- Analysis of 37 participants immunized with BNT162b2 showed a broad immune response with SARS-CoV-2-specific neutralizing antibodies, TH1 type CD4+ T cells, and strong expansion of CD8+ T cells of the early effector memory phenotype
- All vaccinated participants demonstrated neutralizing antibody as well as T cell responses. T cell responses were directed against multiple regions of the spike protein, including the RBD, suggesting immune recognition of multiple independent epitopes
- Data confirm previous findings from the U.S. trial demonstrating a good safety profile and robust induction of antibody responses with a longer follow-up period of 85 days
- Antibodies generated in trial subjects were able to neutralize pseudo-viruses representing 19 diverse SARS-CoV-2 variants, indicating potential for broad protection against viruses with reported mutations
NEW YORK, NY, USA and MAINZ, Germany I December 14, 2020 I Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany. The study results demonstrate that BNT162b2 elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into the composite nature of BNT162b2-induced T cell immunity. The results were published on the preprint server MedRxiv and are available here. BNT162b2 is an investigational COVID-19 vaccine developed by Pfizer-BioNTech. It has been authorized for emergency use for individuals 16 years of age and older in several countries around the world.
“In parallel to working with regulators around the globe to make our vaccine available, we will continue to share important data from our ongoing studies with the global scientific community and the public in order to advance our collective understanding of the underlying vaccine mechanism of action,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “While there is a broad consensus that vaccines should induce antibody responses against the virus, experiences from the prior SARS pandemic indicate that CD8+ T cell responses may be of critical importance to achieve long-term protection.”
“These results from the ongoing German Phase 1/2 study help illustrate the multiple arms of the immune system that are activated to fight SARS-CoV-2 by the vaccine candidate BNT162b2. Advancing the understanding of the duration of antibody responses is critical as the global scientific community continues to look for potential vaccines to help overcome this pandemic,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “We continue to add to the body of scientific evidence supporting BNT162b2 and are pleased to see the consistency in our findings across studies.”.”
The ongoing non-randomized open-label Phase 1/2 trial (NCT04380701) is being conducted in Germany in parallel to the Phase 1/2/3 trial (NCT04368728) that started in the U.S. The German study evaluated the safety and immunogenicity of BNT162b2 in different dose cohorts (1 µg, 10 µg, 20 µg and 30 µg) with 11-12 participants per cohort. BNT162b2 was administered in two doses 21 days apart to healthy adults between 18 and 55 years of age.
Overall, these results mirror those from the U.S. study (NCT04368728) that were previously published, and support the favorable safety profile and robust induction of virus-specific antibody responses. A longer follow-up period of 85 days showed sustained neutralizing antibody titers in the range of, or above, those in convalescent sera cohort. BNT162b2 immune sera efficiently neutralized 19 pseudo-viruses, indicating the potential for broad BNT162b2-elicited protection against reported mutations.
All 37 participants vaccinated with BNT162b2 showed newly generated spike protein-specific CD4+ T cell responses, and almost 92% of participants demonstrated CD8+ T cell responses. The majority were strong T cell responses comparable to or significantly higher than memory responses of the same individuals against common viruses, such as cytomegalovirus (CMV), Epstein Barr virus (EBV) and the influenza virus. Even with the lowest dose of 1 µg BNT162b2, most of the vaccinated participants elicited robust expansion of CD4+ and CD8+ T cells. Expression of cytokines IFNγ and IL-2, but only low levels of IL-4 in BNT162b2-induced CD4+ T cells indicated a TH1 profile. CD8+ T cell responses were directed against multiple regions of the spike protein, and several of the multiple epitopes recognized by BNT162b2-induced CD8+ T cells were molecularly identified.
Effectors of the adaptive immune system have complementary roles in defense against viral infections. While neutralizing antibodies are the first line of defense, CD8+ T cells contribute to virus clearance from intracellular compartments that are inaccessible to neutralizing antibodies. Antigen-specific CD4+ T cells have immune orchestrating functions, including support of memory generation. Therefore, detailed characterization of the cellular immune responses will be important in understanding the mechanisms contributing to protection against SARS-CoV-2.
As of today, BNT162b2, Pfizer-BioNTech Covid-19 vaccine candidate, has been authorized or approved for emergency use for individuals 16 years of age and older in the U.S, U.K., Bahrain, Canada, Saudi Arabia, and Mexico. Pfizer and BioNTech have submitted a final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.
U.S. AUTHORIZED USE:
The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
U.S. IMPORTANT SAFETY INFORMATION:
- Do not administer Pfizer BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer BioNTech COVID-19 Vaccine
- Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer BioNTech COVID-19 Vaccine
- Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer BioNTech COVID-19 Vaccine
- The Pfizer BioNTech COVID-19 Vaccine may not protect all vaccine recipients
- In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
- Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
- Available data on Pfizer BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
- Data are not available to assess the effects of Pfizer BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
- There are no data available on the interchangeability of the Pfizer BioNTech COVID 19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer BioNTech COVID-19 Vaccine should receive a second dose of Pfizer BioNTech COVID-19 Vaccine to complete the vaccination series
- Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
- Vaccination Providers should review the Fact Sheet for mandatory requirements and Information to Provide to Vaccine Recipients/Caregivers and the Full EUA Prescribing Information for Requirements and Instructions for Reporting Adverse Events and Vaccine Administration Errors
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.
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 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
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. For more information, please visit www.BioNTech.de.
