Weeks away from the results of ongoing US and China trials testing its experimental antiviral remdesivir, Gilead is going to trial the failed Ebola drug in a small group of coronavirus patients in England and Scotland. The United Kingdom is also home to a range of other therapeutic efforts, as the pandemic rages on across the globe.
On Tuesday, Southampton, UK-based startup Synairgen kicked off a mid-stage placebo-controlled study testing its experimental drug, SNG001 an inhaled formulation of interferon-beta-1a that has previously shown to be safe and effective in improving lung function in asthma patients with a respiratory viral infection in a pair of Phase II trials.
Interferons, a family of naturally occurring proteins secreted by the immune system, typically boost the bodys immune response to uninvited guests such as viruses, bacteria and cancer.
When weve collected cells from patients with COPD and asthma and older peoplewe find that their lung cells dont respond very well to viruses, CEO Richard Marsden said in an interview. We have also along the way always recognized that with an emerging virus, the drug could be used.
As Covid-19 started to gather steam in China, Synairgen tried to get things started, but to no avail. Italy was the next plan. We had some really good interaction there, said Marsden. But they went from, you know, just busy to very busy to extremely busy to unable-to-communicate busy.
Eventually, they decided their home ground the UK, where they have an ongoing COPD trial would be the best place to kick off a Covid-19 study. Initially, the pilot phase of the trial will have 100 patients (50 will get a placebo, and 50 will get SNG001). If all goes well, a pivotal study will be conducted.
This approach is one of many, as companies race to design and develop diagnostics, drugs and vaccines to stem the tide of the pandemic. (W)e need high quality clinical research to work out what is working, what isnt working; we believe placebo-controlled trials are the way to do that, Marsden said.
Last week, the UK government issued a statement confirming that the two decades-old malaria drugs: chloroquine and hydroxychloroquine, which have been touted as potential treatments for patients infected with the coronavirus, have not been sanctioned for use against the virus in the UK.
Although clinical trials are ongoing, no conclusions have been reached on the safety and effectiveness of these medicines, noted the Medicines and Healthcare products Regulatory Agency. In stark contrast, in the United States, the FDA on Sunday issued emergency authorization for the pair of drugs that President Donald Trump has repeatedly backed, on the basis of anecdotal reports.
In the UK, scientists at Oxford University are also looking at repurposing other drugs for use against Covid-19. Last week, researchers announced they would be testing lopinavir-ritonavir, approved used to treat HIV, and the steroid dexamethasone, in consenting adults that have tested positive for Covid-19 in NHS hospitals. The project, in which patients will either get one of the two drugs, or placebo in addition to standard-of-care treatment, has won 10.5 million in government funding.
The streamlined design of this clinical trial allows consenting patients to be enrolled in large numbers easily and without compromising patient safety or adding significantly to the workload of busy hospitals and their staff, said the trials deputy chief investigator Martin Landray, who also serves as a professor of medicine and epidemiology University of Oxford, in a statement.
Oxford researchers also have a vaccine candidate in place.
On January 10 long before the coronavirus infection was named Covid-19 or assumed pandemic proportions a team of Oxford researchers led by Professors Sarah Gilbert, Andrew Pollard, Adrian Hill and Dr. Sandy Douglas had begun their search for a vaccine. On March 18, they honed in on a candidate: a chimpanzee adenovirus vaccine vector (ChAdOx1).
Chimpanzee adenoviral vectors are well studied, having been used in vaccines targeting over 10 different diseases. The Oxford vaccine contains the genetic sequence of the surface spike protein found on SARS-CoV-2 the virus behind Covid-19 inside the ChAdOx1 construct. If the project is successful, vaccination with this product will produce the surface spike protein of the coronavirus, priming the immune system to attack the coronavirus if it later infects the body.
The researchers who have previously developed a vaccine for MERS that showed promise in early clinical trial said last week they would start screening people for a clinical trial, although the vaccine is still weeks away from being ready for human testing. The enrollment goal is to hit 510 volunteers, and work is being done to scale up manufacturing in haste.
