Covid vaccines for the youngest Americans could be rolled out within days after the Food and Drug Administration recommended approving the Moderna shot, although some experts have warned they are not needed for children under the age of five.
On Wednesday, members of the Vaccines and Related Biological Products Advisory Committee debated whether the benefits of Moderna and Pfizer outweigh the risks to America’s 18 million children under the age of 5.
They approved the Moderna vaccine and are expected to soon vote to give the green light to the Pfizer vaccine as well. Formal approval should follow quickly, with the first gunfire expected next week.
“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 and one of the 21 experts who unanimously said the Moderna vaccine’s benefits outweighed its risks.
Wednesday’s vote is the first phase of the four-part process that will also see them under scrutiny by FDA chiefs on Thursday and by the Centers for Disease Control and Prevention (CDC) on Friday and Saturday.
Some scientists have warned that children between the ages of six months and five years are at vanishingly small risk of dying from Covid and that demand for the shots is low. Under-fives account for just 0.05 percent of America’s more than 1 million Covid deaths, while nationwide fewer than a third of five- to 11-year-olds who are eligible for two doses of the Covid vaccine have received the shot.
If all vaccines are approved, the US is likely to be the first country to offer vaccines against the pandemic virus to children under the age of two. Cuba has been vaccinating children as young as two since October, while Chile and China are offering the shots to anyone over the age of three.
It comes as national Covid cases continue to plateau at around 107,000 a day, while deaths fall 36 per cent to a seven-day average of 374 and hospital admissions also remain stable.
But new omicron subvariants — scientifically named BA.4 and BA.5 — are spreading rapidly across the US and are responsible for up to three in 10 infections in some areas. It is feared that in some cases they could trigger a relapse, although there is no evidence that they are more likely to cause serious illness or death.
Members of the Vaccines and Related Biological Products Advisory Committee met today to consider whether to approve Moderna’s and Pfizer’s vaccines for children ages six months to five years. Pictured is dr. Peter Marks at the meeting, who is leading vaccine approval at the FDA at today’s meeting. On the right is a chart showing the number of hospitalizations for children under the age of four, with the most recent Omicron wave shown in grey. He said just because there have been a small number of deaths in the age group, people shouldn’t become desensitized to the risk they posed to children
Covid cases in the US have plateaued for the sixth straight day, with the seven-day average now standing at about 107,000 new cases per day. It comes as new Omicron subvariants gain ground in the country
The number of deaths from Covid fell by 33 per cent yesterday compared to the same time last week, with around 374 now being recorded on a daily basis
FDA advisory panel unanimously supports Moderna’s Covid vaccine for children ages six to 17
Moderna’s Covid vaccine should be made available to children ages six to 17, an independent panel from the Food and Drug Administration said Tuesday — as America’s Covid wave hit on all fronts.
All 22 members of the FDA-convened panel voted to approve the two-dose vaccine for the age group after a day-long debate on the issue.
The FDA is now expected to approve the recordings in the coming weeks. The Centers for Disease Control and Prevention (CDC) must also give them the green light before they can roll out nationwide.
dr Paul Offit, a pediatrician who sits on the committee, said the benefits of the sting outweigh the risks in youngsters – but added it was a “different time” now in the Covid pandemic.
Children under the age of 11 are offered two half-strength doses of the vaccine, while those over this age are given injections of the same strength as adults.
Many experts have expressed concerns about introducing Covid vaccines to children given the vanishingly small risk they face from the virus. Under-18s account for about 0.1 percent of the more than 1 million Covid deaths in America.
Pfizer’s Covid vaccine was made available months ago for children over the age of five, but uptake has been sluggish with fewer than a third of children aged five to 11 having come forward to get full vaccinations.
Moderna is seeking emergency use authorization for its two-dose course for children ages six months to five years. His injection contains 25 micrograms of mRNA, or about a quarter of the adult dose, and is given four weeks apart.
Pfizer is also seeking the green light to offer a three-dose cycle of its vaccine to children ages six months to four years. Its jab contains 3 mcg, or about 10 percent of that, in adult shots.
Both injections use mRNA, which tricks cells into making antigens from Covid — which the virus uses to enter cells — to induce immunity to the pandemic virus.
The panel will vote today on whether to approve the age group shots, and their decision will then be shared with FDA leaders. This group normally follows the recommendation of this panel of experts. After that, the CDC must also approve the recordings before they can be made available to the public.
A number of states — including New Jersey — have already begun mandating juvenile jabs pending approval.
The White House — which says approving the shots would be a “historic milestone” — has plans to deliver the shots as early as June 20.
For months there has been pressure to allow Covid vaccines even for the youngest children, especially from parts of the left-wing media.
However, a number of experts have raised concerns about vaccinating children who are at low risk of developing serious illness from Covid and vanishingly small chance of death.
There are also concerns about myocarditis, a form of heart inflammation that can be detected in up to 1 in 20,000 boys after vaccination. Girls are less at risk from the complication.
While the condition is mild in most cases, scientists are not yet sure of the long-term effects.
Earlier this year, Dr. Michael Kurilla – who previously sat on the panel – was one of the few members who refused to authorize Covid vaccinations for five to 11 year olds.
He told at the time that he believed children with certain medical conditions that put them at high risk should be given the shot, but it was not clear if they should be allowed for healthy children.
Pfizer’s Covid vaccine is already available for everyone over the age of five.
But CDC statistics show that to date, just over 28 percent of five- to 11-year-olds have received the shot. Almost 60 percent of 12 to 17 year olds are now fully vaccinated.
By comparison, nationally, about three in four Americans have now received two Covid vaccines and nearly 50 percent have received a booster shot.
A survey conducted last month found that just 18 per cent of parents would “definitely” give their child under the age of five the Covid vaccine. Almost two in five parents said they would refuse to have their child vaccinated or only do so when necessary.
More than 1,800 parents took part in the survey by health research firm Kaiser Family Foundation, including 181 with children under the age of five.
Moderna was the first to present its vaccine to the committee today, saying it elicits as many Covid-fighting antibodies in children as an adult’s dose.
It presented data from clinical trials in which 6,600 children under the age of six received the injections and were monitored for at least two months after the second dose. Among them were 3,100 children between the ages of two and five years and 1,911 between the ages of six and 23 months.
It was reported that only 15 children had a temperature above 40 ° C afterwards. There were no other side effects recorded.
It comes as America’s Covid wave continues to plateau, with the seven-day average of cases barely shifting for the sixth straight day.
Across the states, 20 are seeing a drop in their infections compared to the same time about two weeks ago.
Just two — Oklahoma and Wyoming — are seeing twice the number of cases as they were about two weeks ago.