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Pfizer/BioNTech say data show COVID-19 vaccine safe and protective in kids By Reuters


© Reuters. FILE PHOTO: A lady holds a small bottle labeled with a “Coronavirus COVID-19 Vaccine” sticker and a medical syringe in entrance of displayed Pfizer brand on this illustration taken, October 30, 2020. REUTERS/Dado Ruvic

By Michael Erman

(Reuters) – Pfizer Inc (NYSE:) and BioNTech SE (NASDAQ:) mentioned on Monday their COVID-19 vaccine induced a strong immune response in 5 to 11 yr olds, and so they plan to ask for authorization to make use of the vaccine in youngsters in that age vary in america, Europe and elsewhere as quickly as potential.

The businesses mentioned the vaccine generated an immune response within the 5-to-11 yr olds of their Part II/III medical trial that matched what that they had beforehand noticed in 16-to-25 yr olds. The security profile was additionally usually akin to the older age group, they mentioned.

“Since July, pediatric circumstances of COVID-19 have risen by about 240 p.c within the U.S. – underscoring the general public well being want for vaccination,” Pfizer Chief Government Albert Bourla mentioned in a information launch.

“These trial outcomes present a powerful basis for looking for authorization of our vaccine for youngsters 5 to 11 years previous, and we plan to submit them to the FDA and different regulators with urgency.”

High U.S. well being officers consider regulators might decide on whether or not the shot is protected and efficient in youthful youngsters inside three weeks of the businesses submitting a request for authorization, two sources informed Reuters earlier this month.

COVID-19 hospitalizations and deaths have surged in america in current months as a result of extremely contagious Delta variant. Pediatric circumstances are additionally up, notably as youngsters beneath 12 are all unvaccinated, however there isn’t a indication that, past being extra transmissive, the Delta virus is extra harmful in youngsters.

A speedy authorization might assist mitigate a possible surge of circumstances within the fall, particularly with faculties already open nationwide.

The businesses’ vaccine, referred to as Comirnaty, is already licensed to be used in youngsters as younger as 12 in lots of international locations, together with america. The vaccine was initially licensed for emerenecy use in individuals 16 or older in america in December 2020 and obtained full U.S. approval in that age group final month.

The 5-to-11 yr olds got two pictures of a 10-microgram dose of the vaccine, one-third the dose dimension that has been given to individuals 12 and older. The businesses anticipate knowledge on how properly the vaccine works in youngsters 2-to-5 years of age and youngsters 6 months-to-2 years of age as quickly because the fourth quarter of this yr.

Not like the bigger medical trial the drugmakers beforehand performed in adults, the two,268 participant pediatric trial was not primarily designed to measure the vaccine’s efficacy by evaluating the variety of COVID-19 circumstances in vaccine recipients to those that obtained a placebo.

As a substitute, the trial compares the quantity of neutralizing antibodies induced by the vaccine within the youngsters to the response of older recipients within the grownup trial.

A Pfizer spokesperson mentioned the businesses could later disclose vaccine efficacy from the trial however there had not been sufficient circumstances of COVID-19 but among the many contributors to make that willpower.

The vaccine was round 95 p.c efficient within the grownup medical trial, however Pfizer has mentioned that immunity wanes some months after the second dose. U.S. regulators are anticipated to authorize a 3rd, booster dose of the vaccine for older and high-risk Individuals early this week.

The businesses mentioned the vaccine was well-tolerated, with unwanted side effects usually akin to these noticed in contributors 16 to 25 years of age.

Each the Pfizer and Moderna (NASDAQ:) vaccines have been linked by regulators to uncommon circumstances of coronary heart irritation in adolescents and younger adults, notably younger males. Pfizer mentioned they didn’t see any cases of coronary heart irritation within the trial contributors.