The effectiveness of the Germany-American Covid-19 vaccine exceeds 90% ? Before confirming success, let the “bullet” fly for a while
This week, the cumulative number of confirmed cases of new Coronavirus pandemic worldwide exceeded 50 million. Ryan, Executive Director of the WHO Emergency Program, pointed out that this represents a “serious milestone.”
The effectiveness of Germany-American vaccines exceeds 90%? Expectations for vaccines make stocks soar
Also this week, the news that the effectiveness of Covid-19 vaccine developed by US and European companies exceeded 90% also attracted attention. For this reason, New York Times Square put a subtitle on the electronic screen: “Expectations for vaccines make the stock market soar.” On November 9, the three major US stock indexes collectively opened sharply higher. In the morning, the American pharmaceutical company Pfizer announced that a Coronavirus vaccine project developed in cooperation with the Germany Biotech Company has made positive progress.
Burkhart, vice president of global drug safety research and development at Pfizer: Many people have heard of this good news. In the interim effect analysis, the effectiveness of the vaccine exceeded 90%, which means that 90% of those who received the vaccine did not Will be infected.
The 90% effectiveness claimed by the R&D team is much higher than the 50% effectiveness threshold set by the U.S. Food and Drug Administration. As a control, the effectiveness of a common flu vaccine is around 70%. According to the WHO website, no vaccine is 100% effective.
The R&D staff also emphasized that as of now, this Germany-American Coronavirus vaccine has not had serious safety issues in clinical trials. But according to the British “Daily Mirror” report, a 45-year-old trial participant in Missouri, Kelly, experienced headache, fever and body aches after being vaccinated. De Silz, 44, from Texas, described the side effects of the vaccine as a serious hangover.
“The stock market is soaring, and the vaccine is about to be launched. It is said to be 90% effective. What a good news!” Trump’s tweet on the same day was considered by critics to invite credit, and on the same day, Coronavirus in the United States The cumulative number of confirmed cases exceeded 10 million. In Ohio, where the pandemic has deteriorated significantly, Governor Devine, who was once infected with Coronavirus pandemic, could not hide his joy.
Disclosure of Germany and American vaccine trials
The vaccine code-named BNT162b2 jointly developed by Germany and American companies. In a statement issued on Monday, the research and development team announced some details of the test. The Phase 3 clinical trial was carried out simultaneously in six countries, recruiting a total of 43538 participants. They are from the United States, Germany, Brazil, Argentina, South Africa and Turkey. Among them, 30% of American participants have different racial or ethnic backgrounds, and 42% of participants from other countries.
Participants in the trial were divided into a vaccine group and a control group, with half the number of each group. The vaccine group was vaccinated with the BNT162b2 Coronavirus vaccine, and the control group was vaccinated with a “placebo” that had no effect on Coronavirus.
Since the trial was a “double-blind trial”, the two vaccine development companies and all trial participants did not know who received the vaccine and who received the placebo. The only person with real data is the Data Monitoring Committee (DMC) from a third party.
On July 27, the Phase 3 clinical trial was officially launched. Participants will receive two injections, 21 days apart. According to the original design, the data monitoring committee will analyze clinical trial data at several predetermined time points.
- first time node: 32 infected persons appeared among all participants;
- second time node: 62 infected persons appeared;
- third time node: 92 infected persons appeared;
- fourth time node: 120 infected persons appeared;
- time node: 164 infected persons appeared.
In other words, the phase 3 clinical trial will not end until 164 confirmed cases appear among all participants.
In October, after discussing with the US Food and Drug Administration, the R&D team decided to postpone the time of the first analysis from the appearance of 32 infected persons to the appearance of 62 infected persons. However, as the global pandemic worsened, when the Data Monitoring Committee began to analyze the data for the first time, the number of infected people had risen to 94.
It is worth noting that the R&D team did not announce the specific number of infections in the vaccine group and the control group in the statement. However, the “New York Times” based on the “90% effective” reverse speculation that among the 94 infected people, there are probably 8 people in the vaccine group and 86 people in the control group.
Ghani, an epidemiologist at Imperial College London: Experimental data shows that people who have not been vaccinated have more cases in a short period of time. This proves that the vaccine has played a protective role in a short time.
