by Ganesh Sahathevan
More from BioNTech's SEC filings:
On November 18, 2020, we and Pfizer announced that, after conducting the final efficacy analysis in our ongoing Phase 3 study, BNT162b2 met all of the study’s primary efficacy endpoints. In this pivotal Phase 3 trial of BNT162b2, there were over 44,000 participants who were 16 years and older, 21,720 of whom received the two-dose regimen of 30 μg BNT162b2, which was given 21 days apart, and 21,728 of whom received the placebo. Among 36,523 participants who had no evidence of existing or prior SARS-CoV-2 infection at the time of the immunizations, there were 170 cases of COVID-19 observed at least seven days after the second dose. Of these 170 cases of COVID-19, 162 cases occurred among placebo recipients and eight cases occurred in vaccine recipients, corresponding to 95.0% vaccine efficacy. Among participants with and without evidence of prior SARS CoV-2 infection, there were nine cases of COVID-19 among vaccine recipients and 169 among placebo recipients, corresponding to a 94.6% vaccine efficacy. The cumulative incidence of COVID-19 cases over time among placebo and vaccine recipients began to diverge by 12 days after the first dose, and 52.4% vaccine efficacy was observed between the first and second doses, indicating the early onset of a partially protective effect of immunization. Two doses of vaccine provide the maximum protection observed. Ten cases of severe COVID-19 were observed with onset after the first dose. Nine cases occurred among placebo recipients and one among BNT162b2 recipients.
Meanwhile government leaders everywhere, the latest being the NSW Premier Gladys Berejiklian, insist that all vaccines including the Pfizer BioNTech are working, for they prevent the severe cases that require hospitalisation. That is not what BioNTech claimed.
TO BE READ WITH
realpolitikasia
Monday, August 30, 2021
BioNTech's SEC disclosed risk factors include " limited regulatory experience with mRNA immunotherapies": Despite the warning, governments worldwide have insisted that they have the skills to evaluate, at record speed, the use of the Pfizer/BioNTech COVID vaccine
by Ganesh Sahathevan
More from BioNTech's SEC disclosures. Again, from 2020 Annual Report:
Saturday, August 28, 2021
Pfizer/ BioNTech warned investors that the durability of the immune response of its COVID vaccine had " not yet been demonstrated in clinical trials"-US SEC disclosure by BioNTech calls for investigation into Scott Morrison, Daniel Andrews, and Gladys Berekilian's promotion of Pfizer/ BioNTech
by Ganesh Sahathevan
Prime Minister Scott Morrison had his Covid jab in February 2021.
The developer of the Pfizer COVID vaccine, Comirnaty,
BioNTech SE has lodged documents at the US Securities and Exchange Commission (SEC), pursuant to US securities disclosure laws.
The documents include BioNTech SE's annual report for the year ended 31 December 2021 It includes this statement which is among a range of cautionary statements that the company is bound by law to alert investors to:
"......the durability of (the) immune response generated by our COVID-19 vaccine....has not yet been demonstrated in clinical trials........."
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