These are the first such results published for a U.S. Covid-19 vaccine for this age group, and the data has not yet been peer-reviewed or published. Pfizer said it plans to file emergency approval with the U.S. Food and Drug Administration soon.
The study enrolled 2,268 participants, ages 5-11, and used two-dose therapy of the vaccine given 21 days apart. A 10 microgram dose was used in these studies – smaller than the 30 microgram dose used for people 12 years and older.
Participants’ immune responses were measured by examining neutralizing antibody levels in their blood and comparing these levels to a control group of 16-25 year olds who received two-dose therapy at the higher 30 microgram dose. Pfizer said the values compare well with those of older people who received the higher dose, demonstrating “a strong immune response in this cohort of children one month after the second dose”.
“Also, the COVID-19 vaccine was well tolerated, with side effects generally similar to those seen in participants aged 16-25,” the company said.
A Pfizer spokesman also confirmed that there were no cases of myocarditis, a type of heart inflammation that has been linked to mRNA vaccines.
Pfizer said these data will be included in a “short-term filing” for EEA and the companies will continue to collect the data required to file for FDA approval for individuals ages 5-11.
The Pfizer / BioNTech vaccine is currently approved for people aged 16 and over and approved for people aged 12 to 15 years.
Pfizer said it expects study data for children as young as 6 months “as early as the fourth quarter of this year”.
“Since July, COVID-19 cases in children in the US have increased by approximately 240 percent – underscoring the need for vaccination in the public health sector. and we plan to urgently submit it to the FDA and other regulatory agencies, “said Albert Bourla, chairman and chief executive officer of Pfizer.
Dr. Scott Gottlieb, a former FDA commissioner and current Pfizer board member, said a vaccine could be available for children ages 5-11 by Halloween.
Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Research and Evaluation, said in a statement earlier this month that the agency will deliver data for a vaccine for younger children “as soon as possible, probably in a few weeks rather than months” as soon as it is due Approval has been submitted.
“The agency’s ability to quickly review these submissions, however, depends in part on the quality and timeliness of the manufacturers’ submissions,” they wrote.
Calls for a Covid-19 vaccine for younger children have grown louder in recent months as cases in children have increased.
Coronavirus infections have increased “exponentially” in children in the United States and now account for nearly 29% of all cases reported nationwide, the American Academy of Pediatrics reported last week.
Still, U.S. health officials have stressed that children are not just small adults, and even those approaching the age of 12 should not be given the larger dose of vaccine available for the elderly.
“We don’t want children to have side effects. Granted, we want them to get vaccinated as soon as possible, but let’s get it right,” said FDA’s Marks in a fireplace chat hosted by the ResearchAmerica Alliance last week became.
“There’s a difference here because they’re not just getting the same old dose as a person 12 and over. You need to get a reduced dose. And so it’s not a good idea for doctors to take it” things in their own hands on this Time.”