" Shares in Moderna soared 15.6 per cent to $21.33 in after-hours trading in New York as the drugmaker said that its new way of making vaccines helped it rapidly create the candidate known as mRNA-1273, cutting the time it takes to develop a new potential vaccine to try to curb the impact of the coronavirus outbreak." ...... The vaccine still needs to be tested in humans, where it could fail, and if it succeeds, it will still take months until it is widely available. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, part of the NIH, told the Wall Street Journal that he expects a clinical trial of about 20 to 25 healthy volunteers to start in April, with initial results available in July and August. Moderna uses a molecule called messengerRNA that transfers genetic information into cells, which the company says mimics a natural infection to stimulate a more potent immune response. This vaccine tries to mimic the spike protein found on the novel coronavirus and other coronaviruses such as Severe Acute Respiratory Syndrom and Middle Eastern Respiratory Syndrome.
The manufacture of the vaccine candidate was funded by the Coalition for Epidemic Preparedness Innovations, a group of governments and non-profits that launched a $1bn programme to cut vaccine development time in Davos in 2017.
Moderna had up to 100 employees working on the effort, including through the weekend. The first batch was finished on February 7 but it had to be tested over two weeks."
看起来是两轮测试 The first trial will be conducted at NIAID’s clinical-trials unit in Bethesda. If the first one is successful, a second trial of hundreds or thousands of participants could begin, which could take six to eight months, Dr. Fauci said. This trial could be conducted partly in the U.S. but also in China or a region where the virus is spreading, so the testing could gauge whether the vaccine reduces infection rates. If the second trial is positive, the vaccine could be ready for widespread use, he said. How widely the virus has spread by then will determine whether it is given to targeted groups such as health-care workers, or more broadly to the general population, Dr. Fauci said.
看起来是两轮测试 The first trial will be conducted at NIAID’s clinical-trials unit in Bethesda. If the first one is successful, a second trial of hundreds or thousands of participants could begin, which could take six to eight months, Dr. Fauci said. This trial could be conducted partly in the U.S. but also in China or a region where the virus is spreading, so the testing could gauge whether the vaccine reduces infection rates. If the second trial is positive, the vaccine could be ready for widespread use, he said. How widely the virus has spread by then will determine whether it is given to targeted groups such as health-care workers, or more broadly to the general population, Dr. Fauci said.
好多事儿呢,写protocol, set up case report form, database...... 四月底已经挺快的了。做个新药不容易。美国这边做事还是一板一眼的,长期来说是好的,比较能保证质量和安全,现在这种时候就有点着急
【The institute expects by the end of April to start a clinical trial of about 20 to 25 healthy...】 还是既定时间啊 那e从现在开始到四月底的两个月做什么呢? bingmi 发表于 2/24/2020 8:57:00 PM
Drugmaker Moderna Inc. has shipped the first batch of its rapidly developed coronavirus vaccine to U.S. government researchers, who will launch the first human tests of whether the experimental shot could help suppress the epidemic originating in China.
Moderna on Monday sent vaccine vials from its Norwood, Mass., manufacturing plant to the National Institute of Allergy and Infectious Diseases in Bethesda, Md., the company said. The institute expects by the end of April to start a clinical trial of about 20 to 25 healthy volunteers, testing whether two doses of the shot are safe and induce an immune response likely to protect against infection, NIAID Director Anthony Fauci said in an interview. Initial results could become available in July or August.
Researchers are using new technologies toaccelerate vaccine development afterinfectious diseases emerge.
Moderna’s turnaround time in producing the first batch of the vaccine—co-designed with NIAID, after learning the new virus’s genetic sequence in January—is a stunningly fast response to an emerging outbreak.
If a trial starts as planned in April, it would be about three months from vaccine design to human testing. In comparison, after an outbreak of an older coronavirus, severe acute respiratory syndrome, in China in 2002, it took about 20 months for NIAID to get a vaccine into the first stage of human testing, according to Dr. Fauci.
“Going into a Phase One trial within three months of getting the sequence is unquestionably the world indoor record. Nothing has ever gone that fast,” Dr. Fauci said.
