Coronavirus: Israeli adolescents to receive Pfizer vaccine if FDA approves

Pfizer Inc and BioNTech SE said their COVID-19 vaccine was safe and effective and produced robust antibody responses in 12- to 15-year olds

Syringes are seen in front of displayed Biontech and Pfizer logos in this illustration (photo credit: REUTERS)
Syringes are seen in front of displayed Biontech and Pfizer logos in this illustration
(photo credit: REUTERS)
Israel plans to give the Pfizer Inc/BioNTech COVID-19 vaccine to 12-to-15-year-olds upon FDA approval, the health minister said on Wednesday after the manufacturer deemed the shots safe and effective on the age group.
Vaccinating at a world-beating pace, Israel has already given both Pfizer doses to more than half of its 9.3 million citizens and residents, and has seen an accompanying fall in infections.
“The Pfizer announcement is terrific news,” Health Minister Yuli Edelstein said over social media on Wednesday.
“There is nothing more in order now than a speedy approval of more vaccine procurements (by Israel), so we can be poised to vaccinate immediately upon FDA approval.”
Pfizer and BioNTech’s COVID-19 vaccine is safe, effective and produces robust antibody responses in 12-to 15-year-olds, the two vaccine developers said on Wednesday, paving the way for them to seek US and European approval within weeks for extending inoculations to this age group.
The read-out from a clinical trial, which puts the pair ahead of other Western vaccine developers in the quest to protect children, will likely allow inoculations for that age group before the next school year, Albert Bourla, Pfizer’s chief executive, said in a statement.
Whether COVID-19 vaccines work and are 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 has infected 128.3 million.
Young people are less likely to develop serious symptoms and are more likely to have an asymptomatic infection, allowing them unknowingly to transmit the disease to others, said Dr. Peter English, a retired consultant in communicable disease control.
The Pfizer and BioNTech vaccine is already authorized for those aged 16 and up. The new study offers the first evidence of how the vaccine will also work in school-age adolescents.
In the trial involving 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. The companies 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 was given and found it was comparable to that for study participants aged 16 to 25 in the pivotal trial in adults.
Bourla said the company planned to seek emergency authorization from the US Food and Drug Administration (FDA) “in the coming weeks and ... (from) other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
Scientists welcomed the news, which has not been published in a medical journal or peer reviewed, but said more data was needed.
“It will be important to do this (vaccinate younger people to achieve herd immunity,” said English, who is also former chair of the British Medical Association’s 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 to test its COVID-19 vaccine on children aged six months to 11 was launched this month, while Johnson & Johnson, which recently won approval for its vaccine in adults, has yet to begin a planned trial on children.
AstraZeneca in December removed children from a mid-to-late stage trial of its COVID-19 vaccine in Britain.
The British-Swedish drug-maker’s vaccine has been linked this year with a very rare form of blood clotting in the brain, prompting some European countries to halt its use in younger adults even though the cause of the condition remains unclear.
Top US infectious disease expert Anthony Fauci in January raised the prospect of a US vaccination campaign for children by late spring or early summer.
In Israel, longer-term vaccine purchases have snagged, however, over a dispute within Prime Minister Benjamin Netanyahu’s cabinet. The prime minister on Tuesday pledged to resolve the issue, saying, “God willing, we will continue to be a global model of success.”