The first COVID-19 vaccine is about to officially complete clinical trials, and its efficacy and safety are worth looking forward to. The world is finally seeing a glimmer of light. The epidemic has entered the second stage, which will challenge the government’s ability to grab and distribute vaccines. The pharmaceutical industry must quickly mass produce and build a logistics system. Can human beings restore order on their own, or will they fall into deeper chaos due to competition for resources?
Pfizer (Pfizer) and German partner (BioNTech) announced on November 9 that the preliminary analysis of the third phase clinical trial of the 2019 new crown pneumonia virus disease (COVID-19) vaccine jointly developed by them showed that the preventive effect of COVID-19 exceeds 90%. %. The first new coronavirus pneumonia (COVID-19) vaccine is about to complete clinical trials, and the results are exciting.
As of this week, the raging epidemic has caused 1.2 million deaths worldwide and there is no sign of slowing down. It has severely damaged the world economy and disrupted people’s daily lives.
If the vaccine is successfully launched in December, it will be a record-breaking development speed. Generally, it takes 5 to 8 years from development to verification of drugs, but vaccines have appeared about 9 months after the outbreak, which seems to show that the efforts of the global medical community have achieved initial success. In this issue, the author has compiled 12 Q&A questions to discuss the significance of this technological breakthrough (the author is a master of biology, familiar with the basics of vaccines, but not a physician or immunologist).
1. What is the division of labor among vaccine R&D partners?
The vaccine developed by German pharmaceutical startup BioNTech and its partner Pfizer is about to complete the third phase of clinical trials, and preliminary data from both parties show excellent results.
Among them, BioNTech is responsible for the development of vaccines. It originally studied RNA therapy for cancer cells. Later, when the founders’ husband and wife files Ugur Sahin and Oezlem Tuereci saw that the epidemic was serious, they chose to use the same concept to develop a COVID-19 vaccine.
Pfizer is a pharmaceutical giant responsible for the scale and commercialization of vaccines. In addition to capital injection, it is mainly responsible for the execution of clinical trials, license application, public relations marketing, mass production and shelf-sales. The task volume is no less than BioNTech.
2. How effective is the vaccine?
The Food and Drug Administration (FDA) requires a vaccine to be at least 50% effective. The BioNTech/Pfizer team (hereinafter collectively referred to as Pfizer) announced that the current observation effect is 90%, which is a high score. 90% is roughly equivalent to the polio vaccine, far higher than 40% to 60% of the flu vaccine.
3. What does 90% effective mean?
Here it means that the chance of infection can be reduced by 90%. For example: in the same situation, if there are 10 people who have not received the vaccine, only one person will get the disease at most.
The actual method is that Pfizer recruited volunteers to inject vaccines, half of the subjects were in the experimental group, and the vaccines were real. There are two doses of vaccine, 21 days apart. The other half is the control group, and the placebo is injected (referring to the phenomenon that although the patient has received an ineffective treatment, but “expects” or “believes” that the treatment is effective, the symptoms of the patient are relieved. Also known as counterfeit drug effect, fake drug Effect, agent effect), neither the subject nor the administer knows.
After the injection, the subjects go home and live a normal life, and need to report on the condition regularly, such as whether there are infections, side effects, etc. The report data is handed over to the external independent Data Monitoring Committee (DMC), and Pfizer itself cannot see the collective data.
According to preliminary results, 7 days after the second of the two doses and 28 days after the first dose, the effect of protecting patients is achieved. Pfizer said that this experimental vaccine has a preventive effect of more than 90% against COVID-19 and is a major victory against the new coronavirus epidemic.
When the number of infected cases accumulates to a certain number, the information committee will look at all the information like a general election, and compare whether the infected person belongs to the experimental group or the control group. Pfizer claims that the vaccine is 90% effective, so it can be inferred that up to 9 patients belong to the experimental group.
4. Is the vaccine safe?
It is not yet certain, but the signs are good. The analysis included 43,538 volunteers undergoing the test. Pfizer said that no serious safety concerns were observed, but the British media reported temporary dizziness.
The current information is limited to 7 days after the second dose of the vaccine, and Pfizer will monitor the next 14 days, and also track the situation two years after the injection.
5. Can the epidemic be eliminated with a vaccine?
No, there is still a long way to go from the vaccine market to popularization.
At present, Pfizer only mentions that vaccines can prevent people from getting sick, but it does not say that it can prevent subjects from carrying pathogens or spreading viruses.
6. How does this vaccine work?
This mRNA vaccine is designed based on the spike protein on the surface of the new coronavirus pneumonia virus
The role of the vaccine is to allow the body to encounter pathogenic substances in advance, activate the immune mechanism, and cultivate cells that can quickly produce corresponding antibodies. When the body encounters a real virus one day, it can react quickly.
Biological proteins are encoded in DNA, and DNA is first transcribed into mRNA (messenger-ribonucleic acid, ribonucleic acid information carrier). mRNA activates the protein production mechanism in the cytoplasm and translates the protein. Traditional vaccines consist of injections of weakened pathogenic substances (such as polio vaccine), partial fragments (such as type B vaccine) or dead pathogenic substances (such as flu vaccine).
When mRNA is injected into the human body, human cells will translate it into spine protein, and the immune system will recognize: “foreign protein appears”! It’s like the bad things I’ve touched before! Quickly produce antibodies against it! So humans have immunity. The two doses of this vaccine simulate different spike proteins to improve the vaccine effect.
The advantages of mRNA vaccines are rapid production, safety, and have been proven effective in some cancers, but this will be the first time it will be used for epidemic diseases.
