EU regulator approved Pfizer’s COVID vaccine for ages 12-15 | Coronavirus pandemic news

The vaccine is ‘highly tolerated’ by young people and there are no ‘primary concerns’ of side effects, says EU drug watchdog

The European Union drug watchdog has approved the Pfizer-BioNTech coronavirus jab for 12 to 15 years of age, the first vaccine to get the green light for children on the block.

The vaccine is “well tolerated” by young people and there are no “primary concerns” about side effects, the Amsterdam-based European Medicines Agency said on Friday.

“Expanding the protection of a safe and effective vaccine to a much smaller population is an important step in combating this pandemic,” said Marco Cavaleri, head of health threats and vaccination strategy at EMA , say.

The United States and Canada have already approved Pfizer for young people.

The EMA states that two doses of the vaccine, labeled Comirnaty, are required in the 12-15 age group and should be given at least three weeks apart, the same as for adults.

It is up to each EU state to decide when and when to offer the vaccine to teenagers, it added.

Germany on Thursday laid out plans to offer shots to the 12-year-old from June 7, while awaiting Ema’s sentencing. Italy also said they were preparing to expand the campaign to more than 12.

The inoculation of children and young people is considered a critical step in achieving “herd immunity” and protecting the pandemic, and Japan on Friday joined countries with ahead for Comirnaty at 12-years-old.

Adolescents are less likely to suffer from severe illness, many of whom do not experience symptoms, allowing them to be immobilized to transmit COVID-19 to others.

Pfizer and BioNTech in March released trial data showing that their vaccine offered 100 percent protection against infectious disease in a trial with 2,260 young people aged 12 to 15. It was also good. allowed.

The much shorter duration of safety monitoring trials to date in the 12-15 age group compared to the elderly cohort is of no concern, Cavaleri said.

“Consistent with the experience we’ve accumulated with other vaccines over the years… what we’ve seen in young adults is also seen in young people,” he said in a news release, when asked about effects. He added that the monitoring will get worse as vaccine recipients become more young in the future.

Some expressed caution, however, such as a member of the advisory committee with influence on the German Stiko vaccine. Paediatrics professor Ruediger von Kries said the vaccine could only be called for children with specific health risks, citing a lack of data on long -term side effects.

At the briefing, the EMA also said that reports of cases of an inflammation of the heart muscles after Comirnaty vaccination are not cause for concern as they continue to occur at a rate that typically affects the majority of the population. .

Other vaccine manufacturers have also studied whether it is safe and effective for them to shoot children. Earlier this week, Moderna Inc. said its shooting strongly protects children as young as 12; it said it will submit a request for emergency use permission to the U.S. Food and Drug Administration next month.

But the World Health Organization has criticized rich countries for moving to vaccinate a much smaller and less risky population, saying a more limited number of COVID-19 vaccines should be shared with poor countries. so that they, too, can protect their workers ’health. and the weakest.

“I understand why some countries want their children and teenagers to be vaccinated, but for now I urge them to reconsider and instead provide COVAX vaccines,” the WHO chief that Tedros Adhanom Ghebreyesus said last month, referring to the UN-initiated move to distribute vaccines to lower-income countries.

Of the more than 1 billion shots of COVID-19 given worldwide, less than 2 percent went to poor countries.

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