Public-health authorities say advances in vaccine technology, aided by government and private investments, are shortening development timelines when outbreaks occur. In the past, researchers scrambled to develop vaccines in response to outbreaks such as SARS, Ebola and Zika with mixed results. Older types of vaccines are developed from viral proteins that must be grown in eggs or cell cultures, and together with animal testing it can take years before a vaccine can be used in humans.
Scientists racing to find a vaccine for the Wuhan coronavirus are hoping a cutting-edge approach called ‘rapid response platforms’ will quickly yield a breakthrough. WSJ’s Jason Bellini explains what these are and how they work. Newer approaches rely on what are known as platform technologies—building blocks that can be tweaked quickly with the genetic information from a newly emerged pathogen.
The fast production of a vaccine and plans to test it soon don’t guarantee its success. “You’re never sure until you’re at the end what you have,” said Bruce Gellin, president of global immunization at the Sabin Vaccine Institute. Saying there are other coronavirus vaccines in the works, he added: “The sequence of testing is designed to sort out what works from what doesn’t. That’s why it’s important to try as many things as possible that seem feasible, because not all horses will finish the race.”
It is uncertain whether Moderna’s vaccine will work because its gene-based technology hasn’t yet yielded an approved human vaccine. And even if the first study is positive, the coronavirus vaccine might not become widely available until next year because further studies and regulatory clearances will be needed, Dr. Fauci said.
But health authorities say it is worth placing bets on these new technologies in the face of fast-moving outbreaks. Since early January, when only a few dozen cases were confirmed in central China, the virus has spread to more than 79,000 people, including more than 2,600 who have died. The vast majority of the cases are in China, according to the World Health Organization.
Dr. Fauci said it is possible the spread of coronavirus could lessen during warmer months, but then return next winter and become a seasonal virus like the flu, making a vaccine useful even if it isn’t ready for widespread distribution until next year.
“The only way you can completely suppress an emerging infectious disease is with a vaccine,” Dr. Fauci said in his office in Bethesda. “If you want to really get it quickly, you’re using technologies that are not as time-honored as the standard, what I call antiquated, way of doing it.”
Moderna, which has more than 800 employees, was founded in 2010 to develop drugs and vaccines based on what is known as messenger RNA, the genetic molecules that carry instructions from DNA to the body’s cells to make certain proteins. The company is targeting cancer, heart disease and infectious diseases. It hasn’t brought any drugs or vaccines to market.
Moderna Chief Executive Stephane Bancel said he got in touch with NIAID after hearing about the new China virus while vacationing with his family in France in early January, to discuss collaborating on a vaccine.
Chinese scientists found the genetic sequence of the new virus and published it online around Jan. 10. Researchers at NIAID and Moderna analyzed the sequence and homed in on a section they believed was most likely to induce the desired immune response if incorporated into a vaccine. NIAID agreed to run a clinical trial if Moderna could supply a vaccine.
Moderna didn’t need actual samples of the virus or its proteins. The company’s vaccines instead contain nucleic acids with genetic codes that instruct the body’s own cells to make certain proteins from the virus that don’t infect a person, but trigger an immune response.
Moderna in 2018 opened a manufacturing site in the shell of a former Polaroid plant in Norwood, near the company’s Cambridge, Mass., headquarters. In the plant, employees wearing white lab gowns, hair nets and safety goggles work amid lab hoods, robotic machinery and steel tanks to produce drugs and vaccines for clinical trials. Meeting rooms are named after famous scientists such as Curie and Pasteur.
To make the coronavirus vaccine, Moderna repurposed some of the robotic equipment that was making cancer vaccines tailored to the genetic mutations of patients’ tumors.
As many as 100 manufacturing and quality-control employees were involved in the effort, many working nights and weekends. As manufacturing ramped up, the company’s leaders had frequent meetings, calls and WhatsApp messaging chains to monitor progress, and stayed in close contact with NIAID.
After Moderna’s effort became public in January, friends and family members became interested.
Juan Andres, Moderna’s head of technical operations, said, “I wasn’t used to my kid thinking I did anything cool,” but his 15-year-old son began asking questions about the project at dinner.
As many as 100 manufacturing and quality-control employees were part of Moderna’s effort to make the coronavirus vaccine.
