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Since March, the COVID-19 epidemic has rebounded and spread in many parts of the country, and a "late-spring cold snap" has made the epidemic prevention and control situation remain severe, but good news about the development of COVID-19 vaccines continues to come. Late-spring cold snap The epidemic prevention and control situation remains severe, but good news about the development of COVID-19 vaccines continues to come.

According to Xinhua News Agency According to a March 19 report from Xinhua News Agency, at a press conference of the State Council's joint prevention and control mechanism, it was revealed that China currently has 29 vaccines in clinical trials, 16 of which are being conducted overseas. Phase III clinical trials, 7 have received conditional marketing approval or emergency use authorization, and 2 have been included in the World Health Organization's emergency use list.

In this official list, the "Lizhu V-01", which is currently applying for listing, has made a new breakthrough in enhancing the immune protection of elderly special groups and those with underlying diseases, which has attracted strong attention in the world's vaccine circle and has made the world even more expectant.

Judging from the current research and development progress, China, supported by its superior technological platform, is committed to tackling global "common problems". In the race against the COVID-19 epidemic, especially for high-risk special groups such as the elderly, Chinese companies have made real contributions to the global fight against the epidemic, demonstrating humanitarianism of helping the world and boundless love, and have won widespread praise from the international community.

Today, we use "Lizhu V-01" as an example to see how China's vaccine research and development is racing against the epidemic, thus winning the world's respect.

High-risk groups are the focus and difficulty

Currently, the multi-point, multi-source, sporadic outbreak, and local outbreaks are still continuing nationwide, with a large number of daily reported local positive infected persons, and the hidden transmission characteristics of the epidemic are becoming more obvious, and inter-provincial transmission will become the norm.

On March 19, Zheng Zhongwei, head of the working group of the vaccine research and development special team of the State Council's joint prevention and control mechanism's scientific research and technological development group, revealed at the press conference of the State Council's joint prevention and control mechanism:

"Now, the Omicron variant has become the main circulating strain globally. Its characteristics are fast transmission speed and strong concealment. ...Positive progress has been made in the research and development of Omicron variant monovalent and multivalent vaccines. The faster-progressing ones have completed pre-clinical research and are rolling in the relevant clinical trial application materials to the national drug regulatory authorities."

"Studies have shown that the Omicron variant has not completely escaped existing vaccines."

Zheng Zhongwei said that completing the full course of vaccination can still effectively reduce the risk of hospitalization, severe illness, and death caused by the Omicron variant. Carrying out booster vaccinations can also effectively reduce the risk of breakthrough infections caused by the Omicron variant.

It seems that to "fundamentally" curb the development of the epidemic, the top priority is to develop a vaccine against "Omicron" and to bring it to market as soon as possible.

In fact, as early as 2020, Chinese companies began to invest in the research of the "Omicron strain" and develop related vaccines.

Zheng Zhongwei also said at the press conference of the State Council's joint prevention and control mechanism: "Since the outbreak of the COVID-19 epidemic, China has deployed five technical routes in parallel: inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, nucleic acid vaccines, and attenuated influenza virus vector vaccines. Currently, all technical routes have achieved full coverage of clinical trials. Among them, adenovirus vector inhaled vaccines and attenuated influenza virus vector nasal spray vaccines are currently being conducted overseas." Phase III clinical trials. ”

Zheng Zhongwei revealed that China currently has 29 vaccines in clinical trials, 16 of which are being conducted overseas. Phase III clinical trials, 7 have received conditional marketing approval or emergency use authorization, and 2 have been included in the World Health Organization's emergency use list.

In this official list, the "Lizhu V-01", which is in the clinical stage, is also actively applying for listing, and it has better immune protection for elderly special groups and people with underlying diseases.

Data show that with the daily increase in local infections exceeding 1,000, improving the protection of high-risk groups is the current priority. In the past few days, the number of COVID-19 deaths in Hong Kong has exceeded 100. Comparing other developed countries and regions, we can find that the biggest problem with vaccination in Hong Kong is the low vaccination rate among the elderly. As of March 10, only 32% of elderly people over 80 years old in Hong Kong have received at least one dose of the vaccine, compared with 96% of elderly people in Japan who have received a full course of vaccination.

Some experts believe that improving the protection of high-risk groups is the focus and difficulty of current epidemic prevention and control, and its protein recombinant vaccine as a booster shot is the key. A large number of studies have shown that using a protein subunit vaccine such as Lizhu vaccine as a heterologous booster on the basis of inactivation may result in a higher level of protection.

