An epidemiologist answers the biggest questions she's getting about coronavirus. Wochit
The first coronavirus vaccine trial began Monday inSeattle when four volunteers got a version of a vaccine against a disease that as of Thursday has killed 150 people in 22 states, with more than 10,000 cases nationwide.
They were the beginning of an all-out effort by thousands of scientists worldwideworking to create vaccines againstthe new coronavirus in what inresearch terms is a blindingly fast response to theglobal threat. As of last week, the World Health Organization had posted a list of 41 possible vaccine candidates on its site.
Still, no one will be lining up this summer for vaccinations. It will be at least a year to 18 months before any vaccine is ready for large-scale use, according to most estimates. Before being deployed, vaccines must go through multiple rounds of testing to make sure they are safe,effective and dont have unintended consequences.
Researchers are not starting from scratch. Work on two previous coronaviruses, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS)provide a road map for howto create an immune response toSARS-CoV-2,the virus that causes the illness COVID-19.
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The process was immensely sped up by the decision ofprofessor Yong-Zhen Zhang at theShanghai Public Health Clinical Center in China to publish the virus' genome on Jan. 10.
Early financial support from the Oslo-basedCoalition for Epidemic Preparedness Innovations(CEPI), a nonprofit global partnership to develop vaccines, also has been crucial.
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While no one knows who will cross the finish line with a vaccine first, several companies and groups are off to strong starts, particularly those alreadyworking on SARS and MERS vaccines. Here are some of the noteworthy efforts underway:
This Boston-based company already was working on RNA therapies and vaccines. It began working with the National Institutes of Allergy and Infectious Disease in February to create an experimental SARS-CoV-2 vaccine. It began testing its first vaccine candidate on humansMonday. Agroup of four people was given the vaccineand researchers will first study its safety. If after several weeks it appears to be safe, another round of testing will begin to see whether it stimulates their immune system to make antibodies against the virus. It was one of three groups that received funding for the effort Jan. 23 from the CEPI.
The Australian research group was working on molecular clamp vaccines against MERS for several years and had a version showingresults in animal studies. It got funding from CEPI and retooled its research for SARS-CoV-2 in February. The clamp method uses a sequence of amino acids to lock down the spikes SARS-CoV-2 uses to infect cells, allowing the immune system to target it before the virus can activate itself. Testing of the trial vaccine in mice is underway and the group is hoping to begin human trials by mid-year.
This Pennsylvania-based biotech company alsoreceived one of the early CEPI grants. Inovio, was working on a DNA-based vaccine against MERS. The company president said it designed a COVID-19 vaccine candidate in three hours after the genetic sequence was published by the Chinese. The company plans to begin human trials in April.
This German-based company was in the news last week after reports surfaced President Donald Trump suggested the U.S. might buy access to its vaccines only for Americans.CureVac, which wasmainly working on anti-cancer vaccines, uses messenger RNA to make vaccines. It signed a development agreement with CEPI on Jan. 31 to work on SARS-CoV-2. The company hopes to have a possible vaccine ready to test within several months.
Maryland-based Novavax was working on vaccines against SARS and MERS.On March 10 it announced a $4 million award from CEPI to work on a SARS-CoV-2 vaccine. It hopes to begin testing in late spring.
A team at Oxford's Jenner Institute in Britain is creating SARS-CoV-2 vaccine seed stock in conjunction with Italian medical product manufacturer Advent. The JennerInstitute wasworking on a vaccine against MERS and currently has a trial underway in Saudi Arabia.
A large consortium of European research universities and biotech companies is working on a vaccine for SARS-CoV-2. The effort received nearly $3 million in European funding on March 9 and includes German, Dutch and Danish universities and biotech companies.
This United Kingdom-based company is one of the worlds largest vaccine producers. It has signed an agreement with CEPI to bring GSKs adjuvant systeminto the SARS-CoV-2 mix. Adjuvants can be added to vaccines to boost the immune response they produce. This could decrease the amount of vaccine (once one becomes available) needed per dose, allowing more doses to be produced more quickly.
Researchers at the Chinese academy are working with scientists atCanSino Biologics, a Hong Kong-based biotech company that licensed a vaccine for the Ebola virus in 2017. According to China's clinical trial registration database, the experimental COVID-19 vaccine is in the early stages of safety testing and tests were approved to begin as soon as March 17.
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Thousands of people have volunteered to be infected in the hope of finding a vaccine for the new coronavirus.
hVIVO, a clinical research group in London, has attracted more than 20,000 volunteers willing to be infected with tamer relatives of the virus that causes Covid-19 in exchange for a fee of 3,500 ($4,480). It says such experiments could play an important role in the development of a vaccine against the new coronavirus, for which there are no proven treatments or vaccines.
This week, scientists at the Kaiser Permanente Research Institute in Seattle, Washington, administered the first injection of a trial vaccine for the coronavirus. As The Associated Press reported it, the mood was optimistic. Were on team coronavirus now, said Kaisers Dr. Lisa Jackson. The recipient of this first dose, 43-year-old Jennifer Haller, offered tones of civic pride: This is an amazing opportunity for me to do something. These are just the first steps in what would be, in the best-case scenario, a 12- to 18-month wait for a medical breakthrough. All over the world, similar efforts are ongoing, the hope being that this vital work can be carried out without interruption or interference.
