The EU regulator authorizes Pfizer’s COVID vaccine for children 5-11 years old
The Hague – The European Union’s drug regulator on Thursday allowed the use of the Pfizer coronavirus vaccine on children aged 5 to 11, paving the way for millions of primary schoolchildren to be given the vaccines amid a new wave of infections sweeping the continent.
This is the first time that the European Medicines Agency has approved a COVID-19 vaccine for use in young children.
The agency said it had “recommended that an extension of indication be granted for the COVID-19 Comirnaty vaccine to include children aged 5 to 11 years.”
After evaluating a study of the vaccine in more than 2,000 children, the EMA estimated that the vaccine was about 90% effective in preventing symptoms of COVID-19 in young children, and said the most common side effects were pain at the injection site, headache, and muscle soreness and chills. The agency said the two-dose regimen should be given to children three weeks apart.
At least one country facing rising infections has not waited for EMA approval. Authorities in the Austrian capital Vienna have already started vaccinating the 5- to 11-year-old group. Europe is currently at the epicenter of the pandemic, and the World Health Organization has warned that the continent could see the death toll rise to two million by spring unless urgent measures are taken.
The EMA green light for a vaccine developed by Pfizer and German company BioNTech must be sealed by the European Union’s executive branch, the European Commission, before health authorities in member states can begin administering the vaccines.
Earlier this week, German Health Minister Jens Spahn said shipments of vaccines for young children in the European Union would begin on December 20.
The US signed off on baby-sized footage from Pfizer earlier this month, followed by other countries including Canada.
Pfizer tested a dose equal to one-third the amount given in adults to children of primary school age. Even with the smaller shot, Dr. Bill Gruber, Pfizer’s vice president, told The Associated Press, kids ages 5 to 11 developed levels of anti-coronavirus antibodies just as strong as teens and young adults who get the regular strength shots. in September.
But studies of Pfizer’s vaccine in children were not large enough to detect any rare side effects from the second dose, such as the chest infection and heart infection seen mostly in older teens and young adults.
US officials note that COVID-19 has caused more deaths in children age 5 to 11 than some other diseases, such as chickenpox, before children were routinely vaccinated.
Earlier this month, the European Food Agency said it had begun evaluating the use of Moderna’s COVID-19 vaccine for children aged 6 to 11. She estimated that a decision would be made within two months.
Although children often have mild symptoms of COVID-19, some public health experts believe that immunizing them should be a priority to reduce the ongoing spread of the virus, which could theoretically lead to the emergence of a dangerous new variant.
Researchers disagree about the extent to which children will influence the course of the epidemic. Early research indicated that they did not contribute much to the spread of the virus. But some experts say children have played an important role this year in spreading infectious variants such as alpha and delta.
In a statement this week, the World Health Organization said that because children and adolescents tend to have milder COVID-19 disease than adults, “their vaccination is less urgent than the elderly, those with chronic health conditions and health workers.”
It called on rich countries to stop immunizing children and asked them to donate their doses immediately to poor countries that have not yet provided an initial dose of the vaccine to health workers and vulnerable populations.
However, the World Health Organization has acknowledged that there are benefits to vaccinating children and adolescents that go beyond the direct health benefits.
“A vaccination that reduces transmission of coronavirus in this age group may reduce transmission from children and adolescents to the elderly, and may help reduce the need for mitigation measures in schools,” the World Health Organization said.
Maria Cheng reported from London.
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