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The European Union’s drug regulator on Thursday authorized Pfizer’s coronavirus vaccine for use on children aged 5 to 11, paving the way for the shots to be given to millions of primary school students amid a new wave of infections across the continent Gaya.

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


The agency said it “recommended to expand the indication for the COVID-19 vaccine community to include use in children 5 to 11 years of age.”

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After evaluating studies 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 noted that the most common side effects were pain at the injection site, headache, and muscle aches. I was in pain. pain and chills. The agency said two-dose doses should be given to children at three-week intervals.

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At least one country facing spiking infections did not wait for EMA approval. Authorities in the Austrian capital Vienna have already started vaccinating people aged 5 to 11. Europe is currently at the epicenter of the pandemic and the World Health Organization has warned that unless immediate measures are taken, the continent could see deaths top 2 million by spring.

The EMA green light for a vaccine developed by Pfizer and German company BioNTech has to be rubber-stamped by the European Union’s executive arm, the European Commission, before health officials in member states can begin administering the shots.

An exterior view of the European Medicines Agency, EMA, in the business district of Amsterdam, The Netherlands, Tuesday, April 20, 2021.

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Earlier this week, Germany’s Health Minister Jens Spahn said shipping vaccines for young children in the EU would begin on 20 December.

The United States signed off on Pfizer’s child-sized shots earlier this month, followed by other countries, including Canada.

Pfizer tested a dose that is one-third of the amount given to adults for children of primary school age. Even with the shorter shot, the levels of coronavirus-fighting antibodies in children ages 5 to 11 are as strong as those of teens and young adults who get the regular-strength shot, said Pfizer’s senior vice president. Doctor. Bill Gruber told the Associated Press. in September.

But studies on the Pfizer vaccine in children are not large enough to detect any rare side effects from the second dose, such as chest and heart swelling seen mostly in male older teens and young adults.

US officials noted that COVID-19 caused more deaths in children aged 5 to 11 than some other diseases, such as chickenpox, occurred before children were routinely vaccinated.

Earlier this month, the EMA said it had begun evaluating the use of Moderna Inc.’s COVID-19 vaccine for children ages 6 to 11; It is estimated that a decision will be made within two months.

A worker prepares a syringe with the Pfizer vaccine against the coronavirus and the COVID-19 disease on a vaccination bus in Berlin, Germany, Tuesday, November 23, 2021.

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Although children mostly have only mild symptoms of COVID-19, some public health experts believe that immunizing them should be a priority to reduce the continued spread of the virus, which could theoretically be a dangerous new type of virus. may cause emergence.

Researchers disagree about how much children have influenced the course of the pandemic. Early research suggested that they did not contribute much to viral spread. But some experts say that this year children played an important role in spreading infectious forms like alpha and delta.

In a statement this week, the WHO said that because children and adolescents have milder COVID-19 disease than adults, “it is less necessary to vaccinate them than older people, those with chronic health conditions, and health workers.” “

It has urged rich countries to stop vaccinating children and asked them to immediately donate their doses to poor countries, which have not yet given their health workers and vulnerable populations their first vaccine doses.

Nevertheless, the WHO acknowledged that there are benefits of vaccination to children and adolescents that go beyond immediate health benefits.

“Vaccination that reduces 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.