Naturally, we have also recently received a reminder of the extent to which our dreadful politics might provide the impediments necessary to blunt the efforts of vaccine researchers. Word leaked out this week that Donald Trump had apparently tried to lure a team of German researchers to the United States so that they could carry through cutting-edge research on developing a coronavirus vaccine here. (The European Union is now responding to try to keep its researchers there.)
Its not clear exactly what Trump hoped to gain if his efforts succeeded. There was speculation that he had planned to make the vaccine available exclusively for people in the U.S., although as a practical matter, it is difficult to envision how this could have been accomplished. Perhaps Trump was just hoping for bragging rights, that the U.S. had developed the first effective coronavirus vaccine. (In a best-case scenario, it will be at least a year until one is widely available, an inconvenient truth for those who are currently endeavoring to engineer the presidents reelection.)
While it is not worth a lot of effort unraveling Trumps thinking, we should be doing some serious thinking ourselves about the development of a coronavirus vaccine and biomedical research more generally. The situation we see today is that many top-notch researchers, in Germany, China, the U.S., and elsewhere, are racing to develop a vaccine that can enter the testing process. The problem with this picture is that they are working in competition, not collaboration. This means that they are not widely sharing information with each other, since they dont want to give their competitors an edge.
Moderna has moved incredibly quickly to begin testing a potential vaccine for the new coronavirus in U.S. patients. The biotech company went from taking the genetic sequence of the new coronavirus to manufacturing its first batch of vials in less than a month.
Reality check: Best-case scenario, a vaccine could be ready for production by next year but that's assuming the drug proves to be both safe and effective, which is completely unknown right now.
What they're saying: My colleague Dan Primack and I spoke with Moderna CEO Stphane Bancel to understand the timing of this very fluid situation.
Yes, but: There's no data yet. It's a scientific feat to get to this stage so quickly, but that will matter a lot less if the vaccine doesn't work well or if people suffer serious side effects.
The intrigue: Moderna, which uses a complex gene-based technology that changes how cells function, has a lot of experience researching vaccines it has done some animal testing on a vaccine for a related coronavirus, MERS.
The bottom line: The global desire to find something to prevent another COVID-19 pandemic should not kick aside the need for scientific evidence.
The new coronavirus could kill millions across the United States, said Dr. Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland's School of Medicine.
"It would not surprise me," she told CNBC on Thursday when askedwhether the U.S. could see millions of deaths. "We need to prepare for the worst."
Neuzil is the only U.S. member of the World Health Organization's Strategic Advisory Group of Experts on Immunization and previously sat on the Centers for Disease Control's Advisory Committee on Immunization Practices. She's part of the leadership team of infectious disease experts working with NIH to test a coronavirus vaccine and therapies to treat those sick with COVID-19.
"We have 350 million people in the United States, and you do the math," she said on CNBC's "Squawk Box." If 70 million people are eventually infected with this virus and again if there are multiple waves of this virus, then you can do the math and then you can get there."
COVID-19 has now infected more than9,159 across every state in the U.S., according to Johns Hopkins University, and killed at least150 people in the country. On March 1, there were about 100 confirmed cases of the rapidly spreading virus in the U.S.
The number of actual cases in the country is likely significantly higher, state and local officials say. Testing in the U.S. has been hampered by delays and a restrictive diagnostic criteria that limited who could get tested.
Almost half of all confirmed U.S. cases are concentrated in three states: Washington, California and New York, where local and state officials have rolled out aggressive social distancing measures.
Those policies could reduce the number of deaths, said Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland's School of Medicine.
"I firmly believe that the very aggressive social distancing and other strategies we're implementing now will reduce the deaths," she said. "What we're worried about is overwhelming that system."
However, there's little uniformity across the country regarding social distancing policies. Without meaningful federal intervention, local leaders have adopted what New York Gov. Andrew Cuomo called Monday a "hodgepodge" of actions across the nation to contain the outbreak.Cuomo and other tri-state area officials on Monday banned all gatherings of 50or more people and placed restrictions on restaurants, bars and other places of recreation.
Governors in Maryland and Washington state, which has the second-highest number of cases behind New York but the nation's most deaths, followed suit with similar actions.
San Francisco Bay area officialsordered some 7 million residents to "shelter in place"on Monday, marking what might be the most aggressive and restrictive measures in the country yet.
"Never since World War II have we faced a situation like this," Washington Gov. Jay Inslee said when announcing new social distancing policies earlier this week. "For the next several weeks, normal is not in our game plan."
Correction: This article was updated to reflect that Neuzil is a past member of the CDC's Advisory Committee on Immunization Practices.
We look forward to applying our broad molecule-to-market services, including our ability to work with a multitude of delivery systems, execute under expedited timelines, and meet Vaxarts potential need for future scalability and large-scale capacity for commercial quantities, said Syed T. Husain, Emergents senior vice president and unit head for contract development and manufacturing.
