Pfizer and BioNTech said Monday that trial results showed their coronavirus vaccine was safe and produced a robust immune response in children aged five to 11, adding that they would seek regulatory approval shortly.
The vaccine would be given at a lower dose than for people over 12, they said.
“In participants aged five to 11, the vaccine was safe, well tolerated and showed strong neutralizing antibody responses,” US giant Pfizer and its German partner said in a joint statement.
They plan to submit their data to regulators in the European Union, United States and around the world “as soon as possible.”
Ashish Jha, dean of Brown University School of Public Health and one of the leading experts on Covid in the United States, called this “good news” that many parents have been waiting for.
If all goes well and approval ensues, “My nine year old will have a chance by Halloween!” He tweeted.
The results of the trial are the first of its kind for children under 12, with a Moderna trial for children aged 6 to 11 still ongoing.
Pfizer and Moderna injections are already given to adolescents over 12 years of age in several countries, as well as adults around the world.
England, Scotland and Wales have become the latest to join the list of nations immunizing young adolescents, rolling out vaccines for 12 to 15 year olds this week. Northern Ireland is expected to follow suit next month.
Delta is worried
Although children are considered less at risk of severe Covid, there are fears that the highly contagious Delta variant could lead to more serious cases.
Inoculating children is also seen as essential to keeping schools open and helping end the pandemic.
“We look forward to extending the protection offered by the vaccine to this younger population,” said Albert Bourla, CEO of Pfizer, noting that “since July, pediatric cases of Covid-19 have increased by around 240% in United States”.
Children in the 5 to 11-year-old age group were given a two-dose regimen of 10 micrograms in the trial, compared to 30 micrograms for the older age groups, the companies said. The beatings were delivered 21 days apart.
The 10 microgram dose was “carefully chosen as the preferred dose for safety, tolerability and immunogenicity” for this age group, the statement said.
The side effects were “generally comparable to those seen in participants aged 16 to 25,” he added.
Some of the most common side effects reported in the past include pain and swelling at the injection site, as well as headache, chills and fever.
The Pfizer-BioNTech statement made no mention of the rare side effect of myocarditis, an inflammation of the heart muscle that has been linked to the vaccine, primarily in young men.
Less than five years before the end of the year
The Pfizer vaccine received full formal approval in the United States in August and is therefore technically available to young children if prescribed by a doctor, but U.S. officials have warned against doing so until the safety data are available.
The US regulator, the Food and Drug Administration (FDA), said in a statement earlier this month that it would “carefully” review emergency clearance requests for vaccines for those under the age of 12, a process that should take “weeks rather than months”.
Israel has already given special permission to vaccinate children aged five to 11 who “are at significant risk of serious illness or death” from Covid, using the Pfizer vaccine at the lowest dose.
Pfizer and BioNTech are also testing their vaccine on infants aged six months to two years and children aged two to five years.
The first results of these tests are expected “as early as” the fourth quarter of this year, the companies said.
In total, up to 4,500 children aged six months to 11 years have enrolled in the Pfizer-BioNTech trials in the United States, Finland, Poland and Spain.
Like its rival Moderna, the Pfizer jab is based on new mRNA technology that delivers genetic instructions to cells to build the coronavirus spike protein, in order to evoke antibodies when bodies encounter the real virus.
by Michelle Fitzpatrick, AFP