At the capital level, affected by the news, Hong Kong shares of Sinopharm holdings rose nearly 10% at one time, and finally closed up 5.56%. The shares of other listed companies of sinopharma group also soared, with China Pharmaceutical (000028. SZ) up nearly 4%, Sinopharm Holdings (01099. HK) up nearly 4%, Tiantan Biology (600161. SH) up 2.29%, and Hyundai Pharmaceutical Co., Ltd. rose 1.64%. There is market speculation, from the above reaction, the National Pharmaceutical Group vaccine may indeed be only one step away from the market.
Previously, Liu Jingzhen, Secretary of the CPC Committee and chairman of the board of directors of sinopharma group, said that the protection rate of inactivated vaccine II dose was 100%, and the examination and approval process would be started after the clinical trial was completed. It is expected that the vaccine will be put on the market by the end of December this year.
On November 25, Tao Lina, a vaccine expert, told 21 new health analysis that when Chinese medicine submitted its listing application, it should have obtained reliable protection rate data and safety data, and it would be OK to submit it directly to the regulatory authorities without being published. Tao Lina believes that the safety and effectiveness of Chinese medicine vaccines should be guaranteed, and the vaccines themselves are very safe. Except for live vaccines, there may be some risks, other vaccines are OK.
Adenovirus vector vaccines and mRNA vaccines need to be observed again, but I dont think there will be any big problems in terms of medical principles. I dont know the protection period, but it has been nearly one year since the epidemic, and secondary infection is very rare, indicating that immunity is relatively long-lasting. I personally think it will last for at least 2-3 years. Tao Lina pointed out.
In addition to the two new coronal vaccines of sinopharma group, there are kangxinuo, Kexing biological and Zhifei biological products, which have just entered the clinical phase III. The relevant responsible persons of the first two enterprises said to 21 new health that it was not yet time to submit the listing application stage, except that there was no update progress previously announced.
Application of new crown vaccine submitted by Sinopharm
On February 1, Sinopharm group, as the leading unit, won the urgent approval of the key special inactivated vaccine project of public security risk prevention and emergency technical equipment of the national key R & D plan of the Ministry of science and technology. On April 12, the new crown inactivated vaccine developed by Wuhan Institute of biological products obtained the approval of clinical trial, and carried out domestic phase I / II clinical trial simultaneously. On April 27, the new crown inactivated vaccine developed by Beijing Institute of biological products was approved for clinical trial again, adding double insurance for the development of new crown vaccine.
From the perspective of public information, since then, the research and development of new crown vaccine of Sinopharm group has been progressing smoothly.
On October 16, the international medical academic journal Lancet published the results of phase I / II clinical trial of Chinese new biological crown inactivated vaccine. This study included 4064 people in each age group. The test results showed that the vaccine was safe and could effectively induce neutralizing antibody in the population of all ages. High titer immune response was produced after vaccination with different ages, different procedures and different doses of vaccine. The level was similar to that reported in other vaccine studies, which confirmed that the vaccine had good immunogenicity It has good safety in human body. The positive conversion rate of neutralizing antibody reached 100% after two doses of vaccine were inoculated according to the 0 and 28 day program.
Novel coronavirus pneumonia vaccine developed by the national drug group has been launched in three countries, including the United Arab Emirates, Bahrain, Egypt, Jordan, Peru and Argentina. In November 17th, Liu Jingzhen was now in the three phase of the international clinical trial. Now, the group has nearly 60 thousand people, including more than 40 thousand who have completed two days of blood sampling after 14 days.
In terms of emergency use of the new coronal vaccine, sinopharma group has now used it on nearly one million people. No serious adverse reactions have been reported, only some mild symptoms are found in individual cases.
Among them, 56000 people left after vaccination, including construction personnel, diplomats and international students in more than 150 countries in the world. So far, there is no case of infection. Liu cited an example of a multinational company having 99 employees in foreign offices, 81 of whom were vaccinated. After the outbreak of the epidemic, 10 of 18 people who had not been vaccinated were infected, while none of the vaccinated personnel were infected.
The incidence rate of incidence of infection in 81 persons in the same room is 0%, and the infection rate of 10 people in the same room is 10, with an incidence rate of 56%, and the incidence rate of the whole room is 10%.
Vaccine protection rate = (56% - 0%) / 56% = 100%. In fact, the 100% protection rate of inactivated vaccine with Chinese medicine is very convincing, unless there is evidence that the risk of infection of these 18 unvaccinated people is higher than that of 81 vaccinated people. He said.
