France recommends AstraZeneca COVID-19 vaccine only for those 55 and older, breaking with EU guidance

France's medical regulator approved the resumed use of AstraZeneca-Oxford's COVID-19 vaccine on Friday, but said it should be given only to people 55 and older.

The restriction breaks with the European watchdog's guidance that the shot is safe for all age groups, and comes just weeks after Paris initially said the vaccine should be used only on people under 65.

The European Medicines Agency said on Thursday it was convinced the benefits of the AstraZenecavaccine outweighed the risks after reports of rare instances of blood clotting.

The recommendation from the National Authority for Health (HAS) reflected signs that the clotting affected mostly younger people, whose risk of dying from COVID-19 was lower than the elderly.

"Given the data provided by the EMA, it is the HAS's belief that vaccination with the AstraZeneca vaccine can resume immediately," the French regulator said in a statement.

"However, the EMA has identified a possible increased risk of (thrombosis) in people under 55 years old. The HAS recommends using the AstraZeneca vaccine 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 U.K. and the European Economic Area, which links 30 European countries, included seven cases of blood clots in multiple blood vessels and 18 cases of a rare, difficult to treat condition called cerebral venous sinus thrombosis (CVST).

Meanwhile, the World Health Organization's vaccine safety panel said on Friday that data from AstraZeneca's COVID-19 shot do not point to any overall increase in clotting conditions but that it would continue to monitor its effects.

It also stressed that the vaccine "continues to have a positive benefit-risk profile, with tremendous potential to prevent infections and reduce deaths across the world."

France lifting suspension

France was one of more than a dozen European Union states that suspended use of the Anglo-Swedish vaccine this week.

The HAS said it would review its opinion as soon as new data came in. It said guidance would also be given soon to those under 55 who have already received a first dose of AstraZeneca.

The new restrictions add yet another complication to France's troubled vaccination rollout, which has been beset by onerous red tape, supply difficulties and a high level of public mistrust.

France has so far delivered 5.7 million first doses roughly eight per cent of the population compared with more than 25 million in Britain and more than 100 million in the United States.

When France first approved use of the AstraZeneca shot in early February, it said it should be only for those under 65, with President Emmanuel Macron calling it "quasi-ineffective" for anyone beyond their mid-60s.

France only removed that restriction this month.

On Friday, French Prime Minister Jean Castex received the AstraZeneca vaccine at a hospital near Paris, in an event that was broadcast live on French TV as part of efforts to restore public confidence in the vaccine.

Expandedage recommendations in Canada

In Canada,the National Advisory Committee on Immunization (NACI) on Tuesdayexpanded its guidelines on the AstraZenecavaccine to recommend it be given to those over the age of 65.

The committee, which makes recommendations on the use of newly approved vaccines in Canada, had previously recommended that Canadians over 65 not receive an AstraZenecashot, while Health Canada, the regulator, had authorized its use in adults of all ages.

NACI's initial recommendations were based largely on clinical trial data and didn't examine real-world evidence past Dec. 7 months before the effectiveness of the vaccine was fully realized in other countries for older age groups.

Dr. Caroline Quach-Thanh, chair of the committee, said the team updated its guidance based on recentreal-world effectiveness studies including new evidence from the United Kingdom, whichhas been administering the AstraZeneca vaccine to people 65and older.

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Canada's Chief Public Health Officer Dr. Theresa Tam says the benefits of the AstraZeneca COVID-19 vaccine outweigh the rare risks.

At a briefing Friday, Chief Public Health Office Dr. Theresa Tam echoed the EMA and WHO's conclusions that the benefits of the AstraZenecavaccine in protecting form COVID-19 outweigh the risks.

"Health Canada has been working closely with international regulators to gather and assess the available information and has determined that the AstraZeneca vaccine has not been associated with an increase in the overall risk of blood clots," she said."Rare adverse events are expected to be detected when vaccines are given to millions to people."

Tam said Health Canada will continue to work with international regulators and to review data and evidence as it becomes available.