However, other health experts are more cautious. They believe that the 90% effectiveness released by the R&D team is only an interim analysis data, and does not represent the final analysis result of a phase 3 clinical trial.
Kramer, a virologist at Icahn School of Medicine at Mount Sinai in the United States, pointed out that one detail missing from the trial was that it failed to reflect the effect of the vaccine on specific populations. For example, it is difficult to determine the effectiveness of the vaccine in people over 65 or people of African descent.
Other experts believe that this very high percentage is obtained under ideal conditions and under specific clinical trial conditions, and the complex conditions of the real world may bias the results.
DuPrix, director of the University of Pittsburgh Vaccine Research Center: When the effectiveness reaches 90%, does it mean that Coronavirus pandemic has been cured? It’s not. Does it mean that this is the best vaccine? It’s not. Does it mean that this vaccine can provide immunity for many, many years, or even lifelong immunity like measles vaccine? It’s not. What we know from this limited study is that humans have made progress in slowing the pandemic through candidate vaccines, but there is still a long way to go.
Germany-American Coronavirus vaccine uses mRNA technology
According to reports, BNT162b2 is an mRNA vaccine or “messenger ribonucleic acid” vaccine, a new force in the vaccine family. The new coronavirus looks like a ball, and the thorns outside the ball are called S proteins. They are the key proteins for the virus to infect human cells. The principle of the mRNA vaccine is to inject the genetic material mRNA corresponding to the S protein into the human body, let it express the virus S protein in human cells, and then allow the cells to recognize and activate the antigen-specific T cells and B cells to cause the body’s immune response. . This is like drawing a portrait of a virus, so that immune cells will remember that any enemy with this characteristic will destroy it.
Clarke, an expert in cellular microbiology at the University of Reading: This is a brand-new vaccine production technology. People have been trying this technology for many years, but without success. This is different from traditional vaccine technology. Traditional vaccines usually inject inactivated viruses into the body to generate an immune response.
Compared with traditional vaccines, the mRNA vaccine production process is relatively simple, the development speed is fast, and the cost is lower. “Forbes” magazine believes that if it passes the approval, this vaccine is expected to become the world’s first vaccine using mRNA technology. However, before mass production and application, there is a thorny problem that must be solved.
Cold storage difficulties may hinder the large-scale application of mRNA vaccines
Hepatitis B vaccine, rabies vaccine, and chickenpox vaccine. The cold chain and storage temperature of these traditional vaccines usually only need 2 degrees Celsius to 8 degrees Celsius, and they can be stored in the freezer of the refrigerator. The Germany-American Covid-19 vaccine, due to the new mRNA technology, must be stored at a very low temperature of at least minus 70 degrees Celsius for 6 months without affecting the effect. If it is stored in a refrigerator at 2 degrees Celsius to 8 degrees Celsius, it will only Can be stored for 5 days. This also means that most of the existing cold chain systems are difficult to meet the transportation needs of the vaccine.
According to public documents from the US Centers for Disease Control and Prevention, some states have indicated that they lack such ultra-low temperature transportation and storage equipment. According to the Stars and Stripes, even the prestigious Mayo Medical Center in Minnesota does not have the cold chain and storage conditions of minus 70 degrees Celsius, let alone clinics in rural and remote areas.
Clarke, an expert in cell microbiology at the University of Reading: The cold chain of drugs and vaccines is inherently a problem, let alone minus 80 degrees Celsius. Unfortunately, this will be a challenge for some developing countries. Even in developed countries, the vaccine may only be vaccinated in central areas at first.
According to the New York Times, the vaccine research and development team has specially designed a cold chain transport box for vaccines. The transport box is filled with dry ice. Each transport box can hold 1,000 to 5,000 vaccines. The vaccine can be stored in the transport box. Save for 15 days. Each transport box is also equipped with a GPS global positioning system, so that the vaccine can be transported to hospitals in various places in a safe and timely manner.
It is envisaged that when the cold chain transport box is delivered to the hospital, even if the hospital does not have the storage conditions of minus 70 degrees Celsius, the transport box can be used to store the vaccine directly. Only enough dry ice needs to be added in time, but the number of times the transport box is opened every day No more than twice.