New breakthrough in protection for the elderly and those with underlying diseases

In July 2020, the recombinant novel coronavirus fusion protein vaccine (V-01) jointly developed by Zhuhai Lizhu Monoclonal Antibody Biotechnology Co., Ltd., a wholly-owned subsidiary of Lizhu Group, and the Institute of Biophysics, Chinese Academy of Sciences, was officially launched.

After 44 months of day and night efforts, after the unremitting efforts of scientists, overcoming numerous difficulties, especially in addressing patent monopolies, drug safety, lasting efficacy, and quantitative production, Lizhu has now surpassed other R&D platforms with its super implementation capabilities and achieved excellent results.

Relying on Lizhu Monoclonal Antibody's mature recombinant protein vaccine R&D platform, in addition to the prototype vaccine V-01, in the early stage, it also successfully developed vaccines for several variants of particular concern to the WHO, including Beta and Delta variant vaccines, which have completed pre-clinical development and production of clinical trial samples, and can be scaled up at any time, while also rapidly developing Omicron variant vaccines. At the same time, a bivalent COVID-19 vaccine has recently been successfully developed, which has the characteristic of broad-spectrum effectiveness against multiple variants.

This bivalent vaccine is based on the variant vaccines V-01-351 (against Beta) and V-01D (against Delta). Because the Omicron variant S protein RBD contains key mutation sites of the Beta and Delta variants, it is expected that the bivalent vaccine will not only be effective against the Delta and Beta variants, but also against Omicron.

Lizhu monoclonal antibody previously released the domestic first neutralizing experiment results of the two-price COVID-19 vaccine, showing a strong neutralizing activity against Omicron virus.

Data from clinical studies on sequential booster immunization initiated by domestic researchers show that, V-01 has good safety; significantly improved immunogenicity, strong neutralizing activity against Omicron; good immune persistence; good strengthening effect in the elderly group, four major effects. And in terms of commercial production capacity, there are three outstanding advantages:

First, easy to mass produce, the annual production capacity of the original solution is 3.5 billion doses;

Second, easy to store and transport, can be stored at 2~8℃ for a long time, 25℃ under conditions stable for 6 months;

Third, stable supply of raw materials, with multiple suppliers, stable supply chain, sufficient reserves. All of the above can prove the superiority of Lizhu Group's COVID-19 vaccine products and the future market share, which have also been the goals and motivation of Lizhu's research and development.

Of course, at present, Omicron is the main virus variant, but in vaccine research, what people need is more “universal” efficacy.

It is worth noting that whether the vaccine is applicable, safety is the primary consideration for everyone. Lizhu monoclonal antibody Phase I and II clinical trial data has shown that, the incidence of adverse events in the target dose group of V-01 is comparable to that of the placebo group, the severity of adverse reactions is mild, the duration is short, and the overall incidence of vaccine-related adverse reactions in the elderly group is lower than that in the corresponding adult group.

In terms of immune effect, V-01 vaccine Phase II clinical data show that the neutralizing antibody titer is up to 3 times that of convalescent serum, this ratio has reached the international first echelon level, and has the same immune effect on the elderly population.

Medical data show that more effective protection for the elderly is a highlight of the V-01 vaccine. The elderly have always been a high-risk group for COVID-19 infection, and there are still about 50 million elderly people in China who have not been vaccinated against COVID-19. The good protection of V-01 vaccine for the elderly can indeed help improve the overall vaccination rate.

Of course, the booster shot, which is currently the most concerned, is the V-01 vaccine using the recombinant protein technology route is suitable for market opportunities. The results of the booster shot of V-01 vaccine (the third shot of V-01 4-5 months after two doses of V-01) show that: the neutralizing antibody titer increased by 60 times compared with before vaccination, and increased by 9 times compared with the peak value after the second shot, and the strengthening effect in the elderly group is obvious.

In the context of the continued development of the epidemic, and in the context of the continued uneven distribution of vaccines globally, giving vaccines long-term value is also an important mission that Lizhu has long undertaken.

To cope with the ever-changing viruses globally

On December 22, 2021, WHO Director-General Tedros Adhanom Ghebreyesus said at a press conference that the organization had called on all countries to vaccinate 40% of their population by the end of 2021, but only half of the member states have met the target, and the main reason for this result is the inequitable global distribution of vaccines.

