Health experts analyze AstraZeneca’s safety data as Europe recovers from vaccine suspensions

AMSTERDAM (Reuters) – Global health experts came under increasing pressure on Tuesday to answer questions about the safety of AstraZeneca’s COVID-19 vaccine, while Sweden and Latvia joined countries that have suspended its use in yet another coup for the launch. vaccination in Europe.

The European Medicines Agency (EMA) said it was investigating reports of 30 cases of unusual blood diseases in 5 million users of the AstraZeneca vaccine. In total, 45 million COVID shots were delivered across the region.

The EU regulator will release its findings on Thursday, but its director, Emer Cooke, said he saw no reason to change his recommendation from AstraZeneca – one of four vaccines he approved for use.

“The benefits continue to outweigh the risks, but this is a serious concern and needs a serious and detailed scientific assessment,” Cooke said at a news conference.

A committee of experts from the World Health Organization (WHO) is analyzing the cases and is expected to issue a statement by the end of the day, a spokesman said.

The largest EU members – Germany, France and Italy – suspended the use of the AstraZeneca vaccine on Monday, pending the outcome of investigations into unusual cases of a rare cerebral thrombosis in people who received it.

The addition of Sweden and Latvia on Tuesday brought the number of EU countries that must act to 13 since the first reports of thromboembolism that affected people after they received the AstraZeneca injection emerged.

WHO and EMA had previously joined AstraZeneca in stating that there is no proven link, but some experts said that episodes of blood clots, bleeding and low platelet counts in younger people seemed to indicate a causal connection with the AstraZeneca injection. .

“The benefits of vaccination significantly outweigh the risks, especially for the elderly,” said Karl Lauterbach, health spokesman for the Social Democratic Party of Germany.

ARCHIVE PHOTO: The boxes of the Oxford / AstraZeneca COVID-19 vaccine are depicted in a refrigerator at an NHS coronavirus mass vaccination center at Robertson House in Stevenage, Hertfordshire, Great Britain, January 11, 2021. Joe Giddens / Pool via REUTERS // Photo file

“But it may be that the risks of the vaccine are greater for certain groups of patients, such as young women,” said Lauterbach, an epidemiologist whose party is part of the Berlin coalition, in an interview with Deutschlandfunk radio.

Other epidemiologists note that similar cases have not been found in unusual numbers in Britain, which started using AstraZeneca earlier and administered more than 10 million doses.

“A very likely explanation for at least some of the observed clotting disorders is the result of COVID-19, not the vaccine,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine.

“There are published studies that make it clear that these problems definitely occur in COVID-19 and there is no doubt that all vaccines in use prevent this disease. Therefore, the balance between risk and benefit of the AstraZeneca vaccine remains clearly in favor of its benefits. “

Graphics: Launch of vaccines across the EU by brand –

ECONOMIC FALLOUT

In the largest EU states, including Germany, France, Italy, the Netherlands and Spain, AstraZeneca has been responsible for about 13-15% of injections administered since the launch started almost three months ago, with Pfizer-BioNTech being the majority, according to official data.

As the cheapest to be developed, the AstraZeneca injection should be the basis of vaccination programs in much of the developing world.

Governments say they acted on the AstraZeneca shot out of caution – out of 1.6 million people in Germany who received the vaccine, seven fell ill with a rare cerebral venous thrombosis, three of whom died.

In a detailed analysis of its findings, Germany’s vaccine oversight body, the Paul Ehrlich Institute, said six of the cases occurred in young or middle-aged women – a statistically significantly higher number than normally expected.

Nicola Magrini, the director general of the Italian drug authority AIFA, told the La Repubblica newspaper that the AstraZeneca injection was safe and its benefit-risk ratio was “largely positive”. There were eight deaths and four cases of serious side effects in Italy after vaccinations, he added.

In France, Health Minister Olivier Veran told reporters that the risk-reward ratio of the AstraZeneca vaccine remained positive.

A third wave of infection in Europe, driven by more infectious viral variants, threatens to worsen a pandemic that claimed 575,000 lives in the European Union and further delays the recovery from a pandemic economic crisis.

Deutsche Bank on Tuesday reduced its 2021 economic growth forecasts for the euro area by a full percentage point, citing the contagion of current pandemic activity restrictions.

Coronavirus infections are increasing exponentially in Germany, said an expert at the Robert Koch Institute for infectious diseases, putting plans to lift the block at risk. France is considering a possible third national blockade.

Vaccination campaigns had a slow start due to scant supply, but the European Commission said on Tuesday that it expects to receive more than 200 million doses of the vaccine from Pfizer and BioNTech in the second quarter, putting the EU on track to meet its targets .

The EU plans to vaccinate at least 255 million people, or 70% of its adult population, by the end of the summer. The bloc has administered 11 vaccines so far for every 100 residents, while Israel – a world leader in vaccination – has given 108 doses, according to Our World in Data.

Anthony Deutsch reported from AMSTERDAM and Caroline Copley from BERLIN; Additional reporting by Kate Kelland, Elizabeth Piper, Giulia Segreti, Emilio Parodi, Matthias Blamont, Sudip Kar-Gupta, Matthieu Protard, Andreas Rinke, Francesco Guarascio, Anna Ringstrom, Johan Ahlander and Andrius Sytas; Written by Douglas Busvine; edition by Josephine Mason and Philippa Fletcher

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