The new crown pneumonia vaccine is finally here!
Please dispel these doubts before getting the vaccine
Produced by Deep Eye Studio
Written by: Our reporter Zhang Jiaxing Planning: Chen Lei
[On December 19, Zeng Yixin, deputy director of the National Health Commission of China, stated at a press conference held by the Information Office of the State Council that, based on the experience of the early emergency use phase, my country has already carried out some key points when the winter and spring seasons arrive. New crown pneumonia vaccination work for the population. ]
Looking forward to, looking forward to, the new crown pneumonia vaccine is here, and the pace of world recovery is approaching.
Since December, the United States has announced that the new crown pneumonia vaccines produced by Pfizer and Modena have been approved for emergency use. On the 14th, a nurse in New York State became the first person to receive emergency new crown pneumonia vaccines in the United States.
Previously, the United Kingdom, Canada and other countries have also approved the use or marketing of the new coronary pneumonia vaccine.
On December 19, Zeng Yixin, deputy director of the National Health Commission of China, said at a press conference held by the Information Office of the State Council that, based on the experience of the early emergency use phase, my country has already launched some key population groups when the winter and spring seasons arrive. Vaccinations against new coronary pneumonia.
Emergency vaccination is started in various places, and Shenzhen, Shanghai and other places have issued vaccination related notices.
According to the official official account of the Shenzhen Health and Health Commission on the 26th, the cost of vaccination for 9 types of high-risk personnel shall be borne by the government.
Since the new crown pneumonia virus has disturbed human society, the new crown pneumonia vaccine has been developed, tested, used urgently, and approved for marketing at a record speed...
The new crown pneumonia vaccine is really here!
To fight or not to fight?
Is it safe?
How long can it provide protection?
Which is better, new or old technology?
The virus keeps mutating, can the vaccine be held?
For these issues of public concern, a reporter from Science and Technology Daily conducted an interview.
Question 1
I heard that some people were paralyzed after being vaccinated, and others died? Is vaccination safe?
Fever, fainting, allergies, transverse myelitis, Bell's palsy... Some countries have adverse reactions after vaccinating the new coronary pneumonia vaccine:
——In early September, news revealed that a suspected case of transverse myelitis was found among the first Oxford vaccine vaccinators who entered clinical phase III, which caused the Oxford vaccine clinical trial to be suspended at that time;
——On December 8, two Pfizer vaccinators in the United Kingdom developed severe allergic reactions. Subsequently, the U.S. Food and Drug Administration (FDA) stated that four volunteers who received Pfizer's new crown pneumonia vaccine in the third phase developed Bell Palsy, that is, facial paralysis;
——On December 17, a nurse in Tennessee, USA, after being vaccinated with Pfizer's new crown pneumonia vaccine, fainted directly in an interview with the media. This was after a medical worker in Alaska was severely allergic and the other was sent to the emergency room Another adverse reaction afterwards;
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With so many adverse reactions, is it unsafe to receive the new coronary pneumonia vaccine?
In fact, the unexpected conditions listed above, there is no clear conclusion that they are directly related to vaccination.
In the judgment of the adverse events of the new coronary pneumonia vaccine, several "oolong incidents" have even occurred.
The rare adverse reaction that caused the Oxford vaccine to stop, the FDA investigation results showed that although the connection cannot be completely ruled out, the Oxford vaccine is not the cause of the side effects of the volunteers' nervous system.
On October 21, the Brazilian National Health Supervision Agency stated that a 28-year-old Brazilian volunteer who participated in the Oxford vaccine clinical trial died. Later investigations revealed that the dead volunteer did not receive the Oxford vaccine.
On November 10, Brazil’s National Health Supervision Agency suspended the clinical trials of the new crown pneumonia vaccine of Beijing Kexing Zhongwei Biotechnology Co., Ltd. on the grounds that the vaccinators had "serious adverse reactions". Later investigations revealed that the death of the person was Because of suicide.
...
Needless to say, to prove the safety of vaccines, trials are the "kingway".
In continuous trials, through the analysis of the accumulated adverse reaction data, the safety of the vaccine is inferred, the safe vaccine is retained, the response to possible problems is given, and the unsafe vaccine is eliminated. This will be a long-term process.