About a two-hour drive away, researchers at the University of Cambridge also have a Covid-19 vaccine in the works.
Professor Jonathan Heeney, head of the laboratory of viral zoonotics and chief of spinoff company DIOSynVax, has spearheaded research, aided by computer modeling of the virus structure.
By putting the genetics of the virus under a microscope, the company has identified a key part of the genetic code that the virus uses to produce the essential part of its coat: the spikes, which is what the vaccine is engineered to target.
A vaccine strategy needs to be laser specific, targeting those domains of the virus structure that are absolutely critical for docking with a cell, while avoiding the parts that could make things worse, he said in a statement. Our technology does just that.
Preclinical trials are yet to be conducted, but he expects the vaccine candidate could be ready for human trials by June. Funding, however, is required.
We need a Big Pharma partner to help us scale up our activities, he said.
For a look at all Endpoints News coronavirus stories, check out our special news channel.
As the novel coronavirus continues to spread across the country, those who are not infected can protect themselves by avoiding close contact with others and aggressively washing their hands. But beyond this, many are desperately hoping for another form of protection: a vaccine.
Vaccines work by exposing our bodies to something that resembles a certain pathogen, training our immune systems to recognize, attack and kill the invader. When presented with the real pathogen itself, our immune armies are ready to fight.
While not a treatment or cure, vaccines can help eradicate a disease by starving the virus of people to infect and transmit the disease.
Vaccines are especially needed by health care workers on the front lines and other vulnerable members of the population who have a higher risk of contracting the infection.
While the race to develop a COVID-19 vaccine is well underway with over 40 hopeful candidates, only three have entered Phase I of clinical trials, the first of three stages of human testing before drug approval.
Phase I testing is only a test to see if the vaccine is safe. Researchers won't know if it's effective until Phase II is studied. Below is a brief overview of these three candidates, plus three promising ones that are still in earlier stages of development.
mRNA-1273: The front-runner in the U.S., which is backed by the NIAID and developed by Moderna Therapeutics, is based upon a specific type of genetic material, mRNA. This vaccine, mRNA-1273, codes for a specific protein on the novel coronavirus -- the spike protein the key into a human cell. An mRNA-based virus has never been approved for use in humans, but animal studies have been promising. This particular vaccine, however, was rushed to human trials before it was even tested in animals -- skipping a step in traditional vaccine development.
A Phase I trial testing the vaccines safety in 45 healthy adult volunteers began earlier this month at Kaiser Permanente Washington Health Research Institute in Seattle. The participants will receive two injections of low, medium or high doses of the vaccine and be monitored for any adverse events or immune response. The company is hopeful that it may have a vaccine as early as fall 2020 for some particularly vulnerable groups, such as health care workers. The Phase I safety study should be completed by June 2021.
Donna Schaferkotter, medical laboratory scientist at UMMC, analyzes samples during COVID-19 testing in Jackson, Miss., March 25, 2020, The Medical Center started in-house testing for the novel coronavirus using a commercially available kit and is developing additional ways to test for COVID-19.
Ad5-nCoV: The front-runner across the globe, Ad5-nCoV, was developed by the Beijing Institute of Biotech and CanSino Biologics, a Chinese biopharmaceutical company. This vaccine uses a viral vector, a virus that has been engineered to not contain its infectious properties and instead delivers genetic material to the recipient. Phase I testing of this vaccine is underway at Hubei Provincial Center for Disease Control and Prevention, where 108 healthy adult volunteers will receive one of three doses of the vaccine to assess for safety. Ad5-nCoV is perhaps the most promising because CanSino has already produced a nearly identical vaccine, Ad5-EBOV, to protect against Ebola. The Ebola vaccine has already entered Phase II testing, meaning its even further along. Still, the official anticipated completion date for Ad5-nCOV safety testing is December 2020, with all testing completed by 2022.
