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Chinese city to offer COVID-19 vaccine candidate as emergency use expands

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Plans Made To Infect Humans With Coronavirus To Speed Up Vaccine Development

"Protecting older people is a key aim of a successful COVID-19 vaccine as this age group is at greater risk of severe illness from the disease", says study author Xiaoming Yang, from the Beijing Institute of Biological Products Company Limited, which is developing the BBIBP-CorV vaccine in affiliation with Sinopharm, a Chinese pharmaceutical company.

Dr Chris Chiu, from Imperial College London and lead researcher on the human challenge study, said: "Our number one priority is the safety of the volunteers".

But even if they are needed, "human challenge trials would not replace Phase 3 trials" of COVID-19 vaccines, according to a September statement from NIH that said standard, rigorous studies were its priority.

The government has said it will initially invest £33.6m in the studies, although the research will need to be approved by regulators and the ethics committee before they can go ahead.

"Deliberately infecting volunteers with a known human pathogen is never undertaken lightly", said Peter Openshaw, co-investigator of the research.

It comes with a 33.6 million pound investment for experts from the National Health Service (NHS), academia and the private sector to join forces to make the United Kingdom among the first countries in the world to explore and establish human challenge trials to accelerate the development of a COVID-19 vaccine.

While the challenge study may come too late to accelerate vaccine development, it could also arrive too early for the liking of some people. Officials at the briefing didn't provide details of how people who receive vaccines under the emergency-use program are being monitored.

But that has since been widened to include employees of state-owned companies, and the government is also considering offering experimental jabs to students heading overseas to study. However, proponents say they can speed up vaccine development and, ultimately, save lives.

The researchers would use the results to study how vaccines might work and to explore potential treatments.

"The UK's experience and expertise in human challenge trials as well as in wider COVID-19 science will help us tackle the pandemic, benefiting people in the UK and worldwide".

Pending approval, the process will start in January at a London hospital.

Business Secretary Alok Sharma said the trials would be carefully controlled and marked an important next step in building understanding of the virus and accelerating vaccine development.

Volunteers will be monitored for up to a year after participating in the study to ensure their long-term well-being.

In an October 20 statement to TIME, NIAID officials said the agency is "currently prioritizing randomized controlled clinical trials to evaluate the safety and efficacy of SARS-CoV-2 vaccine candidates". The approach, called a human challenge trial (HCT), is not unheard of, as similar trials take place in the USA each year involving the influenza virus. "Challenge trials will be key to making multiple safe and effective COVID-19 vaccines available for the whole world, including those in low-income countries bearing the brunt of this pandemic".

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