Pfizer Inc and BioNTech SE announced on Wednesday that their COVID-19 vaccine was safe and effective in 12 to 15-year-olds, paving the way for approval in the United States and Europe in the coming weeks.
The read-out, which puts the pair ahead of other western vaccine developers in the quest to also protect children, will likely allow for the use of the vaccine in that group before the next school year, Albert Bourla, Pfizer’s chief executive, said in a statement.
Whether vaccines work and safe to use on children is one of the big questions drugmakers are trying to answer. Inoculating children and young people is considered a critical step towards reaching “herd immunity” and taming the pandemic, which has killed more than 2.9 million and infected 128.3 million.
Young people are less likely to have severe disease and more likely to have asymptomatic infection, allowing them to transmit the disease to others, said Dr. Peter English, retired consultant in communicable disease control.
Pfizer’s vaccine is already authorized for use in people starting at age 16. The new study offers the first evidence of how the vaccine will also work in school-age adolescents.
In the trial of 2,260 adolescents aged 12 to 15, there were 18 cases of COVID-19 in the group that got a placebo shot and none in the group that got the vaccine, resulting in 100% efficacy in preventing COVID-19, the companies said in a statement.
The vaccine was well tolerated, with side effects in line with those seen among those aged 16 to 25 in the adult trial. It did not list the side effects for the younger group, but the adult trial’s side effects generally were mild to moderate and included injection-site pain, headaches, fever and fatigue.
The companies also studied a subset of teens to measure the level of virus-neutralizing antibodies a month after the second dose and found it was comparable to study participants aged 16 to 25 in the pivotal trial in adults.
Bourla said the company planned to seek emergency authorization from the U.S. Food and Drug Administration “in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
Shortly after the news, Israel, which is leading the world in its vaccination roll-out, said it would start administering the shot to adolescents if the FDA gives it the green light.
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Scientists welcomed the news, but more data was needed, including how many cases of infection were identified, their severity and how effective the shot is at preventing asymptomatic disease.
“It will be important to do this (vaccinate younger people to achieve herd immunity),” said English, who is also former chair of the BMA Public Health Medicine Committee.
Last week, the companies gave the first vaccine doses in a series of trials testing the vaccine in younger children, that will eventually go to those as young as 6 months of age.
Rivals are also testing their shots on younger people.
A trial by Moderna Inc to test its COVID-19 vaccine in children aged six months to less than 12 years was launched this month, while Johnson & Johnson, which recently won approval for its vaccine in adults, has yet to begin a planned trial here on children.
AstraZeneca in December removed children from a mid-to-late stage trial of its COVID-19 vaccine in Britain.
Despite the fact that the cause of the disorder is unknown, the British drug-maker’s vaccine has been related this year to a very unusual type of blood clotting in the brain, leading several European countries to halt its use in younger adults.
In January, top US infectious disease specialist Anthony Fauci boosted the likelihood of a children’s vaccine program in the United States by late spring or early summer.
