is looking forward, looking forward to the new crown pneumonia vaccine is coming, and the world's recovery is approaching.
html Since November, the United States has announced that the new coronavirus vaccine produced by Pfizer and Merdner has been approved for emergency use. On the 14th, a nurse in New York State became the first person to receive the new coronavirus vaccine in the United States.Previously, the United Kingdom, Canada and other countries also approved the use or marketing of the new coronavirus vaccine.
htmlOn November 19, Zeng Yixin, deputy director of the National Health Commission of China, said at a press conference held by the State Council Information Office that based on summarizing the experience of the early emergency use stage, as the winter and spring season approaches, my country has carried out new crown pneumonia vaccination work for some key groups.Emergency vaccination is launched in various places, and Shenzhen, Shanghai and other places have issued vaccination related notices. According to the official official account of Shenzhen Health Commission on the 26th, the vaccination costs of 9 types of high-risk personnel shall be borne by the government finance.
Since the COVID-19 virus hits human society, the COVID-19 vaccine has been developed, tested, used urgently, and approved for marketing at a record speed...
COVID-19 vaccine is really here!
or not? Is it safe? How long can it be protected? Which new and old technology is better? The virus continues to mutate, can the vaccine be held?
A reporter from Science and Technology Daily conducted an interview with these issues of concern to the public.
Question 1
I heard that someone was paralyzed after being vaccinated, and some people died? Is it safe to get vaccinated?
fever, fainting, allergic, transverse myelitis, Bell's paralysis... Some countries have adverse reactions after receiving the COVID-19 vaccine:
-early September, it was revealed that suspected cases of transverse myelitis were found among the first Oxford vaccinator to enter the third phase of clinical trials, causing the Oxford vaccine clinical trial to be stopped at that time;
-December 8, two Pfizer vaccinators in the UK had severe allergic reactions, and then the U.S. Food and Drug Administration (FDA) It is said that four volunteers vaccinated with the Pfizer COVID-19 vaccine developed Bell's paralysis, i.e. facial paralysis;
-December 17, a nurse in Tennessee, USA, fainted in an interview with the media after receiving Pfizer's COVID-19 vaccine. This is another adverse reaction after a medical staff member in Alaska was severely allergic to the emergency room;
...
...
has so many adverse reactions, is it unsafe to get the COVID-19 vaccine?
In fact, there is currently no conclusion that the unexpected situation listed above clearly shows that it is directly related to vaccination.
In the judgment of adverse events of the new coronavirus vaccine, several "mistakes" even occurred.
causes rare adverse reactions to stop the Oxford vaccine. The FDA survey results show that although the connection cannot be completely ruled out, the Oxford vaccine is not the cause of the side effects of the volunteers' neurological system.
On October 21, Brazilian National Health Supervision Bureau said that a 28-year-old Brazilian volunteer who participated in the clinical trial of the Oxford vaccine died. Later investigations showed that the dead volunteer did not receive the Oxford vaccine.
htmlOn November 10, the Brazilian National Health Supervision Bureau stopped the clinical trial of the new coronavirus vaccine of Beijing Sinovac Biotechnology Company in Brazil, on the grounds that the vaccinator had "serious adverse reactions". Later investigation found that the death of the person involved was caused by suicide.…
There is no doubt that testing is the "kingdom" to prove the safety of vaccines.
The new crown vaccine produced by Sinovac Biotech (Reuters)
In continuous trials, through analyzing the data of persistently accumulated adverse reactions, inferring the safety of the vaccine, retaining safe vaccines, giving a way to deal with possible problems, and eliminating unsafe vaccines, this will be a long-term process.
htmlOn November 21, the Science website published an analysis and commentary article "Nanoparticles in the Pfizer COVID-19 vaccine may trigger rare allergic reactions". The article introduced that within two weeks, at least 8 people experienced severe allergic reactions after receiving the Pfizer COVID-19 vaccine. Some scholars analyzed that it was caused by the unique ingredients in the mRNA vaccine, but it was only limited to speculation.Other relevant data statistics show that after receiving the mRNA vaccine from Pfizer and Merdner, 2% of the vaccinated people will have high fevers above 39°C. If 35 million people are given vaccination, 700,000 people will have high fevers.
