Pfizer COVID-19 Vaccine Approved for Children Ages 5-11 in EU

It is the first time that the European Medicines Agency has approved a COVID-19 vaccine for use in young children.

THE HAGUE, Netherlands — The European Union’s drug regulator approved Thursday Pfizer’s coronavirus vaccine for use on children from 5 to 11 years, paving the way for the administration of injections to millions of elementary school students amid a new wave of infections sweeping the continent.

It is the first time that the European Medicines Agency has Covid-19 vaccine for use in young children.

The agency said it “recommended extending the indication for the COVID-19 vaccine Comirnaty to use in children ages 5 to 11.”

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 symptomatic COVID-19 in young children and said the most common side effects were injection site pain, headache were muscle aches. pain and chills. The agency said the two-dose regimen should be given to children three weeks apart.

At least one country facing peak infections did not wait for EMA approval. The authorities in the Austrian capital Vienna have already started vaccinating the age group from 5 to 11 years. Europe is currently at the epicenter of the pandemic and the World Health Organization has warned the continent could see 2 million dead by spring unless urgent action is taken.

The EMA green light for the vaccine developed by Pfizer and German company BioNTech must be stamped by the EU’s executive, the European Commission, before health authorities in member states can start administering injections.

Earlier this week, German Health Minister Jens Spahn said vaccine shipments for younger children in the EU would begin on December 20.

The United States approved Pfizer’s child-sized photos earlier this month, followed by other countries, including Canada.

Pfizer tested a dose that is one-third the amount given to adults for elementary school-aged children. Even with the smaller injection, children ages 5 to 11 developed antibody levels to the coronavirus that were just as strong as teens and young adults who received the normal injections, Dr. Bill Gruber, a senior vice president of Pfizer, told The Associated Press in September.

But the studies of the Pfizer vaccine in children were not large enough to detect rare side effects of the second dose, such as the breast and heart inflammation seen in mostly male older teens and young adults.

US officials noted that COVID-19 has caused more deaths in children between the ages of 5 and 11 than some other diseases, such as chickenpox, did before children were routinely vaccinated.

Earlier this month, the EMA said it was limiting the use of Moderna Inc.’s COVID-19 vaccine. for children aged 6 to 11 began to evaluate; it was estimated that a decision would be made within two months.

While children usually only get 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 strain.

Researchers disagree on the extent to which children have influenced the course of the pandemic. Early research suggested that they did not contribute much to the viral spread. But some experts say children have played a significant role in spreading infectious variants such as alpha and delta this year.

In a statement this week, the 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, people with chronic health conditions and health professionals.”

It has called on rich countries to stop immunizing children and asked them to immediately donate their doses to poor countries that have yet to give their health workers and vulnerable populations a first dose of vaccine.

Still, the WHO recognized that there are benefits to vaccinating children and adolescents beyond the immediate health benefits.

“Vaccination that reduces transmission of COVID 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,” the WHO said.

Maria Cheng reported from London.

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