As epidemic prevention and control policies are gradually relaxed, routine nucleic acid testing, travel codes, health codes, and other epidemic prevention measures have been phased out. In many places across the country, there has been a sharp increase in the number of COVID-19 infections and an overloaded healthcare system. The public's demand for effective measures to prevent the novel coronavirus has risen. Vaccination with booster shots against the novel coronavirus can maintain and increase antibody levels and is an effective means of preventing infection, reducing severe cases, and lowering mortality rates.
Recently, public willingness to receive COVID-19 vaccinations has significantly increased. From December 7th to 13th alone, 1,115.3 million doses of the COVID-19 vaccine were administered nationwide. As of now, 13 COVID-19 vaccines have been approved for market release. The country has adjusted the interval between the first booster dose from 6 months to 3 months, and the second booster dose schedule has also been introduced. These measures will further promote the administration of booster doses of COVID-19 vaccines in our country.
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The COVID-19 vaccination policy continues to be optimized
The introduction of the booster dose vaccination plan for the second booster will expand market demand
Recently, the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council for Responding to the Novel Coronavirus Pneumonia has intensively issued multiple documents related to booster shots of the novel coronavirus vaccine, vigorously promoting the vaccination of booster shots against the novel coronavirus in China.
On November 29, in order to further accelerate the vaccination of the elderly against COVID-19 and ensure the safety and health of the people, the Comprehensive Group of the Joint Prevention and Control Mechanism for the Novel Coronavirus Pneumonia Epidemic under the State Council issued the 'Work Plan for Strengthening the Vaccination of the Elderly against COVID-19' (Guowei Mingdian [2022] No. 484). The 'Plan' sets requirements for the selection of booster vaccines against COVID-19 and the interval between doses: all approved vaccines and combinations for booster vaccination can be used for the first dose, and the interval between the first dose and full-course vaccination has been adjusted to more than 3 months.
On December 13, the Comprehensive Group of the Joint Prevention and Control Mechanism for the Novel Coronavirus Pneumonia Epidemic of the State Council issued the 'Implementation Plan for the Second Dose Booster Immunization of the Novel Coronavirus Vaccine' (Guowei Mingdian [2022] No. 531), proposing to carry out the second dose booster vaccination of the novel coronavirus vaccine for key populations.
In terms of the choice of second booster shots for the COVID-19 vaccine, the 'Plan' includes all 8 available vaccines except for the 5 inactivated vaccines. It recommends giving priority to sequential booster immunizations or using vaccines containing the Omicron variant or those that have good cross-immunity against the Omicron variant.
On December 15th, to guide rural areas in carrying out COVID-19 prevention and control and health services under the current situation, the Comprehensive Group of the State Council's Joint Prevention and Control Mechanism for the Novel Coronavirus Pneumonia issued the 'Work Plan for Strengthening COVID-19 Prevention and Control and Health Services in Rural Areas' (Joint Prevention and Control Mechanism Comprehensive Release [2022] No. 131), listing 'accelerating the vaccination of the rural population, especially the elderly', as one of the four major tasks.
Regarding the introduction of the aforementioned series of policies, Dr. Liu Yong, founder, chairman of the board and general manager of Ruike Biotech, said in an interview with Frost & Sullivan that the current policies have clarified that the key populations for the future COVID-19 vaccine market are the elderly, high-risk individuals after infection, and minors. These groups have relatively weaker immunity and a long-standing demand for vaccination, placing higher demands on vaccine effectiveness and safety. Whether the market will adopt a government procurement model or a self-funded model in the future, vaccine manufacturers need to pay close attention to and make strategic arrangements for them.
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The vaccination rate against the COVID-19 booster shot is insufficient
The booster vaccination campaign for key populations will continue to be promoted.
Data from the official website of the National Health Commission shows that as of December 13, a total of 3.451677 billion doses of COVID-19 vaccines have been reported nationwide, with a total number of recipients reaching 137.222 million. 1.274018 billion people have completed the full course of vaccination, covering 92.73% and 90.37% of the country's total population respectively. However, only 8157.18 million people in China have completed booster immunization, accounting for less than 60%. Among them, only 1841.79 million people aged 60 and above have completed booster immunization, with a vaccination rate of about 70%, while only 151.53 million people aged 80 and above have completed booster immunization, with a vaccination rate of only 40%.
Although epidemic prevention measures have been relaxed, the vaccination rate with booster shots in our country is still not ideal. Moreover, most people have taken a long time to complete the full course of COVID-19 vaccination, and their existing immunity may not be sufficient to provide effective protection. Therefore, it is urgent to accelerate the rollout of booster shots for COVID-19 vaccines.
Recently, the Comprehensive Group of the State Council's Joint Prevention and Control Mechanism issued the 'Work Plan for Health Services for Key Groups Affected by COVID-19', and at several press conferences, it recommended that key groups actively receive vaccinations. On December 13th, at a press conference of the State Council's Joint Prevention and Control Mechanism, Wang Huaqing, the chief expert on immunization programs at the Chinese Center for Disease Control and Prevention, provided professional guidance on vaccinating the elderly and those with underlying diseases, advocating for 'full vaccination coverage'.
