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.
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 epicenter 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. Vera 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.
What’s happening around the world
s 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 percent 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 percent of Africans by the end of next year, he said. He named the 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 percent 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 percent of its population against COVID-19, up from a previous target of 70 percent, as it looks to cut the risk posed by further waves of the pandemic, Health Minister Fernando Ruiz said.
COVID-19 vaccinations for kids 5-11 in Nova Scotia to begin Dec. 2
Children between the ages of five and 11 in Nova Scotia will start getting vaccinated for COVID-19 on Dec. 2.
Dr. Robert Strang, the chief medical officer of health, said the first shipments of the vaccine for kids will be delivered to the province this week.
The online system for booking vaccines for kids is not yet open, but will open “very soon,” Premier Tim Houston said during a COVID-19 briefing on Wednesday morning.
Strang said staff are still making adjustments to the online booking system to accommodate the new age group, and that once the delivery date and time of the vaccines are finalized, the system will open and the public will be notified.
Bookings will be opened to the entire new age group all at once — a population of about 68,000.
Health Canada approved Pfizer-BioNTech’s vaccine for kids five to 11 on Friday. The province has previously announced that vaccines for children will be delivered through pharmacies. The IWK Health Centre will also administer the shots.
Asked why Nova Scotia is lagging behind other provinces that have already opened bookings and are vaccinating kids, Strang said Nova Scotia has asked for its bulk shipment to be broken down into smaller shipments so they can be sent directly to pharmacies.
“Over time, that efficiency of shipping directly to pharmacies will stand us in good stead,” he said.
Strang said Nova Scotia has the capacity to administer first doses to all kids aged five to 11 who want them before Christmas.
‘Make the COVID-19 vaccine a priority
Children aged five to 11 will be considered fully vaccinated 14 days after their second dose. Strang said a minimum of eight weeks between doses is recommended.
If a child turns 12 between the first and second doses, the second dose will be the adult dose, Strang said.
He said children under 12 should not receive other vaccinations at the same time as the COVID-19 shot, but rather should leave 14 days between the COVID-19 vaccine and a different shot.
“If you do have to make a choice, make the COVID-19 vaccine a priority,” Strang said.
Those 12 and older can receive a COVID-19 dose at the same time as another vaccine.
Strang said data on vaccines for newborns to four-year-olds is still being collected through clinical trials and there is no timeline yet for vaccination of that age group.
Pharmacies are preparing for the start of child vaccinations by looking at staffing and setting up their spaces to accommodate kids, said Diane Harpell, the chair of the board of the Pharmacy Association of Nova Scotia.
She told the CBC’s Information Morning that rather than the five- to seven-minute intervals allotted for adult vaccinations, pharmacists may plan for seven- to 10-minute intervals for kids to allow extra time to make them comfortable.
Pharmacists may also have, or encourage parents to have, distractions available, such as a special toy, a device to show a video, games in the office or a TV in the location where the vaccine is being administered.
Daily case numbers
Nova Scotia reported 20 new cases of COVID-19 on Wednesday, bringing the active caseload to 172.
Twelve of the new cases are in the central zone, six are in the northern zone and two are in the eastern zone.
Eighteen people are in hospital, including six in intensive care.
On Tuesday, four schools received notification of an exposure.
Strang said in the Halifax Regional Municipality, cases are shifting from central Halifax to suburban or semi-rural areas, and most cases are appearing in children under 12. He acknowledged that is having an impact on some schools, but with the imminent rollout of vaccines, that impact will be diminished.
The case numbers in the western and northern zones are stabilizing, but there is still evidence of low-level community transmission in the northern zone, Strang said.