Moderna finished manufacturing about 500 vials on Feb. 7, a Friday. Normally, the company would have waited until Monday to start quality-control tests, but about 10 to 15 workers spent the weekend testing samples for potency and other features. The batch cleared most tests that weekend, but it took about two weeks to complete sterility testing. Moderna stored the supply in freezers set to minus-70 degrees Celsius.
One risk of moving so fast is that Moderna and NIAID won’t know for sure they picked the best fragment of the virus’s genetic sequence to target until the human study is completed.
“It is possible it’s going to work, but we have to wait and see,” said Mr. Bancel, Moderna’s CEO.
The first trial will be conducted at NIAID’s clinical-trials unit in Bethesda. If the first one is successful, a second trial of hundreds or thousands of participants could begin, which could take six to eight months, Dr. Fauci said. This trial could be conducted partly in the U.S. but also in China or a region where the virus is spreading, so the testing could gauge whether the vaccine reduces infection rates.
If the second trial is positive, the vaccine could be ready for widespread use, he said. How widely the virus has spread by then will determine whether it is given to targeted groups such as health-care workers, or more broadly to the general population, Dr. Fauci said.
WSJ的那篇文章说到4月底才会开始 clinical trial. The institute expects by the end of April to start a clinical trial of about 20 to 25 healthy volunteers, testing whether two doses of the shot are safe and induce an immune response likely to protect against infection, NIAID Director Anthony Fauci said in an interview. Initial results could become available in July or August.
回复1楼 xylona09 的帖子 Drugmaker Moderna Inc. has shipped the first batch of its rapidly developed coronavirus vaccine to U.S. government researchers, who will launch the first human tests of whether the experimental shot could help suppress the epidemic originating in China. Moderna on Monday sent vaccine vials from its Norwood, Mass., manufacturing plant to the National Institute of Allergy and Infectious Diseases in Bethesda, Md., the company said. The institute expects by the end of April to start a clinical trial of about 20 to 25 healthy volunteers, testing whether two doses of the shot are safe and induce an immune response likely to protect against infection, NIAID Director Anthony Fauci said in an interview. Initial results could become available in July or August. Researchers are using new technologies toaccelerate vaccine development afterinfectious diseases emerge. Moderna’s turnaround time in producing the first batch of the vaccine—co-designed with NIAID, after learning the new virus’s genetic sequence in January—is a stunningly fast response to an emerging outbreak. If a trial starts as planned in April, it would be about three months from vaccine design to human testing. In comparison, after an outbreak of an older coronavirus, severe acute respiratory syndrome, in China in 2002, it took about 20 months for NIAID to get a vaccine into the first stage of human testing, according to Dr. Fauci. “Going into a Phase One trial within three months of getting the sequence is unquestionably the world indoor record. Nothing has ever gone that fast,” Dr. Fauci said. Public-health authorities say advances in vaccine technology, aided by government and private investments, are shortening development timelines when outbreaks occur. In the past, researchers scrambled to develop vaccines in response to outbreaks such as SARS, Ebola and Zika with mixed results. Older types of vaccines are developed from viral proteins that must be grown in eggs or cell cultures, and together with animal testing it can take years before a vaccine can be used in humans. Scientists racing to find a vaccine for the Wuhan coronavirus are hoping a cutting-edge approach called ‘rapid response platforms’ will quickly yield a breakthrough. WSJ’s Jason Bellini explains what these are and how they work. Newer approaches rely on what are known as platform technologies—building blocks that can be tweaked quickly with the genetic information from a newly emerged pathogen. The fast production of a vaccine and plans to test it soon don’t guarantee its success. “You’re never sure until you’re at the end what you have,” said Bruce Gellin, president of global immunization at the Sabin Vaccine Institute. Saying there are other coronavirus vaccines in the works, he added: “The sequence of testing is designed to sort out what works from what doesn’t. That’s why it’s important to try as many things as possible that seem feasible, because not all horses will finish the race.” It is uncertain whether Moderna’s vaccine will work because its gene-based technology hasn’t yet yielded an approved human vaccine. And even if the first study is positive, the coronavirus vaccine might not become widely available until next year because further studies and regulatory clearances will be needed, Dr. Fauci said. But health authorities say it is worth placing bets on these new technologies in the face of fast-moving outbreaks. Since early January, when only a few dozen cases were confirmed in central China, the virus has spread to more than 79,000 people, including more than 2,600 who have died. The vast majority of the cases are in China, according to the World Health Organization. Dr. Fauci said it is possible the spread of coronavirus could lessen during warmer months, but then return next winter and become a seasonal virus like the flu, making a vaccine