Pfizer and BioNTech have published early in vitro study data showing that the BNT162b2 COVID-19 vaccine generates antibodies that neutralise the pseudovirus bearing the SARS-CoV-2 UK-discovered strain spike protein in cell culture.
COVID-19 vaccine neutralises SARS-CoV-2 U.K. pseudovirus in cell culture
On Wednesday, Pfizer and BioNTech revealed results from an in vitro study that provides additional data on the capability of sera from individuals immunized with the companies COVID-19 vaccine to neutralize the B.1.1.7 lineage or VOC 202012/01, commonly referred to as the SARS-CoV-2 U.K. strain. The findings were published on the preprint server bioRxiv and submitted to a peer-reviewed journal.
The B.1.1.7 lineage is a fast-spreading variant of SARS-CoV-2 first detected in the United Kingdom that carries a larger than usual number of genetic changes with 10 mutations located in the spike protein. BioNTech and Pfizer have previously published data from an in vitro study that evaluated one of the key mutations (N501Y) in the U.K. strain, which is also shared by the South African strain. That study showed efficient neutralization of the N501Y mutated spike bearing virus by sera of individuals who had received the Pfizer-BioNTech COVID-19 vaccine.
In vitro study investigates full set of U.K. strain mutations
The current in-vitro study investigated the full set of UK strain spike mutations. To facilitate this investigation, a pseudovirus featuring the UK strain spike protein was generated.
The generated pseudovirus recapitulates the SARS-CoV-2 virus binding and cell entry. Sera of participants from the previously reported German Phase 1/2 trial inhibited pseudovirus bearing the U.K. strain SARS-CoV-2 spike in a neutralisation range that is regarded as biologically equivalent to the unmutated Wuhan SARS-CoV-2 spike.
Whilst the pseudovirus system used is a surrogate for the real SARS-CoV-2 virus, past studies have shown excellent concordance between pseudotype neutralisation and SARS-CoV-2 neutralisation assays. The preserved neutralization of the pseudovirus bearing the U.K. strain spike by BNT162b2-immune sera makes it likely that COVID-19 caused by the UK virus variant will also be prevented by immunization with BNT162b2.
BioNTech mRNA vaccine platform has the flexibility to address new virus variants in the future
Pfizer and BioNTech are encouraged by these positive early in vitro study findings. Additional data are needed to monitor the Pfizer-BioNTech COVID-19 vaccine’s effectiveness in preventing COVID-19 caused by new virus variants. For COVID-19 vaccines it has not yet been established what reduction in neutralisation might indicate the need for a vaccine strain change. Should a vaccine strain change be needed to address virus variants in the future, the Companies believe that the flexibility of BioNTech’s proprietary mRNA vaccine platform is well suited to enable such adjustment.
The Pfizer-BioNTech COVID-19 Vaccine has not been fully approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorised for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorised for the duration of the declaration that circumstances exist justifying the authorisation of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) including Full EUA Prescribing Information available at www.cvdvaccine.com.
Similarly, the European Commission (EC) granted a conditional marketing authorization (CMA) for the Pfizer-BioNTech COVID-19 Vaccine use for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older. The United Kindom was first to have the Pfizer-BioNTech authorised for emergency use by the Medicines and Healthcare products Regulatory Authority (MHRA), before decisions by the US and Europe.