New variants of the coronavirus are threatening the effectiveness of existing vaccines, and insufficient production capacity is hindering the equitable distribution of vaccines worldwide.

However, Chinese vaccine R&D and production enterprises are faced with the fact that their key raw materials and related equipment are heavily reliant on imports, and the pressure on the supply of raw materials is great. In addition, due to the uncertainty of overseas policies, vaccine raw materials are easily subject to import restrictions.

Under the catalysis of the COVID-19 epidemic, the domestic substitution process of V-01 raw materials is further accelerating.

Lizhu Group also believes that after the raw materials are localized, it can effectively get rid of the control of foreign companies on the vaccine industry chain, and avoid being “stuck neck” Chinese enterprises can also achieve rapid expansion of production capacity to meet the production needs of COVID-19 vaccines.

Vaccines primarily address the challenges of immunogenicity and safety. Among them, adjuvants largely determine the efficacy and safety of vaccines, while the reality is that protein vaccines rely on patented, monopolistic adjuvants.

Therefore, how to get rid of dependence on imported raw materials and ensure safety, while achieving large-scale mass production, has become a test for many domestic protein vaccine research projects.

In addition, Lizhu Group also stated that Lizhu uses a platform-based recombinant protein production process, and the main raw materials are based on years of experience in biopharmaceutical R&D, and most of the materials have been gradually replaced by domestic products. At the same time, V-01 uses conventional aluminum adjuvant, with multiple suppliers of raw materials, stable supply chain and sufficient reserves.

It is understood that the production of V-01 has achieved 90% localization of raw materials, and has started the work of replacing the remaining imported materials, striving to achieve complete localization to ensure high production capacity and continuous and stable capacity release.

It is gratifying that at present, the commercial production workshop of V-01 has been completed and put into use in May 2021. The company's original solution production line and preparation production line have passed the on-site inspection of the vaccine production license by the Guangdong Provincial Drug Supervision and Administration Bureau, and obtained the vaccine production license. The original solution workshop and the preparation workshop have completed the process transfer and amplification.

At present, the company's original solution production line and preparation production line have passed the on-site inspection of the vaccine production license by the Guangdong Provincial Drug Supervision and Administration Bureau, and have the production conditions and obtained the vaccine production license. Its preparation production capacity can reach 3.5 billion doses of the original solution. According to the needs, the annual production capacity of the preparation can be increased through various methods such as increasing the preparation production line, multi-person production, and entrusted production. The preparation is expected to reach 1.5 billion doses in 2022.

Recently, Lizhu Group has submitted to the review department of the National Medical Products Administration The application for V-01 as a sequential booster shot is also being promoted simultaneously in multiple countries and regions overseas, including Emergency Use Authorizations (EUAs), marketing applications, and WHO certifications. This vaccine is expected to provide more flexible and scientific candidate options for sequential booster immunization.

Currently, V-01 is the first and only COVID-19 inactivated vaccine + protein vaccine sequential immunization Phase III clinical trial project approved by regulatory authorities in Pakistan, Malaysia, and other countries, according to publicly available global information. It is also the first COVID-19 vaccine in Pakistan approved for Phase III clinical trials of booster shots. Phase III clinical trial plan for a new coronavirus vaccine.

Currently, Omicron has once again highlighted the global inequity in vaccine distribution. Africa's overall vaccination rate is currently less than one-fifth of the global average, resulting in a significant "immunization gap".

The WHO has long warned that the longer vaccine inequity persists, the greater the likelihood of more virus variants emerging. Global vaccination is arguably the only way out of the pandemic crisis for all countries.

WHO Director-General Tedros Adhanom Ghebreyesus has stated that no country, region, or individual can be truly safe unless everyone is safe, as fighting the epidemic is not simply a matter of sweeping one's own doorstep; the battle lines should be drawn worldwide.

Therefore, in addition to being used for booster shots, V-01 vaccine, with its guaranteed production capacity and good protective efficacy, as a member of China's vaccine team, will also have long-term value in improving global vaccination rates.

Chinese companies, represented by Lizhu Group, supported by superior technological platforms, are committed to tackling global "common challenges." In the race against the COVID-19 virus, they have continuously strengthened international cooperation in vaccine research, development, production, and distribution, treating vaccines as a global public good and injecting strong impetus into the global fight against the pandemic. This is a just and righteous cause that is universally welcomed by the international community.

From: Shenzhen News Network