On December 21, an analytical review article "Nanoparticles in Pfizer's New Coronary Pneumonia Vaccine May Cause Rare Allergic Reactions" was published on the "Science" website. According to the article, at least 8 people received Pfizer's new coronary pneumonia vaccine within two weeks. There is a serious allergic reaction. Some scholars have analyzed that the allergy is caused by a specific component in the mRNA vaccine, but it is limited to speculation.
Other relevant statistics show that after vaccination with Pfizer and Modena's mRNA vaccine, 2% of vaccinators will have a high fever above 39°C. If 35 million people are provided for vaccination, 700,000 people will have a high fever.
In this regard, the National Institute of Allergy and Infectious Diseases is organizing scientists to discuss and find ways to deal with the matter, such as identifying people who are not suitable for injection in the front row of injections and providing treatment for severe adverse reactions.
Compared with the "rookie" mRNA vaccines that appeared in the new crown pneumonia epidemic, the performance of traditional inactivated vaccines is relatively "stable".
At a press conference held by the Joint Prevention and Control Mechanism of the State Council not long ago, Zheng Zhongwei, the leader of the Vaccine Research and Development Team of the Joint Prevention and Joint Control Mechanism of the State Council and Director of the Medical Science and Technology Development Research Center of the National Health Commission, made it clear that July Since then, under the premise of voluntary, informed, and consent, China has carried out emergency vaccination for high-risk exposed populations, and has now completed more than 1 million doses of emergency vaccination against new coronary pneumonia.
Strict adverse reaction monitoring and follow-up observation showed that no serious adverse reactions occurred.
The Phase III clinical trial of China's new crown pneumonia vaccine carried out overseas has accumulated 150,000 doses and no serious adverse reactions have occurred.
Question 2
I heard that the new crown pneumonia vaccine development uses 5 technical routes, so many "genres", which is better or worse?
Authoritative statistics from the World Health Organization (WHO)——
As of December 22, of the 61 new coronary pneumonia vaccines that entered clinical research, 18 were recombinant protein vaccines, accounting for 30%; viral vector vaccines (non-replicating vectors), accounting for 15%; inactivated vaccines, DNA, RNA vaccines There are 8 vaccines, each accounting for 13%; and 10 vaccines including viral vector vaccines (replicable vectors).
"The mechanism of action of each technical route is very different, and the awakening of the immune system in the body is also very complicated. Each vaccine has its own characteristics." said Li Zhongming, a vaccine expert and former US FDA examiner. From a safety perspective, protein recombination Vaccines and inactivated vaccines have more advantages; from the perspective of effectiveness, mRNA and protein recombinant vaccines have more advantages.
For the existing vaccines that have already been vaccinated urgently, many people are more inclined to vaccinate China’s inactivated vaccines because of safety concerns. It is not because of resistance to the "rookie" mRNA vaccine, but because they want to wait and see for a while because of mRNA After entering the cell, I don’t know what to do.
The use of mRNA vaccines requires large-scale population evidence-based research, while inactivated vaccines and recombinant protein vaccines have been verified in the prevention and control of other infectious diseases: inactivated vaccine products have already used tens of billions of doses on the human body. Secondly, it proved to be safe and effective; protein recombinant vaccines also have "star products" used on a large scale-hepatitis B vaccine and cervical cancer vaccine.
For mRNA, a new "dark horse" in the vaccine industry, scientists have also made a lot of safety improvements to minimize the risks it may bring, such as replacing "mild" bases and adding "navigation" sequences And so on, so that foreign mRNA can trigger a moderate immune response in the body.
Regarding the deficiencies of the mRNA vaccine, Li Zhongming explained: “After the mRNA vaccine enters human cells, it has the function of self-replication. Therefore, although the dose injected to each vaccinator is the same, it cannot be controlled to replicate after entering human cells. How much and how much. This may cause serious side effects in people with some allergies due to excessive replication of mRNA molecules. Among Pfizer mRNA vaccination patients, 4 cases of facial paralysis side effects are allergic. From this perspective , The dose of the inactivated vaccine is controllable after it enters the body."
