BioNTech has presented data to the U.S. FDA and to the European Medicine Agency confirming the safety and effectiveness of bivalent COVID vaccine candidates.  The company incorporated mRNA from both omicron BA variants and the original COVID-19 strain of SARS-CoV-2 virus in a single dose.  Both candidates neutralized BA.4 and BA.5 at 30 microgram and 60 microgram dose levels when administered as a fourth booster compared to the original monovalent vaccine.

As previously predicted, vaccines will have to be "tweaked" to provide adequate protection against emerging strains.  Selection of mRNA technology to develop vaccines has facilitated rapid adaptation and enhancement of antigenicity to make available more effective vaccines.

BioNTech in collaboration with Pfizer Inc. has received and order from the Department of Health and Human Resources for 105 million doses of COVID vaccine that may include antigenicity against Omicron variants of SARS-CoV-2 subject to FDA approval.