Germany’s vaccine committee (Stiko) has advised giving the Oxford-AstraZeneca Covid-19 vaccine only to people aged 60 + because of a risk of rare blood clots.
The German drugs regulator found 31 cases of a type of rare blood clot among the nearly 2.7 million people who had received the vaccine in Germany.
Canada earlier suspended use of the AstraZeneca jab in people under 55.
AstraZeneca said international regulators had found the benefits of its vaccine outweighed risks significantly.
The company said it was continuing to analyze its database to understand “whether these very rare cases of blood clots associated with thrombocytopenia occur any more commonly than would be expected naturally in a population of millions of people”.
“We will continue to work with German authorities to address any questions they may have,” AstraZeneca added.
The EU and UK medicine regulators both backed the vaccine after previous cautionary suspensions in Europe this month.
The European Medicines Agency (EMA) and the UK Medicines & Healthcare products Regulatory Agency stressed that the benefits of the AstraZeneca vaccine continued to outweigh the risk of side effects.
AstraZeneca’s vaccine is one of the most widely used coronavirus vaccines in the West, and is meant to be supplied on a not-for-profit basis to the developing world.
The EU’s rollout of its vaccination program has been dogged by delays because of delivery and production problems, and Germany is among several states now fearing a third wave of infections.
On March 30, Italy’s PM Mario Draghi and his wife, who are both 73, received their first doses of AstraZeneca in a display of confidence in the vaccine.
Ahead of the Stiko announcement, the German cities of Berlin and Munich, and the region of Brandenburg, halted use of the vaccine in people below the age of 60.
“After several consultations, Stiko, with the help of external experts, decided by a majority to recommend the AstraZeneca Covid-19 vaccine only for persons aged 60 years and older on the basis of available data on the occurrence of rare but very severe thromboembolic side effects,” the committee said, as quoted by Reuters.
“Regarding the question of administering the second vaccine dose to younger persons who have already received a first dose of the AstraZeneca Covid-19 vaccine, Stiko will issue a supplementary recommendation by the end of April.”
Germany was one of the European states which briefly suspended use of the AstraZeneca vaccine earlier this month pending an EMA review into the possible link to blood clots.
When the EMA declared the vaccine “safe and effective”, Germany and others resumed its use but investigations continued.
The German medicines regulator, the Paul Ehrlich Institute, has found 31 cases of cerebral sinus vein thrombosis (CSVT) among people who received AstraZeneca in Germany.
Almost all the cases are reportedly in younger and middle-aged women.
France already limits use of AstraZeneca to those aged over 55.
The Oxford-AstraZeneca coronavirus vaccine will be tested on children aged between 6 and 17 in a new trial.
Some 300 volunteers will take part, with the first vaccinations in the trial taking place later in February.
Researchers say they will assess whether the vaccine produces a strong immune response in children aged between six and 17.
The vaccine is one of two being used to protect against serious illness and death from Covid-19 in the UK, along with the Pfizer-BioNTech vaccine.
As many as 240 children will receive the vaccine – and the others a control meningitis vaccine – when the trial gets under way.
Volunteers who live near one of the four study sites – the University of Oxford, St George’s University Hospital, London, University Hospital Southampton and Bristol Royal Hospital for Children – are being asked to sign up.
Those interested in taking part must complete a short questionnaire.
Andrew Pollard, professor of pediatric infection and immunity, and chief investigator on the Oxford vaccine trial, noted that most children were relatively unaffected by Covid and were unlikely to become unwell with the virus.
However, Prof. Pollard said it was important to establish the safety and immune response to the vaccine in children and young people as some children might benefit from vaccination.
There are currently no plans for children to be vaccinated with the Oxford-Astrazeneca vaccine in the UK, as it has only been authorized to prevent Covid-19 in people aged 18 or over.
The Pfizer-BioNTech vaccine is only authorized in those aged over 16. The vaccine priority list also excludes anyone under the age of 16, even the clinically extremely vulnerable.
The University of Oxford said it was the first trial of a Covid vaccine in the 6 to 17 age group. It said other trials had begun but only measuring efficacy in those aged 16 and 17.
South Africa is considering swapping or selling the Oxford-AstraZeneca Covid-19 vaccine, the health minister announces.
The African country has 1.5 million doses of the AstraZeneca vaccine.
However, plans to use it to vaccinate health workers have been put on hold after a small study suggested a “minimal” effect against the South African new variant in young people.
