The US is prepared to start vaccinating children aged 5 to 11 against Covid-19 starting next month, a move that will make 28 million more Americans eligible for shots, the White House said on Wednesday.
President Joe Biden's administration said it had already set aside enough supply and partnered with 25,000 sites nationwide — including doctors' offices, hospitals, pharmacies and even schools — in the expectation that regulators would soon authorise the Pfizer vaccine for children.
“We expect the [Food and Drug Administration] and [Centres for Disease Control and Prevention] decision on Pfizer's Covid-19 vaccine for children ages 5 through 11 in the next couple of weeks,” White House Covid co-ordinator Jeff Zients told reporters.
“We know millions of parents have been waiting for a Covid-19 vaccine for kids in this age group and should the FDA and CDC authorise the vaccine, we will be ready to get shots in arms.”
The FDA will convene a panel of experts on the issue next week, followed by the CDC on November 2-3, with authorisation expected soon after.
During a clinical trial, children in the 5-11 age group received a two-dose regimen of 10 micrograms, compared with 30 micrograms for older age groups. The shots were given 21 days apart.
The side effects were “generally comparable to those observed in participants 16 to 25 years of age,” Pfizer said in a statement, and added that the shots induced a robust antibody response.
Pain and swelling at the injection site have been among the most commonly reported side effects in people of all ages, along with headaches, chills and fever.
Pfizer made no mention of the rare side effect of myocarditis, an inflammation of the heart muscle that has been linked to the vaccine, mostly among adolescent males and those in their twenties.
The Pfizer-BioNTech vaccine has been granted full FDA approval for those aged 16 and up and the FDA in May authorised its emergency use in children ages 12 to 15.
Experts say it is essential to vaccinate children to progress towards achieving population immunity against the disease.
While younger children are less likely to develop severe cases, they can still become sick and transmit the virus to the general population.
Overall vaccine confidence in the US has risen in recent months.
As of Wednesday, 77.1 per cent of the currently eligible population aged 12 and up had received one or more doses of a Covid vaccine.
The differing risk-benefit profile for younger children nevertheless may present challenges in persuading some parents the shot is worthwhile.
The US — officially the hardest-hit country in the world with more than 720,000 deaths — is emerging from its latest Covid wave, driven by the highly contagious Delta variant.
The seven-day average of daily cases is around 75,500, down 16 per cent from last week.
Hospital admissions are averaging 6,000 per day while daily deaths are now about 1,200.
Experts believe cases may once again rise with the arrival of winter, particularly in the country's northern states, as respiratory viruses — including others such as RSV and influenza — tend to thrive in colder weather.
Vaccination against Covid has been shown to significantly de-link cases from hospital admission. A high level of vaccination among the population is deemed critical to protect those who are most vulnerable, such as the elderly and the immunocompromised.