Pharmaceutical company Pfizer has pronounced that it is satisfied with its Covid-19 vaccine clinical trials for infants and toddlers and will proceed with submitting a 3-dose vaccine regimen to the Food & Drug Administration for approval.
The vaccine manufacturer claimed that the Covid-19 mRNA vaccine tested on children 6 months to 5 years old was 80% effective at preventing illness during the omicron wave. The preliminary clinical trial results were released on Monday.
Pfizer and BioNTech claimed that a third dose of the vaccine elicited a robust immune response. The company also said that it was ‘well tolerated’ with side effects varying from ‘mild to moderate.’
“BioNTech CEO Ugur Sahin said the companies plan this week to complete their application asking the Food and Drug Administration to authorize the vaccine for emergency use,” CNBC reported. “Pfizer CEO Albert Bourla said he hopes the vaccine will be available to younger kids as soon as possible.”
“Hours after Pfizer released the data, the FDA announced its committee of independent vaccine experts would meet June 15 to discuss Pfizer’s and Moderna’s applications to have their shots authorized for infants through preschoolers,” the report added.
The Food and Drug Administration on Tuesday authorized Pfizer-BioNTech’s Covid-19 “booster” shots for small children ages 5-to-11.
“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” FDA Commissioner Robert Califf said in a statement.
A recent study showed that booster shots offered “very little” protection for children in the 5-11 age group.
“Pfizer and BioNTech’s two-dose Covid vaccine provided very little protection for children aged 5 to 11 during the wave of omicron infection in New York, according to a study published Monday,” CNBC reported in late February.
“The New York State Department of Health found that the effectiveness of Pfizer’s vaccine against Covid infection plummeted from 68% to 12% for kids in that age group during the omicron surge from Dec. 13 through Jan 24,” the report added. “Protection against hospitalization dropped from 100% to 48% during the same period.”
CDC data indicate that Covid-related mortality was 334 deaths out of 40,000,000 children for ages 5-14. Covid-related mortality was 287 total for under one years old and and 140 total for 1-4 years old for a grand total of 417 out of 20,000,000 children in this age cohort. This is a survival rate of 99.998% over the course of the pandemic. The current BA.2 and Omicron variants were found to be less deadly than prior strains.
As reported earlier,a Centers for Disease Control and Prevention panel met on Thursday to approve its recommendation that children receive Covid-19 boosters.
“A single Pfizer-BioNTech Covid-19 vaccine booster dose is recommended for persons ages 5-11 years at least 5 months after the primary series, under the FDA’s Emergency Use Authorization,” the CDC panel voted to approve.
There was only one “no” vote from Dr. Helen Talbott from Vanderbilt University. Dr. Talbott questioned whether it was feasible to ‘vaccinate’ children every six months for a general mild Covid variant that rapidly phases out of the population. There were eleven “yes” votes. There was one abstention.
The FDA updated the schedule for its vaccine advisory committee. It is slated to meet to discuss pediatric COVID-19 vaccines on June 15.