Every editor: Hu Ling
As of today, four vaccines have been conditionally approved for marketing in China. Two of them are from Sinopharm Group China Biotechnology, and the latest two approved, in addition to Academician Chen Wei’s adenovirus vector vaccine, the other one is the latest approved vaccine of Sinopharm Group. Is this vaccine different from before? In addition to inactivated vaccines and adenovirus vector vaccines, will we have vaccines with new technical routes? The “News 1+1” column connected with Yang Xiaoming, chairman of Sinopharm Group China Biotechnology.
Sinopharm already has a new crown vaccine, why should it produce another one?
Yang Xiaoming, Chairman of Sinopharm Group China Bio: Sinopharm Group set the inactivated vaccine process route in the early stage of research and development last year.At the same time, the two biological products research institutes of China Bio-Beijing and Wuhan are set up to be developed in parallel, in order to ensure that they can be developed, mass-produced and listed. We call it “double insurance”.
The new crown inactivated vaccine of the Beijing Institute was approved (with conditions) on December 30 last year, and the Wuhan Institute was listed on February 25. The technical routes of these two vaccines are inactivated vaccines. One month, in general, is to ensure that the vaccine can be marketed, mass-produced, and supplied. This was our goal at the time.
Are there competition between Sinopharm’s two new crown inactivated vaccines? How should vaccinators be selected?
Yang Xiaoming, Chairman of Sinopharm Group China Biotechnology: Judging from the current global demand for vaccines due to the new crown epidemic, the supply is still less than the demand.From the production capacity of the two production lines laid out by Sinopharm China Bio, weStrive to produce more than 1 billion doses in 2021. From this perspective, supply and demand are balanced, but for the global fight against the epidemic, vaccines are far from enough.
In terms of process route, both vaccines are virus inactivated vaccines. From the clinical data obtained in Phase I, Phase II, and Phase III, both of them meet the requirements of the State Food and Drug Administration. 1. Effectiveness.Judging from the protection rates obtained from the Phase III clinical data, one reached 79.34% and the other reached 72.51%, are better than the protection rate of more than 50% required by the World Health Organization. 2. Neutralizing antibody positive conversion rate. Both vaccines are close to 100%, and they can also reach 100% in terms of severe protection rate.soIn terms of efficacy and safety data, these two vaccines should be on a par in selection..
The new crown vaccine of Sinopharm Group China Biotechnology has been vaccinated nearly 46 million times, with no serious adverse reactions
Yang Xiaoming, Chairman of Sinopharm Group China Biotechnology: From June last year, it was approved for listing in Beijing on December 30 last year, and it was approved for listing in Wuhan on February 25 this year. Up to now, more than 40 million doses of the vaccine have been used. .Observe the overall safety of use, the vaccine is very safe, and no serious adverse reactions have been foundIn terms of effectiveness, the current monitoring situation, there are vaccinators who have received two doses, and some who have received one dose. The overall situation is still in an orderly manner according to the plan of the joint prevention and control mechanism.Nearly 46 million doses of the vaccine have been administered.
Sinopharm China Bio’s new crown vaccine, the antibody has not declined in half a year
Yang Xiaoming, Chairman of Sinopharm China Biotechnology:From the clinical data of Phase III, Phase II, and Phase I, the antibody did not decline within half a year.The third phase was launched a little later, but the data for half a year also proved that there was no problem, the same as the first and second period data. Judging from the longer data, the “vanguard” of volunteers, including myself, has been vaccinated for almost a year. From the data, the antibodies still exist, but this is a small-scale observation.A really large number of phase III clinical persistence observations, that is,More than half a year of data, we are monitoring the processBecause of the large amount of data and the large amount of serum samples, it is still being tested, but we are still confident that its protection rate is still acceptable.
Do people who have been vaccinated against the new crown for more than half a year need a third dose?
Yang Xiaoming, Chairman of Sinopharm China Bio: According to the immunization procedure approved for emergency use and marketing, the interval between two injections is 21 to 28 days, and the data after the interval between two injections is valid for half a year.According to the situation observed so far, there is no argument that the third needle will be strengthened after half a year..We will know whether to strengthen it when more detailed data comes out.How about the durability, this data looks forward to more complete data from the Phase III clinical trials.
When can people under the age of 18 get the new crown vaccine?
Yang Xiaoming, Chairman of Sinopharm Group China Biotechnology: The susceptible population of the new coronavirus is of all ages, and vaccine prevention is best for all ages, but when we are conducting clinical trials of Phase I, II and III, for the sake of safety, first do 18 to 18 59 years old, so the data from 18 to 59 years old came out the earliest, followed by those over 60 years old, followed by those under 17 years old and above 3 years old, which are divided into different ages. So for emergency use, the approval is for the age group of 18 to 59. As for the Beijing Institute listed on December 30 last year, and the Wuhan Institute listed on February 25, the applicable age group in the listing instructions is over 18 years old, that is, over 18 years old, including all age groups over 60 years old can be used.For the 3 to 17-year-old age group, the clinical research data has been completed, and it must be submitted to the State Food and Drug Administration as soon as possible after sorting..
Is Sinopharm’s inactivated vaccine effective against mutated new coronavirus?
Yang Xiaoming, Chairman of Sinopharm China Bio: Does the new crown vaccine have any effect on the mutant strains? Now the mutant strains from the United Kingdom and South Africa are more representative, which poses a serious challenge to the effectiveness of the vaccine. We have conducted cross-neutralization tests at home and abroad, including British and South African strains, and a dozen strains with serum from Phase II and Phase III clinical trials, that is, the serum after immunization with inactivated vaccines.The results show that we have also neutralized two mutant strains including the United Kingdom and South Africa, and nearly a dozen strains of viruses isolated in China are also effectively neutralized, indicating that the inactivated vaccine immunization is effective against the mutant strains encountered so far. of.
Sinopharm China Bio’s genetic recombinant protein vaccine is applying for clinical research
Yang Xiaoming, Chairman of Sinopharm China Biotechnology: The new crown epidemic has never happened in a century, and it is a new virus and a new challenge for scientists around the world, especially for vaccine workers. When the epidemic situation was very tense last year, Sinopharm China Biotechnology has arranged all the technical route research. The first two inactivated vaccines are the ones we think are the most reliable and most likely to be developed, so we mainly promote inactivated vaccines.The rest of the others are doing nowThe genetic recombinant protein vaccine has also completed the clinical research work, the data is also very good, and it is applying for clinical research.Apart from that weThere are some arrangements for adenovirus vector vaccines, including nucleic acid vaccines.