ChAdOx1: The University of Oxford is one of the most recent groups to bring its vaccine candidate into human studies -- a major milestone. The vaccine is simultaneously being tested for both safety (Phase I) and efficacy (Phase II) by injecting 510 healthy participants with either vaccine or placebo. This vaccine uses an inactivated (non-infectious) virus that contains genetic material for the key protein on the novel coronavirus, similar to Ad5-nCoV in China. This viral vector, however, was derived from chimpanzees which, the researchers argue, creates an even more robust response than other viruses to which humans may have already been exposed. This vaccine is being funded by the United Kingdom government and is moving quickly. Still, its anticipated completion date of this phase isnt until May 2021.
BNT162: Biopharmaceutical giant Pfizer, along with partner company BioNTech, is working on an mRNA-based vaccine that is similar to Modernas model. The duo was already working on an influenza vaccine using this scientific strategy so their vaccine candidate, BNT162, is moving particularly fast. Clinical trials are anticipated to begin in April in both the U.S. and Germany.
INO-4800: An entirely different technology is being developed by Inovio Pharmaceuticals, a company that uses a proprietary platform for activation immunotherapy. This vaccine delivers DNA, another genetic material, into a hosts cells by utilizing a hand-held smart device CELLECTRA. The DNA is translated into proteins that activate an individuals immune system to generate a targeted immune response. While that may sound like science fiction, the company has used the same technology to rapidly advance vaccines against MERS, a closely related coronavirus, and HPV-related cervical precancer, among others. None of these, however, have completed their trial phase and entered the market. Trials for the COVID-19 specific vaccine, INO-4800, are anticipated to begin in April.
Sanofi recombinant DNA vaccine (unnamed): Last month, Sanofi Pasteur announced that it was partnering with the U.S. Department of Health and Human Services to create a DNA-based vaccine. Their vaccine, which is yet to be named, relies on recombinant (engineered) DNA that encodes for proteins found on COVID-19 surface -- the same basic principle of many of the other candidates. The company had been previously working on a vaccine for SARS, a close relative of the novel coronavirus, which showed promise in animal models. More importantly, however, Sanofi has proved immensely successful in the vaccine market: they have influenza vaccines, including Flublok and Fluzone, that are widely in use today. They claim that their technique -- and their experience with mass production of their products -- would allow a COVID-19 vaccine to be introduced much more quickly than traditional production methods. Still, human trials are yet to begin but will likely start in April.
Chlo E. Nunneley, MD, is a pediatric resident physician at Boston Childrens Hospital & Boston Medical Center and a contributor to the ABC News Medical Unit.
A scientist works in a lab at Moderna in Cambridge, Mass., in February. Moderna has developed an experimental coronavirus medicine, but an approved treatment could be more than a year away. David L. Ryan/Boston Globe via Getty Images hide caption
A scientist works in a lab at Moderna in Cambridge, Mass., in February. Moderna has developed an experimental coronavirus medicine, but an approved treatment could be more than a year away.
The Department of Health and Human Services outlined how it will support Moderna and Johnson & Johnson as they develop vaccines against the novel coronavirus that's sickened more than 800,000 people worldwide as of Tuesday afternoon.
HHS's Biomedical Advanced Research and Development Authority, BARDA, said Monday that it will help speed up clinical trials for both companies' experimental vaccines, and support Janssen Pharmaceuticals, a unit of Johnson & Johnson, in making up to 300 million doses annually in the U.S.
"Vaccines are essential to saving lives," BARDA director Rick Bright said in a statement. "Delivering a safe and effective vaccine for a rapidly spreading disease like COVID-19 requires accelerated action with parallel development streams. The rapid progress we are making with industry partners clearly demonstrates a commitment to protecting people at home and abroad."
The Janssen vaccine clinical trials are expected to begin "no later than" this fall, according to the HHS announcement, which also said the goal is to get a COVID-19 vaccine ready for emergency use in the U.S. in early 2021.
Meanwhile, the company will begin preparation for large-scale vaccine production Wednesday, Janssen spokeswoman Katie Buckley wrote in an email. The company would be able to make 600 million vaccine doses by the end of 2020, with 300 million manufactured in the U.S., she wrote. "We are however investing in new production facilities to increase that number."
