The coadministration trial is primarily aimed at determining the safety when both vaccines are co-administered, with follow up six months after vaccination
Pfizer commenced a new study exploring the coadministration of its 20-valent pneumococcal conjugate vaccine (20vPnC) with a booster dose of the Pfizer-BioNTech Covid-19 Vaccine in adults aged 65 years or above.
The coadministration trial is primarily aimed at determining the safety when both vaccines are co-administered, with follow up six months after vaccination.
Its secondary objectives include determining immune responses produced by the individual vaccine candidates, said the company.
Pfizer and BioNTech jointly developed the Pfizer-BioNTech Covid-19 Vaccine, leveraging the unique mRNA technology.
Pfizer-BioNTech Covid-19 Vaccine is currently authorised by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) to prevent Covid-19 in individuals aged 12 years and above.
It has been granted the marketing authorisation in the European Union (EU), along with emergency use authorisations or equivalent in the US, the UK, Canada and other countries.
Pfizer and BioNTech have shipped their vaccine to 91 countries and territories around the world as part of an emergency use authorisation or conditional marketing authorisation.
Pfizer’s 20vPnC vaccine candidate is under development for the prevention of invasive disease and pneumonia caused by 20 serotypes of Streptococcus pneumoniae, in adults aged 18 years and above.
In December last year, the company has received the US FDA priority review for its Biologics License Application (BLA) for 20vPnC with a Prescription Drug User Fee Act (PDUFA) target date in June 2021.
In February this year, the European Medicines Agency (EMA) has accepted Pfizer’s Marketing Authorization Application (MAA) for review of its 20vPnC for use in adults aged 18 years and above.
The 20vPnC vaccine contains capsular polysaccharide conjugates for the 13 serotypes in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]).
Also, it comprises capsular polysaccharide conjugates for seven additional serotypes that cause pneumococcal disease and associated with high case-fatality rates, antibiotic resistance, and/or meningitis.