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European Union Approves Pfizer-BioNTech Vaccine for Adolescents


The European Union’s health agency approved the Covid-19 vaccine from

Pfizer Inc.


BioNTech SE

for children between the ages of 12 and 15 years old, a move that will give a boost to the continent’s vaccination campaign.

The decision on Friday by the European Medicines Agency greatly increases the pool of people in the EU who can be vaccinated at a time when the infection rate has begun falling quickly. The U.S. began administering the Pfizer-BioNTech vaccine to kids 12 to 15 earlier this month.

The EMA gave the green light after reviewing data from a trial in which none of the 1,005 children who got the vaccine developed Covid-19. Of the 978 who got the placebo, 16 got Covid. The results were similar to those from a trial in the U.S. concluded earlier this year.

Europe’s vaccination campaign has been accelerating in recent weeks, leading to a steep drop in infections and deaths. Daily confirmed new cases in the EU have fallen by three-quarters since the beginning of April, according to Our World in Data. Daily deaths are down by almost 70%, compared with six weeks ago.

In a sign of the advancing vaccination campaign on Friday, Italy said that beginning June 3 all people over the age of 16 can sign up to get vaccinated.

Pfizer has started to test its Covid-19 vaccine in children ages six months to 11 years old. In this video, some of the first recipients — twin sisters from North Carolina — receive their vaccinations. Photo: Shawn Rocco/Duke Health

Across the EU, about 37% of the population has received at least one dose of a coronavirus vaccine, compared with about 50% in the U.S. About 62% of Americans over the age of 18 have received at least one dose.

Children in the EU trial developed a level of immunity similar to what has been observed in people age 16 to 25, said Marco Cavaleri, EMA’s head of biological health threats and vaccines strategy. The children showed the same side effects as those 16 and over, including pain at the injection site, fatigue, headache, general muscle pain and fever. The side effects are usually mild or moderate and improve within a few days after the injection, EMA said.

Due to the limited number of children in the trial, rare side effects wouldn’t have been detected, but the benefits of the vaccine outweigh any potential risks, Dr. Cavaleri said. The regulator is expecting that

Moderna Inc.

will soon send data from a study carried out in adolescents for its vaccine.

The EU Commission, the bloc’s executive arm, still must give its approval. Then it will be up to the individual member countries to decide if and when to begin giving the Pfizer-BioNTech vaccine to 12-to-15-year-olds.

While children are at lower risk of catching the virus than adults, and when they do get infected they tend to have milder symptoms, some do get seriously ill. Children can also spread the virus. Vaccinating adolescents is seen as fundamental for reaching a rate of overall immunity that could halt the spread of the virus.

Separately, the EMA said the rare combination of thrombosis and low blood platelets has continued to occur in about 1 in every 100,000 people who receive the

AstraZeneca PLC

vaccine. But the death rate has declined, an indication that people getting the vaccine and doctors are watching for the rare adverse reaction that can first manifest as severe and lasting headaches or stomach pain.

The AstraZeneca and

Johnson & Johnson

vaccines use a similar technology to stimulate immunity in the body. In Europe, there has been 1 case of thrombosis and low blood platelets among the 2.1 million people who have received the Johnson & Johnson shot. The U.K. approved the shot on Friday.

The J&J vaccine is seen as key for vaccination campaigns because the one-shot regime will make it easier to vaccinate hard-to-reach groups, often living in remote areas.

Write to Eric Sylvers at [email protected]

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