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Sinopharm’s COVID-19 vaccine scores approval in China

Vaccine found to be 79% effective in top-line results

COVID vaccine

China’s state-owned pharmaceutical company Sinopharm has scored approval from Chinese health authorities after reporting a 79% efficacy rate in phase 3 trials.

The vaccine has been granted a conditional marketing approval, after 60,000 volunteers took part in phase 3 clinical trials across China, UAE and Bahrain.

Last week, the company said that the vaccine’s ‘protective efficacy’ against COVID-19 was 79.34%, slightly less than the previously reported efficacy rate of 86% in UAE.

In a separate statement, published on 2 January, Sinopharm added that “because the standards of diagnosis of infection cases and review process of phase 3 clinical trials vary in different countries, the 86% efficacy rate announced by UAE and 79.34% by China are both real and valid”.

The efficacy rate of other COVID-19 vaccines, namely those developed by Moderna and Pfizer/BioNTech, have reported particular high efficacy rates of 94.1% and 95%, respectively.

AstraZeneca/Oxford University’s jab, which was recently approved in the UK, has a rate similar to Sinopharm’s vaccine, reporting a 70.4% efficacy rate in phase 3 trials.

“After a series of strict reviews, verification, test and data analysis in accordance with the law and procedures, it is concluded that the known and potential benefits of Sinopharm's new inactivated coronavirus vaccine are bigger than the known and potential risks, and it fully meets the pre-set requirements of conditional marketing standards," said Chen Shifei, deputy commissioner of China's National Medical Products Administration.

Another vaccine, currently being developed by Chinese biotech Sinovac, produced neutralising antibodies in a mid-stage trial, according to results published in The Lancet Infectious Diseases last November.

The trial researchers found that a more robust antibody response against COVID-19 was generated and ‘longer persistence’ could be expected in the day 0 and 28 vaccination schedule compared to the day 0 and 14 schedule.

However, the study also found that the level of neutralising antibodies induced by the vaccine at day 28 was lower than that seen in patients who had recovered from COVID-19.

The researchers maintained that the vaccine could still provide ‘satisfying protection’ against COVID-19. This conclusion was based on researchers’ previous experience with other vaccines and preclinical data involving macaques.

Despite the range of efficacy rates observed across the various COVID-19 vaccines, each respective jab has succeeded in surpassing the bar for flu vaccines, which can be approved at only 50% efficacy.

Article by
Lucy Parsons

4th January 2021

From: Regulatory



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