China is accelerating the pace of introducing the new coronavirus vaccine. In response to investor inquiries at the shareholders’ meeting, Fosun Pharma stated that the State Food and Drug Administration has basically completed the review of the mRNA new crown vaccine “Fubitai”, the expert review has been passed, and the administrative approval stage is currently being stepped up. Fosun Pharma has started production preparations in advance with BioNTech. Once approved, Fubitai vaccine can be supplied to the country as soon as possible; people familiar with the matter said that in the future, Fubitai is likely to be used as an intensified injection in China for free vaccination. . (Caixin.com)

Introducing is one thing, but whether or not it can be mixed is another. According to the news: Fosun Pharma’s introduction of China’s mRNA vaccine “Fubitai” is likely to be used as a booster injection and vaccination is free. As for when it will be available, I don’t know yet (I expect it will be after summer vacation at the earliest?). But one of the points that needs special attention is the problem of vaccine mixing. I will specifically talk about this. In the early morning of July 15, 2021, the “New England Journal of Medicine” (NEJM) published an online paper by a Swedish scholar: “Heterologous ChAdOx1 nCoV-19 and mRNA-1273 Vaccination” [1]. The results showed that the neutralizing effect of antibodies produced after mixed vaccination of adenovirus vector vaccine (Oxford-AstraZeneca) and mRNA vaccine (Modena) was better than that of two doses of Oxford-AstraZeneca vaccine. (Because the AstraZeneca vaccine may cause rare thromboembolic events, especially in people younger than 60-65 years old, many European countries recommend mixed AstraZeneca vaccine and mRNA vaccine for the above population) and there have been several articles about The research on the safety and immune efficacy of mixed vaccination with the new coronavirus vaccine was published on the preprint website, and this is the first paper officially published after peer review. This longitudinal study included a total of 88 medical staff, all of whom were vaccinated with AstraZeneca 9 to 12 weeks ago. After that, 37 cases were boosted with AstraZeneca vaccine, and the other 51 cases chose to boost Modena vaccine. Participants in the study collected blood on the day of booster vaccination, 7-10 days and 30 days later to detect the levels of new coronavirus spike protein (S)-specific IgG (antibody) and receptor binding domain (RBD)-specific IgG. In addition, the study also used immunofluorescence test or cytopathic observation method to carry out serum neutralization test on the new coronavirus strain or B.1.351 (β variant strain) isolated in Sweden. The results of in vitro antibody neutralization experiment after booster vaccination The booster vaccination test results show: ① On the day of booster vaccination, the levels of S-specific and RBD-specific IgG and neutralizing antibodies were similar in the two groups; ② 7-10 days after booster vaccination , The booster AstraZeneca group was 5 times the day of booster vaccination (P<0.001); while the booster vaccination group was 115 times and 125 times the day of booster vaccination (P<0.001); ③ 30 days after booster vaccination The levels of S-specific IgG in the two groups were similar to those at 7-10 days. The results of the in vitro serum neutralization test showed that 7-10 days after the booster vaccination with Modena vaccine, the serum neutralizing antibody level (ID50) rose to 20 times of the day of booster vaccination (P<0.001). In contrast, the serum neutralizing antibody level (ID50) of the boosted AstraZeneca vaccine group only increased by about 2 times (P=0.09). Thirty days after the booster vaccination, the neutralizing antibody levels of the two groups rose to 1.6-1.7 times that of 7-10 days, but the difference was not statistically significant. In particular, it should be pointed out that after the booster vaccination with Modena vaccine, the serum can neutralize the B.1.351 variant strain, but the booster vaccination with AstraZeneca vaccine did not see this effect. The incidence of fever, headache, chills, and muscle aches in the boosted Modena vaccine group was higher than that in the boosted AstraZeneca vaccine group. However, a comparison after classification of adverse events found that there was no statistical difference in the incidence of adverse events between the two groups. Moreover, these adverse events are the same as those reported for booster immunization with the same vaccine. The author of the study believes that for people who received the first dose of AstraZeneca vaccine, booster vaccination of Modena vaccine can effectively stimulate B cell memory and provide better protection against the B.1.351 variant. The study further suggests that for people who have received two doses of AstraZeneca vaccine, the third dose of mRNA vaccine is expected to provide better protection. Of course, this is only the test result of mixed vaccination of adenovirus vector vaccine and mRNA vaccine, and given that most of my country’s vaccination is inactivated vaccine, the question also comes: Can inactivated vaccine + mRNA vaccine be combined? How long is the vaccination interval? How much has the effect of strengthening needles improved? I haven’t seen any research in this area so far, if it comes out, there will be more waves. Instead, the chief scientist of the World Health Organization Sumia Swaminatan reminded on July 12: Don’t “mix and match” vaccines from different manufacturers. This is a “dangerous trend” because of the current situation regarding this practice. Data on the impact on human health are still limited. My other answer about vaccines: What is the difference between Connaught vaccine and other vaccines? I made an appointment with Connaught for this injection, but I saw a lot of people reacted greatly? Which one is better for Coxing and Beisheng (China National Medicines) for the new crown vaccine? Kexing published the results of Phase I/II of the new crown vaccine for children and adolescents aged 3-17 years. What information is worth paying attention to? What are the characteristics of the new coronavirus Delta variant? Is the current vaccine effective? How about Shenzhen Kangtai’s new crown vaccine? Why are there so few vaccines in Anhui Zhifei? Can the vaccines currently administered by China be able to withstand the variant strains of India?

