EU regulator approves Pfizer’s 12-15 year old COVID vaccine | Coronavirus pandemic news


The EU drug watchdog said the vaccine was “well-tolerated” among adolescents and there were no “major concerns” about side effects.

The European Union’s drug regulatory agency has approved the Pfizer-BioNTech coronavirus vaccine for children aged 12 to 15. This is the first vaccine to give the green light to children in the region.

The Amsterdam-based European Medicines Agency said on Friday that the vaccine was “well-tolerated” in adolescents and had no “major concerns” in terms of side effects.

Marco Cavaleri, head of EMA’s health threats and vaccine strategy, said: “Expanding the protection of safe and effective vaccines among this young population is an important step in the fight against this epidemic.”

The United States and Canada have authorized Pfizer for use in young people.

EMA said that in the 12 to 15-year-old age group, two doses of the vaccine, branded as Comirnaty, should be injected at least three weeks apart as adults.

It added that it is now up to individual EU countries to decide whether and when to provide vaccines to young people.

Germany made a plan on Thursday to provide shooting to 12-year-old children from June 7 until the EMA makes a ruling. Italy also stated that it is preparing to extend its campaign to more than 12 seconds.

Vaccination of children and young people is considered a key step in achieving “herd immunity” and curbing the pandemic. Japan joined the country on Friday to provide Comirnaty permits for 12-year-old children.

Young people are much less likely to develop serious illnesses, and many have no symptoms, so they can spread COVID-19 to others inadvertently.

Pfizer and BioNTech published test data in March, showing that the vaccine provided 100% protection against infectious diseases in 2,260 12 to 15-year-old teenagers.

Cavaleri said that compared with older people, so far, in trials in the 12 to 15-year-old age group, the shorter duration of safety monitoring is not important.

When asked about the side effects, he said at a press conference: “Based on the experience of many other vaccines we have collected over the years, … we can also see the situation of adolescents in adolescents.” He added that with vaccination In the future, the monitoring work will be strengthened.

However, some others have expressed caution, such as the member of Stiko, Germany’s influential vaccine advisory committee. Pediatrics Professor Ruediger von Kries said that due to the lack of data on long-term side effects, the vaccine may only be used in children with special health risks.

At the briefing, EMA also stated that there is no need to worry about case reports of myocarditis after Comirnaty vaccination, because their incidence usually continues at a rate that affects the general population.

Other vaccine manufacturers are also studying whether their vaccines are safe and effective for children. Earlier this week, Moderna Inc stated that its shooting protected children under the age of 12; it stated that it would submit an emergency use authorization request to the U.S. Food and Drug Administration next month.

But the World Health Organization criticized rich countries for taking action to vaccinate young people and those at lower risk, and said that a limited number of COVID-19 vaccines should be shared with poor countries so that they can also protect their health workers and those most vulnerable. People.

WHO Director-General Tedros Adhanom Ghebreyesus stated earlier this month: “I understand why some countries want to vaccinate children and adolescents, but now I urge them to reconsider , But donate vaccines to COVAX.” Provide vaccines to low-income countries.

Of the more than 1 billion COVID-19 shots managed globally, less than 2% of shots went to poor countries.





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