7. The disadvantages of the vaccine?
The biggest problem is that mRNA will dissolve at room temperature, so this vaccine needs to be stored at -70°C, which is slightly higher than the temperature of dry ice (-78.5°C). Pfizer also needs to establish cold chain logistics to ensure compliance with standards from production, transportation, storage to delivery, which is a major challenge.
China’s large and medium-sized cities have high medical standards and dense populations. The vaccine does not need to be too long or too far away from the ice store. Vaccination should not be a problem. However, the lack of cold chain facilities or qualified medical personnel in remote areas has problems with the quality of delivery. Fortunately, the current domestic epidemic has basically not appeared in remote areas.
8. What is the progress of other types of vaccine development?
According to the September statistics of the journal Nature, there are 166 vaccines in the world under development, and 29 of them have entered or will enter the clinical trial period.
At present, Pfizer is the first team to announce the data of the third phase clinical trial, followed closely by Moderna and the Cambridge University/AstraZeneca team. In the future, Johnson & Johnson, Novavax, Sanofi-GSK and Merck will enter the third phase of testing.
Four vaccines in China have also entered clinical trials, but the results of the third phase have not been officially announced. One of them has just been suspended by Brazil.
The good news is that the three leading companies use mRNA vaccines to target spike proteins, and most of the other 26 companies target spike proteins. Therefore, if Pfizer’s vaccine is effective, other vaccines are also likely to be effective, but the effect and safety are different. Pfizer’s 90% will become a low standard, and it will not be easy to obtain approval for vaccines below 90% in the future.
Another good news is that Moderna’s vaccine only needs to be stored at -20°C. The University of Cambridge/AstraZeneca vaccine only needs to be refrigerated, and it is said that the reserve capacity has reached 200 million a year, so it is possible that the first vaccine to arrive in China is not Pfizer.
9. Doesn’t Russia already have a vaccine on the market?
Russia approved the vaccine in August and named it Sputnik V, named after the Soviet Union’s first artificial satellite launched into space orbit, “Sputnik 1”.
However, the day after Pfizer released the results, Russia announced the initial results of the third phase of clinical trials-a total of 16,000 subjects participated and claimed that Sputnik V had 92% efficacy. A discerning person can see that the vaccine is on the market before it has completed clinical trials.
In fact, the vaccine development time is similar to everyone. The real test is the speed and execution level of clinical trials. Never use the public to take risks instead of volunteers.
10. How is the priority order of vaccine administration arranged?
Pfizer’s data monitoring committee will make the final ticket when the 164th case appears, approximately in late November. The irony is that the rapid progress of the experiment is due to the outbreaks in Europe and the United States, and the probability of subjects being infected by the virus has increased. Relatively speaking, vaccine developers in China and New Zealand are at a disadvantage because they cannot accumulate cases quickly.
The committee will analyze the effects and side effects of the vaccine based on the response 14 days after the second dose of the vaccine. If everything goes well, Pfizer will apply to the drug regulatory agency for an accelerated review. At the same time, Pfizer will step up mass production and delivery, purchase refrigerators, liquid nitrogen, incubators and other facilities. It is estimated that 50 million vaccines will be produced by the end of 2020 for 25 million people to administer (two doses per person), and 1.3 billion will be produced in 2021. Support vaccine.
The new vaccine enters the sprint period
Then there are two headaches to be solved: Which countries get the vaccine first? Who gets the vaccine first? The former depends on the agreement between the state and the enterprise. At present, it is known that the European Union has ordered 200 million doses with Pfizer and has the right to purchase an additional 100 million doses; Japan orders 120 million doses; the United States orders 100 million doses and can purchase an additional 50 million doses; the United Kingdom orders 30 million doses; this means 2020 Capacity has been split.
The order of individual vaccinations is mainly based on the occupational division of labor and social class—emergency personnel, ambulance drivers, etc. are the first priority; the elderly and the frail are second; next are those in high-risk environments, such as teachers and prisons. Of the elderly. Then there are teenagers, children, people working in hotels, restaurants, factories, and finally others. Most people may not get the vaccine within next year.
11. What is the impact of vaccines on technology and business?
As mentioned above, this is a comprehensive competition. Starting from the development of a vaccine, it has now entered the final stage of clinical trials. Next comes production, delivery, and distribution. Which government can negotiate prices, obtain vaccines, and administer vaccines safely will be the first to resume economic operations.
Another comprehensive issue is personnel management. The founder of BioNTech expects that the vaccine effect will be maintained for at least one year. This means that in the next two years, there will be four kinds of people at the same time: they have been vaccinated; they have recovered from the disease and have immunity; they have not been vaccinated; and they have been vaccinated but lose their immunity.
Obviously, the first two types of people should enjoy greater freedom, and can travel, party, etc. Therefore, some kind of digital authentication is needed to quickly identify people with existing immunity. This system must be applicable to airports and stations, and it must be able to be used internationally, and many companies should be willing to adopt it. Diagnosis, medicines and vaccines are a trinity, and the government, enterprises and people must cooperate with each other.
12. What impact will vaccines have on society in the future?
Vaccines will revive people’s expectations for the future. The real economy is expected to restart, changing from dormant to aggressive, starting to increase investment, or taking advantage of the trend of internal reforms to make preparations.
But the impact is not all positive. Fighting for a vaccine is a competition in itself, which will intensify hostile relations between countries and test the unity of society. If the vaccine successfully controls the epidemic, it will be a milestone in the global biomedical industry. Mankind must grasp this crisis, build the resilience of the medical system, and prepare to face the next challenge.