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Covid-19: What do we know about China’s Sinopharm vaccine?

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Covid-19: What do we know about China’s Sinopharm vaccine?

Mauritius has received 100,000 Sinopharm vaccines against Covid-19 from Sinopharm, a donation from the Chinese government, Tuesday 13th of April. The 100,000 doses of the Sinopharm vaccine will guarantee the inoculations of 50,000 Mauritians, given that the vaccine comes in two doses. The administration of the Chinese vaccine is expected to start this Friday 16th of April. 

Sinopharm, a Chinese state-owned company, is developing two vaccines, one of which Mauritius will be given 100,000 doses as a donation from the Chinese government. The vaccine in question is the BBIBP-CorV, an inactivated vaccine also known as Sinopharm (Beijing). It was China’s first Covid-19 vaccine to receive conditional approval for the country’s domestic market on the 31st December 2020.  

Interim analysis of the Phase III clinical trials has reported the vaccine to be 79% efficient against Covid-19, but another interim analysis of UAE’s clinical trial had shown that the vaccine was 86% efficient. The detailed results of their Phase III trial is yet to be published by the company. Meanwhile the Phase III clinical trials are still ongoing in the UAE, and so far 30 countries have already approved of the Sinopharm (Beijing) vaccine, namely Argentina, Bahrain, Belarus, Bolivia, Brunei Darussalam, Cambodia, China, Egypt, Equatorial Guinea, Gabon, Guyana, Hungary, Iran (Islamic Republic of), Iraq, Jordan, Lao People’s Democratic Republic, Maldives, Montenegro, Morocco, Mozambique, Namibia, Nepal, Pakistan, Peru, Senegal, Serbia, Seychelles. United Arab Emirates, Venezuela (Bolivarian Republic of), and Zimbabwe.

According to Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial, published by The Lancet, the BBIBP-CorV inactivated vaccine, given as a two-dose immunisation, was deemed safe and well tolerated at all three doses in both age groups. A robust humoral immune response was observed in 100% of vaccine recipients. 

Preclinical studies had also shown that immunisation with Sinopharm (Beijing) vaccine can indulge high levels of neutralising antibody titres in mice, rats, guinea pigs, and non-human primates to provide protection against the Covid-19.

The most common adverse reactions in human recipients were pain and fever, which were reported in small proportions of vaccine recipients and with no significant difference across the groups. All adverse events were mild or moderate in severity. 

Experts views on Sinopharm (Beijing) vaccine after it obtained conditional approval for China’s domestic market

In an interview with Reuters, Song Dae-Sub, Professor of College of Pharmacy at Korea University in Seoul, an international expert on virology said: “There was no paper presented, which makes it hard to accept at face value, but an efficacy of 79% sounds rather realistic, rather than an idealistic-sounding 95% effectiveness in mRNA based vaccines.”

Paul Griffin, Professor and Infectious Diseases Physician and Microbiologist at the University of Queensland said: “A conditional approval like this obviously very much contingent on the on-going clinical trial results as well as the close-up observation of the people who were receiving the vaccine. I think it’s acceptable, but it’s really important for people to understand that for conditionally approved, there’s further research currently under way.

“Most countries’ regulatory systems are fairly independent, so receiving approval elsewhere doesn’t necessarily guarantee approval in each individual country. Most countries will still have their own process to be applied. But the fact that it has gotten to the stage where it has received its approval is certainly positive in that, provided the data reviewed by other countries demonstrates what we think we knew already, it’s very likely it could be approved elsewhere as well.”

Meanwhile in an interview with Defimedia, Dr Laurent Musango, WHO’s representative in Mauritius, announced that Sinopharm’s vaccine as well as Covaxin and Sputnik V will be homologated by the WHO in the coming days. It is to be noted that the Sinopharm (Beijing) vaccine was approved for general public use in China on the 31st of December 2020 and its approval is expected in April 2021 which is after 4 months.

Timeline of the Sinopharm (Beijing) Vaccine

  • January 2020: Sinopharm (Beijing) starts developing an inactivated vaccine against Covid-19
  • June 2020: Researchers announce the vaccine has started to show promising results in non-human primates. The Phase 1 and 2 clinical trials are published by the Lancet and no severe side effects were reported. It was also noted that the candidates were able to make antibodies against Covid-19.
  • July 2020: Phase 3 of the clinical trials starts in the UAE
  • August 2020: Morocco and Peru start Phase 3 clinical trials
  • 14th September 2020: UAE announces emergency approval for the use of the vaccine against Covid-19
  • November 2020: The chairman of Sinopharm reports that almost one million people in China received the Sinopharm (Beijing) vaccine. 
  • 9th December 2020: The UAE approves fully of the vaccine announcing that it has an efficacy rate of 86%. However no details were given as to how it reached such a conclusion. 
  • 13th December 2020: Bahrain approves of the vaccine
  • December 2020: Sinopharm (Beijing) announces the vaccine efficacy to be 79.34%, which led to the approval of the vaccine by the Chinese government. Though the phase 3 clinical trial is yet to be published. 
  • January 2021: Egypt approves the vaccine for emergency use 
  • 13th April 2021: Mauritius receives 100,000 doses of the Sinopharm vaccine as a donation from the Chinese government.

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