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February 14, 2022

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

The FDA postponed the Vaccines and Related Biological Products Advisory Committee meeting planned for 15 February.

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. 

In the latest observations from various other age groups, three doses of the vaccine showed to boost neutralising antibody levels as well as real-world vaccine protection for omicron versus two-dose vaccine series. 

The companies anticipate reporting the three-dose vaccine data in April.

Furthermore, the independent Data Monitoring Committee (DMC) backed the trial progression according to the protocol and believes that the results obtained so far indicate the Covid-19 vaccine is well tolerated and support a three-dose vaccine series.

With the latest development, the FDA postponed the Vaccines and Related Biological Products Advisory Committee meeting planned for 15 February. 

The extension will also aid FDA in analysing the latest data on the two and three-dose vaccine series.

Earlier this month, the companies commenced the rolling submission seeking an amendment to EUA for the Covid-19 vaccine to include children aged six months to four years.

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