In terms of effectiveness, inactivated vaccines use the whole virus as an antigen to trigger immunity, and its specific neutralizing antibodies account for a part; while protein recombinant vaccines, mRNA vaccines, etc. are selected through biotechnological means to generate specific immunity, mainly It is the specific neutralizing antibody that is produced; the advantage of adenovirus vector vaccine is that it can produce longer-lasting cellular immunity, which not only mobilizes antibodies in the immune system, but also mobilizes T cells to resist virus attacks.
Facing the "short board" of effectiveness, the research and development of my country's new coronary pneumonia inactivated vaccine has been optimized through technological innovation.
"Only for the inactivation item, Sinopharm SinoBio has simultaneously promoted the research on the inactivation effects of four or five different inactivators during the research and development." Director of Sinopharm SinoBio (hereinafter referred to as Sinopharm Zhongsheng) Chief Yang Xiaoming told a reporter from Science and Technology Daily that if the inactivated vaccine is not sufficiently inactivated and there are live viruses, it will cause infection; it cannot be “overfired”. If the inactivation destroys all antigens on the surface of the virus, the effectiveness of the vaccine will be poor. .
Inactivated vaccines are not simply "cutting down" the virus. It is more like "cutting the tofu". It can neither crush the "tofu" (virus) but also eradicate the "grass" (toxicity).
"R&D personnel are faced with a large number of experiments and massive data analysis and monitoring." Yang Xiaoming said that through a large number of technological and engineering innovations in the control of time, temperature, and dose, the best results are obtained under the circumstances that every second counts. Excellent solution to improve the effectiveness of the new coronary pneumonia inactivated vaccine.
Question 3
How is the progress of the 5 technical routes? Will there be a better vaccine for COVID-19?
Although no new coronary pneumonia vaccine has actually been approved for marketing, they are getting closer and closer to us in clinical phase III and approved for emergency use. Which technical route do they belong to?
How is the current progress?
The Science and Technology Daily sorted out the information that had been disclosed.
Inactivated vaccines (4 types):
1. The inactivated vaccine developed by Sinopharm Beijing has entered the third clinical phase (effective rate 86%) and has been approved for emergency use. According to data from the State Food and Drug Administration website, its marketing application has been accepted.
2. The inactivated vaccine developed by Sinopharm Wuhan has entered the third clinical phase (effective rate 86%) and was approved for emergency use.
3. The inactivated vaccine developed by Kexing Zhongwei entered the third clinical phase and was approved for emergency use. Due to the overall analysis of the Phase III clinical data carried out in all countries, Kexing Zhongwei announced its effective data on December 23 The announcement will be delayed for two weeks.
4. The new coronary pneumonia inactivated vaccine developed by India's Bharat Biotechnology Company entered the third clinical phase.
mRNA vaccine (2 types):
1. The mRNA vaccine developed by Pfizer in the United States, Biotech in Germany, and Fosun in China has entered clinical phase III (efficiency 95%) and has been approved for emergency use in the United States and the United Kingdom.
2. The mRNA vaccine developed by Modena in the United States has entered clinical phase III (effective rate 94.5%), and has been approved for emergency use in the United States.
Non-replicatable vector vaccine (4 types):
1. The non-replicable vector vaccine developed by the Chinese Academy of Military Medical Sciences and Kangsino has entered the third clinical phase.
2. The non-replicable vector vaccine developed by Oxford University and AstraZeneca has entered the third clinical phase (effective rate 70%).
3. The non-replicable vector vaccine developed by the Gamalieya Center in Russia entered the third clinical phase (effective rate 92%).
4. The non-replicable vector vaccine developed by Johnson & Johnson in the United States has entered the third clinical phase.
Recombinant protein vaccine (2 types):
1. The recombinant protein vaccine developed by the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifeilongkoma Company entered the third clinical phase.
2. The recombinant protein vaccine developed by Novavax in the United States has entered clinical phase III.
In addition, DNA vaccines developed by Inovio Pharmaceuticals in the United States and mRNA vaccines developed by CureVac in Germany have entered the phase II/III clinical trials.