If Janssen's vaccine is proven safe and effective, the company will also make it available "in China and other parts of the world," said a statement by Paul Stoffels, chief scientific officer at Johnson & Johnson.
Moderna's early vaccine trials are already underway with help from the National Institutes of Health. BARDA will support phase 2 and 3 clinical trials, which typically involve hundreds or thousands of patients.
"Given the pandemic, Moderna has already started to prepare for the rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and of expected benefit," the company said in a statement. "Moderna is engaged in discussions for outside funding, including with BARDA, of such activities and will continue to work with government, industry and other third parties to responsibly and rapidly move forward."
HHS declined to share specific dollar figures with NPR, but Johnson & Johnson said that the company and BARDA would together contribute $1 billion toward its COVID-19 vaccine efforts.
A Moderna spokesperson didn't respond in time for publication to a question about how much money BARDA was committing toward the company's vaccine development.
When the late Bob Simon interviewed Gary Kobinger for 60 Minutes in 2015, Kobinger was working principally in a space suit in a special clean room behind bulletproof glass. At the time, he was a top virologist at Canadas National Microbiology Lab, where he became a critical player in the development of the early Ebola vaccine ZMapp. Now hes the director of the Infectious Disease Research Center at the Universit Laval in Quebec City, his hometown. His lab helped with the early development of Inovio Pharmaceuticals Zika vaccine in 2017.
Today, Kobinger is among hundreds of scientists worldwide working on potential Covid-19 vaccines; he is working with Inovio and Medicago, another drug company. WIRED talked with Kobinger by phone last week. The conversation has been condensed and edited.
WIRED: You've been watching and helping with epidemics your entire career. How does Covid-19 compare to, say, the Ebola epidemic?
GARY KOBINGER: Well, it's on a global scale of course, so its more widespread than Ebola. But its also important to remember that this virus has a less than 5 percent fatality rate, versus 80 percent for Ebola before vaccines. [There were 28,652 Ebola cases during the 2014-2016 outbreak in West Africa and 11,310 deaths, according to the Centers for Disease Control and Prevention. There are more than 775,000 Covid-19 cases, according to Johns Hopkins University. It has killed more than 37,000 people.]
But pandemics are so similar in the way societies respond. I went to many different countries in Africa because of Ebola outbreaks. And often we were accused of being the ones bringing in the virus and infecting the population. We have the same thing today, where countries are saying its the Army or a secret Defense Department plan or whatever to export the virus.
Read all of our coronavirus coverage here.
We also see the same delays. Theres this natural optimism of societies, where you think the virus isnt going to come here, and you end up facing exactly the same last-minute urgent needs for things like PPEs [personal protective equipment like masks and gowns]. China had problems with PPEs in mid-January. So you could argue that we should have planned for that. Instead we are scrambling as if we never saw it coming.
The difference this time is, because Covid-19 is affecting so many countries, you see a lot more sense of urgency to develop countermeasuresvaccines, treatments, better supportive care like ventilators. Compare that to being in the middle of the tropical forest in Africa, like we were with Ebola. We would have liked to have had all that fancy equipment. But people were not that interested in what we were doing. With Covid-19, Ive had all levels of the Canadian government coming to me, saying, Gary, if you need anything, please let us know. We are here to help. I've never had that kind of support in my career.
There are dozens of labs worldwide working on a Covid-19 vaccine, including yours. Is that a good thing, or should we be coordinating and focusing that effort more to maybe get a vaccine faster?
Its a good thing. Its actually important to test a lot of vaccines. We dont want to put all our eggs into one basket, only to have that one vaccine fall short in clinical trials. If we could have five vaccines that are safe and work and are potent, that would be much better. It also reduces the chances for manufacturing bottlenecks. With five vaccines, maybe we could manufacture enough for everybody on the planet. But with only one manufacturer, I dont think it will be possible.
But it needs to be done the right way. If you develop a vaccine thats not powerful enough to counter the virus, it can actually make the infection harder to treat. What you could see are people becoming more susceptible to acquiring the infection and maybe more susceptible to severe disease. That's something to really watch out for.