In this regard, the National Institute of Allergy and Infectious Diseases is organizing scientists to discuss and find ways to deal with this matter, such as checking out people who are not suitable for injection before injection, and providing treatment for serious adverse reactions. Compared with the vaccine "newcomer" mRNA vaccine that appeared in the new crown pneumonia epidemic, the traditional inactivated vaccine is relatively "calm".
At a press conference held by the Joint Prevention and Control Mechanism of the State Council not long ago, Zheng Zhongwei, head of the Vaccine Research and Development Special Team of the Scientific Research and Development Group of the State Council’s Joint Prevention and Control Mechanism and Director of the Research Center of the Medical and Health Science and Technology Development of the National Health Commission, made it clear that since July, under the premise of voluntary, informed and agreed, China has carried out emergency vaccination for high-risk exposed people, and has completed more than 1 million doses of emergency vaccination for the new crown pneumonia vaccine. Strict monitoring and follow-up observation of adverse reactions showed that no serious adverse reactions occurred. The third phase clinical trial of China's new coronavirus vaccine conducted overseas has so far 150,000 doses of vaccination, and no serious adverse reactions have occurred.
Question 2
I heard that 5 technical routes have been used for the development of the new crown pneumonia vaccine. There are so many "genres", which one is better and who is worse?
Authoritative statistics from the World Health Organization (WHO) -
As of December 22, among the 61 new coronary pneumonia vaccines that have entered clinical research, 618 recombinant protein vaccines, accounting for 30%; 9 viral vector vaccines (no replication vectors), accounting for 15%; inactivated vaccines, DNA, and RNA vaccines are all 8, accounting for 13% each; and 10 vaccines including viral vector vaccines (replicable vectors).
"The mechanism of action of each technical route is very different, and the arousal of the immune system in the body is also very complex. Each vaccine has its own characteristics." Li Zhongming, a vaccine expert and former examiner of the US FDA, said that from the perspective of safety, protein recombinant vaccines and inactivated vaccines have more advantages; from the perspective of effectiveness, mRNA and protein recombinant vaccines have more advantages.
For existing vaccines that have been urgently vaccinated, many people prefer to receive China's inactivated vaccines due to safety concerns. They are not because they resist the "rookie" mRNA vaccine, but because they hope to wait and see for a while, because they don't know what the mRNA will do after entering the cell. Whether the
mRNA vaccine works requires large-scale evidence-based research on the population, and inactivated vaccines and protein recombinant vaccines have been verified in the prevention and control of other infectious diseases before: inactivated vaccine products have been used in the human body for hundreds of billions of doses to prove that they are safe and effective; protein recombinant vaccines also have "star products" used on a large scale - hepatitis B vaccine, cervical cancer vaccine, etc.
has also made a lot of safety improvements to mRNA, a new "dark horse" in the vaccine industry, to minimize the risks it may bring, such as replacing "generative" bases and adding "navigation" sequences, so that foreign mRNA can trigger a moderate immune response in the body.
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still has shortcomings in mRNA vaccines. 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 control how much and how much it replicates after entering human cells. This may cause serious side effects in some people with allergic constitutions due to excessive replication of mRNA molecules. The four patients with facial paralysis in Pfizer's mRNA vaccinator have allergic constitutions. From this perspective, The vaccination dose of live vaccines is controllable after entering the body. "In terms of effectiveness of
, inactivated vaccines are used to inactivate the whole virus as an antigen to trigger immunity, and its specific neutralizing antibodies account for a part; protein recombinant vaccines, mRNA vaccines, etc. select part of specific immunity through biotechnology, and mainly produce specific neutralizing antibodies; the advantage of adenovirus vector vaccines is that they can produce longer-lasting cellular immunity, which not only mobilizes antibodies in the immune system, but also mobilizes T cells and others to resist the attack of the virus.
