The Pfizer/BioNTech COVID-19 vaccine, according to recent clinical trials, is claimed to be well tolerated and produces a strong immune response in children between the ages of 5 and 11. Pfizer plans to submit the results of their research for consideration by health regulators as soon as possible.
These findings come from phase 2 and 3 clinical trials involving 2,268 participants aged 5 to 11 years. They tested two doses for children at three-week intervals. Each dose is one third of that given to the group 12 years and over. One month after the second dose, the immune response of the children was claimed to be similar to that seen in Pfizer-controlled adolescents and young adults.
Pfizer and BionNTech now plan to submit the data to the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other health regulators for Emergency Use Authorizations, which are also rigorously tested. Regulators will then assess the quality of clinical trials and decide whether and when to recommend vaccines to children with those vaccines passed or not.
"We are pleased to be able to submit data to regulatory authorities for this group of school-age children before the start of winter," said Dr Ugur Sahin, CEO and co-founder of BioNTech, in a statement.
During the wave of COVID-19 infections currently spreading across the US, the number of infected children is much higher. In total, the US had nearly 5.3 million cases of COVID-19 in children, with more than 243,000 new cases in the first week of September. That week and the previous week were responsible for a 10% increase in the number of cases in children since the start of the pandemic.
"Over the past nine months, hundreds of millions of people aged 12 and over from around the world have received our COVID-19 vaccine. We want to extend the protection provided by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the virus. the Delta variant and the substantial threat it poses to children," said Albert Bourla, Chairman and Chief Executive Officer of Pfizer.
"Since July, cases of COVID-19 in children have increased by approximately 240% in the US - underscoring the public health need for vaccination. The results of this trial provide a solid basis for seeking authorization of our vaccine for children aged 5 to 11 years, and we plan to turn it over to the FDA and other regulators very soon."