Looking at the research and development of the new crown pneumonia vaccine in the past year, the new crown pneumonia epidemic can be said to have opened two rounds of research and development of the new crown pneumonia vaccine, one is emergency research and development, and the other is normalized research and development.
"Next year we will apply for clinical trials of recombinant protein vaccines." Yang Xiaoming said that in the future, recombinant protein vaccines will replace inactivated vaccines.
So why did Chinese companies choose to develop inactivated vaccines in the first place?
In the early stage of the epidemic, the number of deaths increased, Wuhan was closed down... Under the critical situation, vaccine experts needed professional judgment: which vaccine would succeed and the fastest.
"Preliminary observations show that the pathogenic symptoms of the new coronary pneumonia virus are different from those of hepatitis B. There is no chronic carrier, indicating that its genes will not enter the host genome, and an inactivated vaccine is feasible." Yang Xiaoming said, and the early development time is short, and the later production can also be Guarantee.
Nowadays, the epidemic situation in my country is stable, and the new coronary pneumonia vaccine has entered the stage of normalization. Sinopharm Zhongsheng and other units are also continuing to develop new vaccine products. In addition to the known ones including recombinant protein vaccines, vector vaccines, and nucleic acid vaccines, more and more diverse The research and development of the new coronary pneumonia vaccine is also continuing.
As the global pandemic of the new crown pneumonia epidemic has further intensified, research and development teams continue to join the research and development tasks of the new crown pneumonia vaccine.
As of December 22, WHO data shows that there are currently 223 new coronary pneumonia vaccine research and development projects carried out globally.
On May 5, this data was still 108.
The continuous development of new coronary pneumonia vaccines has brought about the gradual maturity and application of new technologies and new platforms, including the continuous improvement of existing vaccine deficiencies and the enhancement of vaccine effectiveness.
For example, the immune antigen used in the vaccine no longer focuses on the spike protein (S protein) indicated by the new coronavirus pneumonia virus.
"We are working with other research teams to develop a universal coronavirus vaccine." Experts from the Chinese Center for Disease Control and Prevention told reporters that the universal vaccine will incorporate multiple functional proteins of the new coronavirus pneumonia virus, which will not only produce antibody immunity but also stimulate cellular immunity. Hopefully Produce long-term immunity to multiple coronaviruses.
For example, in order to reduce the dose, stimulate more antibodies, and obtain longer-lasting antibody protection, the Institute of Medical Biology of the Chinese Academy of Medical Sciences and collaborators are developing a DNA+recombinant glycoprotein combination vaccine, which will be used in non-human primates. Very beautiful data was obtained in the experiment.
The new crown pneumonia epidemic has aroused enthusiasm for vaccine research and development in the life sciences field, and more talents, funds, and resources will be pooled with this, which is undoubtedly a great incentive for innovation.
Question 4
How effective is the new crown pneumonia vaccine?
Whether the new coronary pneumonia vaccine is effective, do not listen to the advertisement to see the effect.
Whether a vaccine has a protective effect is exactly the question that the Phase III clinical trial will reveal.
Because of this, the industry is extremely concerned about the Phase III clinical data.
According to previous disclosures, there is such a set of efficient data, 95%, 94.5%, 91.4%, 86%, 70%.
Representatives who have contributed to this report card are: Pfizer, Modena, Russia's Gamalea Center, Sinopharm Zhongsheng, and AstraZeneca.
These new coronary pneumonia vaccines that disclose mid-term clinical data clearly answer a question: the new coronary pneumonia vaccine shows effectiveness when it is on the same stage as the new coronary pneumonia virus.
But this data cannot answer the question of who is better.
Although on the surface, there are three grades of 70, 80, and 90, it is reflected in the number of cases and only a few infected people.
If the number of patients with new coronary pneumonia in the placebo group is 100, and the number of patients with new coronary pneumonia in the vaccine group is 10 people.
Then the effective rate of immunity will be 90%. If there are 80 patients with new coronary pneumonia in the placebo group and 11 patients with new coronary pneumonia in the vaccine group, then the effective rate of immunity will be 86%.
It can be seen that a small increase in the number of new coronary pneumonia patients in the vaccine group or the fluctuation of patients in the placebo group will have a significant impact on the final data.