SOURCE: Pfizer
Post Views: 98
- Analysis of 37 participants immunized with BNT162b2 showed a broad immune response with SARS-CoV-2-specific neutralizing antibodies, TH1 type CD4+ T cells, and strong expansion of CD8+ T cells of the early effector memory phenotype
- All vaccinated participants demonstrated neutralizing antibody as well as T cell responses. T cell responses were directed against multiple regions of the spike protein, including the RBD, suggesting immune recognition of multiple independent epitopes
- Data confirm previous findings from the U.S. trial demonstrating a good safety profile and robust induction of antibody responses with a longer follow-up period of 85 days
- Antibodies generated in trial subjects were able to neutralize pseudo-viruses representing 19 diverse SARS-CoV-2 variants, indicating potential for broad protection against viruses with reported mutations
NEW YORK, NY, USA and MAINZ, Germany I December 14, 2020 I Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany. The study results demonstrate that BNT162b2 elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into the composite nature of BNT162b2-induced T cell immunity. The results were published on the preprint server MedRxiv and are available here. BNT162b2 is an investigational COVID-19 vaccine developed by Pfizer-BioNTech. It has been authorized for emergency use for individuals 16 years of age and older in several countries around the world.
“In parallel to working with regulators around the globe to make our vaccine available, we will continue to share important data from our ongoing studies with the global scientific community and the public in order to advance our collective understanding of the underlying vaccine mechanism of action,” said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. “While there is a broad consensus that vaccines should induce antibody responses against the virus, experiences from the prior SARS pandemic indicate that CD8+ T cell responses may be of critical importance to achieve long-term protection.”
“These results from the ongoing German Phase 1/2 study help illustrate the multiple arms of the immune system that are activated to fight SARS-CoV-2 by the vaccine candidate BNT162b2. Advancing the understanding of the duration of antibody responses is critical as the global scientific community continues to look for potential vaccines to help overcome this pandemic,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “We continue to add to the body of scientific evidence supporting BNT162b2 and are pleased to see the consistency in our findings across studies.”.”
The ongoing non-randomized open-label Phase 1/2 trial (NCT04380701) is being conducted in Germany in parallel to the Phase 1/2/3 trial (NCT04368728) that started in the U.S. The German study evaluated the safety and immunogenicity of BNT162b2 in different dose cohorts (1 µg, 10 µg, 20 µg and 30 µg) with 11-12 participants per cohort. BNT162b2 was administered in two doses 21 days apart to healthy adults between 18 and 55 years of age.
Overall, these results mirror those from the U.S. study (NCT04368728) that were previously published, and support the favorable safety profile and robust induction of virus-specific antibody responses. A longer follow-up period of 85 days showed sustained neutralizing antibody titers in the range of, or above, those in convalescent sera cohort. BNT162b2 immune sera efficiently neutralized 19 pseudo-viruses, indicating the potential for broad BNT162b2-elicited protection against reported mutations.
All 37 participants vaccinated with BNT162b2 showed newly generated spike protein-specific CD4+ T cell responses, and almost 92% of participants demonstrated CD8+ T cell responses. The majority were strong T cell responses comparable to or significantly higher than memory responses of the same individuals against common viruses, such as cytomegalovirus (CMV), Epstein Barr virus (EBV) and the influenza virus. Even with the lowest dose of 1 µg BNT162b2, most of the vaccinated participants elicited robust expansion of CD4+ and CD8+ T cells. Expression of cytokines IFNγ and IL-2, but only low levels of IL-4 in BNT162b2-induced CD4+ T cells indicated a TH1 profile. CD8+ T cell responses were directed against multiple regions of the spike protein, and several of the multiple epitopes recognized by BNT162b2-induced CD8+ T cells were molecularly identified.
Effectors of the adaptive immune system have complementary roles in defense against viral infections. While neutralizing antibodies are the first line of defense, CD8+ T cells contribute to virus clearance from intracellular compartments that are inaccessible to neutralizing antibodies. Antigen-specific CD4+ T cells have immune orchestrating functions, including support of memory generation. Therefore, detailed characterization of the cellular immune responses will be important in understanding the mechanisms contributing to protection against SARS-CoV-2.
As of today, BNT162b2, Pfizer-BioNTech Covid-19 vaccine candidate, has been authorized or approved for emergency use for individuals 16 years of age and older in the U.S, U.K., Bahrain, Canada, Saudi Arabia, and Mexico. Pfizer and BioNTech have submitted a final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.
U.S. AUTHORIZED USE:
The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
U.S. IMPORTANT SAFETY INFORMATION:
- Do not administer Pfizer BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer BioNTech COVID-19 Vaccine
- Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer BioNTech COVID-19 Vaccine
- Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer BioNTech COVID-19 Vaccine
- The Pfizer BioNTech COVID-19 Vaccine may not protect all vaccine recipients
- In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
- Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials. Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine
- Available data on Pfizer BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
- Data are not available to assess the effects of Pfizer BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
- There are no data available on the interchangeability of the Pfizer BioNTech COVID 19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer BioNTech COVID-19 Vaccine should receive a second dose of Pfizer BioNTech COVID-19 Vaccine to complete the vaccination series
- Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
- Vaccination Providers should review the Fact Sheet for mandatory requirements and Information to Provide to Vaccine Recipients/Caregivers and the Full EUA Prescribing Information for Requirements and Instructions for Reporting Adverse Events and Vaccine Administration Errors
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.
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 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
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. For more information, please visit www.BioNTech.de.
SOURCE: Pfizer
Post Views: 98
