The European Union’s drug regulator on Thursday recommended approval of Pfizer’s coronavirus vaccine for use on children from five to 11 years old, clearing a path for shots to be administered to millions of elementary school pupils amid a new wave of infections sweeping across the continent.
It is the first time the European Medicines Agency has cleared a COVID-19 vaccine for use in young children. The agency said it “recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged five to 11.”
A news release outlining the decision said a committee concluded that the benefits of the vaccine in children aged five to 11 “outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19.”
While final approval is up to the European Commission, it typically follows EMA recommendations.
‼️ EMA recommends approval of BioNTech/Pfizer’s <a href=”https://twitter.com/hashtag/COVID19vaccine?src=hash&ref_src=twsrc%5Etfw”>#COVID19vaccine</a>, Comirnaty, for children aged 5 to 11.<br><br>In this population, the dose of <a href=”https://twitter.com/hashtag/Comirnaty?src=hash&ref_src=twsrc%5Etfw”>#Comirnaty</a> will be lower than that used in people aged 12 and above. <br><br>Read the full press release: <a href=”https://t.co/uqqBAklVvl”>https://t.co/uqqBAklVvl</a> <a href=”https://t.co/NZQhli4SDl”>pic.twitter.com/NZQhli4SDl</a>
At least one country facing spiking infections didn’t wait for the EMA approval. Authorities in the Austrian capital, Vienna, already have begun vaccinating the five to 11 age group. Europe is currently at the epicentre of the pandemic and the World Health Organization has warned the continent could see deaths top two million by the spring unless urgent measures are taken.
Earlier this week, Germany’s Health Minister Jens Spahn said shipping of vaccines for younger children in the EU would begin on Dec. 20.
France’s medical ethics body and health regulator will examine whether or not children in France aged five to 11 should have the COVID-19 vaccine, Health Minister Olivier Veran said. Veran added on Thursday that any vaccination of children in France aged five to 11 would not take place before 2022.
The United States signed off on Pfizer’s kids-sized shots earlier this month, followed by other countries including Canada.
Pfizer tested a dose that is a third of the amount given to adults for elementary school-age children. Even with the smaller shot, children who are five to 11 years old developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice-president, told The Associated Press in September.
But the studies done on Pfizer’s vaccine in children haven’t been big enough to detect any rare side effects from the second dose, like the chest and heart inflammation that has been seen in mostly male older teens and young adults.
Although children mostly only get mild symptoms of COVID-19, some public health experts believe immunizing them should be a priority to reduce the virus’s continued spread, which could theoretically lead to the emergence of a dangerous new variant.
Earlier this month, the EMA said it began evaluating the use of Moderna Inc.’s COVID-19 vaccine for children ages six to 11; it estimated that a decision would be made within two months.
-From The Associated Press, with files from Reuters and CBC News, last updated at 7:35 a.m. ET
What’s happening across Canada
What’s happening around the world
As of early Thursday morning, more than 259.6 million cases of COVID-19 had been reported worldwide, according to Johns Hopkins University’s COVID-19 tracker. The reported global death toll stood at more than 5.1 million.
In Europe, official figures show Germany has become the latest country to surpass 100,000 deaths from COVID-19 since the pandemic began. Germany’s disease control agency said Thursday it recorded 351 additional deaths in connection with the coronavirus over the past 24 hours. That took the total toll to 100,119.
Germany is the fifth country to pass that mark in Europe after Russia, the United Kingdom, Italy and France. The Robert Koch Institute is a federal agency that collects data from about 400 regional health offices. It said Germany also set a record for daily confirmed cases at 75,961 in a 24-hour period. Germany has had more than 5.57 million confirmed cases of COVID-19 since the start of the outbreak.
As deliveries of COVID-19 vaccines to Africa finally pick up, many nations are struggling with the logistics of accelerating their inoculation campaigns, the head of Africa’s disease control body said on Thursday.
Only 6.6 per cent of Africa’s population of 1.2 billion is fully vaccinated, Dr John Nkengasong, head of the Africa Centres for Disease Control and Prevention, told a virtual news conference. That puts the continent far from reaching the African Union’s aim of fully vaccinating 70 per cent of Africans by the end of next year, he said. He named Democratic Republic of Congo and Cameroon as having particular logistical challenges but said many other African countries faced similar problems.
In the Americas, a total of 92 per cent of U.S. federal workers have received at least one dose of a COVID-19 vaccine, in compliance with the administration’s mandate, the White House Office of Management and Budget (OMB) said.
Colombia will seek to vaccinate more than 80 per cent of its population against COVID-19, up from a previous target of 70 per cent, as it looks to cut the risk posed by further waves of the pandemic, Health Minister Fernando Ruiz said.
In the Middle East, Iran saw 41,523 new cases of COVID-19 and 810 new deaths last week, according to a weekly situation report from the WHO released on Wednesday.
In the Asia-Pacific region, Singapore and Malaysia will launch a quarantine-free travel lane next week at their land border crossing for people vaccinated, the two countries said.
-From The Associated Press, Reuters and CBC News, last updated at 7:25 a.m. ET