FDA approves covid vaccines in children aged six months to five years

Covid vaccines for the youngest Americans could be rolled out in a matter of days after the Food and Drug Administration recommended approving both the Moderna and Pfizer shots, despite some experts warning that they are not needed for children under the age of five. 

On Wednesday, members of the Vaccines and Related Biological Products Advisory Committee convened debated whether the benefits of Moderna and Pfizer outweigh the risks for America’s 18million under-5s.

They gave the greenlight for both vaccines. Formal authorization should follow quickly, with the first shots in arms expected by next week.

‘This recommendation does fill a significant unmet need for a really 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 benefits of the Moderna vaccine outweighed the risks.

The vote on Wednesday is the first stage of the four-part process that will also see them examined by FDA chiefs on Thursday and 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 old face a vanishingly small risk of dying from Covid and that there is little demand for the shots. Under-5s account for just 0.05 percent of America’s more than a million Covid deaths, while nationally less than a third of five to 11-year-olds who are eligible for two doses of the Covid vaccine have got the shots.

If all shots are approved, it is thought the U.S. would become the first country to offer shots against the pandemic virus for children under two years old. Cuba has been vaccinated children as young as two years since October, while Chile and China are offering the shots to everyone over the age of three years.

It comes as national Covid cases continue to plateau at about 107,000 a day, while deaths fall 36 percent to a seven-day average of 374 and hospitalizations also remain steady.

But new Omicron subvariants — scientifically named BA.4 and BA.5 — are spreading quickly in the U.S., now accounting for up to three in ten infections in some areas. It is feared they could trigger a rebound in cases, although there is no evidence that they are more likely to cause severe disease or death.

Members of the Vaccines and Related Biological Products Advisory Committee met today to consider whether to approve Moderna and Pfizer’s shots for children aged six months to five years. Pictured is Dr Peter Marks at the meeting who heads up vaccine approval at the FDA at the meeting today. On the right is a graph showing the number of hospitalizations among children under four years with the most recent Omicron wave shown in grey. He said that just because there was a small number of deaths in the age group, people should not become desensitivized to the risk it posed to children

Covid cases in the US have plateaued for the sixth day in a row, with the seven-day average now standing at about 107,000 new cases every day. It comes as new Omicron subvariants gain ground in the country

Covid deaths dropped 33 percent yesterday compared to the same time last week, with about 374 now being registered daily

FDA advisory panel gives unanimous support to Moderna’s Covid vaccine for children aged six to 17

Moderna’s Covid vaccine should be made available for children aged six to 17 years, an independent panel at the Food and Drug Administration said Tuesday — as America’s Covid wave fell on all fronts.

All 22 members of the panel convened by the FDA voted to approve the two-dose jab for the age group following an all-day debate on the issue.

The FDA is now expected to sign-off on the shots in the coming weeks. The Centers for Disease Control and Prevention (CDC) will also need to give them the green-light before they can be rolled out nationwide.

Dr Paul Offit, a pediatrician who sits on the committee, said the benefits of the jab ‘outweigh’ the risks among youngsters — but added that it was now a ‘different time’ in the Covid pandemic.

Children less than 11 years old will be offered two half-strength doses of the shots, while those above this age will get jabs that are the same strength as those administered to adults.

Many experts have raised concerns over rolling out Covid vaccines to children because of the vanishingly small risk they face from the virus, with under-18s making up about 0.1 percent of America’s more than a million Covid fatalities.

Pfizer’s Covid jab was made available for children over five years old months ago, but uptake has been sluggish with less than a third of children aged five to 11 having come forward to get fully-vaccinated.

Moderna sought emergency use authorization for its two-dose course for children aged six months to five years. Its jab holds 25 micrograms of mRNA, or about a quarter of that in doses for adults, and is given four weeks apart.

Pfizer is also seeking the green-light for offering a three-dose course of its vaccine to children aged from six months to four years. Its jab contains 3mcg, or about 10 percent of that in shots for adults.

Both jabs use mRNA, which gets cells to manufacture antigens from Covid — which the virus uses to invade cells — in order to trigger immunity against the pandemic virus.

The panel will vote on whether to approve the shots for the age group today, with their decision then passed to chiefs at the FDA. This group normally follows the recommendation of this expert panel. Afterwards, the CDC will also need to sign off on the shots before they can be rolled out to the public.

A number of states — including New Jersey — have already begun ordering jabs in for youngsters in anticipation of the approval.

The White House — which says approving the jabs would be a ‘historic milestone’ — has plans in place to start dishing out the shots as soon as June 20.

There has been pressure to get Covid vaccines approved for even the youngest children for months, especially from sections of the left-wing media.

But a number of experts have raised concerns over vaccinating children, who face a small risk of becoming seriously ill with Covid and a vanishingly small chance of death.

There are also fears over myocarditis, a form of heart inflammation that may be detected in up to one in 20,000 boys following vaccination. Girls are less at risk from the complication.

While in most cases the condition is mild, 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 to refuse to approve Covid jabs for five to 11-year-olds.

He told DailyMail.com at the time that while he thinks children with certain conditions that put them at a high risk should receive the shot, it was not clear if they should be approved for healthy children.

Pfizer’s Covid vaccine is already available for everyone more than five years old.

But CDC statistics show just over 28 percent of five to 11-year-olds have got the shot to date. Among 12 to 17-year-olds, almost 60 percent are now fully vaccinated.

For comparison, nationally about three in four Americans have now got two Covid vaccines and almost 50 percent have got a booster.

A survey carried out last month found just 18 percent of parents would ‘definitely’ get their child who was less than five years old the Covid vaccine. Almost two in five parents said they would refuse to get their child inoculated, or only do so when it was required.

More than 1,800 parents took part in the survey by health pollster the Kaiser Family Foundation, including 181 with children younger than five years.

Moderna was first to present its vaccine to the committee today, saying that it triggered as many Covid-fighting antibodies in children as the adult’s dose.

It presented data from clinical trials where 6,600 children under six years old were given the shots and monitored for at least two months after the second dose. This included 3,100 children aged two to five years, and 1,911 aged six to 23 months.

Only 15 children were reported as suffering a temperature afterwards which was over 104F (40C). There were no other recorded side-effects.

It comes as America’s Covid wave continues to plateau with the seven-day case average having barely shifted for the sixth day in a row.

Across the states 20 are seeing their infections fall compared to the same time about two weeks ago.

Only two — Oklahoma and Wyoming — are seeing cases double compared to the same time about a fortnight ago.

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