In an interview with the media on November 18, Liu Jingzhen said that up to now, the two new crown inactivated vaccines of sinopharma group are leading the world in all aspects of research and development, clinical trials, production and emergency use.
Liu Jingzhen also pointed out that at present, dozens of countries have proposed to Sinopharm group for the purchase of new crown vaccines. Once approved, Chinas vaccine will officially appear on the international market. In order to ensure the supply of vaccines, China biology has made preparations for large-scale mass production. Two high-level biosafety workshops of Beijing Institute of biological products and Wuhan Institute of biological products have been completed. The production capacity is expected to reach more than 1 billion doses next year, which can ensure the safe and sufficient supply of vaccines.
Phase III clinical trials in progress
For the action of the above national medicine, the market believes that the pace of Chinas new crown vaccine on the market has been accelerated.
However, both Kexing bio and kangxinuo, which have made rapid progress in the third phase of the project, both said that no updated information has been released. The relevant person in charge of Kexing biology said to 21 new health that it was still early to submit the listing application.
In July this year, Kexing bio announced that Brazils national regulatory authority had approved the use of the companys new crown vaccine for phase III clinical trials. The coronavac vaccine is currently undergoing large-scale late trials in Brazil, Indonesia and Turkey. Recent preliminary tests in Ankara, Turkey, have shown that the vaccine can induce an immune response quickly, although it produces fewer antibodies than are detected in new crown survivors. According to past experience, the vaccine provides adequate protection, the researchers said.
On November 17, Kexing bio announced the results of phase I / II clinical trial of corona VAC, a new crown vaccine produced by the company, on the lancet infection diseases. The results showed that the vaccine was safe, could induce rapid immune response, and developed antiviral antibody within 14 days after receiving the dose, which was suitable for emergency use in case of outbreak or for medical staff Use.
Recently, the Brazilian health agency Anvisa said in a statement that it had suspended testing of Chinas corona VAC vaccine after serious adverse events. In this regard, Kexing biological to 21 new health said that after communication with the Brazilian partner butantan Institute, the head of the Institute believed that the incident had nothing to do with the vaccine. Kexing will continue to communicate with Brazil on this matter. Brazils clinical research will continue to carry out relevant work in strict accordance with GCP requirements, and is confident in the safety of the vaccine.
Kexing biology also released the statement on the suspension of clinical research on the new crown inactivated vaccine phase III in Brazil through its official website. According to relevant media reports, it was learned that the death of the test victim died of suicide, which had nothing to do with the vaccine.
Like Kexing biological, the relevant person in charge of consinor also replied to 21 new health, saying that at present, after three phases of clinical trials in Russia, Pakistan and Mexico, no updated information has been released.
At the same time, yuxuefeng also mentioned the cold chain storage and transportation issues of public concern. Our vaccine can be stable for a long time at 2-8 degrees Celsius, which brings great convenience to use.
According to the Hunan Provincial Disease Control System, on November 18, the third phase international multicenter clinical trial of Zhifei biological new crown vaccine was officially launched in Xiangtan. It is planned to recruit 29000 people aged 18 and above to participate in the trial. Meanwhile, the three phase clinical trials abroad will be carried out in Uzbekistan, Indonesia, Pakistan, Ecuador, etc.
On November 19, the Ministry of innovation and development of Uzbekistan has sent the samples of Zhifei biological new crown vaccine and related sample reagents to the national drug and medical supplies Identification Center for quality inspection. If the test results are normal, phase III clinical trial will be officially started in Uzbekistan. It is understood that Uzbekistan can purchase the vaccine at a preferential price if the clinical trial is successfully completed.
Recently, the results of several new coronal vaccines which have entered the third phase clinical trial have been published.
On November 23, Moderna announced the price of its new crown vaccine, which could range from $25 to $37 per dose, depending on the quantity ordered. By the end of 2020, Moderna is expected to deliver about 20 million doses of new coronavirus vaccine in the United States, and is expected to produce 500 million to 1 billion doses worldwide by 2021.
On November 18, Pfizer officially announced that bnt162b2, a new mRNA crown candidate vaccine developed by Pfizer in cooperation with biontech, had an effective rate of 95% 28 days after the first administration of bnt162b2, without serious side effects. This is the complete result of the phase III clinical trial of its new coronal vaccine. On November 20, Pfizer said it had submitted an emergency use authorization for the new crown vaccine to the FDA. If the application is approved, it will start to launch the vaccine in limited quantities as early as December.
