The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed the data, and voted 17 to 0, with one abstention
The US Food and Drug Administration (FDA) advisory committee has recommended the Emergency Use Authorisation (EUA) of Pfizer and BioNTech’s Covid-19 vaccine for use in children aged five to 11 years.
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed the data shared by the companies, including results from a Phase 2/3 trial, and voted 17 to 0, with one abstention.
In the Phase 2/3 trial, around 4,500 children aged five to 11 years, received a two-dose regimen of 10-µg strength each, administered 21 days apart.
Pfizer and BioNTech said that the dose level in the study was selected based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study.
The study showed a favourable safety profile, superior immune responses and 90.7% efficacy for the Covid-19 vaccine, seven days after the second dose.
According to the study Data Monitoring Committee review, no serious safety concerns related to the use of Comirnaty vaccine were identified.
Pfizer senior vice president and vaccine research and development head Kathrin Jansen said: “We appreciated the opportunity to present our clinical data demonstrating the safety and high efficacy of our Covid-19 vaccine in children five to under 12 years of age.
“About 10% of all weekly U.S. cases occur in children five to under 12 years of age with a potential risk of complications. In addition, immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner.
“We thank the FDA advisory committee for their review and positive recommendation in support of emergency use authorisation to help protect this young population.”
Pfizer-BioNTech Covid-19 vaccine was already authorised in the US, for use in children aged 12-15 years, and was approved for those aged 16 and older in December last year.
The US health agency is anticipated to announce its decision on granting authorisation for the Covid-19 vaccine in children aged five-11 years, in a few days.
If authorised and recommended by the US Centres for Disease Control and Prevention (CDC), Comirnaty will be the first vaccine for use in children aged five to 11 years in the US.
Pfizer and BioNTech said that they will start distributing the paediatric vaccine doses in the US immediately after authorisation, as per the US government directions.
Earlier this month, researchers at the US FDA announced that the benefits of using Comirnaty in children, aged 5 to 11 years, outweighs the risks of rare heart inflammation.
BioNTech co-founder and chief medical officer Özlem Türeci said: “We are committed to support the ongoing efforts to reduce infections and Covid-19 cases around the world by expanding the population of people protected against Covid-19.
“The clinical data reviewed underline that our vaccine induces a strong immune response in children when Delta was the prevalent strain and thus may contribute to help address this public health crisis.”
In a separate development, BioNTech said it will start the construction of an advanced manufacturing site for mRNA-based vaccines in the African Union, from mid-2022.
The German biotechnology company has signed a memorandum of understanding with the Rwandan government and the Institut Pasteur de Dakar.