Faced with the "shortcoming" of effectiveness, the research and development of inactivated COVID-19 vaccine in my country has been optimized through technological innovation. "For the inactivation alone, Zhongsheng Biotechnology, , Sinopharm, has promoted the research on the inactivation effects of four or five different inactivators during its research and development." Yang Xiaoming, chairman of Sinopharm Group Zhongsheng Biotechnology (hereinafter referred to as Sinopharm Zhongsheng), told Science and Technology Daily reporters that if the inactivated vaccine is not inactivated enough, there is still a live virus, it will cause infection; it cannot be "over-ignored". If the inactivation destroys all the antigens on the surface of the virus, the vaccine will be poor. The inactivated vaccine of
is not simply "cutting off the virus" but more like "cutting the roots on tofu". It cannot break the "tofu" (virus) and eradicate the "grass" (toxicity).
"The R&D personnel are facing a large number of tests and massive data analysis and monitoring." Yang Xiaoming said that through a lot of process and engineering innovations in the control of time, temperature and dose, the optimal solution is obtained in a time-to-second battle to improve the efficiency of the inactivated COVID-19 vaccine.
Questions How is the progress of 3
5 technical routes? Will there be a better COVID-19 vaccine?
Although the new coronavirus vaccine has not been approved for market yet, they are getting closer to us as they enter the third phase of clinical practice and are approved for emergency use. Which technical route do they belong to? How is the current progress?
Science and Technology Daily has sorted out the information that has been disclosed.
inactivated vaccine (4 types):
. The inactivated vaccine developed by Sinopharm Zhongsheng Beijing has entered the third phase of clinical practice (86% effective efficiency) and has been approved for emergency use. According to the data of the National Medical Products Administration's website, its application for marketing has been accepted. 2. The inactivated vaccine developed by Sinopharm Zhongsheng Wuhan has entered the third phase of clinical practice (86% effective efficiency) and has been approved for emergency use.
3. The inactivated vaccine developed by Sinovac China-Wei has entered the third phase of clinical practice and has been approved for emergency use. Due to the overall analysis of the third phase clinical data carried out in all countries, Sinovac China-Wei announced on December 23 that its effectiveness data will be delayed by two weeks.
4. The inactivated COVID-19 vaccine developed by Bharat Biotechnology, India has entered the third phase of clinical practice.
mRNA vaccine (2 types):
. The mRNA vaccine developed by Pfizer, Germany's Biotech and Fosun in China has entered the third phase of clinical practice (95% effective) and has been approved for emergency use in the United States, the United Kingdom and other countries. 2. The mRNA vaccine developed by Merdner in the United States has entered the third phase of clinical practice (effectiveness of 94.5%) and has been approved for emergency use in the United States.
unreplicable vector vaccine (4 types):
. The unreplicable vector vaccine developed by the Chinese Academy of Military Medical Sciences and CanSino has entered the third phase of clinical practice. 2. The non-replicable vector vaccine developed by AstraZeneca has entered the third phase of clinical practice (70% effective).
3. The non-replicable vector vaccine developed by the Gamaleya Center in Russia has entered the third phase of clinical practice (92% effective efficiency).
4. The non-replicable vector vaccine developed by Johnson & Johnson in the United States has entered the third phase of clinical practice.
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recombinant protein vaccine (2 types):
. The recombinant protein vaccine developed by the Institute of Microbiology, Chinese Academy of Sciences and Anhui Zhifei Longcoma Company has entered the third phase of clinical practice. 2. The recombinant protein vaccine developed by Novavax in the United States has entered the third phase of clinical practice.
In addition, the DNA vaccine developed by Inovio Pharmaceuticals in the United States and the mRNA vaccine developed by CureVac in Germany have entered the second and third phase trial stages of clinical trials.