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helpmekim
4 months ago

Say a few times. First, it will be a matter of time for Fubitai to pass the approval. But this timing is very important. I said it once before that it is unlikely to be approved before the vast majority of people in China have been vaccinated. It is very likely to cause a group of people in China to pick up the vaccine. Cause delays in vaccination. However, when most of the domestic vaccination was completed and the supply of vaccines was sufficient, Fubitai was approved. This only enriched the vaccination options in our country. Moreover, our own two mRNA vaccines are also in the clinic, and it is estimated that it will not be much later than Fubitai. The second is what this insider said: According to insiders, in the future, Fubitai is likely to be used as an intensified injection in China, and vaccination is free. I don’t know where this person comes from. But here are two very important medical issues. 1. Vaccine booster Vaccine booster I have been saying that a high probability is inevitable. But it depends on the time. The domestic situation in my country is predicted to start at the end of this year or the beginning of next year. The timing depends on whether the existing main population can complete the vaccination before the end of the year, and the second is the mutation of the virus. Taking delta virus mutations as an example, all vaccines now have reduced protection to varying degrees, so whether to inject a separate booster shot for delta vaccine is currently a focus of debate. Pfizer has already done this, and of course the FDA disagrees. The reason is that the main body of the United States has not been vaccinated, and it is easy to cause confusion when the booster is pushed. But in fact, my country has long considered the third shot, but whether this third shot will use the original vaccine to enhance the antibody concentration and duration, or use the new vaccine to reduce immune escape is also under study. But this is not a technical problem, but more from the consideration of the timing of immunity. 2. Mixed use of vaccines. The mixed use of vaccines has been controversial internationally and domestically. Some countries are using it, but many countries do not support it. The current mixed use is divided into two categories, one is the mixed use of different brands of the same kind, such as Sinopharm Mixed Kexing, Modena mixed with Pfizer. There is also a mixed use of different types, such as adenovirus mixed mRNA, or adenovirus mixed inactivation. Judging from the clinical data seen so far, the mixed vaccine may stimulate immunity stronger, but the intuitive consequence is that the side effects are greater. So there are many people who are worried about the side effects, and they are mixing up. Then these people will be more worried and will not go for the vaccination. The core reason for the previous mixing was that the supply was not enough, and it was compelling. Now, at least, there is no situation where vaccines cannot be supplied in a large area in China, and our production capacity has already exploded. Therefore, it is not recommended to mix species in China at present, unless there are large-scale phase III clinical data showing that mixed use has obvious advantages over the same species inoculation. Before there is enough data, just get the same vaccine. As for the future, whether to use mRNA for enhancement or follow up with multivalent inactivation does not depend on our personal wishes, but on the clinical data and the mutation of the virus.

