More than 10 million doses have been vaccinated across the country and no serious adverse reaction reports have been received. Each dose can be traced throughout the whole process
China's vaccine effectiveness exceeds preset targets
Interview with Liu Jingzhen, Secretary of the Party Committee and Chairman of Sinopharm Group
Following the formal approval of registration and listing in the UAE and Bahrain, on December 30, 2020, Sinopharm's China Bio-New Crown Inactivated Vaccine was approved by the State Food and Drug Administration for conditional listing.
Prior to this, the governments of China, the UAE, Bahrain, Egypt, and Jordan successively approved the emergency use of Sinopharm's China Bio-New Crown vaccine.
Abroad, more than 10 heads of state and government have been vaccinated with the new crown vaccine of Sinopharm Group China Biotech.
At present, more than 50 countries have put forward purchase requirements.
In China, Sinopharm China Biotech Covid-19 Inactivated Vaccine has begun to vaccinate key populations in many places.
The number of people vaccinated in Beijing exceeded 1 million; the key populations in Shanghai have been vaccinated to 602,000; more than 10 million doses have been vaccinated nationwide...
Currently, the new coronavirus vaccine has attracted much attention.
Are China's vaccines safe?
How long can I manage after vaccination?
What are the precautions for vaccination?
If the virus mutates, is the vaccine still effective?
Focusing on a series of issues of concern to everyone, the reporter interviewed Liu Jingzhen, Secretary of the Party Committee and Chairman of Sinopharm Group.
Vaccination is based on the principles of informed, consent, and voluntary. It is necessary to truthfully report personal health status during vaccination
Question: In view of the current situation of the epidemic, how do you view the necessity of vaccination?
Liu Jingzhen: On the occasion of winter and spring, the new crown vaccination work for some key populations is of great significance for epidemic prevention and control.
The vaccination plan currently formulated by the Joint Prevention and Control Mechanism of the State Council is implemented in two steps: The first step is mainly for some key populations, including import cold chain, port quarantine, ship piloting, aviation air service, fresh food market, public transportation, medical disease control Wait for staff with a relatively high risk of infection, as well as those who go to work or study in medium- and high-risk countries or regions; in the second step, as vaccines are approved for marketing, or vaccine production gradually increases, more vaccines will be put into use. Preventive vaccinations will be carried out in an orderly manner, so that eligible people will be able to meet their needs.
Question: Currently, the new crown vaccine produced by Sinopharm Group has begun to vaccinate key populations in many places.
What are the precautions for vaccinating the masses?
Liu Jingzhen: Vaccination is based on the principles of informed, consent and voluntary.
During the vaccination process, you must truthfully report to the medical staff your personal health status, what kind of underlying disease you have, whether you are currently in the onset of the disease, whether you have a history of allergies, whether you are allergic, etc.
In addition, according to past experience, adverse reactions often occur within 30 minutes after vaccination, so the vaccinators should stay at the vaccination site for 30 minutes after vaccination.
Phase I and II clinical studies for 3-17 years old have been completed, and the vaccine is expected to cover all age groups over 3 years old
Question: my country is currently vaccinating key populations with the new crown vaccine. The population range is selected between 18-59 years old. Can people in other age groups also be vaccinated?
When can it be vaccinated?
Liu Jingzhen: In the instructions of the inactivated vaccines, the age group we marked is people over 18 years old.
Why didn't we include 3-17 years old this time? We call infant stage and minor stage vaccines for 3-17 years old.
When we were doing Phase I and Phase II clinical studies, we first did 18-59 years old, secondly we did over 60 years old, and then we did 3-17 years old.
3-17 years old, we divided it into 12-17 years old, 5-12 years old, and 3-5 years old. In fact, the entire vaccine is divided into 5 age groups.
We have completed phase I and II clinical studies for the age group of 3-17 years old. The safety is still very good, but the immunogenicity data is in the process of testing.
In the future, the vaccine is expected to cover all age groups over 3 years old.
The new crown vaccine is an innovative vaccine, and the durability and protective effect of immunity need to be observed for a longer period of time
Question: According to what you know, how long will the people be protected after being vaccinated?
Are there corresponding data for support?
Liu Jingzhen: Sinopharm Sinopharm has conducted antibody persistence observations in both domestic phase I and II clinical studies and overseas phase III clinical studies.
According to phase I and II clinical studies of the new crown inactivated vaccine, observational data over 6 months show that antibodies are still maintained at a high level.
The United Arab Emirates and Bahrain have reviewed and approved the official registration and listing of Sinopharm's China Bio-New Crown Vaccine in accordance with the relevant technical standards of the World Health Organization. The clinical trial data results show that the protective data results have reached the predetermined target and met the registration and listing requirements.
