A panel of experts convened by the US Food and Drug Administration on Wednesday unanimously recommended Covid-19 vaccines for children under five, the latest age group awaiting immunization in most countries.
Formal authorizations for Moderna and Pfizer should follow shortly, with first shots in the arms expected early next week, just over a year and a half after the first Covid vaccines were given the green light for the elderly in December 2020.
“This recommendation fills a significant unmet need for a truly ignored younger population,” said Michael Nelson, a professor of medicine at the University of Virginia, one of 21 experts asked to vote for the landmark meeting.
Unlike regulators in other countries, the FDA provides live streams of its internal deliberations and its stamp of approval is considered the global gold standard.
Opening the discussion, senior FDA scientist Peter Marks said that despite studies showing the majority of children are now infected with the coronavirus, the high rate of hospitalizations among infants, toddlers and young children during last winter’s Omicron wave is pressing the issue. necessity of vaccination.
“We’re dealing with a problem where we have to be careful not to get sedated by infant mortality because of the overwhelming number of older deaths,” he said.
“Every life is important and deaths that can be prevented by vaccination are something we would like to do something about.”
The United States has recorded 480 Covid deaths in the 0-4 age group during the pandemic — far higher than even a bad flu season, Marks said.
As of May 2022, there were 45,000 hospital admissions in that group, nearly a quarter of which required intensive care.
Prior to the meeting, the FDA released its independent analyzes of the drug companies’ vaccines, which were deemed both safe and effective.
Both vaccines are based on messenger RNA, which delivers the genetic code for the coronavirus spike protein to human cells, which then grow it on their surfaces, training the immune system to be ready. The technology is now considered the leading Covid vaccination platform.
Pfizer applied for three doses of three micrograms for children ages six months to four years, while Moderna asked the FDA to approve its vaccine as two doses of a higher 25 micrograms for ages six months to five years.
Both vaccines were tested in trials involving thousands of children. They were found to cause similar levels of mild side effects as seen in older age groups and produced similar levels of antibodies.
Two doses, or three?
Efficacy against infection was higher for Pfizer, with the company estimating it at 80 percent, compared with Moderna’s estimates of 51 percent for children six months to two years old and 37 percent for children two to five years old.
But the Pfizer figure is based on very few cases and is therefore considered preliminary. It also takes three doses to achieve protection, with the third injection given eight weeks after the second, given three weeks after the first.
Moderna’s vaccine should provide strong protection against serious illness after two doses, given four weeks apart, and the company is studying adding a booster that would increase efficacy against mild illness.
However, Moderna’s decision to go for a higher dose has been associated with higher fever levels in response to the vaccine compared to Pfizer.
There are approximately 20 million American children ages four and under.
Although obesity, neurological disorders and asthma are associated with an increased risk of serious illness in young children, it is not easy to predict serious consequences.
In fact, 64 percent of hospitalizations in children under five were in patients without comorbidities.
Children can also develop childhood multisystem inflammatory syndrome (MIS-C), a rare but serious post-viral condition. About three to six percent can suffer from Covid symptoms for more than 12 weeks.
The FDA is expected to act on the panel’s recommendation soon, and the matter will go to the Centers for Disease Control and Prevention for a final word.
White House officials said last week that the rollout of 10 million injections at pharmacies and doctors’ offices could begin as early as June 21.
(Except for the headline, this story has not been edited by NDTV staff and has been published from a syndicated feed.)