Covid vaccine 12-15 years, what Pfizer says
The study, the comment of the CEO Bourla and the reactions of the Stock Exchange to the announcement that Pfizer's vaccine is 100% effective on adolescents between 12 and 15 years
New results for Pfizer, which announced together with its partner BioNTech that their vaccine provides long-term protection in adolescents aged 12 to 15. Confirmation came from a late-stage long-term safety and efficacy study.
I STUDY
According to data provided by the pharmaceutical company , collected from November 2020 to September 2021, the effectiveness after administration of two doses, measured from seven days to over four months after the second dose, is 100% in preventing infection in boys. between 12 and 15 years.
"These are the first and only long-term disclosed data demonstrating the safety and efficacy of a Covid vaccine in individuals aged 12 to 15," said Ugur Sahin, CEO and co-founder of BioNTech.
ADMINISTRATION
Also for this age group, the administration is the same as for adults: two doses with a quantity equal to 30 milligrams per dose.
ADVERSE EVENTS
The study also demonstrated that adverse events were generally consistent with other clinical safety data for the vaccine, with no serious problems in individuals with at least 6 months of follow-up after the second dose.
AUTHORIZATIONS FROM FDA AND EMA
On May 10, the Food and Drug Administration (FDA) had already authorized – for emergency use only – Pfizer's vaccine in adolescents between 12 and 15 years and shortly after, on May 28, the European Medicines Agency as well. (Ema) had given the green light stating that the serum is "safe and effective even for adolescents".
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THE NEXT STEPS
Now, these new data reinforce the elements provided by Pfizer to obtain an application for a supplementary biological license (sBLA) to be submitted to the FDA and also to other regulatory bodies to expand the approval of the vaccine for ages 12 and up in countries where emergency authorizations or equivalent were initially granted.
THE REACTIONS OF THE BAG
In early Monday trading, Reuters notes , Pfizer's shares rose and gained 39% this year.
“Opening on Wall Street,” writes Milano Finanza , “Pfizer posted growth of 0.4%, in line with the market, to $ 51 per share. BioNTech, on the other hand, grows by 2.5% to $ 297.5 ".
BOURLA'S COMMENT (PFIZER)
"As the global health community works to increase the number of people vaccinated around the world, this additional data provides further confidence in the safety and efficacy profile of our vaccine in adolescents," said Pfizer CEO Albert Bourla . "This is particularly important because in some regions we see infection rates increase in this age group, while vaccine adoption decreases."
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/vaccino-anti-covid-12-15-anni-che-cosa-dice-pfizer/ on Tue, 23 Nov 2021 08:59:10 +0000.