Pfizer and BioNTech to extend rolling submission for Covid-19 vaccine

Pfizer and BioNTech are set to extend their rolling submission to the US Food and Drug Administration (FDA) for amending the emergency use authorization (EUA) of the Covid-19 vaccine to include children aged six months to four years. Currently, the trial in children of this age group is underway and the results on the first two 3µg vaccine doses in these subjects are being submitted to the regulatory agency on an ongoing basis. The companies noted in December last year that the trial underway will analyse a third 3µg dose of the vaccine a minimum of two months following the second shot in subjects of this age. With the trial progressing rapidly, Pfizer and BioNTech intend to wait for the three-dose inoculation data as the companies anticipate it to offer an increased protection level in this age group of children.