Bridgette Melo, 5, holds the hand of her father, during her inoculation of one of two reduced doses of the Pfizer COVID-19 vaccine during a trial at Duke University in Durham, N.C., Sept. 28, 2021. Photo: Duke University
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 anticipation that regulators may soon authorize the Pfizer vaccine for kids.
"We expect the FDA and CDC decision on Pfizer's COVID-19 vaccine for children ages five through 11 in the next couple of weeks," White House Covid coordinator Jeff Zients told reporters, referring to the Food and Drug Administration and the Centers for Disease Control and Prevention.
"We know millions of parents have been waiting for COVID-19 vaccine for kids in this age group, and should the FDA and CDC authorize 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 authorization expected soon after.
Safe and Effective
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, adding 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 authorized 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.
Rising Vaccine Confidence
Overall vaccine confidence in the United States has risen in recent months.
As of Wednesday, 77.1 percent 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 United States -- 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 percent from last week.
Hospitalizations are averaging 6,000 per day while daily deaths are now around 1,200.
Experts anticipate 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 hospitalizations. A high level of population vaccination is deemed critical to protect those who are most vulnerable, such as the elderly and the immune compromised