https://www.fda.gov/media/144859/download
Here's a snippet from the FOOD AND DRUG ADMINISTRATION (FDA) Center for Biologics Evaluation and Research (CBER) 162nd Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting
DR. WILLIAM GRUBER: Thank you, Kathrin. It's
9 my pleasure to share with you today the development
10 program for our vaccine candidate BNT162b2. I'm going
11 to begin with a very brief summary of the non-clinical
12 data that encouraged us to move forward into the
13 clinic. This includes both toxicity studies as well as
14 a study looking at a challenge study in Rhesus-
15 Macaques. These studies are described in the briefing
16 documents.
17 Two toxicity studies in rats, including the
18 BNT162b2 vaccine construct, were completed with no
19 safety concerns. Development and reproductive toxicity
20 studies are ongoing with preliminary results available
205
www.transcriptionetc.com
1 by mid-December. In a SARS-CoV-2 Rhesus challenge
2 model, the BNT162b2 construct provided complete
3 protection in the lungs as determined by nucleic acid
4 amplification testing for SARS-CoV-2 and
5 bronchoalveolar lavage fluid. This information is now
6 published. And importantly, there was no radiologic or
7 histopathologic evidence of vaccine-elicited disease
8 enhancement.
9 Despite limitations of animal models, these
10 findings anticipated results in our Phase 3 clinical
11 trial in which there is no evidence of enhanced
12 disease. These results were encouraging, satisfied FDA
13 guidance criteria, and permitted progression of human
14 clinical trials. I'm now going to share with you the
15 clinical safety, immunogenicity, and efficacy data from
16 our overall clinical development program.
17 First, I will cover safety and immune response
18 from the German and U.S. studies and then cover aspects
19 of the Phase 2/3 trial finishings with the safety and
20 efficacy results. So let's begin with the two Phase 1
206
www.transcriptionetc.com
1 studies. The German Phase 1 dose-ranging study was
2 conducted in individuals 18 to 55 years of age. 12
3 subjects received the active BNT162b2 vaccine for each
4 dose level cohort. This study evaluated safety,
5 binding, and neutralizing antibody responses, as well
6 as cell-mediated immune response to look for the
7 potential for Th 1-biased, CD4, and CD8 T Cell
8 responses.
9 The U.S. study is a seamless study where we
10 have a Phase 1 portion that moved into Phase 2 and then
11 Phase 3. For the Phase 1 dose-ranging portion, we
12 included 18 to 55 and 65 to 85-year-old individuals.
13 Twelve of whom received vaccine and 3 received placebo
14 per dose-level cohort. We looked at safety and
15 immunogenicity with both binding and neutralizing
16 antibody responses and followed reactogenicity by
17 electronic diary.
18 These individuals will continue to be followed
19 for a full two years after the second dose. The
20 results from the Phase 1 experience have now been www.transcriptionetc.com
207
1 published and you have details in your briefing
2 documents.
Is it common that trails have such few participants? Also stated in the linked transcript is that the manufacturing process can not be disclosed since it's proprietary.
Here's a snippet from the FOOD AND DRUG ADMINISTRATION (FDA) Center for Biologics Evaluation and Research (CBER) 162nd Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting
DR. WILLIAM GRUBER: Thank you, Kathrin. It's
9 my pleasure to share with you today the development
10 program for our vaccine candidate BNT162b2. I'm going
11 to begin with a very brief summary of the non-clinical
12 data that encouraged us to move forward into the
13 clinic. This includes both toxicity studies as well as
14 a study looking at a challenge study in Rhesus-
15 Macaques. These studies are described in the briefing
16 documents.
17 Two toxicity studies in rats, including the
18 BNT162b2 vaccine construct, were completed with no
19 safety concerns. Development and reproductive toxicity
20 studies are ongoing with preliminary results available
205
www.transcriptionetc.com
1 by mid-December. In a SARS-CoV-2 Rhesus challenge
2 model, the BNT162b2 construct provided complete
3 protection in the lungs as determined by nucleic acid
4 amplification testing for SARS-CoV-2 and
5 bronchoalveolar lavage fluid. This information is now
6 published. And importantly, there was no radiologic or
7 histopathologic evidence of vaccine-elicited disease
8 enhancement.
9 Despite limitations of animal models, these
10 findings anticipated results in our Phase 3 clinical
11 trial in which there is no evidence of enhanced
12 disease. These results were encouraging, satisfied FDA
13 guidance criteria, and permitted progression of human
14 clinical trials. I'm now going to share with you the
15 clinical safety, immunogenicity, and efficacy data from
16 our overall clinical development program.
17 First, I will cover safety and immune response
18 from the German and U.S. studies and then cover aspects
19 of the Phase 2/3 trial finishings with the safety and
20 efficacy results. So let's begin with the two Phase 1
206
www.transcriptionetc.com
1 studies. The German Phase 1 dose-ranging study was
2 conducted in individuals 18 to 55 years of age. 12
3 subjects received the active BNT162b2 vaccine for each
4 dose level cohort. This study evaluated safety,
5 binding, and neutralizing antibody responses, as well
6 as cell-mediated immune response to look for the
7 potential for Th 1-biased, CD4, and CD8 T Cell
8 responses.
9 The U.S. study is a seamless study where we
10 have a Phase 1 portion that moved into Phase 2 and then
11 Phase 3. For the Phase 1 dose-ranging portion, we
12 included 18 to 55 and 65 to 85-year-old individuals.
13 Twelve of whom received vaccine and 3 received placebo
14 per dose-level cohort. We looked at safety and
15 immunogenicity with both binding and neutralizing
16 antibody responses and followed reactogenicity by
17 electronic diary.
18 These individuals will continue to be followed
19 for a full two years after the second dose. The
20 results from the Phase 1 experience have now been www.transcriptionetc.com
207
1 published and you have details in your briefing
2 documents.
Is it common that trails have such few participants? Also stated in the linked transcript is that the manufacturing process can not be disclosed since it's proprietary.
