Source: [People's Daily Health Client]
"From the project was approved to the approval of emergency use, we used it for 2 years and 39 days. Compared with other new crown vaccine , this time point is not early. We often joke that "V-01 is a late bloomer." On the evening of September 2, Lizhu Pharmaceutical Group issued an announcement stating that its "recombinant novel coronavirus fusion protein vaccine" (V-01) was proposed by the National Health Commission, and the State Food and Drug Administration organized a demonstration and agreed to include it in the sequential prevention of the new crown epidemic and strengthening the emergency use of immunity.
The main research and development director of the new crown vaccine V-01 and executive vice general manager of Lizhu Biology, Dr. Yang Jiaming, was interviewed by a reporter from the People's Daily Health Client.
Vaccine commercial production workshop, staff are performing liquid dispensing operations, and the photo provided by the respondent
People's Daily Health Client: What does V-01 mean to be included in the sequential strengthening of immunity and emergency use?
Yang Jiaming: The emergency use of strengthening immunity is different from being officially approved for marketing. It refers to the administrative approval for emergency use of vaccines when a particularly serious public health emergencies or other emergency events that seriously threaten public health. The health and health department of the State Council put forward suggestions for emergency use according to the needs of infectious disease prevention and control. After organization and approval by the State Council’s drug supervision and administration department, it can be approved for emergency use within a certain scope and time limit, which complies with the relevant provisions of my country’s Vaccine Management Law. At the same time, the complete Phase III clinical data of V-01 has also been submitted to the drug administration department, and the formal application process for listing is being carried out smoothly.
In order to meet the market demand after V-01 is approved, we have built 1 raw liquid production line and 3 preparation production lines, and completed process verification under commercial scale. Up to now, the number of doses that can be released by third-party inspections has been completed to about 40 million doses, which can quickly meet the vaccination needs of various provinces and cities.
People's Daily Health Client: According to the official news of the National Health Commission, my country began to deploy sequentially strengthened immunization in February this year. Compared with the recombinant protein vaccine and adenovirus vector vaccine (intramuscular injection) that have been approved to sequentially strengthened immunization, what are the advantages of V-01 as a sequentially strengthened injection?
Yang Jiaming: At present, the vaccination rate of for basic immunization in in my country has been above 90%, and is mainly inactivated seedlings. Many domestic and foreign studies have shown that sequential strengthening can significantly improve the protective effect than homologous strengthening and effectively combat mutated viruses such as Omickron . Academician Zhong Nanshan also mentioned in his speech at the 2022 China International Service Trade Trade Fair that according to my country's vaccination strategy, the effect of using xenogenic vaccines (adding subunit protein vaccine/adenovirus vaccine/mRNA vaccine on the basis of two doses of inactivated vaccine ) has been significantly improved. Analysis of key clinical data of the third phase of
V-01 vaccine shows that based on the 2-dose inactivated vaccine, the absolute protective power of V-01 to infection with mild symptoms and above symptoms (relative to those without vaccination) is 61.35%, which is comparable to the recent foreign reports of the mRNA vaccine homologous or heterologous third shot enhancement. The protection of people at high risk of underlying diseases is as high as 71.83%, and the protection of people over 60 years old or with underlying diseases is 61.19%.
In addition, for the safety and durability issues that many people are concerned about, as of now, more than 20,000 people have been vaccinated with V-01 in clinical practice. The incidence of adverse reactions such as injection pain is about 1/10 of mRNA, and the adverse reaction rate is equivalent to that of inactivated vaccines. The immune enhancement response is rapid and durable. After V-01 is strengthened sequentially, the neutralizing antibody level can be increased by about 20 times 7 days after vaccination; it is close to the peak in 14 days and can be used in emergency vaccination; 6 months after vaccination, the antibody level remains at more than 1/3 of the peak.
People's Daily Health Client: How long has V-01 been since its establishment? What challenges have been experienced during the R&D process?
Yang Jiaming: It took 2 years and 39 days from the project establishment to the approval of emergency use. Compared with other new crown vaccines, this time point is not early. We often joke that "V-01 is a late bloomer."