useful even if it isn’t ready for widespread distribution until next year. “The only way you can completely suppress an emerging infectious disease is with a vaccine,” Dr. Fauci said in his office in Bethesda. “If you want to really get it quickly, you’re using technologies that are not as time-honored as the standard, what I call antiquated, way of doing it.” Moderna, which has more than 800 employees, was founded in 2010 to develop drugs and vaccines based on what is known as messenger RNA, the genetic molecules that carry instructions from DNA to the body’s cells to make certain proteins. The company is targeting cancer, heart disease and infectious diseases. It hasn’t brought any drugs or vaccines to market. Moderna Chief Executive Stephane Bancel said he got in touch with NIAID after hearing about the new China virus while vacationing with his family in France in early January, to discuss collaborating on a vaccine. Chinese scientists found the genetic sequence of the new virus and published it online around Jan. 10. Researchers at NIAID and Moderna analyzed the sequence and homed in on a section they believed was most likely to induce the desired immune response if incorporated into a vaccine. NIAID agreed to run a clinical trial if Moderna could supply a vaccine. Moderna didn’t need actual samples of the virus or its proteins. The company’s vaccines instead contain nucleic acids with genetic codes that instruct the body’s own cells to make certain proteins from the virus that don’t infect a person, but trigger an immune response. Moderna in 2018 opened a manufacturing site in the shell of a former Polaroid plant in Norwood, near the company’s Cambridge, Mass., headquarters. In the plant, employees wearing white lab gowns, hair nets and safety goggles work amid lab hoods, robotic machinery and steel tanks to produce drugs and vaccines for clinical trials. Meeting rooms are named after famous scientists such as Curie and Pasteur. To make the coronavirus vaccine, Moderna repurposed some of the robotic equipment that was making cancer vaccines tailored to the genetic mutations of patients’ tumors. As many as 100 manufacturing and quality-control employees were involved in the effort, many working nights and weekends. As manufacturing ramped up, the company’s leaders had frequent meetings, calls and WhatsApp messaging chains to monitor progress, and stayed in close contact with NIAID. After Moderna’s effort became public in January, friends and family members became interested. Juan Andres, Moderna’s head of technical operations, said, “I wasn’t used to my kid thinking I did anything cool,” but his 15-year-old son began asking questions about the project at dinner. As many as 100 manufacturing and quality-control employees were part of Moderna’s effort to make the coronavirus vaccine. Moderna finished manufacturing about 500 vials on Feb. 7, a Friday. Normally, the company would have waited until Monday to start quality-control tests, but about 10 to 15 workers spent the weekend testing samples for potency and other features. The batch cleared most tests that weekend, but it took about two weeks to complete sterility testing. Moderna stored the supply in freezers set to minus-70 degrees Celsius. One risk of moving so fast is that Moderna and NIAID won’t know for sure they picked the best fragment of the virus’s genetic sequence to target until the human study is completed. “It is possible it’s going to work, but we have to wait and see,” said Mr. Bancel, Moderna’s CEO. The first trial will be conducted at NIAID’s clinical-trials unit in Bethesda. If the first one is successful, a second trial of hundreds or thousands of participants could begin, which could take six to eight months, Dr. Fauci said. This trial could be conducted partly in the U.S. but also in China or a region where the virus is spreading, so the testing could gauge whether the vaccine reduces infection rates. If the second trial is positive, the vaccine could be ready for widespread use, he said. How widely the virus has spread by then will determine whether it is given to targeted groups such as health-care workers, or more broadly to the general population, Dr. Fauci said. 四正 发表于 2/24/2020 10:40:00 PM
This is talking about difference between Moderna and Gilead Moderna's and Gilead's approaches to the coronavirus are different. Gilead is attempting to treat patients already infected with the disease. It's using an experimental Ebola virus drug. Moderna is making a coronavirus vaccine which could prevent the disease. U.S. researchers could have clinical results for Moderna's coronavirus vaccine in July or August. The biotech company isn't alone in seeking to prevent coronavirus. Vaccine programs are also underway at Johnson & Johnson (JNJ), Novavax (NVAX) and Vaxart (VXRT). But Moderna is the first to accelerate its coronavirus vaccine into human testing — helping MRNA stock to jump. It's important to note this would be a Phase 1 test. Pharma and biotech companies typically have to pass three clinical studies and then a regulatory review before a drug gains approval. Moderna's technology relies on messenger RNA, which carry instructions from the DNA to create proteins. Chinese scientists sequenced the coronavirus and published that research around Jan. 10. Researchers at NIAID and Moderna analyzed that research. The experimental coronavirus vaccine instructs the body to make proteins from the virus. But, the proteins don't infect a person. Instead, they trigger an immune response — essentially protecting that person from contracting Covid-19.
