Pfizer and BioNTech have filed a supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) for the approval of a third dose of their Cominarty COVID-19 vaccine for those aged 16 years and older.
The news follows last week’s announcement from US health leaders that they are set to greenlight COVID-19 booster shots in light of the “very clear” evidence that protection declines over time.
The sBLA is based on new data from a phase 3 clinical trial investigating the effect of a booster (third) dose of Cominarty between 4.8 and 8 months after the first two doses.
Levels of neutralising titers present after the third dose were more than three times the levels of titers present after the second dose. Side effects were generally consistent with existing clinical data for Cominarty after the first two doses.
While a third dose of the Pfizer/BioNTech vaccine is not currently authorised for broad use in the US, under the current amended Emergency Use Authorisation, a third dose was authorised on 12 August for administration to individuals who are 12 years and older who are immunocompromised or who have undergone solid organ transplantation.
Pfizer and BioNTech have said that they intend to submit the data to a peer-reviewed journal as well as file the data with the European Medicines Agency (EMA) and other regulatory authorities around the world in the coming weeks. They have committed to filing all data for the sBLA by the end of this week.
The sBLA follows a number of studies in recent weeks that have reported that COVID-19 vaccine protection falls over time, backing up the need for boosters. While both Pfizer/BioNTech and AstraZeneca’s vaccines offer good protection, studies released this week from the Zoe COVID-19 Study show that protection could fall by up to 14%.