Looking at the development of the new crown pneumonia vaccine over the past year, the new crown pneumonia epidemic can be said to have started 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, protein recombinant vaccines will replace inactivated vaccines.
So, why did Chinese companies choose the research and development of inactivated vaccines at the beginning? In the early stage of the epidemic, the number of deaths increased and Wuhan was locked down... In the critical situation, vaccine experts need to make professional judgments: which vaccine can succeed and the fastest success.
"Previous observations, the pathogenic symptoms of the new coronavirus are different from hepatitis B. There is no chronic carrier, which means that its genes will not enter the host genome, and the inactivated vaccine is feasible."Yang Xiaoming said that the early R&D time is short and the later output can be guaranteed.
Now, the epidemic in my country is stable, and the new crown pneumonia vaccine has entered the normalized R&D stage. Sinopharm Middle School and other units are also continuing to develop new vaccine products. In addition to known recombinant protein vaccines, vector vaccines, and nucleic acid vaccines, the increasing development of new crown pneumonia vaccines is also continuing to make efforts.
As the global pandemic of the new crown pneumonia epidemic further intensifies, a continuous research and development team has been continuously added to the development task of the new crown pneumonia vaccine.
As of December On the 22nd, WHO data showed that there are currently 223 new coronavirus vaccine research and development projects carried out around the world. On May 5th, this data was still 108. The continuous development of new coronavirus vaccines by
has brought about the gradual maturity and application of new technologies and new platforms, including the continuous improvement of existing vaccines and the strengthening of vaccine efficacy.
For example, the immune antigen used in the vaccine is no longer focused on the spike protein (S protein) indicated by the new coronavirus virus. "We are working with other research teams to develop a general-purpose coronavirus vaccine. ": The relevant experts from the Chinese Center for Disease Control and Prevention told reporters that the general vaccine will include multiple functional proteins of the new coronavirus, which not only produces antibody immunity but also stimulates cellular immunity, hoping to produce long-term immunity to multiple coronaviruses.
For example, in order to have fewer doses, stimulate more antibodies, and obtain more lasting antibody protection, the Institute of Medical Biology, Chinese Academy of Medical Sciences and its collaborators are carrying out the development of a combined vaccine of DNA+ recombinant glycoprotein, and have obtained very beautiful data in non-human primate experiments.
The new coronavirus epidemic has set off a passion for vaccine research and development in the field of life sciences, and will have more talents, funds and resources to gather. This is undoubtedly a great incentive for innovation.
The new president-elect of the United States Biden publicly vaccinated with the new coronavirus vaccine. Source: CCTV.com
Questions 4
How much effect can the COVID-19 vaccine be used? Whether the COVID-19 vaccine works, do not listen to advertisements to see the efficacy. Whether a vaccine of
has a protective effect is the issue that needs to be revealed in the third phase clinical trial. Because of this, industry insiders are extremely concerned about the third phase clinical data. ht According to the disclosures, there is such a set of efficient data, 95%, 94.5%, 91.4%, 86%, and 70%. The representatives of
who contributed to this transcript are: Pfizer, Myrdner, Russian Gamaleya Center, Sinopharm Middle School, and AstraZeneca. These COVID-19 vaccines that disclose interim clinical data clearly answer a question: When the COVID-19 vaccine is on the same stage as the COVID-19 virus , it is effective.
, but this data cannot answer the question of who is better. Although on the surface, there are three levels of 70 points, 80 points and 90 points, it is reflected in the number of cases, and there are only a few differences in the number of infections.
If the placebo group has 100 new coronavirus pneumonia patients, the vaccine group has 10. Then the immune efficiency will be 90%. If the placebo group has 80 new coronavirus pneumonia patients, the vaccine group has 10. If there are 11 patients with COVID-19, then the immune efficiency will be 86%.
shows that a small increase in COVID-19 patients in the vaccine group, or the fluctuation of the placebo group will have a significant impact on the final data.
