Sunday, September 13, 2020

Covid-19 Vaccine Update

Two vaccines, developed by China National Biotec Group (CNBG) – and presently undergoing Phase 3 clinical trials – are expected to enter the market as soon as this December, according to a CGTN news report today. 

Already, the two vaccine candidates, together with another one developed by Beijing-based Sinovac, have been approved for civilian emergency use after reliable results in Phase 1 and Phase 2 trials. 

"We've drawn up a series of plan packages, including medical consent forms, side-effects monitoring plans, rescuing plans, compensation plans, to make sure the emergency use is well regulated and monitored", Zheng Zhongwei (right), head of China's coronavirus vaccine development task force said. 

An emergency use authorization, which is based on Chinese vaccine management law, allows unapproved vaccine candidates to be used among "high-risk" groups, such as health workers, diplomats, and people who travelled to foreign countries still struggling with the pandemic, to be vaccinated. The emergency program began in late July and thus far, there has been no reported cases of infection or adverse effects. 

Similar authorizations have been adopted in many countries. For example, US Food and Drug Administration issued an emergency use authorization on August 23, 2020 for investigational convalescent plasma on hospitalized patients in the treatment of Covid-19. 

It is part of the agency's ongoing efforts to fight the disease. Based on scientific evidence available, the FDA had concluded this product may be effective in treating Covid-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product. 

And trials of the Covid-19 vaccine being developed by Oxford University and AstraZeneca will restart after being paused due to a reported side effect in a patient in the UK. 

Information about the patient's illness hadn’t been disclosed for confidentiality reasons – but the New York Times reported that the volunteer in the UK trial had been diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and can be caused by viral infections. 

The University announced the resumption on Saturday following the recommendations of an independent safety review committee and the UK regulator, the Medicines and Healthcare products Regulatory Agency. 

According to WHO, nearly 180 vaccine candidates are now being tested around the world although none has yet completed clinical trials.

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