"Its actually important to test a lot of vaccines."
Gary Kobinger, virus researcher
Whats clear is that the development is going to be expensive. If we had done this work ahead of time, we could have done it for $500 million to $800 million. Now we're spending billions of dollars because we're rushing, in an emergency. When the virus was first emerging in China, I said this has the potential to show our level of preparedness. We will probably realize we are not very ready for this kind of event.
Is there any way to speed the development, which is expected to take at least 18 months? Thats a long time.
Yes. With some government and regulatory coordination, we can be faster than 12 months rolling out a vaccinenot for the planet, but maybe for target populations like health care workers. You could also target vulnerable populations like the elderly or those with co-morbidities by doing risk analysis for each of those populations. The track we are on nowwith a vaccine that needs to work for everybody with no side effectsis slower. We'll see. With Ebola in West Africa, we saw things happenpeople working together, work that got donethat were unprecedented. I hope we are in another of those moments.
What about therapies? If we made Covid-19 less lethal, that could do almost as much as a vaccine and provide relief much faster.
You need bothdevelop therapies and vaccines. Therapies are important, but you have to be reasonable with your expectations. You have to be very careful about creating false hope with therapies. On one hand, if you dont have a randomized trial, its hard to make any claim about their effectiveness. At the same time, its important to listen to health care workers who are using those drugs on the front lines. They have a very good sense of what may be worth pursuing and not pursuing in trials, even if they are not using it in a randomized trial. So with drugs like chloroquine and azithromycin that are already approved, lets put them in the clinic as soon as possible, and at same time design the best clinical study you can.
"It will get worse before it gets better, but a lot of the control measures are working."
Gary Kobinger, virus researcher
But the ultimate goal is to find a vaccine that keeps people from getting the virus at all. Sometimes patients who get it are left with lung damage that's not repairable. And even if the virus recedes, it could come back worse later. In 1918 the Spanish flu in the spring was a very mild wave, and then it came back with a vengeance in the fall.
The race is on as a number of companies around the globe are fighting for the chance to be first to develop a COVID-19 vaccine.
The World Health Organization has announced that while the search for treatments of COVID-19 continues, even some of the more draconian containment initiatives have only slowed the spread of the virus. Thats why companies are working around the clock to create a vaccine before, as some worry, the virus mutates again.
Financialnewsmedia.com reports:
According to The Guardian, about 35 companies and academic institutions are racing to create such a vaccine, and Human trials will begin imminently but even if they go well and a cure is found, there are many barriers before global immunization is feasible. This unprecedented speed is thanks in large part to early Chinese efforts to sequence the genetic material of the virus.Chinashared that sequence in early January, allowing research groups around the world to grow the live virus and study how it invades human cells and makes people sick.
Active healthcare stocks in news today include: BioSig Technologies, Inc.(NASDAQ:BSGM),Gilead Sciences, Inc. (NASDAQ:GILD), CytoDyn Inc.(OTCQB:CYDY), Novavax, Inc. (NASDAQ:NVAX),Roche Holding AG(OTCQX:RHHBY).
Clinical trials, an essential precursor to regulatory approval, usually take place in three phases. The first, involving a few dozen healthy volunteers, tests the vaccine for safety, monitoring for adverse effects. The second, involving several hundred people, usually in a part of the world affected by the disease, looks at how effective the vaccine is, and the third does the same in several thousand people. But theres a high level of attrition as experimental vaccines pass through these phases. Not all horses that leave the starting gate will finish the race, saysBruce Gellin, who runs the global immunization program for theWashington DC-based nonprofit, theSabin Vaccine Institute.
The Guardian also reported:
Though nobody could have predicted that the next infectious disease to threaten the globe would be caused by a coronavirus flu is generally considered to pose the greatest pandemic risk vaccinologists had hedged their bets by working on prototype pathogens. The speed with which we have [produced these candidates] builds very much on the investment in understanding how to develop vaccines for other coronaviruses, saysRichard Hatchett, CEO of theOslo-based nonprofit theCoalition for Epidemic Preparedness Innovations(Cepi), which is leading efforts to finance and coordinate Covid-19 vaccine development.
