Pfizer vaccine for under-12 could be ready for emergency use by Nov

New York, Oct 7 (Bureau) Pfizer’s COVID-19 vaccine for children aged five to 11 could be authorized for emergency use by federal health regulators by late November, White House COVID Response Coordinator Jeff Zients said in an interview broadcast by CNN on Thursday. “Again, it’s up to the FDA [Food and Drug Administration] and CDC [Centers for Disease Control and Prevention] and scientific processes,” Zients said when asked whether the vaccine would be approved for the 5-11 age group before the US Thanksgiving holiday on November 25. “But yes, it could and we will be ready as soon as the FDA and CDC give the go-ahead.”
Earlier in the day, Pfizer and its vaccine development partner BioNTech Group said in a tweet that they had asked the FDA to grant Emergency Use Authorization for their COVID-19 vaccine in children of ages five to below 12. “We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat,” the two vaccine developers said in the tweet.

The FDA has tentatively scheduled a hearing on October 26 to consider the Pfizer-BioNTech request. Health experts who act for the agency have promised in previous testimony to move quickly on the matter. FDA Acting Commissioner Janet Woodcock was quoted saying in US media last week that children might require “a different dosage or formulation from that used in an older pediatric population or adults”.

Pfizer itself has proposed giving children a third of the adult dosage. Very few children became severely ill from the initial COVID-19 outbreak of 2020. But the more dangerous and transmissible Delta variant that emerged later landed nearly 30,000 of them in US hospitals in August, alarming health authorities. The American Academy of Pediatrics says nearly 6 million Americans younger than 18 have been infected with the coronavirus. Of the roughly 500 Americans under the age of 18 who have died from COVID-19, about 125 were children aged between five and 11. Young people below 12 account for nearly 30 million of America’s 330 million population.