The European Medicines Agency on Friday recommended that the use of the coronavirus vaccine by Pfizer and BioNTech be extended to children aged 12 to 15, a decision it offers to younger and lower-risk populations. the continent access to a COVID-19 feature for the first time.
The Pfizer-BioNTech vaccine was the first authorization granted to the entire European Union in December, when it was given the green light for use in everyone aged 16 and over. Since then, some 173 million doses have been administered in the EU, which is about three-quarters of all vaccines administered to date in the 27-country bloc.
“Expanding the protection of a safe and effective vaccine in this younger population is an important step forward in the fight against this pandemic,” said Marco Cavaleri, head of the health threats and vaccine strategy of the country. ‘EMA based in Amsterdam.
The EU regulator authorized the vaccine for younger adolescents after receiving data from the United States proving that it was highly effective against infection. In a study of 2,000 adolescents, none of those who received the vaccine received COVID-19, compared with 16 from a control group who received a placebo, Cavaleri said.
“The vaccine was well tolerated, and the side effects in this age group were very similar (to) that we have seen in young adults and we have not aroused much concern at this time,” he said.
The decision of the EMA must be sealed by the European Commission and national regulators can decide whether the vaccine will be offered to children under 16 in each country.
The recommendation follows similar decisions by regulators in Canada and the United States last month, as rich countries are slowly approaching their adult vaccination targets and seeking to vaccinate as many people as possible.
Researchers will continue to monitor the long-term protection and safety of the Pfizer-BioNTech vaccine in study participants for two more years. Cavaleri acknowledged that rare adverse effects may not have been detected in the relatively small study on which the authorization was based.
“Once the vaccine has been deployed, it will be important to continue monitoring vaccine performance and determine if there are any safety issues,” he said, adding that in recent months it has been shown that the European reporting system is capable of detecting possible problems with vaccines.
The EMA last month added warnings about the possible risk of rare blood clots in people who had received a dose of vaccines made by AstraZeneca or Johnson & Johnson, after some countries reported that a very small number of the millions vaccinated had experienced rare blood clots.
Most COVID-19 vaccines worldwide have been approved for adults, who are at increased risk for serious illness and death from coronavirus. But vaccinating children of all ages could be key to stopping outbreaks, as some research has shown that older children may play a role in the spread of the virus, although they do not normally fall seriously ill with COVID-19.
In the U.S., children account for about 14 percent of the country’s coronavirus cases and at least 316 have died, according to the American Academy of Pediatrics. Doctors have also identified a rare inflammatory syndrome in a very small proportion of children with COVID-19.
Vaccinating children against COVID-19 can also give the authorities more confidence to reopen schools, as getting children to put on masks and distance themselves has sometimes been a challenge.
But the World Health Organization has criticized rich countries for switching to vaccinating their younger, lower-risk populations, saying the extremely limited number of COVID-19 vaccines should be shared with poor countries because they can also protect their healthcare workers. the most vulnerable.
“I understand why some countries want to vaccinate their children and adolescents, but right now I demand that they reconsider and give vaccines to COVAX,” WHO chief Tedros Adhanom Ghebreyesus said earlier this month. to the UN-backed vaccines initiative strongly. Of the more than one billion shots of COVID-19 administered worldwide, less than 2% have gone to poor countries.
Other vaccine manufacturers are also studying whether their vaccines are safe and effective in children. Earlier this week, Moderna Inc. said his shooting strongly protects children up to 12 years old; he said he would file an application for emergency use authorization with the U.S. Food and Drug Administration next month. Another American company, Novavax, has a COVID-19 vaccine in the final development phase and has just started a study in 12- to 17-year-olds.
Both Moderna and Pfizer-BioNTech have been testing their vaccines in children aged 6 months to 11 years; they receive a lower dose than adolescents and adults receive. Sinovac, from China, has also sent the first data to the country’s regulators, hoping to prove its vaccine is safe in children up to 3 years old.
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Citation: European regulator recommends shooting Pfizer for children aged 12-15 (2021, May 28) recovered on May 29, 2021 at https://medicalxpress.com/news/2021-05-european-pfizer- vaccine-children-.html
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