It is uncertain whether Moderna’s vaccine will work because its gene-based technology hasn’t yet yielded an approved human vaccine. And even if the first study is positive, the coronavirus vaccine might not become widely available until next year because further studies and regulatory clearances will be needed, Dr. Fauci said. 这还是不乐观呀。这个公司的基因疫苗还没有被批准用于人类疫苗过,并且就算有效,大规模接种也要等到明年。黄花菜都凉了。
https://www.wsj.com/articles/drugmaker-moderna-delivers-first-coronavirus-vaccine-for-human-testing-11582579099
希望能成功,要是能成功的话,美国这真的是牛逼!
🔥 最新回帖
你怎么知道国内不在做?
为世人造福的事,如果又名利双收,国内怎么不做呢?
一样的遭遇
🛋️ 沙发板凳
希望吧!但从SARs的经验来看,这疫苗还是未知数。
马上国内就拿去“自主研发”了😓
钱多人多。一个50开往研究型大学里一个assistant professor,许多人手上经费都是1M,再带几个千老,出成果容易
国内is a lost cause, sadly.
研发吧,只要能救人就行
绝对的,气度、决断力,无一不显大国形象。
对比厉害国,混淆视听,连偷带抢。shame on it
" Shares in Moderna soared 15.6 per cent to $21.33 in after-hours trading in New York as the drugmaker said that its new way of making vaccines helped it rapidly create the candidate known as mRNA-1273, cutting the time it takes to develop a new potential vaccine to try to curb the impact of the coronavirus outbreak."
......
The vaccine still needs to be tested in humans, where it could fail, and if it succeeds, it will still take months until it is widely available. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, part of the NIH, told the Wall Street Journal that he expects a clinical trial of about 20 to 25 healthy volunteers to start in April, with initial results available in July and August.
Moderna uses a molecule called messengerRNA that transfers genetic information into cells, which the company says mimics a natural infection to stimulate a more potent immune response. This vaccine tries to mimic the spike protein found on the novel coronavirus and other coronaviruses such as Severe Acute Respiratory Syndrom and Middle Eastern Respiratory Syndrome.
The manufacture of the vaccine candidate was funded by the Coalition for Epidemic Preparedness Innovations, a group of governments and non-profits that launched a $1bn programme to cut vaccine development time in Davos in 2017.
Moderna had up to 100 employees working on the effort, including through the weekend. The first batch was finished on February 7 but it had to be tested over two weeks."
质量不一样啊lol 有的东西山寨质量差点也没事,有的差一点点都不行
为什么?
20-25 健康的志愿者,每个人打2针,看效果
国内已经有“自主研发”了,不知道是不是一个疫苗,天津大学的是以S蛋白为靶点产生抗体,教授本人已经4倍量口服了,牛了个叉
国内的假疫苗事件好象就是不久前的事。不知民众有没有记性。
re 第一反应就是不要又被国内那帮专家抢注了;还有不要中药抢功不给病人用;再有不要只给领导用
不会故意给暴露病毒的,前面健康人就是看看抗体产生如何。
之后也许给Health worker 等等高危人群看效果。
Flu vaccine 每年病毒也不同,疫苗研发周期也就几个月。流感疫苗的主要问题是预测冬季流行的strain, 这个是病毒已经清楚,看看疫苗是不是有保护作用吧。
吞完就敢说可以了……
看起来是两轮测试
The first trial will be conducted at NIAID’s clinical-trials unit in Bethesda. If the first one is successful, a second trial of hundreds or thousands of participants could begin, which could take six to eight months, Dr. Fauci said. This trial could be conducted partly in the U.S. but also in China or a region where the virus is spreading, so the testing could gauge whether the vaccine reduces infection rates.
