2 doses of Pfizer’s vaccine for ages 2-5 fails to give expected COVID immunity

2 years ago 291

(CNN) — Vaccine shaper Pfizer said Friday that trials of its vaccine successful children ages 2 to 5 amusement that it did not supply the expected immunity successful kids this age, and it is adding a 3rd dose to the regimen.

The institution decided to adhd the 3rd dose for each children and babies ages 6 months to 5 years aft its autarkic extracurricular advisers took a look astatine the information truthful far.

It showed that 2 child-sized doses of the Pfizer/BioNtech vaccine were not producing the expected immunity successful the 2- to 5-year-olds, though they were doing truthful for the babies up to property 2.

So the institution said it would “amend” the proceedings to adhd a 3rd dose.

“The survey volition present see evaluating a 3rd dose of 3 micrograms astatine slightest 2 months aft the 2nd dose of the two-dose bid to supply precocious levels of extortion successful this young property group,” it said.

Pfizer had taken the dosage size down for children. For the 12 and up property group, the dose is 30 micrograms of vaccine. Pfizer and BioNTech stepped this down to 10 micrograms for kids 5 to 11 and took it adjacent lower, to 3 micrograms a dose, for the youngest children.

Early tests had indicated that this tiny dose would nutrient a beardown immune effect successful the children and minimize the hazard of broadside effects.

But the interim information — which the autarkic Data and Safety Monitoring Board tin spot without giving details to the institution oregon investigators — indicates this tiny dose regimen did not nutrient the expected immune effect successful the 2- to 5-year-olds.

“No information concerns were identified and the 3 microgram dose demonstrated a favorable information illustration successful children 6 months to nether 5 years of age,” Pfizer said successful a statement.

“The determination to measure a 3rd dose of 3 micrograms for children 6 months to nether 5 years of property reflects the companies’ committedness to cautiously prime the close dose to maximize the risk-benefit profile,” it added.

“If the three-dose survey is successful, Pfizer and BioNTech expect to taxable information to regulators to enactment an Emergency Use Authorization (EUA) for children 6 months to nether 5 years of property successful the archetypal fractional of 2022.”

The institution volition besides trial 3rd doses successful older children, who bash not yet person authorization for booster doses of vaccine. Kids ages 5 to 11 and 12 to 15 volition get full-dose 3rd shots successful the trials.

The changes astir apt mean a hold successful authorization for vaccines for younger children, Dr. Anthony Fauci said.

“I deliberation retired of necessity, Erica, it’s going to marque the clip framework for erstwhile we get an exigency usage authorization for children that young, it won’t beryllium apt until the 2nd 4th of 2022, and we were hoping it would beryllium successful the archetypal quarter,” Fauci, who is manager of the National Institute of Allergy and Infectious Diseases, told CNN’s Erica Hill.

“But astatine slightest from what Pfizer is saying, by the clip they get each of the indispensable information and spell done each of the process of getting an exigency usage authorization, unfortunately, it’s not going to beryllium until the 2nd quarter,” helium added.

“But you privation to truly get the close dose and the close regimen for the children. So though you don’t similar determination to beryllium a delay, you privation to get it right, and that’s what they’re talking about.”