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Several COVID-19 vaccines have recently been approved for marketing
The vaccine market is highly competitive
In early December, the National Health Commission (NHC) approved four COVID-19 vaccines for market launch again, including three recombinant protein vaccines and one influenza vector vaccine. These are the recombinant COVID-19 protein vaccine (SCTV01C) from Sinovac Biotech, the recombinant COVID-19 protein vaccine (Weakened) from Waksensek Biotech, the recombinant COVID-19 protein vaccine (SCB-2019) from Clover Biologics, and the nasal spray influenza vector COVID-19 vaccine (NTIB-V) from Wantai Biotech. Among them, the influenza vector vaccine produced by Wantai Biotech is China's first nasal spray COVID-19 vaccine. At the same time, after these four vaccines were approved, they were recommended by the 'Implementation Plan for the Second Dose Booster Immunization of COVID-19 Vaccines' as second dose booster vaccines for vaccination.
Since the approval of China's first COVID-19 vaccine on December 31, 2020, several COVID-19 vaccines have been successively launched in the past two years. As of now, there are a total of 13 COVID-19 vaccines on the market, including 5 inactivated vaccines, 5 recombinant protein vaccines, 1 adenovirus vector injection vaccine, 1 adenovirus vector inhaled vaccine, and 1 influenza virus vector nasal spray vaccine.
Facing the relatively fierce market competition, vaccine manufacturers of the novel coronavirus have emphasized their 'unique advantages' to enhance competitiveness, while ensuring the effectiveness and safety of their vaccines.
CanSinoThe produced Kweysha Mist is administered via inhalation.WanTai BiologyThe nasal spray influenza virus vector COVID-19 vaccine is administered via nasal spray. Apart from being non-invasive in administration, it also simulates the natural infection mode of the novel coronavirus. It can not only activate humoral and cellular immunity but also respiratory mucosal immunity, making up for the current shortcoming that vaccines cannot prevent Omicron from infecting the respiratory tract.Shenzhou CellThe SCTV01C is China's first approved multivalent COVID-19 vaccine, using a new type of oil-in-water adjuvant developed and produced by the company itself, which can significantly enhance Th1 cells;Clover PharmaceuticalsThe company claims that the SCB-2019 novel coronavirus vaccine can be used to prevent household infections.
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The development of COVID-19 vaccines is accelerating
The vaccine market is a battleground for numerous competitors
Currently, there are over 20 COVID-19 vaccines in clinical trials in China, covering multiple technical routes such as recombinant protein vaccines, mRNA vaccines, and adenovirus vaccines.Among them, recombinant protein vaccines and mRNA vaccines are research hotspots, accounting for the vast majority of ongoing products.
The recombinant protein vaccine for the novel coronavirus is balanced in terms of effectiveness, safety, and cost. Moreover, given the current situation of continuous mutations in the novel coronavirus, recombinant protein vaccines are also a mature choice for developing multivalent vaccines.
Among them, the recombinant protein vaccine ReCOV, a product under development by Ruike Biotech, has entered Phase III clinical trials. According to Dr. Liu Yong, the product uses a trimeric antigen structure and the new adjuvant BFA03, which offer significant advantages in terms of safety, efficacy, accessibility, production process, and cost.
In terms of safety, adjuvant BFA03 has been widely used abroad and is suitable for a wide range of ages. No vaccine-related serious adverse reactions were observed in clinical trials involving thousands of people with ReCOV, and the vast majority of adverse reactions can recover quickly. In terms of effectiveness, ReCOV has a clear broad spectrum, inducing persistent and broadly cross-neutralizing antibodies against multiple variants such as the prototype strain, BA.2, BA.5, BA.2.75, and BF.7. The level of neutralizing antibodies is superior to that of Pfizer's mRNA vaccine, with rapid production of neutralizing antibodies and a Th1-predominant cellular immune response. In terms of accessibility, ReCOV can be stored at room temperature for more than half a year and can be stored in the cold chain for more than two years, facilitating vaccine storage and distribution. In terms of production process and cost, it is easy to scale up production, has good stability, and the adjuvant can be produced independently, giving it a cost advantage in comprehensive manufacturing.
With the advancement of clinical trials for these ongoing products and the expected increase in the variety of vaccine products approved for market release, competition in the COVID-19 vaccine market will intensify. Zhou Jian, Deputy Director of the Consumer Goods Industry Department of the Ministry of Industry and Information Technology, once pointed out that China has built the world's largest COVID-19 vaccine production line with an annual capacity exceeding 7 billion doses and a current output of over 5.5 billion doses.In the post-pandemic era, as the vast majority of people have completed the basic immunization program against the novel coronavirus, the market space for COVID-19 vaccines has gradually narrowed, and vaccination growth rates have slowed down in many parts of the world. In the future, as the second booster dose vaccinations are gradually completed, there may be an overcapacity situation in China's COVID-19 vaccine industry.
In the face of the fierce competitive market ahead, Dr. Liu Yong stated that Ruike Biotech will strengthen market promotion and deployment. Regarding the current government procurement market, Ruike will actively participate in government bidding on one hand, and on the other hand, it will strengthen academic promotion to disease control institutions at all levels, conducting pre-market product warm-up activities; for the future market of self-funded vaccines, Ruike is actively seeking sales partners. It has currently established a nationwide sales network to prepare for market launch, while also doing a good job in online promotion, accurately delivering products to target populations.
The introduction of the second booster dose vaccination plan for COVID-19 vaccines in China will rapidly expand the market demand for COVID-19 vaccines in the country, which can be described as a 'stimulus shot' for the research and development of COVID-19 vaccines and production enterprises in China.In the future, booster shots, the fourth dose, and routine vaccination will become the focal points of competition among COVID-19 vaccine manufacturers.
