FDA approves COVID-19 booster shots for children 5 to 11 years old

Children aged five to 11 years old can now get a booster shot of the Pfizer Covid vaccine, the Food and Drug Administration (FDA) announced Tuesday.

Officials green-lighted the extra shots for the age group from five months after their first jabs — the first booster for children as young as five — saying it offered ‘continued protection’ and that the benefits ‘outweigh’ the risks.

It is despite many experts raising concerns over vaccinating children against Covid, pointing out that they are at low risk of severe disease from the virus. A total of 1,045 children have died from Covid since March 2020, accounting for less than 0.1 of America’s one million fatalities. The vast majority of deaths among over-65s.

Official estimates also suggest that three-quarters of children have already been infected with the virus to date, meaning they may have some form of natural immunity.

Pfizer’s vaccine is the first jab to be approved as a booster to children aged five to 11 years old. It is already available as two doses to everyone over five years old.

The FDA is currently considering whether to approve two shots of Moderna’s Covid jab for children aged six months to five years, with Pfizer having also applied. Moderna’s jab is currently approved for everyone 18 years old and over.

The FDA is set to approve a COVID-19 vaccine booster dose for children aged five to 11 years old, the New York Times report, it would be the youngest age group to receive eligibility for the shots. Pictured:  A child in San Diego, California, receives a shot of a COVID-19 vaccine on November 3

The above graph shows uptake of the first and second doses by age group. It reveals uptake is lagging furthest behind among children aged 5 to 11 years old

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Following today’s approval, the Center for Disease Control and Prevention’s top committee on vaccines, the Advisory Committee on Immunization Practices (ACIP), will meet to review the approval on Thursday.

It will then make a recommendation on whether children should receive the shots, although it is widely expected to also give them the green-light.

Dr Robert Califf, FDA commissioner, said about the approval Tuesday that: ‘The FDA is authorizing the use of a single booster dose of the Pfizer Covid vaccine for children five through 11 years of age to provide continued protection against Covid.

‘Vaccination continues to be the most effective way to prevent Covid and its severe consequences, and it is safe.

‘If your child is eligible for the Pfizer Covid vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.’

Dr Peter Marks, the director of the FDA center behind vaccine approval, said: ‘Emerging data suggests that vaccine effectiveness against Covid wanes after the second dose of the vaccine in all authorized populations.

‘The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer Covid vaccine for children five through 11 years of age at least five months after completing a primary series outweighs its known and potential risks.

‘A booster dose can help provide continued protection against Covid in this and older age groups.’

The vaccine was approved for the age group without a meeting of its committee on Vaccines and Related Biological Products Advisory.

The FDA said this was because the approval ‘did not raise questions that would benefit from additional discussion by committee members’.

The U.S. is one of a handful of countries to offer booster shots to the age group, alongside Israel and Australia among others.

It is already offering third doses to everyone more than 12 years old, and fourth doses to those over the age of 50 years.

Pfizer applied for Emergency Use Authorization (EUA) for its booster shot among five to 11 year olds last month.

The FDA is also looking at an EUA from Moderna to vaccinate children six months to five years old submitted last month.

It has been reviewing an application from Pfizer for its jab to be used in the age group since February, although this has been held up after initial data showed the two-dose regimen was ineffective.

Children receiving Pfizer’s Covid booster shot will get 10 milligrams (mg), the same as in the first two doses.

This is a third of that offered to adults, which is 30 mg.

Many experts have raised concerns over vaccinating children, however, because of the low risk they face from the virus.

CDC estimates suggest about three quarters of children have already caught Covid, giving them a level of protection.

Up to half of these cases were asymptomatic, estimates from the University of Utah suggest.

Previous research from New York state also found that any extra immunity gained from booster jabs quickly wears off.

It comes as the U.S. faces a surging outbreak of Covid, with about 91,000 cases now being recorded every day — the most in nearly three months.

The outbreak is being driven by a more infectious sub-variant of Omicron — scientifically named BA.2.12.1 — which is now behind up to half of cases across the U.S.

However, there is no evidence that the variant is more likely to cause severe disease than the original Omicron.

America’s Covid hospitalizations are rising, ticking up eight percent in a week with 2,600 people now being admitted to wards with the virus every day.

But deaths have fallen about 40 percent in a week, with about 335 now being recorded every day on average.