According to a news release, CytoDyn Inc.recently announced that an additional three critically ill COVID-19 patients have been treated with leronlimab. These additional patients increase the total to 10 patients receiving leronlimab treatment under an Emergency Investigational New Drug (EIND) granted by the U.S. Food and Drug Administration (FDA).
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Researchers at the University of Alabama at Birmingham are working on a potential COVID-19 vaccine. What they're working on is a nasal spray vaccine, and right now, they tell our news partners at AL.com they're testing its effectiveness on mice.
It's a collaboration between UAB and Altimmune, a biopharmaceutical company based in Maryland. According to UAB, first, they will test the vaccine in mice to investigate the immune responses. This will happen at UAB. Later this year, Altimmune plans to start human trials.
According to UAB, the vaccine is called Adcovid and is a single-dose vaccine that is delivered by an intranasal spray. This vaccine is based off other nasal spray vaccines that Altimmune has developed, like the vaccine candidate for the flu.
Experts say that six labs at UAB will be used to work on this collaboration. Testing and collecting the data is their highest priority so that Altimune can move on to the next step in the trial.
Two coronavirus vaccine candidates are in the clinics and 42 more are in preclinical studies, according to updated data provided by the World Health Organization onMarch 20.
Three biopharma companies issued updates Monday on their developmental efforts for vaccines to combat the deadly virus, which has so far killed more than 35,000 people and infected about 735,000 more, according to Johns Hopkins University.
IMV On Track For Summer Start
Canadian pharma Imv Inc (NASDAQ: IMV), which announced March 18 its intention to develop a DPX-based vaccine candidate for the new coronavirus, said it has initiated discussions with Health Canada to prepare for a clinical trial application.
Using the genomic and proteomic sequences of the novel coronavirus, the company said it identified several hundred epitopes and shortlisted 23based on their biological relevance to the virus and potential to generate neutralizing antibodies.
IMV said it has begun manufacturing peptide candidates targeting these epitopes, and said it is in talks with suppliers and contract manufacturers to prepare for the cGMP batch required to support a clinical study.
The company has finalized the design of aplanned Phase 1 study in 48 healthy subjects and identified clinical sites in Nova Scotia and Quebec, according to a press release.
IMV said it is scheduled to meet with regulators in the week of April 20, with a goal of beginning clinical testing in summer 2020. It also said it has submitted several grant applications in Canada to help support the program.
"We remain committed to serving the unmet needs of patients, both through our efforts to potentially develop a prophylactic vaccine to curb this novel coronavirus and across our ongoing clinical studies with DPX-Survivac in advanced-stage cancer patients," CEO Frederic Ors said in a statement.
See also: Novavax Shares Rally On Flu Vaccine Study Results: What You Need To Know
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Altimmune To Work With University of Alabama On Intranasal Vaccine
Altimmune Inc (NASDAQ: ALT) said it has launched a collaboration with the University of Alabama at Birmingham for developing a single-dose, intranasal COVID-19 vaccine, AdCOVID.
The company said it is preparing for immunogenicity studies and manufacturing of Phase 1 trial material. Altimmune said it will work with universityinvestigators on preclinical animal studies and characterization of vaccine immunogenicity. The company is planning a Phase 1 study in the third quarter.
J&J Plans Clinical Testing By September, Commits Over $1B In Funding
Johnson & Johnson (NYSE: JNJ) said it has selected a lead COVID-19 vaccine candidate from constructs it has been working on since January.
The company said that, through a new partnership with the BARDA, it has committed more than $1 billion to co-fund vaccine research, development and clinical testing.
Separately, the company and BARDA have provided additional funding to enable expansion of their ongoing work to identify potential treatments for the virus.
Additionally, J&J said it is expanding its global manufacturing capacity to assist in the rapid production of a vaccine and supply of more than 1 billion doses of a safe and effective vaccine globally.
