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Summary of the Phase III clinical trial of COVID-19 vaccines: The vaccines have already entered the final sprint stage

  • Categories:Industry Trends
  • Author:Yiluo Mu Yiluo
  • Origin:Weibo
  • Time of issue:2020-11-09
  • Views:0

(Summary description)

Summary of the Phase III clinical trial of COVID-19 vaccines: The vaccines have already entered the final sprint stage

(Summary description)

  • Categories:Industry Trends
  • Author:Yiluo Mu Yiluo
  • Origin:Weibo
  • Time of issue:2020-11-09
  • Views:0
Information

 

If all goes well, the United States is expected to approve two mRNA vaccines, namely Pfizer/BioNtech and Moderna, successively in December, with Moderna's early production capacity far below that of Pfizer's.

China's Sinopharm has also predicted to be in December, with no major problems expected. The scale of Sinovac Biotech's individual clinical enrollment is far below that of Sinopharm, and its clinical control ability overseas is also probably not as satisfactory, so we will see if its data quality can be approved.

 

I. Overseas products - Pfizer and Moderna go hand in hand, while Johnson & Johnson and AZ are in suspension
1. Pfizer/BioNTech/Fosun

Enrollment: As of 19, October, 39,862 people have been enrolled in the 44,000-people clinical trial, among which 34,601 have been injected with two doses.
Capacity: 100 million doses in 2020; 1.3 billion doses expected in 2021. The main factory is in Germany, providing vaccines worldwide.
Launch: Interim analysis shows effectiveness data at the end of October. After waiting for the complete preliminary safety data, it will be declared for urgent approval in the United States at the end of November, and the first FDA approval to be launched is expected in December.
Pricing: USD 19.5/dose. Chen Qiyu from Fosun told the Caixin that the current global pricing mechanism of vaccines has been relatively transparent and open, and the price of China's mRNA vaccine will not differ much from the global level.
Fosun: BNT162b1 has been approved for clinical trial in China, and the domestic enrollment is finished; b2 is the vaccine selected for phase III clinical trial overseas, which has not yet been approved for clinical trial. Subsequently, the b2 Phase I should be guaranteed, and then efforts should be made to bridge the overseas Phase III data to be approved.

 

2. Moderna
Enrollment: As of Friday 16, October, 29,531 people have been enrolled in the 30,000-people clinical trial, of which 24,496 have been injected with two doses.
Capacity: 20 million doses in 2020, and at least 500 million doses in 2021. Capacity is a challenge. The U.S. domestic plant supplies the U.S. and the Lonza Swiss plant supplies areas outside the U.S.
Effectiveness: The emergence of 53 individuals showing symptomatic infection will trigger the interim analysis, which is expected to appear in November. However, it is difficult to predict the exact week as it is subject to the development of the COVID-19 pandemic.
Safety: At least 15,000 people will be observed for 2 months before filing for emergency approval, which is expected to be reached in late November.
Launch: After submitting an emergency application, the FDA is expected to take several weeks to review the data with approval to be granted in December at the earliest, not far off from BioNTech. If the first interim analysis does not reach the target, it will be followed by an analysis after 106 people showing signs of infection, which is expected to appear in December. In this scenario, FDA approval is expected in late January/early February.
Price: The U.S. government pays USD 25 per dose.

 

3. Adenovirus vector vaccines, such as Johnson & Johnson Ad26.COV2-S and AstraZeneca AZD1222, are currently suspended in the United States, and will not be launched until at least the middle of next year.
II. China situation

Capacity: Zheng Zhongwei, Director of the Science and Technology Development Center of the National Health Commission, introduced that China's vaccine production capacity is expected to reach 610 million doses by the end of this year, and the annual production capacity of the COVID-19 vaccines in China will be effectively expanded on this basis next year.
Price: Zhejiang government purchases Sinovac Biotech's vaccines for RMB 200 per dose. However, all the ones for the Sinopharm vaccines are still observed to be free of charge.
Pricing principles: Zheng Zhongwei, Director of the Science and Technology Development Center of the National Health Commission, introduced that the price of China's COVID-19 vaccines should first be set by the main enterprise, but we must adhere to several basic principles. The first principle is the principle of public product attributes. As a public product, its pricing must not be based on supply and demand, but based on cost. The second principle is that its pricing should be carried out based on the public's willingness and demand for vaccination. Therefore, I can responsibly tell you that the pricing of COVID-19 vaccines in China must be within the affordable range of the general public.
Manufacturers entering Phase III clinical trials: two subsidiaries of Sinopharm, Sinovac Biotech, and CanSino Biologics.
Enrollment: Up to now, a total of about 60,000 subjects have been vaccinated. The major part of this enrollment is Sinopharm; Sinovac Biotech is mainly in Indonesia and Brazil (13,000 cases in Brazil, with an overall trial design and control seemingly inferior to Sinopharm); while CanSino Biologics is just starting its enrollment in Pakistan and Russia.

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