heloword
4 months ago

On July 9, Pfizer/BioNTech announced that it would submit an application to relevant regulatory agencies to approve the third dose of vaccination to improve immunity against mutant strains. (However, health officials in the United States do not approve of this. Individuals speculate that they do not want to do what they are not good at.) With the increase in the number of people infected with the delta strain of the new crown virus, the Israeli Ministry of Health announced on July 12 that it would be immune to immunity. The injured receive the third dose of the new crown vaccine. WHO Director-General Tedros Adhanom Ghebreyesus condemned, saying that developed countries are ignoring and exacerbating the difficulty of obtaining vaccines for third world countries. By the fourth quarter of this year, “strengthening needle” may become a hot word in public opinion. It is hoped that next year there will be no more “new vaccine” hot words against immune escape mutations.

helpyme
4 months ago

Strengthening is not just okay. Boosting needs to be done after completing the original immunization. For example, 1 injection of adenovirus, inactivated, 2 injections of mRNA vaccine, and 3 injections of recombinant protein; after the injection. For inactivated and mRNA vaccines, the third shot is the so-called booster shot. Why do we need to strengthen the needle? Because you are immune, the virus is escaping. Regardless of the case of booster needles, for the cross-immunity of the variants, there are successive data coming out. Both inactivation and mRNA have declined, but both are okay, but it is still not finalized, which is better. Under normal circumstances, booster shots are also vaccinated with the original vaccine. For example, the more familiar hepatitis B strengthening needle. A while ago, the CEO of Kexing came out and said that a booster shot of an inactivated vaccine can be given, but they are still studying. A senior sister had a very low infection antibody titer. Based on this, it is unreliable to speculate that the neutralization will not be high, and she has been urging her to get a third shot. The third needle of mRNA research has come out, and it can indeed increase the titers of neutralizing antibodies, especially for variants. About gang fights. When inactivated vaccines were shot in the country before, there had been mixed shots. The opinion given by domestic officials is that the same kind can be mixed. For example, both are inactivated vaccines, and Kexing and Sinopharm can mix. I myself am the first injection of Sinopharm and the second injection of Kexing (the infection antibody titer was measured, the population is moderate; the neutralizing antibody has not been asked). After inoculation, it is inactivated, and then inoculated with mRNA mixing. There are not many cases. Of course, this situation can be said to be enhanced, regardless of the variant or the same, after all, it is for the same virus (COVID-19). Research on mixing of other different kinds of vaccines has come out, and a reliable blogger who has been following frequently does document sharing. AZD1222 is an adenovirus vaccine, and BNT162b2 is an mRNA vaccine. The new crown is really a melee. Only when the tide recedes will we know which is the right direction and which is “inappropriate”. It is precisely because of the emergency that the results that are not so confirmed will be announced and disseminated quickly. Everyone wants to stand on the air vent. If it slows down, the wind may not be able to blow. Finally, there are always people who want to make some news. The reason is nothing more than money (stock prices), I don’t know that much either. If you really want to do it, you can do it as a sideline, or just switch to investment consulting. Thanks for the invitation!

sina156
4 months ago

simply put. Operationally speaking: For a thing that has not been approved by the Mainland, its usage has not been clarified, and the supply itself is very limited, it is currently not possible for most people to be vaccinated. When the time comes, how can the regulatory authorities approve the specific usage? Regarding the domestic prevention and control status, most people recommend giving priority to vaccines that are easy to line up, and there is no need to wait for subsequent approval of new vaccines. Theoretically speaking: the data of other countries such as the recommendation of vaccine mixing, the data of two shots of one vaccine in turn cannot replace the data of mixing. And if we need to make this decision, we need to compare the effects of permutations and combinations between vaccines that do not use technical routes. Anyway, other countries may have begun to try, the current situation in our country is not so urgent, and it is still allowed to wait for other countries’ reports. Although vaccine mixing does not sound like a serious safety issue, the cost-benefit ratio is not precise. With regard to the current global epidemic situation and the overall low domestic risk, it is feasible to wait for data from other countries to come out. In addition, vaccine distribution involves cost-effectiveness and fairness issues. In the case that many people do not receive the first and second shots, it is necessary to ensure that people use the existing vaccines to get the first and second shots. Even if the limited mrna vaccine is approved, it is not enough for the whole country, and it may not be available if it is approved. The distribution aspect is also prone to disputes. Therefore, this issue is still allowed to be decided later. For those who have been vaccinated with inactivated vaccines in China and have plans to go abroad and plan to boost the mrna vaccine after going abroad, it is recommended to consult the local medical institution for decision after going abroad. There is no serious problem of principle in mixed fighting. In theory, there will not be a situation where the probability of a serious adverse event is particularly high. However, whether it is worthwhile to put it on the individual in terms of safety and effectiveness is currently insufficient. Determined according to local policy.

