China National Pharmaceutical
Address: No.20 Zhichun
Road, Haidian District, Beijing, China
Postal Code: 100191
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On Jan.15th, China’s state media Zhongguo Jijian Jiancha Bao (China Disciplinary Supervision Newspaper) published the interview with Mr. Liu Jingzhen, Chairman of the state-owned China National Pharmaceutical Group (Sinopharm) on China’s first approved Covid-19 vaccine Sinopharm developed.
Chinese Covid-19 Vaccine Efficacy Better than Expected
Interview with Mr. Liu Jingzhen, Chairman of Sinopharm
On Dec.30th, 2020, the National Medical Products Administration granted conditional market approval to the Covid-19 vaccine developed by Sinopharm CNBG Beijing Institute. Before that, 5 countries had authorized emergency use for the said vaccine including China, the UAE, Bahrain, Egypt and Jordan. Abroad, over 10 heads of countries and government departments had received this vaccination. Up to now, over 50 countries had expressed the willingness to procure the vaccine.
Domestically, Sinopharm’s Covid-19 vaccines are being administered to priority groups of people in many places, with the number exceeding 1 million in Beijing and 602 thousand in Shanghai. Over 10 million doses have been administered across the nation.
Covid-19 vaccines are now having the world’s attention. Is the Chinese vaccine safe? How long is the protection duration? What is the information for the recipients? Is the vaccine still effective if the virus mutates? Mr. Liu Jingzhen, Chairman of Sinopharm, received our interview upon these questions.
The vaccination is based on voluntary informed consent and health reporting.
Q: What is your point of view towards the necessity of vaccination given the current epidemic situation?
Liu Jingzhen: It is of great importance for preventing the epidemic to vaccinate the priority group of people at this winter-spring time. The State Council prevention and control mechanism takes two steps in the vaccination: first for the priority group who are those with higher risk of being exposed to the virus and those to work or study in the countries of medium-high risk of the pandemic; second is to vaccinate all eligible people when bigger quantity of vaccines are released to the market with the vaccine being approved or capacity being expanded.
Q: What is the information for the recipients of the vaccine?
Liu Jingzhen: The vaccination is based on voluntary informed consent. The recipient shall report his/her health condition truthfully to the medical workers. And the recipient should stay for another 30 minutes for observation after the jab as previous experience show that the adverse reaction, if any, is more likely to occur within 30 minutes after the injection.
Phase I and II clinical trial on age group 3-17 is all finished, and the vaccine is expected to cover whole age group above 3.
Q: The ongoing vaccination for the priority group is for the people aged 18-59. Will and when will the people of other age groups eligible for the vaccination?
Liu Jingzhen: The leaflet of the vaccine says the age for vaccination is above 18, and that is to say age 3-17 is not included. This is because our clinical trials were firstly on age group 18-59, followed by age above 60 and then 3-17. And there were 3 sub-groups for age 3-17 which were age 12-17, 5-12, and 3-5. Therefore, there were altogether 5 age groups in the trials. Now we have finished all research work on age group 3-17, the safety data showing good results and immunogenicity data under analyzing. In future, the vaccination is expected to cover whole age groups above 3.
As a new vaccine, the immunity durability and protection effect of Covid-19 vaccine need long-term persistent observation.
Q: How long will the vaccine protect a person after vaccination? is that supported by any data?
Liu Jingzhen: The antibody durability has been observed in Phase I, Phase II and Phase III clinical trials. According to the data of Phase I and Phase II clinical trials, the observation result still shows a high level of antibody after 6 months of vaccination. The UAE and Bahrain have already approved official registration of Sinopharm CNBG’s inactivated vaccine of which the protection rate exceeding the minimum target of WHO. Our clinical trials are still going on and we will keep observing the durability of the antibody.
As a new vaccine, the immunity durability and protection effect of Covid-19 vaccine need long-term persistent observation till we obtain the long-term protection data.
Sinopharm CNBG’s Covid-19 vaccine has been approved for emergency use by China and four other countries, and for official registration by two countries.
Q: How is the Covid-19 vaccine produced? Please introduce its R&D process.
Liu Jingzhen: The development of the vaccine can be roughly divided into five steps: the study on the virus strain and cell or the acquisition of immunogen, production technology study, quality study, animal trials and human trials. It is a rigorous scientific process and maybe seems a bit complicated for the general public.
Virus inactivation is a classic way for producing vaccines. The killed virus is still immunogenic. It can be identified by the immune system of a human body, induce the immune response and thus produce antibody. Sinopharm CNBG’s Covid-19 Vaccine is derived from Vero cell which goes through cultivation, inactivation and purification. The vaccine’s immunogenicity, safety and immune protection are studied with a series of tests on animals like mouse, rat, guinea pig, rabbit, rhesus monkey.
On April 12, 2020, Sinopharm CNBG’s Covid-19 vaccine was the first inactivated one approved for clinical trial I/II in the world. Since June 2020, the Phase III clinical trial of our vaccine has been conducted in 7 countries such as the UAE, Bahrain, Egypt, Jordan, Peru, Argentina and Morocco. So far, Sinopharm CNBG’s Covid-19 vaccine has been approved for emergency use by China and four other countries, and for official registration by two countries.
Long-term study and massive vaccination show that inactivated vaccines are safe and effective.