In this regard, many experts called for the evaluation of the effectiveness of the COVID-19 vaccine to not only look at the efficiency data.
"Efficiency, vaccination rate, and protection time are indispensable. "At the Lancet - Medical and Health Conference of the Chinese Academy of Medical Sciences, Roy Anderson, a professor at the Imperial College of Technology in the UK, said that if the COVID-19 vaccine is 90%, then the vaccination rate of 66.7% can reach herd immunity (in the case of R0=2.5); if the efficiency is 70%, then the vaccination rate of 85.7% can reach herd immunity.
shows that the answer to "how much role does vaccination play" lies not only in the vaccine itself, but also in how many people are vaccinated. The more people are vaccinated, the wider the immune barrier formed, the more conducive it will be to achieve herd immunity as a whole. To cope with risks and strengthen immunity, it is also necessary to build a "community of shared future for mankind."
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Questions 5
Is there any risk of getting vaccinated against the new coronavirus pneumonia? What are the taboos?
large-scale 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 Science and Technology Innovation and Development Conference held earlier that during the 2009 H1N1 influenza virus epidemic, more than 100 million influenza vaccines were vaccinated in more than 80 days across the country.
"Based on China's complete adverse reaction monitoring system, adverse reaction monitoring of 70 million people was also completed during the influenza A, which has also received good evaluation among international peers." Liang Xiaofeng said that previous experience is of reference significance for the large-scale vaccination of the new coronavirus vaccine.
Rationally speaking, the risk of serious adverse reactions always exists objectively, but it is infinitely approaching zero and will never reach absolute "zero". According to existing data, the adverse reactions of the COVID-19 vaccine developed by China mainly include: headache, fever, local redness or lumps at the vaccination site, and some people also have common adverse reactions such as cough, loss of appetite, vomiting, and diarrhea, without serious adverse reactions.
In order to deal with the possible serious adverse reactions in large-scale vaccination, the National Health Commission and other departments have provided guidance and arrangements on the safety and security of COVID-19 vaccination.
Jiao Yahui, inspector of the Medical Administration and Administration Bureau of the National Health Commission, introduced that on the one hand, the vaccination sites must meet the conditions for vaccination, and on the other hand, they must meet the conditions for medical treatment. In addition, vaccination units and medical personnel participating in medical treatment must undergo technical training and must pass the training before they can take up the job to ensure that common adverse reactions can be quickly identified and dealt with quickly. Medical insurance work is divided into responsible areas by local comprehensive hospitals at or above the second level. It ensures the safety of vaccinated people through emergency emergency personnel stationed guarantees, 120 ambulances, and opening green channel referrals.
proper disposal by vaccination workers can minimize the possible impact of adverse reactions.
"Train good doctors, they can do the last 'one meter' of communication." Liang Xiaofeng called on the research data of various R&D institutions, including animal experiment results, clinical data analysis, etc., to let 200,000 vaccinated doctors across the country understand it, and they will be able to handle various possible events more effectively.
So, are there any taboos for getting vaccinated against COVID-19?
Wang Huaqing, chief expert and chief physician of the immunization program of the Chinese Center for Disease Control and Prevention, said that there are no relevant reports on the simultaneous vaccination of the new coronavirus vaccine and other vaccines. Therefore, in general, it is recommended that the COVID-19 vaccine and other vaccines (such as HPV vaccines) be not vaccinated at the same time without the publication of national guidelines and plans.
In addition, it is not recommended to vaccinate the new coronary pneumonia vaccine for special groups such as allergies, fever, acute attacks of chronic diseases, and pregnant women. Will everything be fine after
vaccination?
, Director of the Department of Infectious Diseases at Huashan Hospital Affiliated to Fudan University, , Zhang Wenhong, , once predicted this: Breakthrough progress has been made in the development of the new coronavirus vaccine. If the global vaccination coverage 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"!
(Original title "The new coronavirus vaccine is finally here! Learn about this information in advance". Editor Fan Chengyou)
