The vaccine is ‘tolerable’ in adolescents and there were no ‘major concerns’ about its side effects, says EU drug inspector.
The European Union’s Drug Watchdog has approved the Pfizer-Bioentech coronavirus jab for children between the ages of 12 and 15, the first vaccine to give green light to children in black.
The Amsterdam-based European Drug Administration said on Friday that the vaccine was “well tolerated” in adolescents and that there were no “major concerns” about side effects.
“Expanding the protection of a safe and effective vaccine in this young community is important to move forward in the fight against this epidemic,” said Marco Cavalli, head of health risks and vaccine strategy at EMA.
The United States and Canada have granted Pfizer rights to adolescents.
The EMA said that two doses of the vaccine, called Comirnaty, are required in the 12-1-15 age group and should be administered at least three weeks apart, as in adults.
It is now up to individual EU states to decide when to vaccinate adolescents.
Germany plans to give shots to children between the ages of 7 and 12 in June, pending the EMA’s decision on Thursday. Italy has also said it is preparing to extend the campaign to more than 12 years.
Children and young people are seen as important steps towards reaching “immunity to the disease” and controlling the epidemic, and Japan on Friday joined the ranks of countries leading 12-year-olds in the Comirnaty.
Young people are less likely to get serious illnesses, many of whom have not experienced any symptoms and are unknowingly allowed to pass on COVID-1 to others.
Pfizer and Biotech unveiled test data in March that their vaccine provided 100 percent protection against infectious disease in a trial of 2,260 adolescents aged 12 to 15 years. It was well tolerated.
So far in the short-term testing of security monitoring, the 12-1-15 age group has not been a concern compared to the old city, Cavalleri said.
“Based on our experience accumulating many more vaccines over the years, it’s … what we see with young adults is also seen in adolescents,” he said at a news briefing addressing the side effects. He also said that in the future, if vaccinators are younger, monitoring will increase.
Others have been cautious, though Stico, a member of Germany’s influential vaccination advisory committee. Ruideiger von Chris, a professor of pediatrics, said the vaccine could only be called for children with special health risks, pointing to a lack of data on long-term side effects.
At the briefing, the EMA also said that reports of an inflammation of the heart muscle after the Comirnaty vaccination was not a cause for concern because those rates are consistently that affect the general public.
Other vaccine manufacturers are also studying whether their shots are safe and effective. Earlier this week, Modern Inc. said its shots provide tight protection for children under 12; It will submit a request to the US Food and Drug Administration next month for an emergency use authority.
But the World Health Organization (WHO) has criticized rich countries for vaccinating younger and at-risk populations, saying a very limited number of covid vaccines need to be distributed to poor countries so they can protect health workers. And they are all at risk.
“I know why some countries want to vaccinate their children and adolescents, but now I urge them to reconsider and vaccinate Kovacs instead,” WHO chief Tedros Adhanam Gebreisis pointed to a UN initiative to distribute it earlier this month. Vaccines in low-income countries.
Of the more than 1 billion COVID-1 sh shots operated globally, less than 2 percent have gone to poor countries.