FDA approves Kovid vaccine in children aged six months to five years

The Food and Drug Administration’s recommendation to approve both Moderna and Pfizer shots could allow the youngest Americans to have COVID vaccines, despite warnings from some experts that children under the age of five could There is no need for them.

On Wednesday, members of the Vaccines and Related Biological Products Advisory Committee discussed whether the benefits of modern And pfizer America’s 18 million under-5s are at greater risk.

He gave the green signal to both the vaccines. Formal authorization should follow quickly, with the first shot in the arms expected by next week.

‘This recommendation actually fulfills an important unmet need for neglected youth populations,’ said Michael Nelson, a professor of medicine at the University of Virginia and one of the 21 experts who unanimously said that the benefits of the Moderna vaccine outweigh the risks. have make.

Voting on Wednesday is the first phase of a four-part process in which they will also be scrutinised. FDA Head 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 have a small risk of dying from COVID and have little demand for shots. Under-5s account for just 0.05 percent of the more than a million COVID deaths in the US, while nationally less than a third of five to 11-year-olds who are eligible for two doses of the COVID vaccine are given shots. have met.

If all shots are approved, the US is believed to become the first country to offer shots against the pandemic virus to children under the age of two. Cuba has vaccinated children under the age of two since October, while Chile and China are offering the shots to everyone over the age of three.

It comes as national Covid cases a day continue to hover around 107,000, while deaths fall 36 per cent to a seven-day average of 374 and hospitalizations remain stable.

But the new Omicron subvariants – scientifically named BA.4 and BA.5 – are spreading rapidly in the US, now accounting for three out of ten infections in some regions. It is feared that they may trigger a relapse in cases, although there is no evidence that they can cause serious illness or death.

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

Pfizer is also seeking approval to offer a three-dose course of its vaccine to children between the ages of six months and four years. Its jab contains 3 mcg, or about 10 percent, of shots for adults.

Both jabs use mRNA, which gets cells from Covid to make antigens – which the virus uses to invade cells – 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 the FDA chiefs. This group generally follows the recommendation of this expert panel. Later, the CDC would also require the shots to be signed before they could be rolled out to the public.

Several states, including New Jersey, have begun ordering jabs for youth in anticipation of approval.

The White House – which says approving the jabs will be a ‘historic milestone’ – plans to begin the shots on June 20 as soon as possible.

For months there has been pressure to approve a COVID vaccine for even the youngest children, especially from sections of the Left media.

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

There is also concern about myocarditis, a form of inflammation of the heart that can be found in one in 20,000 boys after vaccination. Girls are less prone to complications.

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 approve Covid jobs for children aged five to 11.

He told DailyMail.com at the time that while he thinks children with certain conditions that put them at higher risk should get the shot, it was unclear whether they should be approved for healthy children.

Pfizer’s COVID vaccine is already available to everyone over the age of five.

But CDC figures show that only 28 percent of five- to 11-year-olds have received the shot. Among 12 to 17-year-olds, about 60 percent are now fully vaccinated.

For comparison, three out of four Americans nationally have now received two COVID vaccines and nearly 50 percent have received a booster.

A survey conducted last month found that only 18 percent of parents would find their child ‘certain’ who was under five years old. Nearly two in five parents said they would refuse to vaccinate their child, or would do so only if it was needed.

More than 1,800 parents took part in the survey, conducted by health surveyor Kaiser Family Foundation, which included 181 children under the age of five.

Moderna first presented its vaccine to the committee today, saying it triggers many of the same COVID-fighting antibodies in children as the adult dose.

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

Only 15 children were subsequently reported to suffer temperatures higher than 104F (40C). There were no other recorded side effects.

It comes as the US Covid wave has barely shifted for the sixth day in a row, with an average of seven days.

20 of the states are seeing a decline in their infections compared to the same time almost two weeks ago.

Only two – Oklahoma and Wyoming – are seeing twice as many cases as they were about a fortnight ago.