In this regard, many experts called for the effectiveness of the new coronary pneumonia vaccine to be judged not only on the effective data.
"Efficiency, vaccination rate, and length of protection time are indispensable." At the Lancet-Chinese Academy of Medical Sciences Conference on Medicine and Health, Roy Anderson, a professor at Imperial College London, said that if the new crown pneumonia vaccine is available If the efficiency is 90%, then the vaccination rate can reach 66.7% (in the case of R0=2.5); if the effective rate is 70%, then the vaccination rate can reach 85.7% to achieve herd immunity.
It can be seen that the answer to "how much effect does vaccination play?" lies not only in the vaccine itself, but also in how many people get vaccinated. The more people get vaccinated, the wider the immune barrier is formed, which will be more conducive to the overall realization of herd immunity for humans.
To deal with risks and strengthen immunity, it is also necessary to build a "community with a shared future for mankind."
Question 5
Is there any risk of getting the new crown pneumonia vaccine? What are the taboos?
Mass vaccination is experienced in our country.
Liang Xiaofeng, Vice President and Secretary-General of the Chinese Preventive Medicine Association, introduced at the first China Health Technology Innovation and Development Conference held earlier that during the 2009 H1N1 influenza virus epidemic, the country completed more than 100 million people in more than 80 days. Stream vaccination.
"Based on China's complete adverse reaction monitoring system, 70 million people have also been monitored for adverse reactions during influenza A. This has also been well evaluated among international counterparts." Liang Xiaofeng said that previous experience has greatly affected the new crown pneumonia vaccine. Large-scale vaccination has reference significance.
To put it rationally, the risk of serious adverse reactions always exists objectively, but it approaches zero infinitely, and will never reach absolute "zero".
According to existing data, the adverse reactions of the new coronary pneumonia vaccine developed in China mainly include: headache, fever, local redness or lumps at the vaccination site, and some people have common adverse reactions such as cough, loss of appetite, vomiting, and diarrhea, and no serious adverse reactions. reaction.
In order to deal with the serious adverse events that may occur in the mass vaccination, the National Health Commission and other departments have made guidance and arrangements for the safety and security of the new crown pneumonia virus vaccination.
According to Jiao Yahui, the inspector of the Medical Administration and Hospital Administration of the National Health Commission, the vaccination sites must meet the requirements for vaccination on the one hand, and have the conditions for medical treatment on the other hand.
In addition, the vaccination unit and the medical staff involved in medical treatment need to undergo technical training. Only after the training is qualified, can they start to work to ensure that common adverse reactions can be quickly identified and quickly dealt with.
The medical security work is divided into responsibility areas by local general hospitals above the second level. The safety of the vaccinated people is guaranteed through systems such as emergency first-aid personnel station protection, 120 ambulance rapid transfers, and green channel referrals.
Proper handling of vaccination workers can minimize the possible impact of adverse reactions.
"Trained doctors, they can do a good job in the last'one meter' of communication." Liang Xiaofeng called on the research data of various research and development institutions, including the results of animal experiments, clinical data analysis, etc., should be available to two or three hundred thousand vaccinators across the country. What we know will be able to deal with various events that may occur more effectively.
So, are there any contraindications to vaccination against new coronary pneumonia?
According to Wang Huaqing, chief expert and chief physician of the China Centers for Disease Control and Prevention's immunization program, there have been no reports on the simultaneous vaccination of the new coronary pneumonia vaccine and other vaccines.
Therefore, under normal circumstances, it is recommended that the new coronary pneumonia vaccine and other vaccines (such as HPV vaccine) not be vaccinated at the same time before there are no national guidelines and programs.
In addition, people with allergies, fever, acute attacks of chronic diseases, pregnant women and other special populations are not recommended to receive the new coronary pneumonia vaccine.
Will everything be alright after vaccination?
Zhang Wenhong, director of the Department of Infectious Diseases at Huashan Hospital affiliated to Fudan University, once predicted that breakthroughs have been made in the development of new crown pneumonia vaccines. If the global vaccination rate reaches 60%, the global epidemic may end in the spring of 2022.
Although some people think this estimate is too optimistic, the acceleration of global vaccine research and development has brought "spring news"!