US Government Agencies Endorse COVID-19 Vaccinations for Children Under 5

Infants as young as 6 months old are now eligible for COVID-19 vaccine coverage. This month has seen further moves in the fight against the pandemic as health officials have authorized COVID-19 vaccines for babies and young children.

Earlier this month, the United States Food and Drug Administration (FDA) independent vaccine advisers voted to approve authorization for Moderna and Pfizer-BioNTech COVID-19 vaccines for children under 5. This age group represents around 18 million infants.

The vaccine advisory panel comprised 21 vaccine, immunology and infectious disease experts, epidemiologists, pediatricians, and vaccine researchers. They unanimously voted in favor of authorizing the vaccines after determining that the merits of vaccinating babies, toddlers, and preschool-age children with either vaccine outweighed any potential risks.

The reviewers said both Moderna and Pfizer-BioNTech vaccines appear safe and effective for young children and babies from 6 months old. In addition, the side effects, including fever and fatigue, were typically mild with both vaccines and less common than seen in adults.

The same expert panel also backed Moderna's half-sized vaccines for children aged 6 to 11 and standard doses for teenagers. Previously, the Pfizer shot was the only option in these age groups.

The endorsement put the country's youngest children one step closer to becoming vaccinated nearly 2.5 years into the pandemic. They were the final age group without vaccine access, and many caregivers had been anxious to protect their youngest children.

The Centers for Disease Control (CDC) advisers then backed the FDA recommendations and signed off both vaccines for all babies and children ages 6 months and older.

What is the Pfizer vaccine?

The Pfizer-BioNTech shot is an mRNA vaccine. It contains a harmless piece of messenger RNA (mRNA) from SARS-CoV-2, the virus that causes COVID-19. The mRNA teaches cells the body's immune system how to respond quickly and effectively to SARS-CoV-2. Once the body produces an immune response, it excretes the vaccine ingredients like any substance that the body no longer needs.

Pfizer's vaccine is authorized for babies of 6 months through to infants of 4 years. The complete vaccine schedule consists of three doses. The first two doses are administered 3 weeks apart, followed by the final dose at least 8 weeks later.

The 3 microgram (mcg) dose shots are one-tenth of the 30 mcg adult dose. The schedule was originally two doses but didn't provide enough protection during testing, so Pfizer added a third shot during the omicron wave.

The efficacy of the vaccines is 80.3% in children of 6 months to 5 years.

What is the Moderna vaccine?

Like Pfizer-BioNTech, the Moderna vaccine is an mRNA vaccine and works in the same way. However, while the vaccines from both Pfizer and Moderna rely on mRNA technology, the formulations are different.

The Moderna vaccine is authorized for babies of 6 months through to children of 5 years. The vaccine schedule consists of two doses 4 weeks apart.

The 25 mcg dose shots are one-quarter of the 100 mcg adult dose.

The efficacy of the vaccines is 50.6% in infants of 6 months to 2 years which drops to 36.8% in children aged 2 to 5 years. This means that the vaccine is effective enough to prevent serious illness but less effective at preventing milder infections.

In light of these figures, Moderna is considering adding a booster to its vaccine schedule. It's currently boosting children following their progress with a promise to roll out the new data over the summer.

Do we need to vaccinate this group?

During the Omicron wave, there has been a surge in hospitalizations among young children.

Additionally, the burden of hospitalizations for severe disease in young children has matched or exceeded that of other vaccine-preventable illnesses, such as the flu. Around 63% of infants under 5 hospitalized for COVID-19 didn't have underlying health issues. Although it's significantly fewer than adult hospitalizations and deaths, it doesn't mean that this age group should be excluded from the protection of COVID-19 immunization.

The expert panel members noted that the chances for severe disease and death in young children are minimal, but it's still a possibility that can be prevented by vaccination.

Vaccinating children also helps limit the spread of the virus and protect those who cannot receive the vaccine or won't make an adequate immune response. This group includes people with allergies to vaccine ingredients and people who are immunocompromised.

Even if children have had COVID-19 infections, they can get added protection by getting vaccinated. However, their doses should be adjusted to 3 months from when symptoms started or when they received a positive test. The delay applies to primary and booster doses.

What is the vaccination uptake rate?

A recent survey from the non-profit organization the Kaiser Family Foundation revealed that around 1 in 5 caregivers and parents are keen to vaccinate their young children at the earliest opportunity. Nearly 2 in 5 plan on waiting to see how the vaccine works in the reported side effects. The remaining 2 in 5 are reluctant to immunize their children.

Less than 1 in 3 United States children in the 5 to 11 age group are fully vaccinated against COVID-19 compared to nearly double this figure in 12- to 15-year-olds.

There are concerns that parents may become confused by the two vaccine products' different dosing regimens — particularly as the Pfizer shot doesn't offer full protection following two doses.

Experts are concerned that children will not receive the third dose of Pfizer, as asking people to attend vaccination centers for two shots is already challenging. Therefore, they are urging the manufacturers to collate data on the prospect of immunizing children against COVID-19 while receiving routine vaccinations.

Otherwise, this could serve as a barrier to the completion of the three-dose series. The ideal situation would be for the manufacturers to develop a single-dose vaccine that can be given to all children regardless of their age. However, this may not be possible, so the next best solution is to offer both products in a shared dosing schedule.

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