The European Union's drug regulator has authorised Pfizer’s coronavirus vaccine for use on children from 5 to 11 years old.
It clears the way for shots to be administered to millions of elementary school pupils in Ireland and other European countries amid a new wave of infections sweeping across the continent.
It is believed the first doses could arrive in Ireland by December 20 once cleared by Irish authorities, meaning younger Irish children could begin vaccinations after Christmas.
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 5 to 11.”
Last night, Tánaiste Leo Varadkar told the Fine Gael parliamentary party he believed younger children would be offered the vaccine in future.
Earlier this week, the Taoiseach said he favoured the move but would await the recommendation of the EMA and Ireland’s National Immunisation Advisory Committee. Irish children as young as 12 may receive the vaccine, but the Taoiseach added that he did not believe younger Irish children would get the vaccine before Christmas.
Niac here will assess if the vaccine will be approved for use here and what guidelines should cover its use.
It is believed the first doses of the vaccine could arrive here after December 20 which could mean the roll-out – if it is approved for use – would happen after Christmas or the New Year.
Nphet will today again discuss recommending face coverings for primary children, which it has previously rejected. Only secondary students currently wear masks.
It comes as primary children now account for the highest number of Covid cases of any age group, with 10,000 in the last fortnight.
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 5 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 2 million by the spring unless urgent measures are taken.
The EMA green light for the vaccine developed by Pfizer and German company BioNTech has to be rubber-stamped by the EU’s executive branch, the European Commission, before health authorities in member states can begin administering shots.
Earlier this week, Germany’s health minister Jens Spahn said shipping of vaccines for younger children in the EU would begin on December 20.
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 5 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, said 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.
American officials noted that Covid-19 has caused more deaths in children in the 5 to 11 age group than some other diseases, such as chickenpox, did before children were routinely vaccinated.
Earlier this month, the EMA said it began evaluating the use of Moderna Inc.‘s Covid-19 vaccine for children ages 6 to 11; it estimated that a decision would be made within two months.
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’ continued spread, which could theoretically lead to the emergence of a dangerous new variant.
Researchers disagree on how much kids have influenced the course of the pandemic. Early research suggested they didn’t contribute much to viral spread. But some experts say children played a significant role this year spreading contagious variants such as alpha and delta.
In a statement this week, WHO said that because children and teens tend to have milder Covid-19 disease than adults, “it is less urgent to vaccinate them than older people, those with chronic health conditions and health workers.”
It has appealed to rich countries to stop immunizing children and asked them to donate their doses immediately to poor countries who have yet to give a first vaccine dose to their health workers and vulnerable populations.
Still, WHO acknowledged that there are benefits to vaccinating children and adolescents that go beyond the immediate health benefits.
“Vaccination that decreases Covid transmission in this age group may reduce transmission from children and adolescents to older adults, and may help reduce the need for mitigation measures in schools,” WHO said.