New Delhi: Pfizer and BioNTech on Monday said that the data from the clinical trials confirms their coronavirus vaccine was safe and produced a robust immune response in children aged 5 to 11.
In a joint statement issued today, the US giant Pfizer and its German partner said that their vaccine was safe, well tolerated and showed robust neutralising antibody responses in participants five to 11 years of age. They said that the vaccine would be administered at a lower dosage than for people over 12.
According to media reports, Pfizer plan to seek regulatory approval soon. They will submit their data to regulatory bodies in the European Union, the United States and around the world as soon as possible to ask for authorisation to use the vaccine in children in that age range.
"We are eager to extend the protection afforded by the vaccine to this younger population," Pfizer CEO Albert Bourla said , as quoted by Agence France-Presse.
Last week, FDA and Pfizer had proposed approving a booster shot for everyone 16 and older but the influential federal advisory panel of expert to the US Food and Drug Administration rejected that idea out of concern saying that the the data to support such a broad application was thin. Over several hours of discussion, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on safety of extra doses.
The panel had however recommended that the Covid-19 vaccine booster shot proposed by Pfizer Inc. and BioNTech SE should be given to 65 and older and those who are the most vulnerable to serious disease. The panel also recommended that the FDA include healthcare workers, teachers and others at high risk of occupational exposure to the Covid-19 virus.