At present, clinical studies in China, the UAE, and Bahrain are still ongoing, and the persistence of antibodies will continue to be monitored.
The new crown vaccine is an innovative vaccine, and the durability and protective effect of immunity need to be observed for a longer time.
With the continued advancement of phase III clinical trials, the effectiveness of the vaccine will continue to be observed and long-term protection rate data will be obtained.
Sinopharm's China Bio-New Crown Vaccine has been approved for emergency use in 4 countries other than my country, and has been approved for registration and marketing in 2 countries
Q: What process does a new crown vaccine need to go through to be born?
Can you introduce the development process of the vaccine in conjunction with the inactivated vaccine of the Sinopharm Group approved for conditional marketing?
Liu Jingzhen: The vaccine development process is generally divided into five steps: the research of virus species and cells or the acquisition of immunogen, production process research, quality research, animal experimentation and human clinical research.
After passing animal experiments, you can enter clinical trials, that is, safety and effectiveness trials on humans.
This is an extremely scientific and rigorous process. From the perspective of the general public, it may even feel a bit cumbersome and complicated.
Virus inactivated vaccines are the classic vaccine preparation method, which "kills" the virus through chemical or physical means.
Although it is only a dead virus, it is still immunogenic. Our immune system recognizes it and can activate the body's immune response to produce corresponding antibodies.
During the research and development process, Sinopharm’s Chinese biological researchers have successively completed the isolation and identification of new coronavirus strains, established a three-level virus seed bank, and used Vero cells to culture the new coronavirus, which was inactivated and purified to complete vaccine preparation; establish antigens, Antibody quantitative detection methods, perfect quality control methods and quality standards; use vaccines to immunize mice, rats, guinea pigs, rabbits and other animals to evaluate vaccine immunogenicity; through rat acute toxicity, guinea pig allergy, rat and monkey chronic toxicity Test to evaluate the safety of the vaccine; establish rhesus monkeys and hACE2 transgenic mice infection models to evaluate the immune protection of the vaccine.
On April 12, 2020, Sinopharm Sinopharm was the first company in the world to obtain a clinical trial approval for a new coronavirus inactivated vaccine, and simultaneously initiated phase I and II clinical trials.
Since June last year, Phase III clinical studies have been carried out in the UAE, Bahrain, Egypt, Jordan, Peru, Argentina, Morocco and other countries. It is the world's most invested and fastest-growing clinical research on the new crown vaccine.
At present, it has been approved for emergency use in 4 countries other than my country, and has been approved for registration and listing in 2 countries.
Long-term research and large-scale clinical use verification, inactivated vaccines are very safe and effective
Q: What are the main types of new crown vaccines currently on the market?
Compared with foreign vaccines, what are the characteristics of Sinopharm China Bio's new crown inactivated vaccine?
Liu Jingzhen: In order to maximize the success rate and speed of my country's new crown vaccine research and development, the State Council Joint Prevention and Control Mechanism Vaccine Special Class Scientific Research Team has determined 5 main technical routes: inactivated vaccines, adenovirus vector vaccines, and attenuated influenza virus vector vaccines , Recombinant protein vaccines, nucleic acid vaccines (including RNA vaccines and DNA vaccines).
Comprehensive evaluation of a vaccine depends on major factors such as safety, effectiveness, accessibility, and affordability.
Sinopharm China Bio-New Coronavirus Inactivated Vaccine has the characteristics of technical safety, protection effectiveness, population universality, convenient storage and transportation, and production capacity. The safety is very good, and the effectiveness data exceeds the preset clinical research The goal is that the cold chain storage and transportation conditions are in line with the national conditions of most countries in the world, and the production capacity is sufficient to meet a wide range of vaccination use.
The technical route of the total virus inactivated vaccine of Sinopharm is a technical route that is widely used and accepted globally.
Inactivated vaccine is a traditional and modern technology.
Long-term research and large-scale clinical use have verified that inactivated vaccines are very safe and effective.
Up to now, most of the successfully marketed globally are inactivated vaccine products, including polio vaccine (a new class of drug), hand, foot and mouth disease vaccine (a new class of drug), forest encephalitis vaccine (a new class of drug), and hemorrhagic fever Vaccines, etc.
We use a mature inactivated vaccine technology route, which is technically safe.
In terms of accessibility, inactivated vaccines have their own advantages and are convenient for storage and transportation.
American Pfizer vaccine and American Moderna vaccine are mRNA vaccines, which are an innovative technical route. These vaccines have not been used in large-scale population and commercialization.
