The topline results showed that the lead formulations of the combination vaccine elicited strong immune responses against influenza A and B and SARS-CoV-2. The mRNA-based combination vaccine previously received Fast Track Designation from the US Food and Drug Administration (FDA).
This development will simplify vaccination practices and address the seasonal nature of respiratory diseases, including Covid-19.
Pfizer head of vaccine research and development Annaliesa Anderson said: “This vaccine has the potential to lessen the impact of two respiratory diseases with a single injection and may simplify immunisation practices.”
The Phase I/II study (NCT05596734) evaluated the safety, tolerability, and immunogenicity of combination vaccine candidates on healthy adults ages 18 to 74, with a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5 Covid-19 vaccine.
Pfizer and BioNTech’s Covid-19 vaccine Comirnaty was authorised in the UK less than a year after the Covid-19 pandemic was declared, with the rest of the world following soon after. The UK’s healthcare regulator the Medicines and Healthcare Products Regulatory Agency (MHRA) approved Pfizer and BioNTech’s vaccine for temporary emergency use.
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The latest MHRA approval came on 6 September for the adapted Comirnaty vaccine, targeting the Omicron XBB 1.5 subvariant. This kind of approval obtained through the European Commission (EC) Decision Reliance Route is valid only in the UK. This is the third adaptation of the vaccine targeting new variants of the SARS-CoV-2 virus.
Comirnaty remains the leading Covid-19 vaccine by total forecast sales, forecast to reach over $51.7bn in sales between this year and 2029, according to GlobalData. However, both companies are expecting a hit to Covid-19 revenues with the sales expectations for the Comirnaty vaccine being reduced in recent earnings reports.
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