As federal officials wax poetic about the prospect of intranasal COVID-19 vaccines and other novel vaccine platforms, Pfizer Inc. (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have announced that a randomized Phase 2 study will study an incrementally improved COVID-19 vaccine known as BNT162b5.
The updated vaccine candidate includes a modified spike protein designed to bolster immunogenicity over the first-generation COVID-19 vaccine.
“BNT162b5 is the first of various approaches Pfizer and BioNTech intend to study in the clinic as we explore next-generation COVID-19 vaccines with the ultimate goal of increasing the durability of the immune response, which may lead to better protection,” explained a Pfizer spokesperson over email.
Pfizer notes that it plans on testing multiple vaccine candidates with the novel spike protein design to offer a more durable and broader immune response against SARS-CoV-2 infections and associated COVID-19.
The companies’ original BNT162b2 vaccine remains one of the most widely used worldwide. In 2021, the vaccine was the best-selling pharmaceutical product, generating $51.1 billion between Pfizer and BioNTech.
The bivalent BNT162b5 vaccine blends RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain and the BA.2 sub-lineage of the omicron variant (BA.2 sublineage). “The enhanced spike protein encoded from the mRNAs in BNT162b5 has been modified with the aim of increasing the magnitude and breadth of antibody neutralization response that could better protect against COVID-19,” a Pfizer spokesperson explained.
The FDA has recommended including omicron BA.4/5 component for future COVID-19 vaccine booster doses.
In its most recent Phase 2 study, Pfizer will evaluate BNT162b5 in approximately 200 participants between 18 and 55. Participants in the study will have received three prior doses of an authorized COVID-19 vaccine at least 90 days before their first study visit.
The study will administer the vaccine booster candidate as a 30-microgram dose.
PFE shares were down 0.66% to $51.95.
Filed Under: clinical trials, Drug Discovery, Infectious Disease