J&Jsaid it is "committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use."
J&J expects to initiate human clinical studies at the latest by September 2020 and make available the first batch of a vaccine for emergency use authorization in early 2021.
At the time of publication Monday:
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2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
What do scientists understand about the COVID-19 virus?
The current pandemic is caused by a virus that is called SARS-CoV-2; SARS-CoV-2 is a coronavirus. The disease caused by SARS-CoV-2 is called COVID-19. The structure of the virus and sequence are well understood, and we believe that we have a good understanding of the protective immunity required to prevent COVID-19 and how a vaccine should be designed. Multiple vaccine approaches are currently being advanced into the clinic.
What has thus far been discovered since the outbreak?
We now know much more about the disease caused by this illness. Many of the basic scientific tools used to study the virus, like strains that grow well in cell culture, specific antibodies against the virus, and animal models of the infection are being developed. However, there is still much to learn.
Is this a deadlier strain that the flu?
The answer to this question is complex, and the final answer remains uncertain. The following statistics provide some perspective. During this flu season, as of March 21, 2020, the CDC estimates that influenza has killed 24,000-62,000 Americans, including 155 children (https://www.cdc.gov/flu/about/burden/preliminary-in-season-estimates.htm). As of March 28, 2020, the CDC estimates that COVID-19 has killed 1,668 Americans (https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html). Childhood deaths due to COVID-19 have been very rare.
However, this comparison does not tell the whole story. First, the northern hemisphere flu season is currently winding down, while COVID-19 is in a period of exponential spread, and we dont know how many Americans will be infected and killed by COVID-19 before the virus that causes the disease is contained. Second, among the elderly who have become sick enough to have been tested, the mortality rate can be high 10-27% in those 85 years of age or older and 3-11% in those 65-84 years of age (MMWR 69:343-346). The big limitation of such case fatality rate estimates for COVID-19 is that, based on the data we have seen thus far, there are probably many people who have been infected by the virus but have not become sick enough to be tested. This means that the true case fatality rate may be much lower than the current estimates.
Indeed, this comparison does not take into account the fatality rates for more deadly strains of flu, which sometimes arise. As high as the reported COVID-19 case fatality rates are among the elderly, they pale compared to the case fatality rates reported for people of all ages who become infected with the most deadly strains of flu, such as highly pathogenic H5N1, which kills ~60% of those who become sick enough to be tested. Fortunately, such very deadly flu strains rarely infect humans and we have never seen sustained transmission between humans. Nevertheless, preparedness for a highly pathogenic influenza pandemic should be a high priority to avoid an event that could make the current situation seem tame by comparison.
What is Pfizer doing to research/find a vaccine for the virus? Is it part of the international team of scientists working on the issue? What kind of collaborations do they have going?
We are working with our partner BioNTech on developing its vaccine candidates which are based on BioNTechs mRNA platforms. mRNA vaccines are a new approach to immunization that have the advantage that a vaccine candidate can be developed quickly for clinical testing. Based on our knowledge of other coronaviruses that have caused outbreaks like those that caused SARS and MERS, and the efforts to develop vaccines against those coronavirus diseases by the scientific community, we have a good idea how to develop a vaccine to prevent COVID-19. We are working to advance multiple mRNA candidates into the clinic in the next month, first in Germany, followed soon thereafter in the US. In addition to BioNTech, we are connected to a large number of institutions with years long experience in the coronavirus field. Some of these centers have specialized assays and models to measure vaccine candidate responses in animals and humans that we would hope to access if helpful to advance this important effort. Given this pandemic and the health care crisis caused by it, we see unprecedented private and public partnerships and collaborations, which include private companies helping each other to advance potential solutions to address COVID-19.
How difficult is it to find a vaccine for a new virus. Compare to former cases. Is it possible that a virus is unresponsive to a vaccine?
