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First vaccine for children: EU Commission approves Biontech vaccine from the age of twelve

2021-05-31T23:28:43.941Z


Good news for children and teenagers. The EU Commission approves the Biontech / Pfizer vaccine for people aged twelve and over.


Good news for children and teenagers.

The EU Commission approves the Biontech / Pfizer vaccine for people aged twelve and over.

Update from March 31, 5.45 p.m.: In the

future, children from the age of twelve in the European Union can also be vaccinated with the vaccine from Biontech / Pfizer.

The EU Commission issued the necessary approval of the vaccine on Monday for children and adolescents from twelve, as announced in the afternoon.

In doing so, the Commission followed the recommendation of the European Medicines Agency EMA, which had already spoken out in favor of approval of the vaccine on Friday.

A recommendation from the Standing Vaccination Commission (STIKO) in Germany is still pending.

Biontech / Pfizer: EMA recommends vaccine approval for children from the age of twelve

Update from March 28th, 4.30 p.m

.: The EMA allows Biontech vaccination for children between 12 and 15 years.

The EMA notes that the use of the corona vaccine is an important component in the fight against the corona pandemic.

The vaccine is urgently needed.

That is why it is important that enough vaccine is made available.

The EMA wants to create further conditions for this.

In addition, the storage period of 30 days in a refrigerator is allowed.

The data from the study (see below) showed that Comirnaty from Biontech / Pfizer is safe and effective for children and adolescents, emphasizes Marco Cavaleri, Head of Biological Health Hazards and Vaccination Strategy at EMA.

Fergus Sweeney admits that the size of the study is not large enough to discover all the rare side effects that can occur.

The dose of Biontech for children is just as great as for adults, explains Marco Cavaleri when asked by a journalist.

A lower dose would be tested in study in children under the age of twelve.

The EMA expects that Moderna will also submit an application for approval of the vaccine for children and adolescents in the foreseeable future.

Update from March 28, 3:44 p.m

.: The EMA wants to announce its decision on the corona vaccine from Biontech at 4:30 p.m.

Update from May 28, 3:05 p.m

.: The EU Medicines Agency (EMA) will decide during these hours whether it will approve the Biontech / Pfizer vaccine for children and adolescents.

This gives children from the age of twelve the chance to have a corona vaccination in Germany for the first time.

From June 7th, the vaccination priority will drop in Germany and at the same time adolescents from the age of twelve can apply for a vaccination appointment.

Chancellor Angela Merkel announced this after the vaccination summit on Thursday.

EMA decides today on approval of corona vaccine for children

First report from May 28, 2021

Amsterdam - In Germany, the corona vaccine from Biontech / Pfizer * is already approved for people aged 16 and over.

The EMA wants to announce this Friday whether the Biontech / Pfizer vaccine called Comirnaty will also be approved for children and adolescents between the ages of twelve and 15.

The result of an extraordinary meeting of the EMA Committee on Human Medicine will be presented at a press conference in the afternoon (3 p.m.).

The approval decision was originally not expected until June, but the EMA had accelerated the process.

First corona vaccine for children

If the vaccine Comirnaty for twelve to 15 year olds gets the green light, it would be the first corona vaccine for children with EU approval.

Once EMA approval is granted, the modified conditional approval will be valid in all 27 EU member states.

The US Food and Drug Administration (FDA) extended its emergency approval for Comirnaty * to 12 to 15 year olds on May 10.

Biontech vaccine safely protects children from the age of twelve against Covid-19

As early as the spring, the vaccine manufacturer Biontech raised hopes for a quick vaccination for children.

On April 30, the company submitted the application for approval to the EMA.

The data from the study were already promising at the time.

Now these data have been published in the

New England Journal of Medicine

.

  • As part of the study, 2,260 adolescents between the ages of 12 and 15 received an injection.

    1,131 received the Biontech corona vaccine and 1,129 received a placebo.

  • There were 16 corona cases in the unvaccinated placebo group.

    In contrast, there was no Covid-19 case among the more than 1,000 vaccinated young people.

Side effects after a corona vaccination with Biontech

According to the scientists, the vaccine is well tolerated inside.

After the vaccination, there were mainly slight vaccination reactions.

More often after the second dose than after the first.

There were no serious undesirable side effects such as thrombosis or anaphylactic shock.

  • Pain at the injection site in 79 to 86 percent

  • Fatigue - at 60 to 66 percent

  • Headache - in 55 to 65 percent

Laboratory tests showed that the vaccination produced a stable immune response.

It was even better than in the group of adolescents and young adults between 16 and 25 years of age.

Corona vaccinations for children - data on Biontech still too thin?

Experts are still skeptical about the corona vaccine for children.

The data situation is still too thin.

More than 1,000 vaccinated children and adolescents are only partially meaningful.

The Standing Vaccination Commission (Stiko) in Germany therefore wants to take its time with its recommendation for the vaccination of children from the age of 12.

A vaccination, possibly only for previously ill children, could be recommended by the Stiko. 

"The data on the risks and benefits of a possible corona vaccination for children and adolescents is currently so inadequate that no recommendation can be made," said medical president Klaus Reinhardt of the

Rheinische Post

.

This debate is important.

Under the heading “Should I have my child vaccinated?” You will find

the most important questions and answers

at

Merkur.de

*.

In our news ticker you will find more information about the corona situation in Germany.

 (afp / ml)

* Merkur.de is an offer from IPPEN.MEDIA

Source: merkur

All news articles on 2021-05-31

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