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dpa
London/Brussels
British medical regulators restricted the roll-out of the AstraZeneca/Oxford vaccine to people aged over 30 on Wednesday after some rare cases of blood clots were reported.
The British Medicines and Healthcare products Regulatory Agency (MHRA) and Joint Committee on Vaccination and Immunisation (JCVI) said people aged 18 to 29 who do not have an underlying health condition will now be recommended other vaccines instead.
MHRA investigated 79 cases of rare blood clots following vaccination with the drug in Britain. There were 19 deaths, with young people and women disproportionately affected.
Each person who died had either cerebral venous sinus thrombosis with thrombocytopenia - which stops blood draining from the brain properly - or thrombosis with thrombocytopenia, which occurs in major veins.
More than 18 million people have received a dose of the AstraZeneca/Oxford vaccine in Britain so far.
EU regulators also saw a link between unusual clotting and the British-Swedish pharmaceutical giant’s coronavirus shot in “very rare” cases, but upheld their endorsement of the drug’s use for all adults in the European Union.
Though unusual blood clots should be listed as a possible side effect, the benefits of the jab still hugely outweigh the risks, the European Medicines Agency (EMA) explained following a similar review of cases on Wednesday.
“Covid-19 is a very serious disease with a high hospitalization and death rate, and everyday Covid is still causing thousands of deaths across the EU,” EMA director Emer Cooke said at a press conference.
Based on the evidence so far, it is not possible to confirm whether age, gender, or a previous history of clotting disorders are risk factors, Cooke told reporters.
“When millions of people receive these vaccines, very rare events can occur that were not identified during the clinical trials,” the head of the Dutch-based agency said.
EMA’s Pharmacovigilance Risk Assessment Committee “can therefore not recommend any specific measures to reduce the risk,” committee chair Sabine Straus said.
AstraZeneca will have to look into the reactions itself, and EMA has commissioned its own research, Straus added.
The World Health Organization (WHO) similarly backed the drug, saying that while a link with thrombosis seemed plausible according to the current data, it was not yet confirmed.
Further studies are needed to investigate the possible link, the WHO vaccination committee said.
Dr June Raine - head of Britain’s MHRA - said the risk of blood clotting in people who receive the AstraZeneca/Oxford vaccine is about four people in a million and the benefits outweigh the risks for the vast majority.
“We are not advising a stop to any vaccination for any individual in any age group,” Professor Wei Shen Lim, chairman of the JCVI, added.
Those in Britain who have had their first dose of the AstraZeneca/Oxford vaccine but have not yet had their second dose are being told to get their second dose as normal.
EU health ministers convened talks on the developments on Wednesday evening.
Despite EMA’s continued endorsement, Belgium announced it would halt vaccinations with AstraZeneca’s drug for all those aged 55 and under for one month. However, given that the inoculation campaign is mainly focussed on those over 65 at present, the impact of the move should be limited, Health Minister Frank Vandenbroucke told VRT news.
Germany’s permanent vaccination commission meanwhile Stiko said it would stick to its recommendation of giving the vaccine only to people over 60, put in place late March. The EMA decision would be a topic in further discussions, Stiko member Christian Bogdan said.
London/Brussels
British medical regulators restricted the roll-out of the AstraZeneca/Oxford vaccine to people aged over 30 on Wednesday after some rare cases of blood clots were reported.
The British Medicines and Healthcare products Regulatory Agency (MHRA) and Joint Committee on Vaccination and Immunisation (JCVI) said people aged 18 to 29 who do not have an underlying health condition will now be recommended other vaccines instead.
MHRA investigated 79 cases of rare blood clots following vaccination with the drug in Britain. There were 19 deaths, with young people and women disproportionately affected.
Each person who died had either cerebral venous sinus thrombosis with thrombocytopenia - which stops blood draining from the brain properly - or thrombosis with thrombocytopenia, which occurs in major veins.
More than 18 million people have received a dose of the AstraZeneca/Oxford vaccine in Britain so far.
EU regulators also saw a link between unusual clotting and the British-Swedish pharmaceutical giant’s coronavirus shot in “very rare” cases, but upheld their endorsement of the drug’s use for all adults in the European Union.
Though unusual blood clots should be listed as a possible side effect, the benefits of the jab still hugely outweigh the risks, the European Medicines Agency (EMA) explained following a similar review of cases on Wednesday.
“Covid-19 is a very serious disease with a high hospitalization and death rate, and everyday Covid is still causing thousands of deaths across the EU,” EMA director Emer Cooke said at a press conference.
Based on the evidence so far, it is not possible to confirm whether age, gender, or a previous history of clotting disorders are risk factors, Cooke told reporters.
“When millions of people receive these vaccines, very rare events can occur that were not identified during the clinical trials,” the head of the Dutch-based agency said.
EMA’s Pharmacovigilance Risk Assessment Committee “can therefore not recommend any specific measures to reduce the risk,” committee chair Sabine Straus said.
AstraZeneca will have to look into the reactions itself, and EMA has commissioned its own research, Straus added.
The World Health Organization (WHO) similarly backed the drug, saying that while a link with thrombosis seemed plausible according to the current data, it was not yet confirmed.
Further studies are needed to investigate the possible link, the WHO vaccination committee said.
Dr June Raine - head of Britain’s MHRA - said the risk of blood clotting in people who receive the AstraZeneca/Oxford vaccine is about four people in a million and the benefits outweigh the risks for the vast majority.
“We are not advising a stop to any vaccination for any individual in any age group,” Professor Wei Shen Lim, chairman of the JCVI, added.
Those in Britain who have had their first dose of the AstraZeneca/Oxford vaccine but have not yet had their second dose are being told to get their second dose as normal.
EU health ministers convened talks on the developments on Wednesday evening.
Despite EMA’s continued endorsement, Belgium announced it would halt vaccinations with AstraZeneca’s drug for all those aged 55 and under for one month. However, given that the inoculation campaign is mainly focussed on those over 65 at present, the impact of the move should be limited, Health Minister Frank Vandenbroucke told VRT news.
Germany’s permanent vaccination commission meanwhile Stiko said it would stick to its recommendation of giving the vaccine only to people over 60, put in place late March. The EMA decision would be a topic in further discussions, Stiko member Christian Bogdan said.