yahoo898
4 months ago

A few weeks ago, China officially released a summary of the adverse reaction data of domestic vaccines. If you look at the percentage, you can say that the performance of Chinese vaccines is quite good. However, there is no comparative data for each type of vaccine (at least in those few days I did not see it when I directly checked the website of the Health Commission), such as the comparison data of inactivated adverse reactions between Kexing and Sinopharm, as well as inactivated and adenovirus The comparison data of recombinant vaccines is regrettable. Another regret is that the definition of severe illness is too general and unclear, and the specific conditions are not specified. According to the vaccine clinical trial standards, blood oxygen concentration lower than 94%, respiratory rate higher than 30 times, etc. are all severe. But the really meaningful data on critical illnesses are, for example, facial paralysis caused by Pfizer, myocarditis/pericarditis associated with Pfizer/Modera, thrombus associated with Pfizer/Modera, thrombocytopenia associated with Oxford/Johnson & Johnson or thrombotic thrombocytopenia Disease, and so on. Do China’s inactivated vaccines have the above symptoms? What is the ratio, if any, is very important in theory and practice. In addition, are there any cases of thrombosis/thrombotic thrombocytopenia observed in our adenovirus recombinant vaccine vaccinators? Real-world data generated on the basis of hundreds of millions of inoculations will be very convincing. According to what some doctors and doctors once said, it is very likely that the adenoviral vector induced thrombotic/thrombotic thrombocytopenia. The recombinant adenovirus vaccine of Chen Wei’s group actually provides an excellent opportunity to verify the above conjecture. If the vaccinators in the Chen Wei group have no or very low thrombotic/thrombotic thrombocytopenia, does it mean that Ad5 is better than Ad26 (Johnson & Johnson carrier)? If this is true, is the so-called adenovirus vector of some doctors and doctors a bit too random? What’s more, the absolute gender characteristic of the Oxford/Johnson & Johnson vaccine mainly affects women under the age of 50 has long collapsed that arbitrary forced interpretation. The myocarditis/pericarditis associated with Pfizer/Modra mainly affects young and middle-aged men, and women are very rarely affected. Therefore, it will be very meaningful if the Health Commission can disclose the relevant data. Knowing this data also helps individuals make choices when possible. For example, if you are a middle-aged or younger woman, you may avoid the recombinant adenovirus vaccine and choose an inactivated vaccine. In the future, it is reasonable to consider defeating Bitel. But if you are a young or middle-aged man, you may want to consider whether you want to defeat Bitex. Adenovirus recombinant vaccine or inactivated may be a better choice for you.

