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Original title: Demystifying the past and present of the new corona vaccine: 48 days of production go back
Beijing Business Daily (Reporter Tao Feng Chang Lei) Recently, a documentary titled “Exploring the Past and Present of the New Coronary Vaccine” was screened. In the first person, the film chronicles the process of changing from a new coronavirus-inactivated vaccine of the novel coronavirus to the finished vaccine. The rigorous and efficient 48-day production process, from production time to vaccinator information, is traceable … Strict quality control is the first priority in the production of the new corona vaccine.
At the end of 2019, the new coronavirus began to appear in human sight, with tens of millions of infections and millions of deaths. Scientists isolated it from the patient and named it COVID-19. Scientists conduct intensive research on it in the laboratory. They cultured the new coronavirus in Vero cells and selected a suitable strain for vaccine preparation: the CZ strain. Since then, the CZ strain has embarked on the path of helping humans fight the epidemic.
In the vaccine production workshop, from “pregnancy” to “birth”, the new coronavirus inactivated vaccine has to go through six main steps: cultivation, inactivation, purification, dosing, filling and packaging.
Specifically, to prepare an inactivated vaccine for the new coronavirus, a large number of new coronaviruses must first be reproduced. The scientists isolated and cultured Vero cells from the renal epithelial cells of African green monkeys. It can undergo multiple divisions without senescence and is the most suitable “soil” for the spread of the virus. After a large number of viruses have multiplied together, they pass through a closed duct and inject an inactivating agent. After a few hours, the virus loses its pathogenicity and cannot reproduce or grow. At this point, the virus has metamorphosed into an inactivated liquid. Subsequently, other impurities were removed from the inactivated solution and the stock vaccine solution was born.
In the vaccine proportioning area, staff mix the vaccine stock solution with adjuvants and diluents to produce semi-finished vaccine products and go into cold storage to await inspection. For convenience of use, the semi-finished vaccine product has two types of packaging: one is a vial. Each vial has to go through processes such as ultrasonic pre-cleaning, high temperature steam condensate washing, compressed air blowing and high temperature drying at 350 ° C.
On the packaging line, the camera will take pictures of the finished vaccine under different angles and backlight to ensure that no impurities are mixed, that the sealing cap is accurately positioned, and that the bottle body is not scratched. The finished vaccine product is then placed with a label printed with the product name and lot number, and packed in the packing box along with an instruction sheet. Each packing box is printed with a unique traceability code, which includes when the product was made, where it was shipped, and who was inoculated with this number, which can be quickly found out from this number. After that, the finished vaccine will be placed in cold storage at 2-8 ° C, and the temperature will be recorded by staff in real-time in cold chain logistics throughout the process.
From cell culture to finished vaccine products, each new inactivated coronavirus vaccine takes 48 days. Before entering the following link, the quality inspector will conduct a strict “physical examination”. Only when all the indicators are qualified, the vaccine will finally appear in front of everyone.
In this regard, vaccine expert Tao Lina explained that my country has fully implemented the regulatory code system for drugs, which means that each new corona vaccine has a unique 20-digit code on the smallest package, and the authenticity is you can check by scanning the code. “Therefore, everyone can be sure of receiving the new corona vaccine through regular institutions,” said Taolina.
The production of the new corona vaccine is strictly controlled, what about the vaccination situation? Recently, Yang Xiaoming, president of Sinopharm Group China Biotech, accepted an interview with CCTV and introduced the situation of the new corona vaccination. “From the perspective of the current global demand for vaccines from the new corona epidemic, the supply is still less than the demand. From the capacity of the two production lines deployed by Sinopharm China, we strive to be able to produce more than a thousand million doses in 2021. From this perspective, there is a balance between supply and demand, but for the global fight against the epidemic, vaccines are far from sufficient, “said Yang Xiaoming.
Since the second half of last year, the country started the COVID-19 vaccination. Do people who have been vaccinated for more than half a year need to receive a third dose? Yang Xiaoming said that according to the immunization procedures for emergency use and marketing approval, the interval between two vaccination doses is 21-28 days, and the data after the two-dose interval is valid for half a year. According to observations, So far, there is no need to strengthen the third dose in six months of declaration. After more detailed data comes out, we can know whether to strengthen.
Nowadays, some areas have gradually started the new vaccination crown for people over 60 years old, and the timing of vaccination for people under 18 years old has attracted a lot of attention. Yang Xiaoming said: “The clinical research data for the age group 3-17 years has been completed and will be sent to the State Food and Drug Administration as soon as possible after compilation. The State Food Administration and Medications will approve the use of the Group of 3-17 years according to regulations after reviewing in accordance with the regulations. “
