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Original title: Fall and Winter Epidemic Hits Domestic Vaccine and Sprints
On November 12, the State Council held a press conference to present that the number of imported cases in China has increased rapidly since October, with a year-on-year increase of 45%. The prevention and control of the epidemic cannot be relaxed for a moment. The situation of prevention and control of the epidemic in autumn and winter is serious. The new corona vaccines from Kexing and Sinopharm have also been widely used in phase III clinical trials, and the national vaccines have entered the final phase of elimination.
Phase III clinical studies have been implemented
On November 12, Beijing time, Brazil’s National Health Supervision Office announced that it authorized the resumption of phase III clinical studies of the new inactivated corona vaccine “Kierlefor” with the support of the Butantan Institute, a partner of Kexing. Bio.
On the night of November 9, the National Health Supervision Agency of Brazil announced that the clinical trial of the new coronavirus vaccine “Kierlefor” cooperated by China Kexing Biological Company and the Butantan Institute in the state of Sao Paulo, Brazil, had a rehearsal on October 29. Serious adverse reactions ”, which is why it was decided to suspend the phase III clinical trials of the vaccine in Brazil.
Subsequently, the Butantin Institute contacted the Brazilian National Health Inspection Agency and presented a report from the Data Security Supervision Committee. After evaluating the new data, Brazil’s National Health Inspection Agency agreed to resume clinical research. The Brazilian National Health Supervision Agency stated that suspension and resumption of research are common events in clinical research, and suspension does not necessarily mean that the product under study has quality, safety or efficacy problems.
Regarding the clinical situation, Kexing Holding Biotechnology Co., Ltd. spokesperson Liu Peicheng introduced a reporter from the Beijing Commercial Daily: “The phase III protective efficacy trial used the randomized, double-blind, and internationally accepted placebo controlled. Test subjects will be randomly assigned to receive the trial vaccine and placebo, and then receive a one-year follow-up observation to understand if the subject has any adverse reactions related to the vaccine and, more importantly, if the subject has symptoms of a new coronavirus infection. It was confirmed by nucleic acid tests, and the protective effect of the vaccine was obtained by comparing the difference in the incidence of confirmed cases of new corona infection in the two groups of laboratories. According to the standards recommended by the World Health Organization and China, the vaccine can be considered effective if the protection rate reaches at least 50%. “
“The phase III protection efficacy trial started in July this year. Based on the current prevalence and speed of entry, the mid-term analysis is expected to be carried out before the end of the year,” Liu said. Peicheng.
Around the same time, Sinopharm also revealed the latest research developments. On November 11, Sinopharm Group stated that currently phase III clinical trials of the Sinopharm China Bio-New Crown Vaccine are progressing smoothly in the United Arab Emirates, Bahrain, Egypt, Jordan, Morocco, Peru, Argentina and other countries, and has entered the final stage of the sprint to vaccinate volunteers. There are more than 50,000 people and the population sample covers 125 nationalities. “Phase III clinical trials of the new corona vaccine in many countries are nearing completion and the trial data is better than expected,” Sinopharm noted.
The new corona vaccine will be available soon, what about the price? Liu Peicheng told Beijing Commercial Daily reporters that many factors should be taken into account when pricing vaccines, including R&D and production costs, procurement scale, dosage form (semi-finished or finished product). ), the delivery period and whether the buyer pays in advance. “We have different price ranges for different situations. However, Kexing promises that the price of the new corona vaccine will be competitive,” Kexing Biotechnology noted.
There is a risk of a clustered epidemic
Corresponding to the intensive phase III research of the new corona vaccine, it is the second wave of the fall and winter epidemic.
On November 12, the State Council held a press conference to present the strengthening of the prevention and control of the winter epidemic and the in-depth development of the patriotic health campaign. Regarding the situation of the epidemic situation in autumn and winter, Li Bin, deputy director of the National Health Commission, noted: “China faces an increased risk of local transmission due to imported cases. The epidemic will be sporadic in winter and Clusters of epidemics may occur in some areas. Epidemic prevention and control work I can’t relax either. “
The second wave of epidemics abroad is fiercely looming. The data shows that the cumulative number of cases has exceeded 52 million. Recently, the number of new cases in a single day in the world has exceeded 600,000, 6 times the peak of spring.
“The second wave of the epidemic and its threat is also a very serious reality. So far, China has imported more than 3,600 cases from abroad. Especially since October, the number of imported cases has increased rapidly. The current average daily import rate it is 16.6, compared to September, an increase of 45%, “said Vice Foreign Minister Luo Zhaohui.
In response to this, China has introduced some new measures: adding a serum antibody test; reduce nucleic acid testing prior to shipment from 72 hours to 48 hours; add a test in transit areas; and adopt a stricter visa policy for some countries with high epidemics. “At the same time, the flight fuse mechanism continues to be applied more strictly,” Luo Zhaohui emphasized.
Disease control expert Tao Lina also said that it is undeniable that after months of high alert, sometimes “the wolf is coming” he yells a lot, everyone will inevitably relax, and staff vigilance may decrease. Citizens have also relaxed in various prevention and control measures, for which everyone must renew their vigilance.
Increase sampling of food from the cold chain
The overseas epidemic has already affected domestic imports of cold chain food. A few days ago, there was a new confirmed case in Tianjin. Since then, an environmental sample from the Hailian cold storage of the China-Singapore eco-city Tianjin in the new Binhai area has tested positive for the novel corona virus, and the patient participated in the company’s frozen food import. on November 4. . Previously, Liaoning, Qingdao and many other places had detected the new coronavirus on the outer packaging of frozen foods.
What measures have the relevant departments taken to prevent the risk of imported food from the cold chain due to the new corona pneumonia epidemic? What are the regulatory measures for imported foods from the cold chain that have entered the domestic market?
Bi Kexin, Director of the General Customs Administration Import and Export Food Safety Office, said: “So far, the General Customs Administration has conducted random inspections of 140 imported cold chain food production companies in 50 countries, and suspended or revoked the registration ratings of 22 troubled companies. Measures such as the suspension of the export of products from companies with employee cluster infections to China. As of midnight on November 11, 99 manufacturing companies in 20 countries where employees were infected with new coronary pneumonia have taken steps to suspend imports of their products; In addition, Carry out the new nucleic acid sampling test for coronavirus in imported foods from the cold chain, focusing on increasing the sampling test for seafood and other imported cold chain foods. At midnight on November 11, a total of 873,475 samples were taken and analyzed in customs across the country, of which positive nucleic acid results were detected13. . “
The epidemic abroad is raging and many industries such as aviation and tourism are badly “damaged.” A few days ago Singapore presented the “tourism bubble”, announcing that it would open exchanges with some countries and regions with better epidemic control. Will China consider forming a closed-loop “tourism bubble” with countries with few new cases?
“This can be studied.” Luo Zhaohui said that even when the epidemic is severe, China has been promoting the establishment of “fast channels” and “green channels” to promote the flow of people, cross-border logistics and economic recovery.
However, Luo Zhaohui also made it clear: “In the current situation, although domestic tourism is relatively hot during National Day, I believe that overseas travel should be cautious. We do not advocate the liberalization of overseas tourism. This it is the opinion of the relevant authorities. Of course, we are also discussing the creation of ‘green channels’ and ‘fast channels’ networks with some countries. “
Beijing Business Daily Reporter Tao Feng Chang Lei