leexin
4 months ago

The biggest impact is that Fubitai’s share price has soared! What the official said is: The relevant state departments have already planned to use Fubitai as a follow-up booster for the inactivated vaccine population, and this part of the vaccine is likely to be free. This enhanced needle plan includes inactivation, adenoviral vectors, recombinant proteins and mRNA (domestic, imported), which has become “Fubitai” on the financial network and is likely to be used as an enhanced needle, and the effect of public opinion is full. of. For Caixin.com, there is no more introduction. If you are interested, click the link below to read it and you will know after reading it. Back to the main topic: The effectiveness of existing vaccines in preventing infections has been greatly reduced due to the ravages of mutant viruses. Even the mRNA vaccine with an efficiency of 94% in the past has been reduced to 64% in the face of Delta mutant strains. When Kexing and Zhifei vaccines faced the B.1.617 variant, the serum neutralizing antibodies of the vaccinators were below the neutralization threshold. Therefore, the follow-up of high-risk groups (such as medical staff) for the third injection of replanting is indeed a trend. For example, Thailand was previously vaccinated with Koxing vaccine, but due to the limited effectiveness of Koxing vaccine in preventing infection (still greatly reducing the severe disease rate and death rate after infection), Thailand decided to supplement the Oxford vaccine for medical staff. Three injections are strengthened, and the follow-up vaccination strategy is also considered to be modified to one injection of Kexing and one injection of Oxford. Therefore, in the future, the third injection of replanting will be used in the country to enhance the protection. At present, research has begun on the question of whether to use inactivated, adenoviral vectors, recombinant proteins or mRNA vaccines. Of course, there must be clinical trials to ensure vaccines. Safety and effectiveness. Speaking of this, I have to talk about vaccine hybrids. Previously, due to insufficient vaccines in Canada, the strategy of mixing Pfizer and Moderna was adopted, while the strategy of mixing Oxford vaccine and Pfizer was adopted in the United Kingdom. Due to insufficient vaccines in some areas of the country, Coxing and Sinopharm vaccines are used for mixed vaccination. So, how safe and effective is mixed vaccination? For mixed vaccination, WHO’s expert attitude is “not recommended”, the main reason is that there is not enough evidence. Sumia Swaminesen, the chief scientist of the World Health Organization, advised the public on July 12 not to mix and vaccinate the new crown vaccines of different manufacturers, calling this a “dangerous trend.” “This is a somewhat dangerous trend. In terms of mixing and vaccination, we are in a field with no data and no evidence. However, in May and June, The Lancet published an article targeting Oxford and The important test results of Pfizer’s new crown vaccine mixed vaccination showed that the mixed vaccination can bring about a strong immune response, including higher antibody levels, neutralizing antibody levels, and the safety is well controllable. Both studies exist. The sample size is too small and there are only hundreds of people, the representativeness is limited, and there is a lack of two injections of the same vaccine as a control. It can only be used as a reference and cannot be used as evidence of hybridization. Therefore, at the current stage, safety and Insufficient evidence of effectiveness, it is still not recommended to use mixed vaccination. At present, after sufficient follow-up evidence shows that there is no problem with safety and effectiveness, the third injection of replanting should also officially debut.

greatword
4 months ago

(Why do you have to review for so long now?) Very interesting. I don’t know who proposed that mRNA vaccines can be used as boosters for inactivated vaccines? This proposal does not conform to the principle of immunity, and it may significantly increase the chance of serious side effects and even death. First of all, if you need to strengthen the needle, it is to deal with the mutant strain, which is largely the Delta strain. According to reports from Israel, the protective efficiency of two doses of mRNA vaccine has been reduced from more than 90% to more than 60%. More than half of the new cases were vaccinated with two doses of Pfizer mRNA vaccine, which is Fubitai. It is known that hundreds of existing mutant strains all occur in the spike protein coding region, and the Pfizer/Fubitai sequence uses the original version of the spike protein. The antibodies induced in this way can recognize the spike protein of the Delta strain. It is already cross-recognition, not specific recognition. This is why the vaccine effect will be reduced, because the recognition site has changed. Inactivated vaccines need to be boosted. Of course, the simplest and most feasible way is to inactivate the Delta strain and use it as the third dose to boost; for people who have not been vaccinated, the original inactivated vaccine and the Delta strain can be inactivated Vaccine mixing, this is the principle of bivalent vaccine. In the future, depending on the mutation, it is possible to prepare trivalent, quadrivalent or even multivalent vaccines. For example, the HPV vaccine has a nine-valent vaccine. To do a booster shot, what’s the point of getting an original version of the mRNA vaccine for boosting? Besides, I predicted in another answer that the side effects of mRNA vaccines will increase with the increase in the number of vaccination; for every additional dose, the incidence and mortality of serious side effects will increase by one level. Even if the first and second doses are inactivated vaccines and the third doses are vaccinated with mRNA vaccines, the side effects of the third dose are equivalent to three consecutive doses of mRNA vaccine, which will greatly increase serious adverse reactions and mortality. Conversely, multiple vaccinations of inactivated vaccines are safe. Hepatitis B virus and rabies vaccines can be vaccinated 5 or more times, and side effects generally weaken from the third dose. This is determined by the principle of immunity. If you are interested in a detailed analysis, you can see here: https://www.zhihu.com/question/434360924 The latest update of this answer is on June 27th. We grabbed all reported deaths from FDA data. After a mass vaccination of more than 300 million doses in the United States (including 1 injection and 2 injections, a total of 152 million people), the reported deaths were close to 6,000, of which Pfizer died of 3000+, Modena died of 2000+, Johnson & Johnson died of more than 400 cases. In the same period, China’s data is about 1.2 billion doses of inactivated vaccines (including one injection and two injections for a total of about 600 million people), and a total of more than 20 deaths have been reported (unofficial data). In fact, what is interesting is not what American scientists have done, but what they have not done. After grabbing these data, we discovered that no American media reported these 6000 deaths in the United States, nor did any American team analyze these deaths, nor did any research papers have been published. In fact, this death rate is close to the crude death rate of AstraZeneca vaccine (Taiwan’s data is AstraZeneca’s crude death rate of 1 in 10,000, and Pfizer + Modena’s crude death rate is about 0.4 in 10,000), but there is no People went to report these 6000 deaths, none of them. This is very strange. And according to my analysis, for every additional dose of mRNA vaccine injection, the serious adverse reaction rate and mortality rate will rise by one level; if the Delta mutant strain will be broken in the United States, then they will definitely prepare mRNA specifically for the Delta strain at the end of the year. Vaccine, then you can see if the third dose of mRNA is more dangerous. As a result, the Chinese jumped out to do the third dose of guinea pigs, and did they use the original version of Fubitai? Is this enough to eat?

