After phase 2 positive result, sinovac plan for the vaccine trial in brazil

Covid-19 cases across the world are crossing about 7.5 million, including almost 400 thousand deaths, Sinovac Biotech Ltd, a NASDAQ listed company —is on the way of making observable progress with their invention for the vaccine. CoronaVac named SARS-CoV-2 Vaccine is based on an inactivated pathogen, a similar technology also used to for vaccination against polio.

Sinovac signed a contract with the Instituto Butantan, a Brazilian biologic research center, last week to run phase 3 of the vaccine in Brazil. In return, the Instituto Butantan gains license in its home country for the investigational shot. Sinovac and the Instituto Butantan will kick off the trial involving 9,000 people in July once approved by the Brazilian authorities.

Source: Sinovac

Dr. Dimas Covas, Director of Instituto Butantan commented on company press release, “This pandemic is having a tragic impact worldwide and this distinguished alliance with Sinovac to conduct the last phase of the clinical trials will bring hope to have a vaccine in the short term. Butantan expects to support not only on the clinical development, but also commercialization and manufacturing activities of CoronaVac in Brazil.”

Trial milestones:

  • On 17th April 2020, the Company has started the onset of  Phase I clinical trial, for its vaccine candidate against COVID-19. Enrollment of the first group of volunteers and the first dose of vaccination for these volunteers have been completed.
  • On 6th May 2020, the company announced the publication of the preclinical study on animals for its vaccine candidate against COVID-19. This is the first challenge of the application of SARS-CoV-2 vaccine on animals to show that the vaccine application is healthy and provides protection to rhesus macaques (monkeys).
  • On May 22nd 2020, the company received approval from China’s National Medical Products Administration (NMPA) to conduct both a phase 1 and phase 2 human clinical trials for CoronaVac in China.
  • On 11th June 2020, Brazilian officials announced an agreement with China’s Sinovac Biotech to produce its coronavirus vaccine in the state of Sao Paulo, where tests involving 9,000 volunteers are to begin in July 2020.
  • On 13th June 2020, the preliminary results of phase I / II clinical trial for the company’s COVID-19 vaccine, CoronaVac, showed good immunogenicity and safety profiles.

There were about 143 volunteers in Phase I, and 600 in Phase II. No adverse effects were found in any of Phase I or Phase II trials. The results of Phase II clinical trial showed that the vaccine induces neutralizing antibodies 14 days after the 14-day interval of vaccination. The seroconversion rate of the neutralizing antibody is above 90%, which concludes that the candidate of the vaccine can induce a positive immune response.

Advantech Capital and Vivo Capital have invested 15 million in Sinovac R&D for the development of an inactivated vaccine. In a press release, Weidong Yin, Chairman, President and CEO of Sinovac said, “Our proven track record of successful vaccination development has allowed us to make excellent progress on CoronaVac, our COVID-19 vaccine candidate, and the funding from Advantech Capital and Vivo Capital will provide us with the necessary resources to continue our work at this unprecedented pace.”

CoronaVac is one of the five vaccines which are developed in China against COVID-19 and all of them have qualified for clinical testing. CanSino Biologics’ adenovirus-based recombinant vaccine is at the top and it was the first vaccine to qualify for the phase 2 trial. Moreover, they are the first company to reveal human data in a peer-reviewed journal. State-run sinopharm also has two inactivated shots from the biological research institutes in Beijing and Wuhan. The Chinese Academy of Medical Sciences’ also reported about the inactivated vaccines.

“Thanks to the huge production capacity of units like CNBG, Sinopharm is able to produce 100 million vials of inactivated COVID-19 vaccines per year,” company said. Sinopharm ranks 169th on the Fortune Global 500 last year, and fourth among pharmaceutical companies.

Sinovac Biotech Ltd is a biopharmaceutical company that is mainly based on research, development, manufacture and commercialization of the vaccines that protect against the infectious diseases caused in humans. The company is located in Beijing, China.

Sinovac’s commercialized vaccines include:-

  • Healive for Hepatitis A
  • Bilive for combined hepatitis A and B virus
  • Panflu specific for the H5N1 strain of Influenza virus
  • PANFLU.1 for H1N1 strain of Influenza virus
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