BioNTech signed up to work with Fosun to bring a COVID-19 vaccine to China in March. The deal, which is worth up to $135 million, led to Fosun registering a phase 1 trial of mRNA vaccine BNT162b1 with the Chinese authorities in July. Less than one week later, BioNTech and its global partner Pfizer selected BNT162b2 as the candidate to take forward into phase 2/3.
Now, Fosun Chief Medical Officer Aimin Hui has told Reuters that BNT162b2 is also the preferred shot for the Chinese market. Fosun has opted against further development of BNT162b1, choosing instead to run a bridging study that may enable it to use global BNT162b2 data to support approval in China.
Chinese authorities have become more accepting of data generated overseas in recent years. If all goes to plan, the bridging study will enable Fosun to show the safety and efficacy seen in the global program is applicable to the Chinese population and win approval “around the same time” as the vaccine is authorized in other countries.
The switch to BNT162b2 could provide benefits. BioNTech and Pfizer selected the vaccine as their phase 2/3 candidate, despite it entering the clinic second, after linking it to a lower rate of adverse events than BNT162b1.
Only 4.3% of the global phase 3 trial participants recruited by the US firm were Asian, while the efficacy rate for the diverse ethnic group was 74.4%. ... As we saw when Pfizer provided data on various ethnicities from its efficacy study, its mRNA vaccine had 74% efficacy among Asians and not the 95% seen overall.Dec 11, 2020
https://www.reuters.com/article/us-health-coronavirus-biontech-fosunphar-idUSKBN2850ZZ
Fosun follows BioNTech in changing COVID-19 vaccine, plans bridging study for Chinese filinghttps://www.fiercebiotech.com/biotech/fosun-follows-biontech-changing-covid-19-vaccine-plans-bridging-study-for-chinese-filing
BioNTech signed up to work with Fosun to bring a COVID-19 vaccine to China in March. The deal, which is worth up to $135 million, led to Fosun registering a phase 1 trial of mRNA vaccine BNT162b1 with the Chinese authorities in July. Less than one week later, BioNTech and its global partner Pfizer selected BNT162b2 as the candidate to take forward into phase 2/3.
Now, Fosun Chief Medical Officer Aimin Hui has told Reuters that BNT162b2 is also the preferred shot for the Chinese market. Fosun has opted against further development of BNT162b1, choosing instead to run a bridging study that may enable it to use global BNT162b2 data to support approval in China.
Chinese authorities have become more accepting of data generated overseas in recent years. If all goes to plan, the bridging study will enable Fosun to show the safety and efficacy seen in the global program is applicable to the Chinese population and win approval “around the same time” as the vaccine is authorized in other countries.
The switch to BNT162b2 could provide benefits. BioNTech and Pfizer selected the vaccine as their phase 2/3 candidate, despite it entering the clinic second, after linking it to a lower rate of adverse events than BNT162b1.
Only 4.3% of the global phase 3 trial participants recruited by the US firm were Asian, while the efficacy rate for the diverse ethnic group was 74.4%. ... As we saw when Pfizer provided data on various ethnicities from its efficacy study, its mRNA vaccine had 74% efficacy among Asians and not the 95% seen overall.Dec 11, 2020
https://www.livemint.com/science/news/covid-19-vaccine-pfizer-trial-lacks-asian-data-11607709392123.html?
当时接受的看法是数据不足：
Pfizer clinical trial for Covid-19 vaccine lacks sufficient data on Asians: Report
Read more at: https://www.deccanherald.com/science-and-environment/pfizer-clinical-trial-for-covid-19-vaccine-lacks-sufficient-data-on-asians-report-926533.html