Chinas

health

China’s Fosun to seek approval for BioNTech’s COVID-19 second vaccine, ends trials on first

SUZHOU, China (Reuters) – BioNTech’s Chinese partner Shanghai Fosun Pharmaceutical Group does not plan to run further clinical trials of the German firm’s coronavirus vaccine candidate that has completed early-stage trials in China, an executive said.

Fosun will focus instead on seeking Chinese approval for BioNTech’s other experimental vaccine which is in final-stage human trials in the United States, Fosun’s Chief Medical Officer Hui Aimin told Reuters in an interview.

The vaccine candidate developed by BioNTech and U.S. drugmaker Pfizer Inc is under real-time regulatory review in Europe and could seek emergency use authorisation in the United States after enough safety data is provided as early as this month.

But the candidate known as BNT162b2 missed an earlier window to be tested in China, as Fosun had rushed into Phase 1 trials of a slightly less satisfactory candidate, BNT162b1, before early trials data overseas showed BNT162b2 is safer.

Hui said he did not regret testing BNT162b1 without waiting for more complete data.

“For ordinary vaccines, it does not matter if you wait for a few days, or a month,” Hui said. “But for (COVID-19 vaccines), how many more people would have died had you waited just for one day?”

Hui said Fosun was applying for a bridge study for BNT162b2, designed to evaluate whether the large trial data gathered overseas could be extrapolated to the populace of China.

A bridge clinical trial is required for pharmaceutical products which are approved abroad but do not have data to show that ethnic differences can affect their efficacy and safety, China’s National Medical Products Administration said.

Hui expected the late-stage candidate could be greenlighted for use in China “around the same time” as the vaccine’s global clearance.

Fosun is licensed to exclusively develop and commercialize COVID-19 vaccine products developed by using BioNTech’s mRNA technology in mainland China, Hong Kong, Macau and Taiwan. In return it agreed to pay up to $85 million in licensing fees and invest $50 million for a stake in the German firm.

(Reporting by Roxanne Liu in Suzhou and Tony Monroe in Beijing; Editing by Miyoung Kim, Stephen Coates and Raju Gopalakrishnan)

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China’s Fosun to end BioNTech’s COVID-19 vaccine trial, seek approval for another

SUZHOU, China (Reuters) – BioNTech’s Chinese partner Shanghai Fosun Pharmaceutical Group does not plan to run further clinical trials of the German firm’s coronavirus vaccine candidate that has completed early-stage trials in China, an executive said.

Fosun will focus instead on seeking Chinese approval for BioNTech’s other experimental vaccine which is in final-stage human trials in the United States, Fosun’s Chief Medical Officer Hui Aimin told Reuters in an interview.

The vaccine candidate developed by BioNTech and U.S. drugmaker Pfizer Inc is under real-time regulatory review in Europe and could seek emergency use authorisation in the United States shortly after enough safety data is provided as early as this month.

But the candidate known as BNT162b2 missed an earlier window to be tested in China, as Fosun had rushed into Phase 1 trials of a slightly less satisfactory candidate, BNT162b1, before early trials data overseas showed BNT162b2 is safer.

Hui said he did not regret testing BNT162b1 without waiting for more complete data. “For ordinary vaccines, it does not matter if you wait for a few days, or a month,” Hui said. “But for (COVID-19 vaccines), how many more people would have died had you waited just for one day?” Hui said Fosun was applying for a bridge study for BNT162b2, designed to evaluate whether the large trial data gathered overseas could be extrapolated to the populace of China.

A bridge clinical trial is required for pharmaceutical products which are approved abroad but do not have data to show that ethnic differences can affect their efficacy and safety, China’s National Medical Products Administration said.

Hui expected the late-stage candidate could be greenlighted for use in China “around the same time” as the vaccine’s global clearance.

(Reporting by Roxanne Liu in Suzhou and Tony Monroe in Beijing; Editing by Miyoung Kim and Stephen Coates)

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Frozen Food Package Polluted by Living Coronavirus Could Cause Infection, China’s CDC Says | Top News

BEIJING (Reuters) – China’s disease control authority said on Saturday that contact with frozen food packaging contaminated by living new coronavirus could cause infection.

The conclusion came as the Chinese Center for Disease Control and Prevention (CDC) detected and isolated living coronavirus on the outer packaging of frozen cod during efforts to trace the virus in an outbreak reported last week in the city of Qingdao, the agency said on its website.

The finding, a world first, suggests it is possible for the virus to be conveyed over long distances via frozen goods, it said.

Two dock workers in Qingdao who were initially diagnosed as asymptomatic infections in September brought the virus to a chest hospital during quarantine due to insufficient disinfection and protection, leading to another 12 infections linked to the hospital, authorities said last week.

However, the CDC’s latest statement does not show solid proof that the two workers in Qingdao caught the virus from the packaging directly, rather than contracting the virus from somewhere else and then contaminating the food packaging they handled, said Jin Dong-Yan, a virology professor at the University of Hong Kong.

The CDC said no instance had been found of any consumer contracting the virus by having contact with frozen food and the risk of this happening remained very low.

Nonetheless it advised that workers who handle, process and sell frozen products should avoid direct skin contact with products that could possibly be polluted.

Staff should not touch their mouth or nose before taking off work garments that could possibly be contaminated without washing their hands and should take tests regularly, the agency said.

Prior to the CDC’s latest findings genetic traces of the virus had been found in some samples taken from frozen food or food packaging, but the amount of virus was low and no living virus was isolated, the agency said.

Only living virus can infect people, while samples containing dead virus could also test positive for virus traces, Jin said.

(Reporting by Roxanne Liu and Tony Munroe; Editing by David Holmes)

Copyright 2020 Thomson Reuters.

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Frozen food package polluted by living coronavirus could cause infection, China’s CDC says

BEIJING (Reuters) – China’s disease control authority said on Saturday that contact with frozen food packaging contaminated by living new coronavirus could cause infection.

The conclusion came as the Chinese Center for Disease Control and Prevention (CDC) detected and isolated living coronavirus on the outer packaging of frozen cod during efforts to trace the virus in an outbreak reported last week in the city of Qingdao, the agency said on its website.

The finding, a world first, suggests it is possible for the virus to be conveyed over long distances via frozen goods, it said.

Two dock workers in Qingdao who were initially diagnosed as asymptomatic infections in September brought the virus to a chest hospital during quarantine due to insufficient disinfection and protection, leading to another 12 infections linked to the hospital, authorities said last week.

However, the CDC’s latest statement does not show solid proof that the two workers in Qingdao caught the virus from the packaging directly, rather than contracting the virus from somewhere else and then contaminating the food packaging they handled, said Jin Dong-Yan, a virology professor at the University of Hong Kong.

The CDC said no instance had been found of any consumer contracting the virus by having contact with frozen food and the risk of this happening remained very low.

Nonetheless it advised that workers who handle, process and sell frozen products should avoid direct skin contact with products that could possibly be polluted.

Staff should not touch their mouth or nose before taking off work garments that could possibly be contaminated without washing their hands and should take tests regularly, the agency said.

Prior to the CDC’s latest findings genetic traces of the virus had been found in some samples taken from frozen food or food packaging, but the amount of virus was low and no living virus was isolated, the agency said.

Only living virus can infect people, while samples containing dead virus could also test positive for virus traces, Jin said.

(Reporting by Roxanne Liu and Tony Munroe; Editing by David Holmes)

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