If the second trial is positive, the vaccine could be ready for widespread use, he said. How widely the virus has spread by then will determine whether it is given to targeted groups such as health-care workers, or more broadly to the general population, Dr. Fauci said.
卫生部的人不是说最快3个月可以出吗
说的太对了
文章说药厂从1月拿到基因排序到4月上人体实验,是史上最快。。。说的是研发的这3个月吧?
我记得记者会说的是现在前两期的实验都很成功,马上要投入人体测试,最快3个月可以出疫苗。也许我记错了,希望早点再早点。
上次是哪里推出的?不过有人说新病毒非常狡猾,cross finger!
动物实验还是得做的吧,要上人体了,说明动物实验做完了?太快了吧。
新闻发布会确实有说在动物上做,并且很成功
有,七秒钟
Drugmaker Moderna Inc. has shipped the first batch of its rapidly developed coronavirus vaccine to U.S. government researchers, who will launch the first human tests of whether the experimental shot could help suppress the epidemic originating in China.
Moderna on Monday sent vaccine vials from its Norwood, Mass., manufacturing plant to the National Institute of Allergy and Infectious Diseases in Bethesda, Md., the company said. The institute expects by the end of April to start a clinical trial of about 20 to 25 healthy volunteers, testing whether two doses of the shot are safe and induce an immune response likely to protect against infection, NIAID Director Anthony Fauci said in an interview. Initial results could become available in July or August.
Researchers are using new technologies toaccelerate vaccine development afterinfectious diseases emerge.
Moderna’s turnaround time in producing the first batch of the vaccine—co-designed with NIAID, after learning the new virus’s genetic sequence in January—is a stunningly fast response to an emerging outbreak.
If a trial starts as planned in April, it would be about three months from vaccine design to human testing. In comparison, after an outbreak of an older coronavirus, severe acute respiratory syndrome, in China in 2002, it took about 20 months for NIAID to get a vaccine into the first stage of human testing, according to Dr. Fauci.
“Going into a Phase One trial within three months of getting the sequence is unquestionably the world indoor record. Nothing has ever gone that fast,” Dr. Fauci said.
Public-health authorities say advances in vaccine technology, aided by government and private investments, are shortening development timelines when outbreaks occur. In the past, researchers scrambled to develop vaccines in response to outbreaks such as SARS, Ebola and Zika with mixed results. Older types of vaccines are developed from viral proteins that must be grown in eggs or cell cultures, and together with animal testing it can take years before a vaccine can be used in humans.
Scientists racing to find a vaccine for the Wuhan coronavirus are hoping a cutting-edge approach called ‘rapid response platforms’ will quickly yield a breakthrough. WSJ’s Jason Bellini explains what these are and how they work.
Newer approaches rely on what are known as platform technologies—building blocks that can be tweaked quickly with the genetic information from a newly emerged pathogen.
The fast production of a vaccine and plans to test it soon don’t guarantee its success. “You’re never sure until you’re at the end what you have,” said Bruce Gellin, president of global immunization at the Sabin Vaccine Institute. Saying there are other coronavirus vaccines in the works, he added: “The sequence of testing is designed to sort out what works from what doesn’t. That’s why it’s important to try as many things as possible that seem feasible, because not all horses will finish the race.”
It is uncertain whether Moderna’s vaccine will work because its gene-based technology hasn’t yet yielded an approved human vaccine. And even if the first study is positive, the coronavirus vaccine might not become widely available until next year because further studies and regulatory clearances will be needed, Dr. Fauci said.
But health authorities say it is worth placing bets on these new technologies in the face of fast-moving outbreaks. Since early January, when only a few dozen cases were confirmed in central China, the virus has spread to more than 79,000 people, including more than 2,600 who have died. The vast majority of the cases are in China, according to the World Health Organization.
Dr. Fauci said it is possible the spread of coronavirus could lessen during warmer months, but then return next winter and become a seasonal virus like the flu, making a vaccine useful even if it isn’t ready for widespread distribution until next year.
