Pfizer and its partner BioNTech are seeking approval from the US Food and Drug Administration (FDA) for their booster dose of Covid-19 vaccine, Comirnaty, for individuals aged 16 years and above.
The companies have initiated the rolling submission of a supplemental biologics license application (sBLA) to the FDA.
The latest move follows the receipt of full approval from FDA to Pfizer/BioNTech’s Covid-19 vaccine for individuals aged 16 years and older.
The submission of the sBLA is anticipated to be completed by the end of this week.
It includes data from a Phase III clinical trial which was conducted on 306 subjects aged from 18 to 55 years.
The booster dose elicited robust neutralising antibodies to the wild-type strain in participants who were without evidence of SARS-CoV-2 infection after one-month.
The participants were given the third Covid-19 vaccine dose between 4.8 and eight months after completion of the initial two doses.
It is found that a 3.3 times greater count of SARS-CoV-2 50% neutralising titers after the third dose was observed after the second dose.
Additionally, 99.5% of subjects had a four-fold response after the booster dose compared to 98% response observed after the second dose.
Currently, Pfizer-BioNTech’s third vaccine dose is not authorised for broad use in the US.
In the coming weeks, the companies also plan to submit the data to the European Medicines Agency (EMA) as well as other regulatory authorities across the world.
Recently, FDA has authorised the third Pfizer-BioNTech Covid-19 vaccine doses for individuals aged 12 and above with compromised immune systems under emergency use authorization (EUA).