As adolescent vaccination progresses around the world, the UK has already this week joined the list of countries that have started dosing for 12-15 year olds.
The Pfizer and BioNTech project goes further. “In participants aged five to 11, the vaccine is safe, well tolerated, and exhibits robust neutralizing antibody responses“, said the American giant Pfizer and its German partner in a joint statement, reporting the results of their clinical work.
These partial results published Monday, September 20 are based on a study conducted on 4,500 children between 6 months and 11 years old in the United States, Finland, Poland and Spain.
Both companies expect to publish “from the fourth trimester“results for the age group 2-5 years as well as 6 months-2 years, who received two injections of 3 micrograms.
The two companies plan to submit this data to the authorities “as soon as possible“, according to this release. He claims that the immune reaction is”comparable“to that observed in 16 to 25 year olds who received a higher dose vaccine.
The announcement was welcomed by Dr Ashish Jha, one of the leading COVID experts in the United States, who called it “good news” expected by many parents.
If all goes well and the homologation follows, “my 9 year old will be vaccinated by Halloween“he tweeted.
Benefits not proven
These are the first clinical data for this age group of 5-11 years.
So far, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have cleared vaccines from Pfizer / BioNTech and Moderna, based on messenger RNA technology, from the age of 12. .
The FDA said in early September that it would review “attentively“emergency authorization requests for vaccines intended for children under 12, a process which should take”weeks rather than months“.
In Israel, children aged 5 to 11 at risk of serious complications from COVID-19 have already been vaccinated since 1is August. It’s about a “special permission“without waiting for clinical data, and each injection is”studied on a case-by-case basis“, according to the Ministry of Health.
The Pfizer and Moderna vaccines are already being given to adolescents over 12 years old in several countries, including the United Kingdom, England, Scotland and Wales – before Northern Ireland next month – as well. than adults around the world.
WHO still skeptical
According to the World Health Organization (WHO), the benefits of immunizing children under 12 have not yet been proven.
But even though children are considered less at risk of developing a severe form of COVID-19, some scientists fear that with the spread of the more contagious Delta variant, severe cases could appear even in the youngest.
Due in particular to the diffusion of the Delta variant, “since July, pediatric cases of COVID-19 have increased by 240% in the United States, underscoring the need for vaccination“of the youngest, commented Albert Bourla, CEO of Pfizer, seeing in the data published Monday, September 20 a”solid basis for authorization requests“.
The side effects of the vaccine, dosed at 10 micrograms by injection against 30 micrograms usually for the elderly, are “generally comparable“to those observed in people aged 16 to 25, note the two laboratories.
The most commonly reported side effects include pain and an inflammatory reaction in the sting area, as well as headache, onset of chills or fever.
A study on children under 12 for the Moderna vaccine is also underway.
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