Whether or not a new virus is vaccine preventable depends on the virus. In general, though many viruses are amenable to vaccine development, others have eluded scientific efforts. For example, a vaccine has not been developed to prevent HIV despite decades long vaccine development efforts. Some viruses, like rhinoviruses (a cause of the common cold), have too many variants that cause disease to make vaccine development practical. That said, new scientific discoveries can make it possible to develop vaccines against viruses that previously eluded control by immunization. A great example is respiratory syncytial virus (RSV the leading cause of severe respiratory infections in infants). This virus has eluded vaccine development efforts since the 1960s. However, new scientific discoveries, have supported development of a vaccine candidate by Pfizer that is now in clinical trials.
In lieu of a vaccine, are there any drugs now, or being researched to deal with COVID-19?
Yes, we are aware of numerous potential approaches to address the disease COVID-19, including antibody therapy (both monoclonal and plasma derived), antiviral drugs, and treatments that temper the destructive immune responses in patients that are, at least in part, responsible for the severity of COVID-19.
What does it look like in the research lab right now: have they ramped up shifts, are they working around the clock, how has life inside their labs changed since the outbreak?
Researchers across the globe are working 24/7 to try to find solutions to stem the spread of SARs-CoV-2. Because there was just a few months between the first report of the disease to a full blown global pandemic, multiple parallel approaches are being pursued. Needless to say, this is stressful for researchers and, even more so for the medical professionals treating these patients. In addition, because of the pandemic, movement of people is restricted, which makes remote communications more critical than ever. Researcher who have to go into laboratories or health care providers who must work in hospital settings are under constant fear of contracting the disease themselves. For example, in Pfizerjs Pearl River laboratories, we are maintaining rigorous precautions, including social distancing required in the workplace, to keep our colleagues as safe as possible. Despite these challenges, there is optimism and an incredible sense of urgency both in private and public settings to do all that is possible to solve this public health crisis. Pfizer colleagues, together with our partners are working tirelessly on solutions.
How is the COVID-19 pandemic the same/different from other pandemics in the last two decades.
The most recent pandemic before the COVID-19 pandemic was the 2009 H1N1 pandemic. The CDC estimates that, in the United States between April 2009 and February 13, 2010, H1N1 pandemic flu infected about 59 million Americans and killed about 12,000 (https://www.cdc.gov/H1N1flu/estimates/April_February_13.htm). Although these numbers are far higher than the current number of infections and deaths from COVID-19, the current pandemic is still in its early stages, and the comparison could look very different a few months from now. One other difference is that the current pandemic seems to affect the elderly more than other populations, although younger people do become sick and sometimes die. The 2009 pandemic was less severe than expected among the elderly, who may have had immunity from infections by related influenza strains that circulated early in the 20th century, but was especially deadly for pregnant women.
The two previous recent outbreaks of severe coronavirus disease, SARS (starting in 2003) and MERS (starting in 2012), never became pandemics. SARS was contained completely. MERS has been reduced to a low level in the Middle East, with no more sustained human to human transmission but occasional isolated human infections or clusters of infection following re-introductions of the virus from a reservoir in camels.
Dr. Phil Dormitzer, Vice President and Chief Scientific Officer for Viral Vaccines based at Pearl River
We know that you are working hard to stay safeand healthy, take care of your families, meet the needs of the individuals you serve, and find creative ways to connect from a distance.ASHA members and volunteers safety is our top priority, and were here to help you during this uncertain time. Check for thelatest updates and resources, including ontelepractice.
Please contact the Action Center (800-498-2071 oractioncenter@asha.org) with any questions.
COVID-19 Oklahoma Test ResultsPositive (In-State)565Positive (Out-of-State)2Negative*1229Hospitalized177Deaths23
*Negative testing results are only from the State Public Health Laboratory and do not include private laboratory negative results.
* Community spreadis defined as thespreadof an illness for which the source ofinfection is unknown. For purposes of our COVID-19 reporting, we are highlightingthe counties that contain a positive case.
Counties highlighted in yellow on the map above indicate a death in that county.
Data Source: Acute Disease Service, Oklahoma State Department of Health.*As of 2020-03-31 at 7:00 AM.
