Health experts pore over AstraZeneca safety data as Europe reels from vaccine suspensions


BERLIN (Reuters) – Global health experts came under increasing pressure on Tuesday to clear up questions over the safety of AstraZeneca’s COVID-19 shot, as Sweden and Latvia joined countries suspending their use in a further blow to Europe’s vaccination rollout.

So far, a handful of cases of bleeding, blood clots and low platelet counts have arisen, compared with 45 million doses of various vaccines given in the European Union and its near neighbours. Germany has reported seven such cases, of which three died, out of 1.6 million people who received AstraZeneca.

A World Health Organization (WHO) committee of experts was reviewing the cases and was in dialogue with the European Medicines Agency (EMA), an EU regulator, which was due to hold a news conference at 1300 GMT.

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

The addition of Sweden and Latvia on Tuesday brought to more than a dozen the number of EU countries to act since reports first emerged of thromboembolisms affecting people after they got the AstraZeneca shot.

The WHO and EMA had earlier joined AstraZeneca in saying there is no proven link, but some experts said rare cases of highly unusual cerebral thrombosis in younger people did appear to indicate a causal connection to the AstraZeneca shot.

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

“But it could be the case that the risks of the vaccine are higher for certain patient groups such as young women. It is possible that the EMA will issue specific warnings,” he told Deutschlandfunk radio in an interview.

European epidemiologists remained baffled that similar cases had not occurred in unusual numbers in Britain, which began using AstraZeneca earlier and has administered more than 10 million doses.

“It still remains the case that a very likely explanation of at least some of the clotting disorders seen are a result of Covid-19 rather than the vaccine,” said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine.

“There are published papers that make clear that these problems definitely occur in COVID-19 and there is no doubt that all the vaccines in use prevent that disease. Hence the risk and benefit balance for the AstraZeneca vaccine remains clearly in favour of its benefits.”

 

POLITICAL DECISION?

In the EU’s largest states, including Germany, France, Italy, the Netherlands and Spain, AstraZeneca has accounted for about 13-15 percent of shots given since the rollout started almost three months ago, with Pfizer-BioNTech making up the majority, according to official data.

Nicola Magrini, the director general of Italy’s medicines authority AIFA, told daily la Repubblica in an interview that the choice to suspend the AstraZeneca shot was “political”.

He said it was safe and said its benefit to risk ratio was “widely positive”. There have been eight deaths and four cases of serious side-effects in Italy following vaccinations, he added.

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

Governments say they acted out of an abundance of caution but the move deprives them of vitally-needed doses to step up vaccination campaigns that have got off to a slow start due to scarce supply.

AstraZeneca said last week it would try to deliver 30 million doses to the European Union by the end of March, down from a contractual obligation of 90 million and a previous pledge made last month to deliver 40 million doses.

Still, the European Commission said on Tuesday it expects to receive more than 200 million doses of COVID-19 vaccine from Pfizer and BioNTech in the second quarter, putting the EU on course to meet its inoculation target.

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

At the same time a third wave of infection, driven by more infectious viral variants, threatens to worsen Europe’s year-old coronavirus pandemic that has claimed 575,000 lives and further delay recovery from a pandemic economic slump.

Deutsche Bank on Tuesday slashed 2021 economic growth forecasts for the euro area by a whole percentage point, citing spillover of the ongoing pandemic-linked activity restrictions.

Sources said Germany had no choice but to act after its vaccine watchdog identified an unusual number of cases of rare cerebral vein thrombosis. Of 1.6 million people in Germany who had got AstraZeneca, seven fell ill and three died.

Yet the risk of dying of COVID is still orders of magnitude greater, especially among those most vulnerable such as the elderly, said Dirk Brockmann, an epidemiologist at the Robert Koch Institute for infectious diseases.

“One is probably 100,000 times more likely to die of COVID than because of an AstraZeneca vaccine,” Brockmann told ARD public television.

Matthias Blamont reported from PARIS, Giulia Segreti from ROME and Caroline Copley from BERLIN; Additional reporting by Kate Kelland, Sudip Kar-Gupta, Matthieu Protard, Andreas Rinke, Francesco Guarascio, Anna Ringstrom, Johan Ahlander and Andrius Sytas; Writing by Douglas Busvine; editing by Josephine Mason and Philippa Fletcher

Image: FILE PHOTO: Boxes of the Oxford/AstraZeneca COVID-19 vaccine are pictured in a refrigerator at a NHS mass coronavirus vaccination centre at Robertson House in Stevenage, Hertfordshire, Britain January 11, 2021. Joe Giddens/Pool via REUTERS//File Photo





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