However, Pfizers vaccine has high requirements for cold chain transportation - it must be stored in the environment of minus 70 u2103, and special storage equipment and transportation tools are required. As for the benchmark price of the new crown vaccine, Pfizer said that it would be $19.5/dose in the United States, and pricing strategies in other countries would comprehensively consider the principles of quantity, advance commitment, fairness and affordability.
On November 23, AstraZeneca announced that the effective rate of its new crown vaccine in key trials was 70%, and it was expected to rise to 90%. There were no reports of hospitalized or severe cases among all subjects. The vaccine could be transported and stored under normal cold storage conditions (between 2-8 degrees Celsius) for at least 6 months. AstraZeneca promised that it would not benefit from the vaccine, and the vaccine produced would be provided to anyone Which country to use, so the price cost is the lowest. According to previous media reports, the Oxford AstraZeneca vaccine with two doses was priced at $3-4.
Ordinary people start fighting in December?
For the new crown vaccine that Sinopharm group has submitted to the SFDA for listing, combined with the information previously disclosed by Liu Jingzhen, the protection rate of the two inactivated vaccines is 100%, and it will enter the examination and approval process after the clinical trial is completed. It is expected that the new crown vaccine of China will be put on the market by the end of December this year. The listing date of Chinas new crown vaccine is not far away, and the universal vaccination time may be earlier than that of the United States.
In fact, before that, China has already started the emergency vaccination of new coronal vaccine. On July 22 this year, China officially launched the emergency use of the new crown vaccine. According to the vaccine management law, special groups such as medical personnel, epidemic prevention personnel, border inspection personnel and basic urban operation personnel can be given emergency vaccination.
At present, emergency vaccination appointment has been opened in many places. For example, on the afternoon of October 15, the center for Disease Control and prevention of Jiaxing City, Zhejiang Province, announced in its official wechat that at present, the center for Disease Control and prevention of Jiaxing City, Zhejiang Province, has successively carried out emergency vaccination of the new crown vaccine among the key targets.
The official account of the Shaoxing health official said that starting from October 20th, the new crown vaccine appointment will be opened for all, and the order of injections is also in accordance with the order of appointment.
According to the relevant announcement, the emergency vaccination program for the new crown vaccine is 2 doses, with an interval of 14-28 days and a recommended interval of 28 days. The vaccination age is 18-59 years old. The price of the vaccine is 200 yuan / bottle, 400 yuan for two doses, and 28 yuan for each dose.
For the current listing application of new crown vaccine of national medicine, Tao Lina thinks that it should have obtained reliable protection rate data and safety data. It is also OK to not publish it to the public and submit it to the regulatory authorities. The listing speed is further accelerated. In special periods, the new crown vaccine is suitable for the prior review and approval process.
On March 30, this year, the State Administration of market supervision promulgated the measures for the administration of drug registration and the measures for the supervision and administration of drug production, which made it clear that priority review and approval procedures could be applied for vaccines and innovative vaccines in urgent need of disease prevention and control. According to the work procedure for priority review and approval of drug marketing license (hereinafter referred to as the work procedure), priority review and approval procedure can be taken for the drugs that meet the requirements of short drugs in clinical urgent need, prevention and treatment of major infectious diseases and rare diseases. In addition, when there is a threat of public health emergencies, as well as after the occurrence of public health emergencies, there is a fast track - the special approval procedure, which means that the SFDA can decide according to law to implement special examination and approval on the prevention and control drugs needed for public health emergencies, and the SFDA will speed up the application for drug registration with special approval Meanwhile, drug registration acceptance, review, verification and inspection work shall be carried out simultaneously. The situation, procedure, time limit and requirements of special examination and approval shall be implemented in accordance with the provisions of special approval procedure for drugs. New crown vaccine application for marketing source: 21st century economic report editor in charge: Chen Hequn_ NB12679
On March 30, this year, the State Administration of market supervision promulgated the measures for the administration of drug registration and the measures for the supervision and administration of drug production, which made it clear that priority review and approval procedures could be applied for vaccines and innovative vaccines in urgent need of disease prevention and control. According to the work procedure for priority review and approval of drug marketing license (hereinafter referred to as the work procedure), priority review and approval procedure can be taken for the drugs that meet the requirements of short drugs in clinical urgent need, prevention and treatment of major infectious diseases and rare diseases.