Immunisation against Covid-19 in children is being ramped up globally, after approval of COVID-19 vaccines for children.

The Pfizer-BioNTech vaccine, which has shown efficiency of 90.7% in children between 5 to 11 years, was approved recently by US health authorities. Earlier, UAE and China had already approved COVID-19 vaccine for children as young as age 3. Since July, Covid-19 cases among children have increased (240% in the US alone). Globally, 1.5 billion school-age children are affected by school closures. On Tuesday, the Centers for Disease Control and Prevention (CDC) approved children of ages 5 to 11 to get Pfizer vaccine. The move has been lauded by paediatricians and other doctors’ groups. Paediatric vaccinations have started in the US.

How many children were enrolled in the COVID-19 paediatric vaccine trial across countries?

The Pfizer-BioNTech vaccine trial included up to 4,650 children enrolled of ages 6 months to 11 years in the United States, Finland, Poland and Spain. Of more than 90 clinical trial sites in these countries, nearly two-thirds received vaccine and others received a placebo. The kids received two vaccine doses that were administered three weeks apart.

What were objectives of the trial?

Trial was designed to evaluate and assess the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule that were given approximately 21 days apart in three age groups:

· ages 5 to 11 years

· ages 2 to 5 years

· ages 6 months to 2 years

What’s the dose of the vaccine?

The Phase 2/3 trial had enrolled children with or without prior evidence of SARS-CoV-2 infection. Doses administered were -

· Children ages 5 to 11 years: two-doses of 10 µg (vs. 30-µg dose used for people 12 and older)

· Children under age 5 received a 3 µg dose for each injection.

· The two-dose regimen were administered 21 days apart.

What were the trial results?

Two important results of the trial were:

1. There was favourable safety profile for the children tested (i.e. that it is safe).

2. There was a "robust" neutralising antibody responses in children 5 to 11 years of age.

According to the Pfizer filing, that was evaluated by US drug regulators, the antibody responses in the participants (5- to 11-year olds) who were given 10-µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age who were given 30 µg doses.

The 10 µg dose was decided upon keeping in mind safety, tolerability and immunogenicity in children in the target age group.

What do the paediatric COVID vaccines mean for global counter-pandemic efforts?

Experts say the impact would be huge. “It will save lives in that age group,” Emma McBryde, an infectious-diseases modeller at the Australian Institute of Tropical Health and Medicine in Townsville, told Nature. “For every child’s life you save, you may well save many, many more adult lives.”

Children are said to be capable of transmitting the coronavirus SARS-CoV-2 to others.

On August 2, 2021, the UAE approved Sinopharm vaccine for children between 3 and 17 years, following clinical studies results. On June 5, 2021, China approved a COVID-19 vaccine for children as young as three.

Any side effects?

mRNA-based vaccines have been linked minor risk of myocarditis, an inflammation of the heart muscle; and pericarditis, an inflammation of the lining around the heart, particularly in young men.

No reports of either condition were found among the children ages 6 months to 11 year olds in the trial conducted in the four countries. “It's a good sign”, Andrew Pavia, chief of the division of paediatric infectious diseases at University of Utah told Nature.

What about rare problems?

Tens of millions of the larger doses have been administered safely to Americans 12 years and older. One very rare serious side effect has emerged to be heart inflammation, seen mostly in young men or teens boys, usually after the second dose, to which they recover quickly. Putting risk in context, doctors say that Covid-19 infection can cause a more serious heart inflammation.

Should children going to elementary school get vaccinated?

Yes, even though the infection is more severe in adults than children, COVID-19 is causing plenty of suffering among youngsters that is easily avoidable. About 1.9 million kids ages 5 to 11 have been diagnosed with COVID-19. 8,300 have been hospitalised, about a third have required intensive care. At least 94 deaths have been verified.

Over this is risk of a serious complication called multisystem inflammatory syndrome that can hit kids several weeks after they have recovered from even a mild infection.

Are kid doses the same size as adult doses?

No. Children aged 5 to 11 years will receive a third of the dose that is given to teens and adults. That’s 10 micrograms per shot for youngsters, compared to 30 micrograms per shot for everyone 12 and older. The younger kids will get two shots given three weeks apart.

How efficient are the vaccines?

In a study, Pfizer’s pediatric vaccine proved nearly 91% effective at preventing symptomatic infection.

Where are the vaccines available?

The vaccines are being offered at pediatricians’ offices, health clinics and pharmacies. Some school systems also are in works to hold vaccination clinics. Two drugstore chains will begin to offer vaccines this weekend: Walgreens on Saturday and CVS on Sunday.

Can my child get a flu shot at the same time?

Yes, according to CDC the COVID-19 and flu vaccines can be given at the same visit.

What if child is about to turn 12?

CDC said children must receive the dose that’s right for their age on the day of vaccination. So if a child gets the 10-microgram dose for the first shot and then turns 12, the second shot should be the 30-microgram dose.

Is the CDC’s decision a mandate?

No. The CDC has not mandated but recommended the COVID-19 vaccinations for youngsters. However, most US schools already have mandate vaccines for other infectious diseases. Objective of the mandates is to stop the spread of potentially fatal diseases.

Research suggests that mandates successfully increase vaccination rates among children. More than 80% of kids in the US are vaccinated for other diseases — including polio, measles, and chickenpox, by age 2. This helps in minimizing serious outbreaks and disrupt schools.

Aren’t only some kids at high risk of serious COVID-19?

Nearly 70% of 5- to 11-year-olds who were hospitalised for COVID-19 have had other medical problems, including obesity and asthma. But otherwise healthy kids get seriously ill, too. And due to high social, mental health and educational impact the pandemic has had on youngsters, health authorities have clarified that all children should get vaccinated.

What if child already had COVID-19?

The CDC recommends that once recovered, they still should be vaccinated. Though prior infection does provide some protection against another infection round, that immunity can vary.

Is Pfizer’s vaccine the only vaccine choice for children?

It is for now in the US. A similar Moderna vaccine is used by teens in some other countries and is being tested in younger children. It's not yet approved in US for those under age 18.

Other countries like UAE, have earlier approved non-mRNA COVID-19 vaccines in young children. On August 2, 2021, the UAE approved Sinopharm vaccine for children aged between 3 and 17 years. The approval was given after an extensive evaluation process.

What about vaccinations for children younger than 5?

Pfizer and Moderna are testing low doses in babies and preschoolers.

Evaluation of COVID vaccines for infants and toddlers is now moving forward. Dr Inci Yildirim, associate professor of paediatrics (infectious diseases) at Yale School of Medicine, is leading Yale’s component of Moderna’s clinical trial of a vaccine for children 6 months to 12 years of age.