EU regulator approves Pfizer COVID vaccine for 12-15 year olds Coronavirus pandemic News

The EU’s drug watchdog says the vaccine is “well tolerated” by teenagers and there were no “major concerns” about side effects.

The European Union’s drug guard has approved the Pfizer-BioNTech coronavab jab for 12- to 15-year-olds, the first vaccine to get the green light for children on the block.

The vaccine was “well tolerated” among teenagers and they did not have “much concern” about side effects, the Amsterdam-based European Medicines Agency said on Friday.

“Extending the protection of safe and effective vaccines to this younger population is an important step forward in the fight against this pandemic,” said Marco Cavaleri, head of EMA’s health threats and vaccination strategy.

The United States and Canada have already allowed Pfizer for teens.

The EMA said two doses of the vaccine, called Comirnaty, should be given to 12-15-year-olds and given at least three weeks apart, the same for adults.

He added that EU states should decide when and when to offer the vaccine to teenagers.

Germany on Thursday set out plans to offer shots to 12-year-olds from June 7, pending an EMA ruling. Italy has also said it is preparing to extend its campaign to those over 12 years of age.

Inoculating children and young people is seen as a critical step in achieving “herd immunity” and mitigating the pandemic, and Japan on Friday called for a 12-year-old Comirnaty to countries.

Young people have been less likely to suffer from a serious illness, as many have no symptoms, allowing COVID-19 to be inadvertently transmitted to others.

Pfizer and BioNTech presented in March that their vaccines offered 100 percent protection against infectious disease in a trial of 2,260 teens between the ages of 12 and 15. They also endured well.

Cavaleri said the 12-15-year-old tests so far have had a shorter duration of security checks compared to older concerns.

“It’s based on the experience we’ve had with so many other vaccines over the years … what we see with young adults is also seen in teenagers,” he told a news release when asked about side effects. He added that monitoring will increase in the future as vaccine recipients become younger.

Others have been cautious, however, as Stiko is a member of Germany’s influential vaccination advisory committee. Pediatric professor Ruediger von Kries said the vaccine can only be applied to children with special health risks, citing a lack of data on long-term side effects.

In a briefing, the EMA said that reports of cases of inflammation of the heart muscle after vaccination with Comirnaty were not of concern, as they continued to occur at a rate that normally affected the general population.

Other vaccine manufacturers are also examining whether children’s shots are safe and effective. Earlier this week, Moderna Inc said its shooting protects children under 12; he said he would file an application for permission to use the emergency with the U.S. Food and Drug Administration next month.

The World Health Organization has criticized rich countries for moving to include their younger and lower-risk populations, saying that a very limited number of COVID-19 vaccines should be shared with poor countries to protect their health workers as well. and the weakest.

“I understand why some countries want to vaccinate their children and adolescents, but right now I urge them to reconsider and instead give vaccines to COVAX,” said WHO head Tedros Adhanom Ghebreyesus earlier this month, referring to the UN-sponsored initiative for vaccines in lower-income countries.

Of the more than 19 thousand shots fired by COVID-administered worldwide, less than 2 percent went to poor countries.