxford AstraZeneca vaccine. Thailand became the first Asian country to discontinue use of the shot on Friday over security concerns.

The UK, Canada and Australia – which continue to use the vaccine – are among some of the countries looking to reassure citizens about its benefits.

The World Health Organization, the European Medicines Regulator and the International Society on Thrombosis and Hemostasis have recommended that all countries continue to use the Oxford AstraZeneca vaccine.

There is no data yet to really justify these decisions.

Michael Head

Senior Research Fellow in Global Health at the University of Southampton

“The decisions of France, Germany and other countries look mind-boggling,” said Dr. Michael Head, Senior Research Fellow in Global Health at the University of Southampton, UK.

“The data we have suggests that the rate of adverse events related to blood clots is the same (and possibly even lower) in vaccinated groups compared to unvaccinated populations,” he continued.

“Halting the rollout of a vaccine during a pandemic has consequences. This results in delays in protecting people and the potential for greater vaccine reluctance, as a result of people seeing the headlines and becoming understandably concerned.” that really justify these decisions, ”added Head.

WHO experts will meet on Tuesday to assess the safety of the shot.

The European Medicines Agency, which is also evaluating the drug’s safety, has said there is no evidence that it causes blood clots, adding that it believes the benefits of the vaccine “continue to outweigh the risks.”

What did AstraZeneca say?

More than 17 million people in the European Union and the UK have received a dose of the Oxford AstraZeneca vaccine, with fewer than 40 cases of blood clots since last week, AstraZeneca said in a statement.

The pharmaceutical giant said 15 cases of deep vein thrombosis and 22 cases of pulmonary embolism had been reported in the EU and UK among the vaccinees.

“This is much lower than would naturally be expected in a general population of this size and is comparable to other approved COVID-19 vaccines,” AstraZeneca said.

The EMA has also said that the data available so far shows that the number of blood clots in vaccinated people is no higher than in the general population.

A bottle of the AstraZeneca vaccine.

Igor Petyx | KONTROLAB | LightRocket via Getty Images

Europe’s caution regarding the drug has exacerbated the woes of the region’s ailing vaccination campaign and comes at a time when Germany’s public health service has warned that a third wave of coronavirus infections has already begun.

Dr. Stephen Griffin, associate professor in the School of Medicine at the University of Leeds, said the news that many countries in Europe had suspended the introduction of the Oxford AstraZeneca vaccine was “disappointing”.

“As many European countries are currently experiencing a resurgence of SARS-CoV2 infections and yet are lagging behind in deployment, the importance of continuing vaccination programs cannot be underestimated, and the harm caused by humans will prevent access to a vaccine. Not to be underestimated. Probably outweighs even the worst case scenario if a link with the coagulation disorders is eventually found, “Griffin said.

“It should also be noted that national gestures such as these will undoubtedly stir up hesitation or more extreme feelings against vaccination, further undermining the vaccination effort,” he added.

How does the vaccine work?

The Oxford AstraZeneca vaccine is an injection designed to prevent the coronavirus in people 18 years of age and older. It consists of an adenovirus modified to contain the gene to make a protein from SARS-CoV-2, the virus that causes Covid-19. As such, the vaccine does not contain the virus and cannot cause Covid.

The most common side effects from the injection are usually mild or moderate and improve within a few days of vaccination.

Late stage clinical studies showed that the AstraZeneca-Oxford injection has an average efficacy of 70% in protecting against the virus.

“We are looking closely at the reports, but the available evidence does not suggest the vaccine is the cause,” said Dr. Phil Bryan, head of vaccine safety at the UK Medicines and Healthcare products Regulatory Agency.

Blood clots can occur naturally and are not uncommon. More than 11 million doses of the AZ vaccine have now been administered in the UK and the number of blood clots reported does not exceed what would have occurred naturally in the vaccinated population, he continued.

“We are working closely with international counterparts to understand the global safety experience of COVID-19 vaccines and to quickly share safety data and reports. People still need to get their COVID-19 vaccine when asked,” Bryan said. .

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