South Africa now intends to use a vaccine from Johnson & Johnson instead.
Health Minister Zweli Mkhize told at a news conference: “There are already some countries that are asking that we must sell it to them.
“Our scientists will continue with further deliberations on the AstraZeneca vaccine used in South Africa and depending on their advice, the vaccine will be swapped before the expiry date.”
Zweli Mkhize added that he was due to speak with the WHO shortly after the news conference.
South Africa has recorded almost 1.5 million cases of coronavirus, and 47,000 deaths – far more than anywhere else on the continent.
Researchers from the University of the Witwatersrand in South Africa and the UK’s Oxford University carried out the trial, which has not yet been published or peer-reviewed, on around 2,000 healthy, young people with an average age of 31.
They found that the Oxford-AstraZeneca vaccine offered “minimal protection” against mild and moderate cases of the South Africa variant of coronavirus in that low-risk group.
This means that even in people who’ve been vaccinated, the virus could still spread from person to person.
However, the research did not look at the impact of the vaccine on severe disease from Covid-19 because there was no-one in the study who was in a high-risk category (over 50) or had an underlying health condition.
Oxford University researchers say promising results from other trials using similar vaccines in South Africa suggest their shot should be effective at preventing severe cases – the main aim of all Covid vaccines.
South Africa now plans to give the AstraZeneca vaccine to a group of 100,000 older nurses and healthcare workers.
That’s to see if it is effective against the new variant and in preventing severe illness in an older age group.
The South Africa variant carries a mutation that appears to make it more contagious or easy to spread.
However, there is no evidence that the variant causes more serious illness for the vast majority of people who become infected.
As with the original strain, the risk is highest for people who are elderly or have significant underlying health conditions.
Scientists say the variant accounts for 90% of new Covid-19 cases in South Africa.
At least 20 other countries, including the UK, Austria, Japan, Kenya and Norway have found cases of the variant.
The health minister for neighboring Eswatini, previously known as Swaziland, said on February 9 that it would no longer use the AstraZeneca vaccine.
The health authorities in Malawi have said they still plan to use the AstraZeneca vaccine.
Negotiations are still going on over the amount and the price South Africa will pay for the Johnson & Johnson vaccine, which is made by Belgian pharmaceutical firm Janssen.
The Johnson & Johnson vaccine has not yet been approved for use in South Africa.
The first of the nine million doses it has ordered are due to arrive next week.
The South African health minister said these would be provided to some 500,000 health workers as “an implementation study”, possibly starting as early as next week, but this was still to be confirmed.
He also promised to explain next week just how much of the vaccine will be coming to South Africa.
Zweli Mkhize said that South Africa had already secured vaccine doses from Pfizer which it has agreed to bring in earlier than originally agreed.
South Africa is also in discussions with other manufactures, including the makers of Sputnik V, Sinovac and Moderna vaccines, he added.
British and Russian scientists are teaming up to trial a combination of the Oxford-AstraZeneca and Sputnik V vaccines to see if protection against Covid-19 can be improved.
According to the researchers, mixing two similar vaccines could lead to a better immune response in people.
The trials, to be held in Russia, will involve over-18s, although it’s not clear how many people will be involved.
Oxford recently published results showing their vaccine was safe and effective in trials on people.
The researchers are still collecting data on the effectiveness of the vaccine in older age groups while waiting for approval from the UK regulator, the MHRA.
AstraZeneca said it was exploring combinations of different adenovirus vaccines to find out whether mixing them leads to a better immune response and, therefore, greater protection.
The Oxford vaccine, developed in partnership with AstraZeneca, and the Russian Sputnik vaccine, developed by the Gamaleya Research Institute in Moscow, are similar because they both contain genetic material from the Sars-CoV-2 spike protein.
They work differently to the Pfizer-BioNTech vaccine, which has been approved in the UK, Canada, Bahrain, Saudi Arabia and recommended for approval by medical experts in the US.
Early results from late-stage trials of the Russian vaccine have shown promising results.
Russia was the first country to register a Covid vaccine for emergency use – in August, despite only having been tested on a few dozen people.
Sputnik V is now being offered to Russians as part of a mass vaccination campaign.
AstraZeneca said it was “working with industry partners, governments and research institutions around the world, and will soon begin exploring with Gamaleya Research Institute in Russia to understand whether two adenovirus-based vaccines can be successfully combined”.
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