Germany, France and Italy suspend use of AstraZeneca’s Covid-19 vaccine

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Germany, France and Italy suspend use of AstraZeneca's Covid-19 vaccine



A cascade of warning breaks that began last week resumed on Monday. Denmark were the first to suspend shooting. Ireland, Norway, the Netherlands and Iceland also said they would wait for the bloc-wide European medicines regulator to investigate a small number of serious blood clotting issues in people who had received the AstraZeneca vaccine.

This regulator, the European Medicines Agency, is expected to deliver its verdict on safety and potential risks by Thursday from a review of reported cases. The agency reiterated an advice from last week on Monday that, for now, it recommended countries continue to use the vaccine, saying the benefits outweighed the possible risks.
The EMA, which acts much like the United States Food and Drug Administration in regulating medicine in the European Union, said there was no evidence of a link between the reported blood clots and the vaccine.

Britain’s medicines regulator, the first to give the green light for mass use at the end of December, has also maintained this position, telling Britons to get vaccinated as scheduled. Around 11 million AstraZeneca snapshots have been administered in the UK, making it a central pillar in the country’s rapid deployment.

The vaccine has not been approved in the United States. AstraZeneca is expected to seek authorization for emergency use once it submits the results of Phase 3 human trials in the United States. These tests should be launched this month.

The temporary halt to AstraZeneca injections is another setback in a wider vaccine rollout in Europe, hampered by supply shortages and other obstacles. It comes as the continent grapples with a growing number of Covid-19 cases. Vaccination rates in Europe are much lower than in the US and UK, where Covid-19 cases have stabilized or are declining.

Delays in administering the AstraZeneca vaccine threaten to exacerbate problems with vaccination and could put additional pressure on governments trying to speed things up. AstraZeneca has become a particular target of European politicians who have accused it of not doing enough to deliver more blows to the continent.

For UK-based AstraZeneca, the suspension of the vaccine in the continent’s richest and most populous countries poses a new threat to the credibility of the vaccine, whether or not there is a link, policy experts have said. of health. Decisions to withdraw from immunization schedules “are doomed to fuel hesitation” over the AstraZeneca vaccine, said Stephen Griffin, associate professor of medicine at the University of Leeds, and could result in the dissemination of more general views on the vaccine. anti-vaccine. “My concern is for those who are anxious” even before the stops, he said.

Karl Lauterbach, professor of epidemiology and lawmaker in the German federal parliament, criticized his country’s decision. He said an investigation without stopping the shooting would have made more sense amid the surge in cases in Europe. “In the third wave, which is now picking up speed, the first vaccinations with the AstraZeneca vaccine would be lifesavers,” he tweeted.

AstraZeneca has warned that it will not meet scheduled vaccine deliveries to Europe in the coming months.

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Sean Gallup / DDP / Zuma Press

Sections of the developing world depend on the shot from AstraZenenca, which has pledged to deliver 3 billion doses this year at cost. Temporary stoppages in Europe could raise concerns among beneficiaries elsewhere.

Reflecting this concern, the World Health Organization recommended on Monday that vaccinations continue as normal to avoid unnecessary deaths from Covid-19. WHO is also examining reports of blood clotting, but has so far found no evidence that the conditions are related to the vaccine, a spokesperson said.

AstraZeneca, which developed the vaccine in partnership with the University of Oxford, said the number of cases of blood clotting among the approximately 17 million people in the EU and UK who received the vaccine is lower to that of the general population. Large-scale human trials also did not raise any signs that blood clotting was a risk.

German Health Minister Jens Spahn said on Monday that suspending the deployment of AstraZeneca was a precautionary measure following advice from the German vaccine regulator, the Paul Ehrlich Institute. The institute advised the stop after seven cases of blood clotting were reported following the administration of 1.6 million doses in the country.

The number of incidents in Germany and across Europe was low and authorities were trying to determine if they were related to the vaccine, Mr Spahn said. Germany is looking to the EMA for advice, he said.

The series of breaks across Europe gives new impetus to AstraZeneca’s vaccination effort just three months after its deployment. The shot was previously skeptical of clinical trial results which suggested it was not as effective as other vaccines on the market. Some of those perceptions faded when the UK inoculated millions of people with the vaccine, generating real data that showed it to be very effective in preventing serious illness and death.

There were also manufacturing delays. Last week, AstraZeneca warned it would fall short of expected vaccine deliveries to Europe in the coming months of 100 million doses, nearly two-thirds less than the continent expected based on previous commitments of the company.

AstraZeneca CEO Pascal Soriot has repeatedly dismissed doubts about the effectiveness of the shot and criticism of its deployment. Last month, AstraZeneca said it would roughly double global vaccine production to 200 million doses per month by April.

As highly transmissible coronavirus variants sweep the world, scientists are rushing to understand why these new versions of the virus are spreading faster and what that could mean for vaccination efforts. New research indicates the key may be the spike protein, which gives the coronavirus its incomparable form. Illustration: Nick Collingwood / WSJ

Blood clots reported in some people who have received AstraZeneca-Oxford vaccine are commonly known as venous thromboembolic events and are relatively common.

They involve the formation of a thickened pool of blood in a blood vessel, which can cause fatal blockages. Health officials in the United States have included thromboembolic events among various types of adverse events of particular interest that they are monitoring as Covid-19 vaccines are widely deployed.

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The Covid-19 vaccine, which was authorized for use in the United States at the end of February, there were slightly more blood clots in those vaccinated than in those who had received a placebo. The Food and Drug Administration said it could not rule out the possibility that the vaccine contributed to the higher number and plans to monitor for clots when the J&J vaccine is rolled out to a larger population.

Venous thromboembolism can also occur in people with Covid-19. The International Society on Thrombosis and Hemostasis, whose members include healthcare professionals who treat blood clots, issued a statement Friday recommending that all eligible adults continue to be vaccinated against Covid-19 because the small number Thrombotic events reported from millions of vaccinations does not suggest a direct link.

Write to Jenny Strasburg at [email protected] and Bojan Pancevski at [email protected]

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