Washington, (UrduPoint/Pakistan Point News – June 16, 2022): A panel of experts convened by the US Food and Drug Administration unanimously recommended Covid-19 vaccines for children under five on Wednesday. , the last age group awaiting vaccination in most countries.
Formal authorizations are expected to follow soon, with the first shots expected early next week, just over a year and a half after the first Covid vaccines were authorized for the elderly in December 2020.
“This recommendation addresses a significant unmet need for a younger population that is truly overlooked,” said Michael Nelson, professor of medicine at the University of Virginia, one of 21 experts invited to vote for the landmark meeting.
Unlike regulators in other countries, the FDA offers live streams of its internal deliberations, and its seal of approval is considered the global gold standard.
Opening the discussion, FDA senior 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 people children during last winter’s Omicron wave highlighted an urgent need for vaccination.
“We are dealing with an issue where we have to be careful not to become numb to pediatric deaths due to the overwhelming number of older deaths,” he said.
“Every life matters and vaccine-preventable deaths are something we would like to try to do something about.” The United States has recorded 480 Covid deaths in the 0-4 age group in the pandemic – far more than even a bad flu season, Marks said.
By May 2022, there had been 45,000 hospitalizations in this group, almost a quarter of which required intensive care.
Ahead of the meeting, the FDA released its independent reviews of the drug companies’ vaccines, deeming them 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 surface, training the immune system to be ready. The technology is now considered the main Covid vaccination platform.
Pfizer has requested approval of three three-microgram doses given to children aged six months to four years, while Moderna has asked the FDA to authorize its vaccine in two higher 25-microgram doses for children aged six. months to five years.
Both vaccines have been tested in trials with thousands of children. They were found to cause similar levels of mild side effects as in older age groups and elicit similar levels of antibodies.
– Two doses, or three? – Efficacy against infection was higher for Pfizer, with the company putting it at 80%, compared to 51% for children aged six months to two years and 37% for those aged two to five years.
But Pfizer’s figure is based on very few cases and is therefore considered preliminary. It also takes three doses to get its protection, with the third injection given eight weeks after the second, which is given three weeks after the first.
Moderna’s vaccine is expected to provide strong protection against severe disease after two doses, four weeks apart, and the company is investigating adding a booster that would boost levels of efficacy against mild disease.
However, Moderna’s decision to go for a higher dose is associated with higher levels of fever in reaction to the vaccine compared to Pfizer.
There are approximately 20 million American children aged 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 the serious consequences.
In fact, 64% of hospitalizations in under-fives occurred in patients without comorbidities.
Children can also get multisystem inflammatory syndrome in children (MIS-C), a rare but serious post-viral illness. About three to six percent may experience long Covid symptoms for more than 12 weeks.
The FDA is expected to act on the panel’s recommendation soon, and the matter will be forwarded to the Centers for Disease Control and Prevention for final word.
White House officials said last week that the rollout of 10 million shots to pharmacies and doctors’ offices could begin as early as June 21.