In terms of design mechanism, our China Biotech vaccines are whole virus inactivated, and mRNA vaccines use the human body as a vaccine factory to stimulate the body to produce antibodies by translating antigens in the cytoplasm, and also produce some cellular immunity.
Question: The development of inactivated vaccines must be combined with live viruses, and the P3 (biosafety protection level three) laboratory is a necessary prerequisite.
Can you introduce what is P3 laboratory?
Why use P3 laboratory?
Liu Jingzhen: According to the infectiousness and harmfulness of infectious pathogens, biosafety laboratories are divided into four biosafety levels: P1, P2, P3, and P4.
In the research and development and production process of the new coronavirus inactivated vaccine, the screening of vaccine strains, the establishment of multiple libraries, the establishment of detection methods, the research of production processes, and large-scale production, all need to be carried out in the third-level biosafety laboratory and workshop .
More than 10 million doses have been inoculated, and no serious adverse reaction report has been received
Q: There are reports that a small number of vaccinators may have side effects. Is it normal and controllable?
Liu Jingzhen: Sinopharm China Biotech's new crown vaccine has been inoculated with more than 10 million doses, and no serious adverse reaction reports have been received.
At present, the COVID-19 vaccination reactions we have monitored are mainly local reactions, mainly pain at the injection site.
Systemic reactions mainly include headache, myalgia and fever.
To view the vaccine response in a correct way, it should be noted that some reactions are not caused by the vaccine, but are coupled reactions of other diseases.
If the recipient is in the incubation period or prodromal period of a certain disease, there is an undiscovered underlying disease, and the disease occurs coincidentally after vaccination, which 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. The benefits it brings far outweigh the risks. We must take a correct view of its adverse reactions, even if they may occur. Take a partial overview and give up eating because of choking.
Because once the vaccination rate drops, it will cause disease outbreaks.
Only countries with continuous intensive vaccination can the disease incidence be maintained at a low level.
We should have a comprehensive and scientific understanding of vaccines and vaccination.
Nearly 100 million doses have been produced by the end of last year, and the production capacity is expected to reach 1 billion doses this year
Question: Sinopharm Group, China Biosciences has launched the large-scale production of the new crown vaccine, and each dose of vaccine has an electronic ID card that traces the flow of the vaccine.
What are the considerations based on this?
Liu Jingzhen: In order to ensure the safety of the entire process of vaccine production, transportation, and injection into the human body, each vaccine has a code, just like our ID card.
The manufacturing process of the vaccine and who the vaccine was delivered to can be found out. It can be traced back to where it came from, and it can be traced back to where it went.
Question: What is the current production capacity of vaccines and how are the vaccines delivered to various places?
Liu Jingzhen: The high-level biosafety production workshops of the new crown inactivated vaccines established by Sinopharm Sinopharm in Beijing and Wuhan have been put into large-scale production after inspection and certification by relevant national departments.
Nearly 100 million doses will be produced by the end of 2020, and the production capacity is expected to reach more than 1 billion doses this year.
Currently, we are planning to further expand production capacity and better meet demand.
How to deliver vaccines safely and effectively to various places is also very critical.
A significant advantage of the Sinopharm China Bio-New Crown Inactivated Vaccine is the convenience of storage and transportation. It only requires an environment of 2~8°C without any special and demanding requirements.
We can now use ordinary cold chain transportation to supply the new crown inactivated vaccine. The cold chain storage and transportation conditions of the vaccine meet the national conditions of most countries, which greatly reduces the cost of storage and transportation.
Sinopharm's China Bio-New Crown Vaccine is a broad-spectrum protection, and is stepping up testing of its effect on mutant strains
Q: Recently, confirmed patients infected with the new crown variant strain were found in Shanghai, Guangdong, Shandong and other places.
Regarding the mutant virus, does the Sinopharm China Bio-New Crown Vaccine have any protective effects?
Are there any countermeasures in the next step?
Liu Jingzhen: When the Sinopharm China Bio-New Coronavirus Inactivated Vaccine was launched, it conducted cross-neutralization protection tests on the new coronavirus strains from different sources around the world.
Judging from the data we got at that time, the new crown vaccine of China Biology now has broad-spectrum protection and has a good cross-neutralizing effect on strains from different regions of the world.
Our Phase III clinical trial was conducted in the UAE. The number of people enrolled in the UAE is close to 50,000, with people from 125 countries coming from different parts of the world. The vaccine chose to carry out Phase III clinical studies at this point, and we obtained protective data. It is broad-spectrum protective data.
Recently, the team has also observed new mutant strains appearing in the UK and other places, and is stepping up trials to see how effective our vaccine is against the mutant strains.
(Reporter Wu Jing)