“The only way you can completely suppress an emerging infectious disease is with a vaccine,” Dr. Fauci said in his office in Bethesda. “If you want to really get it quickly, you’re using technologies that are not as time-honored as the standard, what I call antiquated, way of doing it.”
Moderna, which has more than 800 employees, was founded in 2010 to develop drugs and vaccines based on what is known as messenger RNA, the genetic molecules that carry instructions from DNA to the body’s cells to make certain proteins. The company is targeting cancer, heart disease and infectious diseases. It hasn’t brought any drugs or vaccines to market.
Moderna Chief Executive Stephane Bancel said he got in touch with NIAID after hearing about the new China virus while vacationing with his family in France in early January, to discuss collaborating on a vaccine.
Chinese scientists found the genetic sequence of the new virus and published it online around Jan. 10. Researchers at NIAID and Moderna analyzed the sequence and homed in on a section they believed was most likely to induce the desired immune response if incorporated into a vaccine. NIAID agreed to run a clinical trial if Moderna could supply a vaccine.
Moderna didn’t need actual samples of the virus or its proteins. The company’s vaccines instead contain nucleic acids with genetic codes that instruct the body’s own cells to make certain proteins from the virus that don’t infect a person, but trigger an immune response.
Moderna in 2018 opened a manufacturing site in the shell of a former Polaroid plant in Norwood, near the company’s Cambridge, Mass., headquarters. In the plant, employees wearing white lab gowns, hair nets and safety goggles work amid lab hoods, robotic machinery and steel tanks to produce drugs and vaccines for clinical trials. Meeting rooms are named after famous scientists such as Curie and Pasteur.
To make the coronavirus vaccine, Moderna repurposed some of the robotic equipment that was making cancer vaccines tailored to the genetic mutations of patients’ tumors.
As many as 100 manufacturing and quality-control employees were involved in the effort, many working nights and weekends. As manufacturing ramped up, the company’s leaders had frequent meetings, calls and WhatsApp messaging chains to monitor progress, and stayed in close contact with NIAID.
After Moderna’s effort became public in January, friends and family members became interested.
Juan Andres, Moderna’s head of technical operations, said, “I wasn’t used to my kid thinking I did anything cool,” but his 15-year-old son began asking questions about the project at dinner.
As many as 100 manufacturing and quality-control employees were part of Moderna’s effort to make the coronavirus vaccine.
Moderna finished manufacturing about 500 vials on Feb. 7, a Friday. Normally, the company would have waited until Monday to start quality-control tests, but about 10 to 15 workers spent the weekend testing samples for potency and other features. The batch cleared most tests that weekend, but it took about two weeks to complete sterility testing. Moderna stored the supply in freezers set to minus-70 degrees Celsius.
One risk of moving so fast is that Moderna and NIAID won’t know for sure they picked the best fragment of the virus’s genetic sequence to target until the human study is completed.
“It is possible it’s going to work, but we have to wait and see,” said Mr. Bancel, Moderna’s CEO.
The first trial will be conducted at NIAID’s clinical-trials unit in Bethesda. If the first one is successful, a second trial of hundreds or thousands of participants could begin, which could take six to eight months, Dr. Fauci said. This trial could be conducted partly in the U.S. but also in China or a region where the virus is spreading, so the testing could gauge whether the vaccine reduces infection rates.
If the second trial is positive, the vaccine could be ready for widespread use, he said. How widely the virus has spread by then will determine whether it is given to targeted groups such as health-care workers, or more broadly to the general population, Dr. Fauci said.
中国也有疫苗了,其他一些国家也好像有或者有进展
我的感觉(门外汉)是研究疫苗本身挺快,慢的是各种测试
天朝也有了,而且研发人还亲自服用了
谁敢不打,那么高的致死率
如果口服疫苗是真的有效,那可是天大的喜事,我多希望是真的
厉害!
没用,现在韩国日本意大利病人遍地,土共的已经不稀奇了
当务之急是救人。官媒那套你怎么做都没用的,索性忽略
疫苗再怎么快也不可能用到今年的病人上了,只希望能防住来年
当然,天朝天津大学黄金海教授亲自口服实验的疫苗多半两会的时候就可以人手一打,代替矿泉水了