The research and development team said that the entire phase 3 clinical trial is expected to be completed by the end of November, and then it will apply to the US Food and Drug Administration for emergency use of the vaccine.
CNN reported that if approved, two production lines will be established worldwide, one in the United States and one in Europe. It is expected to produce 50 million vaccines this year and 1.3 billion vaccines in 2021.
Small Germany city attracts global attention due to Coronavirus vaccine
The city of Mainz in the Rhineland-Palatinate state of Germany last time attracted global attention to Gutenberg printing in the late Middle Ages, which triggered a media revolution. More than 500 years later, the city of Mainz once again attracted the attention of the world.
Germany Health Minister Span : This is encouraging. As the Germany Health Minister, I am very happy that this is a Germany company, a Germany R&D team, and a Germany biotechnology company.
No. 12, Jinkuang Road, sounds like a treasure trove of geomantic omen. This is where the Germany biotech company that develops vaccines is located. Germany media joked that this company, which previously focused on the development of cancer drugs, might really be sitting on a gold mine in the future. According to the company, the vaccine produced will be sold to the US government at a price of US$19.5 each.
The British “Financial Times” noted that since neither of the Germany and American R&D companies promised to supply this vaccine on a non-profit basis, it has attracted criticism from some international organizations. Oxfam stated that “for those who cannot obtain or cannot afford the vaccine, the effective rate of the vaccine is zero”. According to Der Spiegel, more than 500 researchers in the 5-story building are eagerly awaiting the results of the vaccine’s Phase 3 clinical trial.
Sahin, CEO of the Germany Biotech Company: We are in close dialogue with regulatory agencies around the world, such as the European Medicines Agency and the US Food and Drug Administration. The earliest time for the supply of vaccines may not be earlier than mid-December. .
Europeans are cautiously optimistic about the progress of Germany-American vaccines
On November 11, the European Union announced that it had signed a contract with Germany-American Vaccine Company to purchase 300 million Coronavirus vaccines. On the same day, the European Commission also proposed the establishment of a European Health Union to better respond to public health emergencies such as Coronavirus pandemic in the future.
On November 9th, British Prime Minister Johnson stated that the British government had previously ordered 40 million Germany-American COVID-19 vaccines, which would guarantee about one-third of the British population to be vaccinated.
British Prime Minister Johnson: We will determine the order of people’s vaccination based on the recommendations of scientists and the Joint Committee on Vaccination and Immunization. Experts are studying a series of factors including the characteristics of different types of vaccines in order to find the most effective way to protect the people and save as many lives as possible.
Two days later, the British government announced a list of ten priority groups and specific numbers of vaccinations. as followed:
- Elderly people and staff in nursing homes;
- People over 80 and health care social workers;
- People over 75 years old; people over 70 years old; people over 65 years old;
- People at high risk of health under 65;
- People under the age of 65 with moderate health risk;
- People over 60 years old; people over 55 years old; people over 50 years old;
Some people welcome the vaccine, and for some people who do not trust the vaccine, the government’s vaccine program is an infringement of freedom or a dangerous medical intervention. There was a protest rally of as many as 2,000 people in Trafalgar Square in London.
According to a poll conducted by the “Daily Mail”, more than 40% of the respondents believe that the British Prime Minister and other political figures should be vaccinated first to prove the safety of the vaccine.
“Vaccine research and development war” is in full swing, there are still many questions about Coronavirus vaccine
Russia is also participating in this “vaccine development war”. On November 11, the Russian Direct Investment Foundation stated that based on the preliminary results of clinical trials, the “Satellite V” vaccine developed by the Russian National Research Center for Epidemiology and Microbiology, funded by the Foundation, has reached 92% effectiveness. None of the more than 20,000 trial participants experienced serious adverse reactions.
According to data released by the World Health Organization, as of November 12, a total of 48 candidate vaccines worldwide have entered clinical trials.
This week, WHO experts said that the development and popularization of vaccines may fundamentally change the curve of Coronavirus pandemic. However, there are still many questions about the Covid-19 vaccine, such as how effective is the vaccine for people of different races and ages? How long can immunity be maintained after vaccination? Reuters pointed out that all parties have stepped up vaccine research and development to bring dawn to the world in the pandemic, but in the foreseeable future, the “new normal” of maintaining social distancing and wearing masks may continue.
