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Saturday, December 03, 2022

EU Regulatory Authority Approves Pfizer COVID Vaccine For Children 5-11 Years Old

GAGA, Netherlands (AP) – The European Union medicines regulator on Thursday authorized the Pfizer coronavirus vaccine for use in children ages 5-11, paving the way for millions of elementary school students to be vaccinated amid a new wave of infections. sweeps across the continent.

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 that the indications for the COVID-19 Comirnaty vaccine be expanded to include its use in children aged 5 to 11.”

After evaluating a vaccine study in more than 2,000 children, the EMA evaluated the vaccine’s effectiveness at approximately 90% in preventing symptomatic COVID-19 in young children and stated that the most common side effects were injection site pain, headaches, and 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 skyrocketing infections has not yet received EMA approval. Authorities in the Austrian capital Vienna have already begun vaccinating the 5-11 age group. Europe is currently at the epicenter of a pandemic, and the World Health Organization has warned that 2 million people could die across the continent by spring unless urgent action is taken.

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

Earlier this week, German Health Minister Jens Spahn said that shipments of vaccines for young children in the EU would begin on December 20.

Earlier this month, Pfizer approved images for children in the United States, followed by other countries, including Canada.

Pfizer has tested a dose that is one third of the dose given to adult primary school children. Pfizer Senior Vice President Dr. Bill Gruber told The Associated Press that even with a small dose, children aged 5 to 11 had antibodies to coronavirus as high as adolescents and young adults receiving conventional injections. in September.

But studies of the Pfizer vaccine in children have not been large enough to detect any rare side effects from the second dose, such as chest and heart inflammation, which has been seen mainly in older adolescents and young males.

US officials noted that COVID-19 caused more deaths among children in the 5-11 age group than some other diseases, such as chickenpox, before children were routinely vaccinated.

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

While children mostly show only mild symptoms of COVID-19, some public health experts believe immunization should be a priority to reduce the ongoing spread of the virus, which could theoretically lead to a dangerous new option.

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

In a statement this week, the WHO said that because children and adolescents tend to have milder COVID-19 than adults, “vaccinating them is less urgent than older people, people with chronic illnesses and healthcare workers.”

He called on rich countries to stop immunizing children and immediately transfer their doses to poor countries that have not yet given the first dose of vaccine to their health workers and vulnerable populations.

However, WHO has recognized that vaccination for children and adolescents has benefits that go beyond the immediate health benefits.

“Vaccinations that reduce transmission of COVID in this age group can reduce transmission from children and adolescents to older people and can help reduce the need for mitigation measures in schools,” WHO said.

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Maria Cheng reported from London.

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Stay tuned for AP posts on the coronavirus pandemic at https://apnews.com/hub/coronavirus-pandemic

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