Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the publication of new results from two laboratory studies demonstrating that three doses of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) elicited antibodies that neutralize the Omicron variant (B.1.1.529).

Data published in the peer-reviewed journal Science, includes readouts of sera data from 51 vaccinated individuals that received two or three doses of BNT162b2 as well as a study evaluating the neutralization potential of serum antibodies from a subset of vaccinated individuals against the live virus. Both data sets confirm previously announced initial study results demonstrating that serum antibodies induced by BNT162b2 neutralize the SARS-CoV-2 Omicron variant after immunization with three doses. In comparison, sera from individuals who received two doses of the COVID-19 vaccine revealed limited neutralization titers against the Omicron variant in both data sets, indicating that two doses of BNT162b2 may not be sufficient to protect against infection with the new variant. However, based on observations that around 85% of epitopes in the spike protein recognized by CD8+ T cells are not affected by the mutations in the Omicron variant, the companies believe two doses may still induce protection against severe disease.

Separately, data from a live virus laboratory study conducted with the University of Texas Medical Branch (UTMB) that support and further extend these findings were posted on the preprint server bioRxiv. Sera taken 1-month following a third dose showed a 22-fold increase in neutralization titers against Omicron compared to titers just prior to the third dose (7.9 to 8.8 months after second dose), suggesting more robust protection against the new variant may be achieved with the current COVID-19 vaccine series plus a booster dose. Additionally, the neutralizing titer levels against Omicron after immunization with three doses were similar to antibody titer levels after two doses against wild-type and other variants that emerged before Omicron. Further, from 1 to 4 months after a third dose, neutralization titers against wild-type and Omicron decreased by 1.6 and 2.0 times, respectively, suggesting similar waning for both variants. All sera effectively neutralized Omicron at 4 months following a third dose.

Pfizer and BioNTech have put into place a robust booster research program to help ensure that the vaccine continues to offer a high degree of protection. Moving forward, the companies will be evaluating the immunogenicity and efficacy of an additional dose of both the current formulation and an Omicron based vaccine in the clinical setting. The companies have previously announced that they expect to produce four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022, and this capacity is not expected to change if an adapted vaccine is required.

About the Pfizer-BioNTech Laboratory Study

To evaluate the effectiveness of BNT162b2 against the Omicron variant, Pfizer and BioNTech immediately tested a panel of 51 human immune sera obtained from the blood of individuals that received two or three 30-μg doses of the current Pfizer-BioNTech COVID-19 Vaccine, using a pseudovirus neutralization test (pVNT). Each serum was tested simultaneously for its neutralizing antibody titer against pseudovirus bearing the wild-type SARS-CoV-2 spike protein as well as the Beta, Delta and Omicron spike variant. The third dose significantly increased the neutralizing antibody titers against the Omicron pseudovirus by 23-fold. Neutralization against the Omicron pseudovirus after three doses of BNT162b2 was comparable to the neutralization against the wild-type SARS-CoV-2 pseudovirus observed in sera from individuals who received two doses of the companies' COVID-19 vaccine. The geometric mean titer (GMT) of neutralizing antibodies against the Omicron pseudovirus measured in the samples was 164 (after three doses), compared to 413 against the Delta pseudovirus (after three doses) and 160 against the ancestral strain (after two doses). The requirement of a third dose to effectively neutralize Omicron was confirmed using a replicating live SARS-CoV-2 virus neutralization assay in a subset of participants suggesting that three doses of BNT162b2 may protect against Omicron-mediated COVID-19. Following a third dose the neutralizing GMT against the Omicron variant was 106 after 1 month compared to a GMT of 368 against the ancestral strain 21 days after the second dose. Data on the persistence of neutralizing titers over time after a booster dose of BNT162b2 against the Omicron variant will be collected.

About the Pfizer and University of Texas Medical Branch (UTMB) Study

The study utilized four panels that included human immune sera from the blood of individuals who had received two or three 30-μg doses of the BNT162b2 vaccine. The first panel included sera from 20 individuals, collected 2 or 4 weeks after the second dose. The second panel included sera from 22 individuals collected on the day of administration of a booster dose. The third and fourth panels were collected 1 and 4 months after the third dose, respectively. This study did not measure other immune indicators, including T cells and non-neutralizing antibodies.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

About Pfizer: Breakthroughs That Change Patients' Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.