Coronavirus: Why Germany limited Oxford vaccine to children under 60

31 March 2021, 08:46 am -03

Credit, Reuters

Photo caption, Manufacturer argues that benefits of its covid-19 vaccine outweigh risks

Germany is suspending the general use of the Oxford-AstraZeneca vaccine against covid-19 for people under the age of 60 after associating it with the risk of rare blood clots.

Health Minister Jens Spahn and the 16 state health secretaries made the decision at an emergency meeting on Tuesday.

People under 60 can still receive the vaccine, but only “at the discretion of doctors and after individual risk analysis and thorough explanation”, according to a document seen by the German news agency DPA.

The German drug regulator found 31 cases of a rare type of blood clot among the nearly 2.7 million people who received the vaccine in Germany.

Canada had also previously suspended the use of the vaccine in people under the age of 55.

AstraZeneca said that international regulators point out that the benefits of its vaccine outweigh the risks significantly. And he said he continues to analyze his database to understand “whether these very rare cases of blood clots associated with thrombocytopenia occur more commonly than would be expected naturally in a population of millions of people.”

“We will continue to work with the German authorities to resolve any questions they may have,” he added.

Drug regulators in the European Union and the United Kingdom supported the vaccine after previous precautionary suspensions in Europe earlier this year. The European Medicines Agency and the UK Medicines and Health Products Regulatory Agency emphasized that the benefits of the Astrazeneca vaccine continued to outweigh the risk of side effects.

In the UK, a government spokesman said: “The Oxford / AstraZeneca vaccine is safe, effective and has already saved thousands of lives in this country. As the UK’s independent regulator said, when people are drafted, they should receive the More than 30 million people have already received the first dose of a vaccine and we are on track to offer vaccines to everyone over 50 by April 15 and to all adults by the end of July “.

Astrazeneca’s product is one of the most widely used vaccines against covid-19 in the West.

The implementation of the European Union’s vaccination program has been hampered by delays due to delivery and production problems, and Germany is among several states that now fear a third wave of infections.

On Tuesday (5/30), Italian Prime Minister Mario Draghi and his wife, both 73, received their first doses of Astrazeneca in a show of confidence in the vaccine.

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Analysis by Nick Triggle, BBC health reporter

If you give a vaccine to millions of people, you will of course see some cases of people seriously ill or even dying shortly afterwards. This does not mean that the vaccine caused the problem – it may have occurred naturally.

What the authorities need to find out is whether the deaths are a cause or a coincidence.

This is done by monitoring adverse events after vaccination and analyzing whether they are above what would normally be expected. The type of blood clot observed is very rare, so it is difficult to know exactly how many cases you would normally expect to see.

We know that it is more common in women and that taking the birth control pill increases the risk.

There is still no evidence to show that the Astrazeneca vaccine increases the chances of these clots. But even if it does, the next thing to consider is whether covid-19 poses a greater danger.

Regulators in Europe and the United Kingdom are clear in saying that – given current evidence – vaccine use should continue at all ages.

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The decision was made following the recommendation of the German vaccine committee (Stiko).

“After several consultations, Stiko, with the help of external experts, decided by a majority to recommend the AstraZeneca vaccine against covid-19 only for people aged 60 and over, based on the available data on the occurrence of rare thromboembolic side effects. , but very serious. “

According to the German committee, additional recommendations on booster vaccines will be issued by the end of April for young people who have already received their first dose of Astrazeneca.

Chancellor Angela Merkel said there should be no doubt about the safety of any medication administered in Germany.

“We have to be able to rely on vaccines. This also includes the subsequent continuous testing of their effectiveness and safety, and the ongoing weighing of risks and benefits.”

Angela Merkel

Credit, EPA

Photo caption,

Merkel: ‘I already said that when my turn comes, I will be vaccinated, also with Astrazeneca’

At 66, she added that she is agreeing to be vaccinated with AstraZeneca when her turn comes.

Before the announcement, the German cities of Berlin and Munich, and the Brandenburg region, had stopped using the vaccine for people under 60.

Germany was one of the European countries that had briefly suspended the use of the Astrazeneca vaccine earlier this month, pending an EMA review on the possible link with blood clots.

When the EMA declared the vaccine “safe and effective”, Germany and other countries resumed its use, and investigations continued.

The German drug regulator, Instituto Paul Ehrlich, found 31 cases of cerebral sinus venous thrombosis (CSVT) among people who received AstraZeneca in Germany. Almost all cases are reported in younger, middle-aged women.

France already limits the use of Astrazeneca to those over 55.

On Monday (March 29), Canada recommended an immediate suspension of the use of Astrazeneca in people under 55 years of age after reports of rare but potentially fatal blood clots in Europe, according to Canadian broadcaster CBC.

There have been no reports of blood clots related to the vaccine in Canada itself, where 300,000 doses of Astrazeneca vaccines have been administered.

In the UK, five cases of CSVT (one of them fatal) were reported among 11 million people who received the vaccine.

Austria has confirmed that it is in negotiations with Russia to buy one million doses of its Sputnik V vaccine, which has not yet been approved by the EMA.

Austrian Chancellor Sebastian Kurz is under pressure from opposition parties because of his government’s failure to buy its full share of vaccines in the European Union’s collective buying program.

“There should be no geopolitical blind people about vaccines,” said Kurz in a statement released by his office. “The only thing that must count is whether the vaccine is effective and safe.”

Despite the lack of approval from the EMA, Sputnik is already being used by another European Union state, Hungary.

Russian President Vladimir Putin discussed possible vaccine cooperation with Merkel and French President Emmanuel Macron when they held a video conference this week, Macron’s office said in a statement.

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