Pfizer Covid vaccine safe and effective for children aged five to 11, trial finds

Schoolchildren spoke to ITV News Correspondent Rebecca Barry about being among the first in the 12-15 age group to receive the Covid vaccine in England

The Pfizer Covid vaccine is safe and effective for children aged five to 11, the pharmaceutical company has announced.

Pfizer and its German partner BioNTech said following their findings, they plan to seek authorisation of their jab for five to 11-year-olds in the UK, the US and Europe.

In what the companies describe as the "first results from a pivotal trial of a Covid-19 vaccine in this age group”, they found their jab was "safe, well tolerated and showed robust neutralizing antibody responses".

Dr Bill Gruber, a Pfizer senior vice president, said that children in this group also showed similar or fewer temporary side effects than what teenagers typically experience, such as sore arms, fever or achiness.

The findings come as 12 to 15-year-olds began to receive their first dose of the Pfizer jab in England on Monday.

Children in the same age group in Scotland and Wales will be offered theirs this week, while Northern Ireland expects to offer the jabs in October.

Schoolchildren spoke about being among the first in the 12-15 age group to receive the Covid vaccine in England, ITV News Correspondent Rebecca Barry reports

Pfizer and BioNTech said they aim to apply to the US Food and Drug Administration by the end of the month for emergency use in children younger than 12 - the current age limit.

They plan to follow with applications to British and European regulators shortly afterwards.

During the trial, a total of 2,268 nursery and primary school-aged children were given two small doses of the vaccine.

Primary school-aged children were given a much lower dose – a third of the amount in each jab administered currently.

(PA Graphics) Credit: PA Graphics

After the second dose, children aged five to 11 developed Covid-fighting antibody levels just as strong as those seen in teenagers and young adults, said Dr Gruber, a paediatrician.

“I think we really hit the sweet spot,” he added.

Earlier this month, FDA chief Dr Peter Marks said once Pfizer turns over its study results, his agency will evaluate the data “hopefully in a matter of weeks” to decide if the jabs are safe and effective enough for younger children.

Following the return to school and the infectious Delta variant causing a jump in paediatric infections, Dr Gruber said he feels a "great sense of urgency" in making the vaccine available to younger children.

“There’s pent-up demand for parents to be able to have their children returned to a normal life," he added.

Pfizer and Moderna are also studying children as young as six months old with results expected later in the year.

Many Western countries have vaccinated no younger than age 12, but Cuba last week began immunising children as young as two with its homegrown vaccines.

Meanwhile, Chinese regulators have cleared two of its brands down to the age of three.

Albert Bourla, chairman and chief executive officer of Pfizer, said: "We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination".

Pfizer said results from the "other two age cohorts from the trial – children two to five years of age and children six months to two years of age – are expected as soon as the fourth quarter of this year".

A second US vaccine maker, Moderna, is also studying its jabs in primary school children.