Q: How many types of vaccines are there in the market? What are the features of Sinopharm CNBG’s Covid-19 vaccine compared to other vaccines?
Liu Jingzhen: A vaccine against Covid-19 should be evaluated comprehensively in multiple aspects such as safety, effectiveness, accessibility and affordability. Sinopharm CNBG’s Covid-19 vaccine has shown comprehensive strength with its outstanding performance in safety, high efficacy rate, cold-chain temperature friendly to most countries and a large capacity ready for massive injection.
Our vaccine adopts the traditional and widely accepted inactivated technology platform. Long-term study and massive vaccination show that inactivated vaccines are very safe and effective. Most of the vaccines with market approval belong to inactivated vaccines including polio vaccine, HFMD vaccine, tick-borne encephalitis vaccine.
We take the mature inactivated vaccine R&D route, which is technically safe. In terms of accessibility, inactivated vaccines have their own advantages and are convenient for storage and transportation. The vaccines of Pfizer and Moderna are both innovative mRNA vaccines which have not been used in large-scale population. With the human body as a vaccine factory, mRNA vaccines can also stimulate the body to produce antibodies by translating antigens and cause immunity.
Q: During the R&D process, the exposure to live virus is inevitable. P3 (biosafety protection level 3) laboratory is a precondition. Could you brief us with the idea of P3 lab?
Liu Jingzhen: According to the degree of infectiousness and hazard of infectious pathogens, biosafety laboratories are divided into four biosafety levels: P1, P2, P3 and P4. In the R&D and production process of inactivated Covid-19 vaccine, activities such as the screening of vaccine strains, virus storage, testing and large-scale production all need to be carried out in the third-level biosafety laboratory or workshop .
Over 10 million doses vaccinated while no reports of serious adverse reactions received.
Q: There are some reports that a small number of person who get vaccinated may have adverse reactions. Is it a normal controllable phenomenon?
Liu Jingzhen: Sinopharm CNBG’s Covid-19 vaccine has been vaccinated more than 10 million doses, but has not received the serious adverse reaction report till now. We monitor the reaction mainly local reaction, mainly just inoculation site pain. Systemic reactions mainly include headache, myalgia and fever.
We should look at the vaccination reaction correctly, since we should note that some reactions are not caused by the vaccine itself, but the coupling reaction of other diseases. If the recipient is in the incubation period or precursor period of a certain disease, or there is an uninspected basic disease, which is coincidental after inoculation. This situation has nothing to do with the vaccine itself.
Vaccination is the most effective, economical and convenient public health intervention to control and even eliminate infectious diseases. It brings more benefits than risks. We should look at its adverse reactions correctly since it could cause some adverse reactions we still need it. When the vaccination rate drops, it will lead to disease outbreaks. Only countries with sustained intensive vaccination can maintain low disease incidence. We should have a comprehensive and scientific understanding of vaccines and vaccination.
By the end of last year, nearly 100 million doses had been produced and production is expected to reach 1 billion doses this year
Q: Sinopharm CNBG has started a large-scale production of Covid-19 vaccine. Each dose of vaccine has an electronic ID card that could be tracked in whole flows. What considerations is this based on?
Liu Jingzhen: Each dose of vaccine has its ID card, like the ID card of ours, that is in order to ensure the safety of vaccine production, transportation and injection, The whole production process and who get vaccinated can be found, which means we could track all the information from A to Z.
Q: what is the current vaccine production capacity and how does the vaccine reach all over the countries?
Sinopharm CNBG have established the Covid-19 inactivated vaccine workshop with high-grade biosafety in Beijing and Wuhan. They all have put into production after inspection and certification of related national department. By the end of 2020, the production has reach nearly 100 million doses, and it is expected to reach more than 1 billion doses this year. At present, we plan to further expanding capacity in order to better meet demand.
How to deliver vaccines safely and effectively to all places is also crucial. One of the remarkable advantages of Sinopharm CNBG Covid-19 inactivated vaccine is the convenient storage and transportation, which just needs under the environment of 2~8℃ with no special and harsh requirements so that we can transport the vaccine with ordinary cold chain. The cold chain storage and transportation conditions of the vaccine are in line with the national conditions of most countries and greatly reduce the cost of storage and transportation.
Sinopharm CNBG Covid-19 Vaccine is a broad-spectrum protection and is stepping up its testing on mutant strains
Q: The mutant novel coronavirus strains cases were found in Shanghai, Guangdong and Shandong recently. How about the protective effect of Sinopharm CNBG Covid-19 vaccine for them and is there a response in the next step?
Liu Jingzhen: Before the launched of the Sinopharm CNBG Covid-19 inactivated vaccine, we had conducted the cross-neutralization tests with the novel coronavirus strains from different sources around the world. According to the data we obtained at that time, Sinopharm CNBG Covid-19 vaccine is broad-spectrum protection and has good cross-neutralization effect on strains from different regions of the world. Our phase III clinic is carried out in the United Arab Emirates, with nearly 50,000 volunteers in 125 countries from different parts of the world. That’s why we choose UAE to carry out phase III clinical studies, so the protective data obtained is also a broad-spectrum protective data. Recently, we observed new mutant strains in Britain and other places, and we are stepping up trials to obtain the protective results of our vaccine for them.