The outbreak of the new crown pneumonia epidemic in 2020. As a part of the pharmaceutical industry, everyone wants to do their best.In July 2020, our team and the Institute of Biophysics of the Chinese Academy of Sciences decided to jointly promote the V-01 project. This time point is already behind some other COVID-19 vaccines, and the epidemic prevention situation of COVID-19 is severe, and we have been racing against time. The new crown vaccine has very high requirements for R&D progress management, and it requires pharmacological research, preclinical pharmacological and toxicological research, as well as clinical phase I, II, and III. Each link must ensure quality and safety. Under various pressures, I happened to encounter the challenges of the global epidemic and experienced many critical moments of sweating.
What impressed me most was a "missing" incident in early January this year. At that time, it had entered the critical stage of phase III clinical trials. A batch of serum and pharyngeal swab samples used for gene sequencing are preparing to be transported back to China for testing from the Philippines. The plane was to be transferred in Hong Kong. Unexpectedly, just three days before the flight took off, the airline notified us that due to the epidemic, all flights to Hong Kong would be circuit-breaked and our original flight would also be cancelled. This news is undoubtedly a major blow. If this batch of samples cannot catch up with the flight circuit breaker before it is transported back to China, it will seriously affect the research and development progress with "days" as the time node. After urgent discussion, we decided to do our best to transport the samples to the airport in advance to the airline to see if there would be a miracle. Unexpectedly, 6 hours after the sample was shipped to the airport, the status actually showed "Entered Cabin" when the original flight was cancelled. More than 2 hours later, the status was updated "Arrivaled".
We were very anxious at the time, worried that the cargo would be lost, so we took turns to check with the local team, agents, and airlines. It turned out that the airline adjusted the flight and arranged the cargo on the last flight before all the cargo was broken. Although it was a false alarm, this incident also gave our team great encouragement: the drug development process may face a lot of uncertainty, but until the last moment, you must never give up a glimmer of hope.
People's Daily Health Client: As of now, 9 new crown vaccines including inactivated vaccines, adenovirus vaccines, and recombinant protein vaccines have been approved for market launch or emergency use. There are many voices in the industry who believe that the new crown vaccine market is close to saturation. How do you view the possible changes in the new crown vaccine market structure of my country's new crown vaccine in the future?
Yang Jiaming: Looking at the epidemic prevention and control situation at home and abroad, building a stronger immune barrier through vaccination, especially through sequential strengthening, is crucial to my country's next stage of epidemic prevention and control. At present, at least 126 countries have issued recommendations for the application of strengthening injections or even a second booster injection. WHO and FDA recommend vaccinating the second dose of the new crown vaccine for people over 60 years old and susceptible, adults aged 50 and above, and those with moderate or severe immunocompromised dysfunction, respectively. Therefore, in addition to meeting the existing population without vaccination and strengthening injections, the future COVID-19 vaccine market also needs to meet the vaccination needs of the second dose of strengthening injections that may be planned in the future.
The vaccine preparation production line in the commercial production workshop. Photo provided by the interviewee
The purpose of innovation is not for "new", but for "good", that is, to develop more advantageous products to better meet clinical needs. Improving the clinical protection of coping with mutant strains will become a key influencing factor in the formation of the competitive landscape of the new crown vaccine/drug market in the future. Due to the continuous mutation of the new coronavirus, the development of mutant vaccines in various technical routes requires a series of preclinical and clinical research and development. , the bivalent vaccine containing the BA.5 variant developed by Pfizer and Moderna, was approved by the US FDA for emergency use. It is mainly based on the large-scale clinical data of its primary vaccine and real-world data. The second-generation vaccine still needs more data accumulation to confirm its safety and effectiveness. Therefore, the currently developed, safer and more effective COVID-19 vaccine is still of great significance as a sequential strengthening of vaccination, and is expected to be the mainstream market for COVID-19 in the future.
In addition to V-01, Lizhu is currently continuing to develop vaccines for variant strains, including the development of bivalent/mixed-valent vaccines containing Omickron BA.4/5, and will continue to pay attention to the epidemic changes of variant strains in the future.
Editor: Sun Baoguang
Editor: Zhang He
Proofreading: Tan Qixin
This article comes from [People's Daily Health Client] and only represents the author's views. National Party Media Information Public Platform provides information release and dissemination services.
ID: jrtt
