Xinhua News Agency, Beijing, August 28 - Title: research and development to which step? How long will the tube be inoculated once? ...Five questions about the new coronavirus vaccine
Xinhua News Agency reporters Dong Ruifeng and Wang Linlin
With the continuous progress in the research and development of new crown virus vaccines, in recent times, there have been news that "the vaccine is about to be approved for marketing" and "people have been vaccinated". Warning sounds such as "may overlap with flu."
The reporter interviewed authoritative organizations and professionals for this, and asked them to answer questions about the new coronavirus vaccine that the public is concerned about.
Where is the vaccine development?
The reporter learned from the State Council’s Joint Prevention and Control Mechanism that my country’s four new coronavirus vaccines have started international phase III clinical trials, and some trials will complete the first round of vaccination in early September.
Phase III clinical trials are the key research to determine whether the vaccine can be approved for marketing. It will truly verify the safety and effectiveness of the vaccine, requiring a sample size of tens of thousands to tens of thousands. It is reported that the phase III clinical trial of the new coronavirus vaccine that has been initiated is expected to obtain preliminary data as soon as November.
Yang Xiaoming, chairman of China National Biotechnology Co., Ltd., introduced that the two inactivated vaccines developed by the company have been approved for phase III clinical trials in many countries in the Middle East and South America, and the total number of participants in the trials exceeds 30,000.
Yin Weidong, chairman of Beijing Kexing Zhongwei Biotechnology Co., Ltd., introduced that a new coronavirus inactivated vaccine developed by the company is steadily advancing phase III clinical trials in several countries in South America and Southeast Asia.
In addition, the adenovirus vector recombinant new coronavirus vaccine developed by Chen Wei's team at the Academy of Military Medicine of the Academy of Military Sciences is also in an orderly progress in international phase III clinical trials.
As the new crown pneumonia epidemic is currently under effective control in my country, the country no longer has the objective conditions for large-scale clinical trials, so the above-mentioned phase III clinical trials are all conducted overseas.
What are the characteristics of different vaccines?
According to Xu Jinghe, deputy director of the National Food and Drug Administration, currently 5 technical routes and 10 new coronavirus vaccines have been approved for clinical trials.
The aforementioned four new coronavirus vaccines, which are expected to be the first to cross the "finish line" of mass vaccination, belong to the two technical routes of inactivated vaccines and adenovirus vaccines. The remaining three technical routes also include recombinant protein vaccines, attenuated influenza virus vector vaccines, and nucleic acid vaccines.
Among them, an inactivated vaccine is a vaccine that kills the virus through physical or chemical methods, but still retains the virus's ability to cause human immune responses. The vaccine of this technical route has a long-term research foundation.
Adenovirus vaccines use a modified replication-deficient adenovirus as a carrier, carry the S protein gene of the new coronavirus, and enter the subject to make the body produce immune memory, thereby achieving the effect of "keeping the virus out".
In addition, the new crown recombinant protein vaccine jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifeilongkema Biopharmaceutical Co., Ltd., which has entered phase II clinical trials, is to express and purify pathogen antigen proteins in engineered cells through genetic engineering. Prepared into a vaccine.
According to reports, regardless of the technical route of the vaccine, strict safety and effectiveness monitoring and evaluation will be put in the first place. Under the premise of ensuring safety, effectiveness, and scientific compliance, relevant companies will launch large-scale vaccine production capacity.
Who is being vaccinated urgently?
The reporter learned from the Joint Prevention and Control Mechanism of the State Council that my country has approved the "New Coronavirus Vaccine Emergency Use (Trial) Plan" on June 24, approved two vaccines for emergency use, and officially launched the new coronavirus vaccine on July 22 Emergency use.
Article 20 of the Vaccine Administration Law of the People’s Republic of China, which came into effect on December 1, 2019, stipulates that in the event of a particularly major public health emergency or other emergency that seriously threatens public health, the health department of the State Council , The control needs to put forward recommendations for emergency use of vaccines, which can be used within a certain range and within a certain period after the approval of the drug regulatory department of the State Council.
Who is being vaccinated urgently? According to Zheng Zhongwei, director of the Science and Technology Development Center of the National Health Commission, according to relevant regulations, emergency use (trial) is limited to specific populations who have high exposure risks and cannot use current effective protective measures to implement protection; people who use vaccines urgently should not be taken lightly. Other protective measures and means are not reduced. Special groups such as medical personnel, epidemic prevention personnel, border inspection personnel, and personnel guaranteeing basic urban operations are the objects of emergency vaccination, which can establish an immune barrier and provide a stable guarantee for social operations.
In addition, it is reported that some overseas staff as well as some medical staff and market staff have also urgently vaccinated against the new coronavirus inactivated vaccine.
How long will the vaccine be effective?
According to the results of phase I and phase II clinical trials that have ended, many new coronavirus vaccines have demonstrated good safety and antibody effectiveness.
Yang Xiaoming introduced that the two vaccines of China Biological were successively approved in April to initiate phase I and phase II clinical trials. The test results showed that after the two doses of vaccines, the positive conversion rate of neutralizing antibodies reached 100%.
How long can these antibodies last? The answer is still to be verified by Phase III clinical trials.
At the same time, a group of scientific researchers are collecting data on cases of infection and recovery from the new coronavirus during the domestic outbreak, analyzing the duration of antibodies in their bodies, and trying to answer the question of whether they will be infected with the new coronavirus again from the mechanism.
According to the "Guiding Principles for Clinical Evaluation of New Coronavirus Vaccines for Prevention (Trial)" issued by the Drug Evaluation Center of the State Food and Drug Administration recently, the effectiveness of the new coronavirus vaccine is specifically proposed: The vaccine should provide protection for 1 year or more. Provide protection for at least 6 months.
Does the new coronavirus vaccine and influenza vaccine overlap?
It is reported that the new coronavirus vaccine is expected to be "two-in-one" with the seasonal flu vaccine in the future to simplify the vaccination process.
However, before the new crown virus vaccine has been approved for marketing, many experts have called for increased flu vaccine vaccination to avoid the formation of new crown pneumonia and influenza infection.
Wang Chen, dean of the Chinese Academy of Medical Sciences and Peking Union Medical College, said that the autumn and winter seasons approach, once the new coronary pneumonia merges with influenza, the differential diagnosis will be very difficult, the difficulty of isolating the population will be significantly increased, and the investment of social resources will also be significantly increased.
"The most effective way is to get the flu vaccine universally in time." Wang Chen said.