Wednesday, June 24, 2020

Finally it is china- Sinopharm vaccine-first phase 3 trial | October 2020


Chinese vaccine - Sinopharm- Phase III trial

The Wuhan Institute of Biological Products, affiliated with Sinopharm becomes the first vaccine candidate to show beneficial safety and immunogenicity in phase I/II  clinical trials. China National Pharmaceutical Group Sinopharm (Sinopharm) is to begin a phase III trial in UAE and it is the first Chinese vaccine candidate that conducts the overseas clinical trial.


During the Phase I trial, 180 volunteers have been vaccinated and recently in phase II trial, 1000 employees of Sinopharm have been vaccinated and it showed safe and effective with adverse effects far lower than other vaccine candidates, a statement given by Sinopharm's officials. Sinopharm's Beijing Institute of Biological Products claims that they have the capacity to 20 million doses of the vaccine a year, while the company's institute in Wuhan will be capable of producing 100 million doses annually.


13 Experimental vaccines have entered human clinical trials and more than 120 others are in the earlier stage of development. 3 vaccine makers are set to race up as they are to enter later clinical trials. They are U.S-Moderna, China-Sinovac Biotech, UK’s Oxford-AstraZeneca. Among the vaccine candidates, china has six vaccine developmental projects that are undergoing human trials.

Top Candidate’s for COVID-19 Vaccine

1.         Oxford- AstraZeneca vaccine (PhaseII/III)

This collaborative  Vaccine project between  AstraZeneca and the University of Oxford, the AZD122 vaccine based on chimpanzee adenovirus called ChAdOx1 is to begin phase II/III testing in the UK and brazil. AstraZeneca has already begun for mass production of vaccines and plans to produce 2 billion doses by September.

2.         Moderna vaccine (phaseII)

This US-based firm is developing a messenger RNA based vaccine, its mRNA-1273 vaccine is set to begin testing on 30,000 people by July and this firm expects that the vaccine would be available by early 2021.

3.         Pfizer-BNTECH vaccine (PhaseII)
Pfizer has partnered with German firm BNTECH, 4 formats of mRNA based vaccine candidates are being tested in the U.S and Germany. Pfizer believes that their vaccine could be ready by the end of October 2020.

4.         Sinovac Biotech vaccine (Phase II)

This Chinese based firm is testing an inactivated vaccine called Coronavac and is preparing for phase III trials in China and Brazil. Based on Phase I/II data, it is safe and elicits an immune response in human trials.

What are the stages in the development of  a Vaccine

Preclinical stage: Invitro/Invivo studies

Invitro- A vaccine to be tested on cell lines.
InVivo- Vaccines will be tested on animals such as mice/monkeys and check for the immune response.

Phase I trial:  Experimental Vaccine will be given to humans and the subject ranges between 20-80 to test the safety and dosage of the vaccine. whether it stimulates the immune system.

Phase II trials- A large of people will be involved in testing and they will be differentiated into groups such as children and elderly people. This stage will be dealing with vaccine safety, immunogenicity, proposed doses, schedule of immunization, and delivery methodology.

Phase III trial- In this stage, the Vaccine will be given to 1000s of people for testing the safety and efficacy. After this, the concerned institution/organization will Submit application to the regulatory authority for approval.






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