Daily briefing: The five questions that scientists hunting a coronavirus vaccine must answer Nature.com
Hypothetical vaccine against COVID-19
A COVID-19 vaccine is a hypothetical vaccine against coronavirus disease 2019 (COVID-19). Although no vaccine has completed clinical trials, there are multiple attempts in progress to develop such a vaccine. In late February 2020, the World Health Organization (WHO) said it did not expect a vaccine against SARS-CoV-2, the causative virus, to become available in less than 18 months.[1] By early March 2020, some 30 vaccine candidates were in development.
Vaccines have been produced against several diseases caused by coronaviruses for animal use, including for infectious bronchitis virus in birds, canine coronavirus and feline coronavirus.[2]
Previous efforts to develop vaccines for viruses in the family Coronaviridae that affect humans have been aimed at severe acute respiratory syndrome coronavirus (SARS) and Middle East respiratory syndrome (MERS). Vaccines against SARS[3] and MERS[4] have been tested in non-human animal models. As of 2020, there is no cure or protective vaccine for SARS that has been shown to be both safe and effective in humans.[5][6] According to research papers published in 2005 and 2006, the identification and development of novel vaccines and medicines to treat SARS is a priority for governments and public health agencies around the world.[7][8][9]
There is also no proven vaccine against MERS.[10] When MERS became prevalent, it was believed that existing SARS research may provide a useful template for developing vaccines and therapeutics against a MERS-CoV infection.[5][11] As of March 2020, there was one (DNA based) MERS vaccine which completed phase I clinical trials in humans,[12] and three others in progress, all of which are viral vectored vaccines, two adenoviral-vectored (ChAdOx1-MERS, BVRS-GamVac), and one MVA-vectored (MVA-MERS-S).[13]
SARS-CoV-2 was identified on December 1, 2019 as the cause of what would later be named COVID-19.[14] A major outbreak spread around the world in 2020, leading to considerable investment and research activity to develop a vaccine.[14][15] Many organizations are using published genomes to develop possible vaccines against SARS-CoV-2.[14][16][17][18] About 35 companies and academic institutions are involved,[19] with three of them receiving support from the Coalition for Epidemic Preparedness Innovations (CEPI), including projects by the biotechnology companies Moderna,[20] and Inovio Pharmaceuticals, and the University of Queensland.[21] Some 300 clinical studies are in progress, as of March 2020.[22]
Social media posts have promoted a conspiracy theory claiming the virus behind COVID-19 was known and that a vaccine was already available. The patents cited by various social media posts reference existing patents for genetic sequences and vaccines for other strains of coronavirus such as the SARS coronavirus.[47][48]
This week, the first patients in a clinical trial for a potential COVID-19 vaccine were given shots, marking a key step in the global race to find a cure. Kaiser Permanente Washington Research Institute in Seattle developed a COVID-19 vaccine in record time and started administering the shots on Monday.
The first person to receive a dose of the potential vaccine was 43-year-old Jennifer Haller, an operations manager at a small tech company, according to The Associated Press. "We all feel so helpless. This is an amazing opportunity for me to do something," Haller said, adding that her two teenagers "think it's cool" that she's taking part in the study.
Ultimately, 45 volunteers, ages 18 to 55, will get two doses the vaccine over a span of about 6 weeks,according to the U.S. National Institutes of Health (NIH).
TheNational Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, is funding the trial. The vaccine is called mRNA-1273 and was developed by NIAID, and Moderna, Inc., a Cambridge, Massachusetts-based biotechnology company.
"Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority," NIAID Director Anthony Fauci said. "This Phase 1 study, launched in record speed, is an important first step toward achieving that goal."
Other potential COVID-19 vaccines are being developed around the world, including at the Walter Reed Army Institute of Research. On Monday's "CBS Evening News," David Martin spoke to doctors there to learn more about the potential cures.
Dr. Kayvon Modjarrad, a director at the Walter Reed Army Institute of Research, is testing a potential vaccine that would block the virus from attaching to a person's lung. "If it can't get into your lung cells, it can't cause the disease," Modjarrad said.
Still, the race for the coronavirus vaccine could take 12 to 18 months to run, Martin reports. So, Lieutenant Colonel Mara Kreishman-Deitrick is working on a drug that people who already have the disease can take.
"What we're aiming to develop here is an antiviral treatment that will kill the virus and actually cure them of the disease so they don't further spread it to the rest of the community," she told Martin.
Kreishman-Deitrick says an existing drug used against Ebola may work against the novel coronavirus as well. "It's ready for a clinical trial in humans and once those clinical trials show that it's affected then it will be available for wider use in humans," she said. It hasn't yet been proved effective but could be used as an emergency treatment.
COVID-19, the disease caused by the coronavirus, has killed at more than 90 people in the United States, according to Johns Hopkins Coronavirus Resource Center. Globally, the death toll is over 7,500, with the most aggressive outbreaks still spreading in Europe and Iran.
Dr. Caitlin Rivers, a senior scholar at the Johns Hopkins Center for Health Security, said Tuesday in a live webcast about the coronavirus pandemic that "in some respects we are just getting started in the United States."