loveyou
4 months ago

The answer is staggering, as if it is our country that is increasing by 30,000. Accepting the introduction of Pfizer proves that my country’s vaccines are poor? Where’s the brain? It is normal to introduce Pfizer, and the general reason will not be mentioned. The key reason is the mutual recognition of vaccines. Why does the European Union not recognize Chinese vaccines now? Is it because of science? Isn’t it that the European Union is now able to let it go, and has introduced a vaccine passport, so that people who have received a certified vaccine can not be isolated. China has not launched a vaccine certification process because of its current anti-epidemic policies, and basically does not recognize vaccine passports. Therefore, what the European Union hopes is definitely foreign exchange and so on. If you want me to recognize your vaccine, even if you don’t let go of the epidemic prevention measures, you must also recognize the effectiveness of my vaccine. Therefore, it is inevitable for China to adopt European and American vaccines, and European and American counterparts will inevitably adopt Chinese vaccines. If China recognizes that vaccine passports can be exempted from quarantine in the future, then Chinese vaccine passports can also be exempted from quarantine in the EU.

strongman
4 months ago

A bunch of people can’t even figure out the brand name, so they start to engage in ideological opposition, absolutely. Shanghai Fosun is directly cooperating with the German BioNTech company. At present, the original name of this vaccine is Comirnaty, and the technology comes from a German pharmaceutical company. Both “Fubitai” and “Pfizer” refer to the same vaccine, code name: BNT162b2, which is more similar to the relationship between agents in different regions, and both belong to the category of BNT.

stockin
4 months ago

If you want to return to normal life, you can only defeat Bitel. Rather than as it is now, even in areas with a high vaccination rate (98% in Ruili), the city will be closed when infection occurs. This virus cannot be eliminated, and mankind can only coexist with the new coronavirus in the future. The city is closed at every turn, seriously affecting the economy and people’s livelihood. It will also have a major impact on the spirit of the people, and it will be fine once or twice occasionally. Who can stand the spirit of normalization? And if you open up the country in the future, think about the previous epidemic in Guangzhou, can the current vaccines be able to withstand it? Is it really an internal loop? Only high-efficiency vaccines can truly achieve herd immunity and minimize the impact of the virus in a normal life. Note that Fubitai is domestically produced, and the vaccine jointly developed by Fosun and BNT fully reflects the level of medical research in my country. Unlike the Pfizer vaccine that was plagued by negative news in the United States, Pfizer did not want to send me the vaccine. I will concentrate on waiting for the domestic Pfizer. Call for the motherland.

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