Pfizer and BioNTech have submitted data from trials of their COVID vaccine on 5 to 11 year old children to the US FDA (Food and Drug Administration) for review.
It is to be noted that this is simply an initial review of the data and the companies have not yet applied for emergency use authorisation of the vaccine for use in children.
Pfizer and BioNTech had earlier this week said that the Phase 2-3 trial results showed their COVID-19 vaccine was safe and produced a robust immune response in children aged 5 to 11.
"In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses," Pfizer and its German partner said in a joint statement.
Meanwhile, Moderna trial for 6-11 year olds is still ongoing.
Pfizer and BioNTech also plan to share these data with the European Medicines Agency (EMA) and other regulators soon.
How was the trial conducted?
The trial included 2,268 participants ages 5 to 11 and used a two-dose regimen of the vaccine administered 21 days apart.
The trial used a 10-microgram dose. This is smaller than the 30-microgram dose that has been used for those 12 and older.
How was the antibody response?
The antibody responses in the participants given 10 microgram doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 microgram doses, Pfizer said.
"The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age," Pfizer said.
What were the side-effects?
The companies side effects were "generally comparable to those observed in participants 16 to 25 years of age".
Among the most commonly reported side effects in the past have been pain and swelling at the injection site as well as headache, chills and fever.
A Pfizer spokesperson also said that were no instances of myocarditis, a type of heart inflammation that has been linked with mRNA vaccines.
When will the vaccine be available?
Pfizer and BioNTech have only just submitted the data for initial review to the US Food and Drug Administration (FDA), next will be the European Medicines Agency (EMA) and other regulators.
For the vaccine to be approved, they will need to separately apply for emergency use authorisation from the US FDA.
Once they apply, depending on how long the US FDA takes to authorize the vaccine, whether it's a four week review or a six week review, it could be available "as early as probably by the end of October, perhaps it slips a little bit into November," CNN reported quoting Dr Scott Gottlieb, a former FDA commissioner and current Pfizer board member.
What about the vaccine for those below 5 years?
Pfizer and Moderna are both studying the vaccine for those younger than 5, down to 6-month-olds. The results are expected later in the year.
(With inputs from CNN.)