The restriction breaks with European watchdog guidelines that the vaccine is safe for all age groups, and comes just weeks after Paris initially said the vaccine should only be used on people under 65 years old. The European Medicines Agency said Thursday it was convinced the benefits of the AstraZeneca vaccine outweighed the risks after reports of rare cases of blood clotting.
The recommendation from the National Health Authority (HAS) reflected signs that coagulation mainly affected younger people, whose risk of dying from COVID-19 was lower than that of older people.
“In view of the data provided by the EMA, the HAS believes that vaccination with the AstraZeneca vaccine can resume immediately,” said the French regulator in a press release.
“However, the EMA has identified a possible increased risk of (thrombosis) in people under the age of 55. HAS recommends that the AstraZeneca vaccine be used at this stage only for people aged 55 and over, who represent the majority of priority people. ”
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An EMA review covering 20 million people in the UK and the European Economic Area, which connects 30 European countries, included seven cases of blood clots in several blood vessels and 18 cases of a rare and difficult disease to be treated called cerebral venous sinus thrombosis (CVST).
Meanwhile, the World Health Organization’s vaccine safety expert group said on Friday that data from AstraZeneca’s COVID-19 vaccine did not suggest an overall increase in clotting conditions, but that it would continue to monitor its effects.
He also pointed out that the vaccine “continues to have a positive benefit-risk profile, with enormous potential to prevent infections and reduce deaths globally”.
Lifting suspension France
France was one of more than a dozen states in the European Union to suspend use of the Anglo-Swedish vaccine this week.
HAS has said it will reconsider its opinion as new data comes in. She said that guidance would also be given soon to those under 55 who have already received a first dose of AstraZeneca.
The new restrictions add another complication to the difficult roll-out of vaccination in France, which has been beset by cumbersome red tape, supply difficulties and a high level of public mistrust.
France has so far delivered 5.7 million first doses – or about 8% of the population – compared to more than 25 million in Britain and more than 100 million in the United States.
When France first approved the use of the AstraZeneca shot in early February, it said it should only be for those under 65, with President Emmanuel Macron calling it “almost ineffective” for anyone beyond. beyond sixty.
France only removed this restriction this month.
French Prime Minister Jean Castex received the AstraZeneca vaccine at a hospital near Paris on Friday during an event broadcast live on French television as part of efforts to restore public confidence in the vaccine.
Expanded age recommendations in Canada
In Canada, the National Advisory Committee on Immunization (NACI) on Tuesday broadened its guidelines for the AstraZeneca vaccine to recommend that it be given to people over 65 years of age.
The committee, which makes recommendations on the use of newly approved vaccines in Canada, had previously recommended that Canadians over 65 not receive an AstraZeneca vaccine, while Health Canada, the regulator, had cleared its use in adults of all ages.
NACI’s initial recommendations were based largely on clinical trial data and did not examine real-world evidence after December 7 – months before the vaccine’s effectiveness was fully realized in other countries. for older groups.
Dr Caroline Quach-Thanh, chair of the committee, said the team had updated their guidelines based on recent studies of real-world efficacy – including new evidence from the UK, which administered AstraZeneca vaccine to persons 65 years of age and older.
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In a briefing on Friday, Dr Theresa Tam, Chief Public Health Office, echoed the EMA and WHO findings that the benefits of the AstraZeneca vaccine in protecting the form COVID-19 outweighs the risks.
“Health Canada has worked closely with international regulatory agencies to collect and assess the available information and has determined that the AstraZeneca vaccine has not been associated with an increased overall risk of blood clots,” she said. declared. “Rare adverse events are expected to be detected when vaccines are administered to millions of people. ”
Tam said Health Canada will continue to work with international regulators and review the data and evidence as it becomes available.