TYLER, Texas With restaurants, movie theaters and now salons reopening, people are starting to wonder what life is going to be like after we've developed a vaccine for COVID-19.
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The phrase "new normal" is constantly getting tossed around, but how "new" will life be after social distancing be?
"I think it's contingent on whether the new normal includes having a virus that we're concerned about because if we don't, I bet the new normal is pretty much the old normal," said Tom Guderjan, chairman of the Social Sciences department at the University of Texas at Tyler.
Also an anthropologist, Guderjan says throughout history, humans have had to be isolated for one reason or another and respond the same way after that period of isolation is over.
"I have friends and loved ones who I speak with, I email with, I text with and I want to hug them and say 'Good to see you're okay,'" said Guderjan. "I think that, that need is going to be very much played out by by all of us. We all have friends and family that we're not seeing."
RELATED: Start of May brings reopenings from coronavirus around the world
However medical experts say not everything will return to the way it was.
Dr. Scott Smith, Senior Vice President at CHRISTUS Health Clinic says there will be several safety measures that we all should keep doing.
"I think the new normal will include being more attuned to hand washing and personal hygiene when you're out in public places, airplanes, stadiums, restaurants, all of that," Dr. Smith said.
Smith says though he thinks it is fine for everyone to be back out and about during this time, it is important that we continue to wear masks in public and keep up with social distancing guidelines.
"The new normal is still not yet known but we're learning," Dr. Smith explained. "As we're learning, we're learning that we do need to be safer when we're out and about by paying attention to what we touch using good hand hygiene and social distancing."
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As Colorado slogs into its third month of the coronavirus pandemic, there is new hope around the globe that somebody, somewhere is getting close to developing a vaccine that would make this interminable misery actually terminable.
Multiple vaccine candidates have launched into human trials in the last couple of weeks the most recent being a trial by the drugmaker Pfizer, which on Monday started poking needles into healthy volunteers in New York and Maryland. The White House has picked 14 vaccine candidates for a project it has dubbed Operation Warp Speed, a name that encapsulates the gonzo-scientific, just-crazy-enough-to-work pace at which vaccine development is taking place.
The latest from the coronavirus outbreak in Colorado:
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But, as this research charges furiously ahead, there is also growing skepticism that its going to end well or, at least, soon. Humankind has never successfully produced a vaccine against any type of coronavirus, much less a brand new coronavirus variant. Previous efforts have been shown to cause harm in their test subjects or lost their funding when the virus they were targeting abated.
The reality is that the majority of vaccines will fail, said Dr. Gregg Dean, a veterinarian and professor at Colorado State University who studies viruses. So its really important that we have as many groups as we do with all their different ideas and hopefully one or a couple of different groups will get it right.
Scientists in Deans lab are among at least four teams in Colorado currently working on developing a vaccine against COVID-19, the disease caused by the coronavirus. (The virus, itself, is known scientifically as SARS-CoV-2.) In the handful of weeks that they have all been hard at work on the challenge, heres what theyve learned:
There are at least 115 COVID-19 vaccine candidates in development across the world right now.
They all attempt to do the same thing induce the bodys immune system to produce antibodies that can fight off an infection by the coronavirus. But they have different methods for what goes into a dose of vaccine. Some deaden the real-deal virus; some synthesize just a bit of that virus; and some hijack other viruses.
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Typically, the researchers arent starting from scratch. They have been working in vaccine development for years and have quickly pivoted their existing methods to create a vaccine for the coronavirus.
In Colorado, each of the four teams is trying a different approach:
MacNeill said its important to have many different options in vaccine development. Some might work better for some people than others. There are manufacturing, transportation, storage and price concerns to think about.
I think of it all as being complementary to each other, she said. I hope that one of the ones thats really advanced will be the one that helps everybody and makes it go away. But chances are it will be helpful to have multiple vaccine platforms available.
All of the research teams working in Colorado right now agree on something: They probably wont be the first to develop a vaccine ready for widespread use. And, they also agree, thats not a bad thing.
This isnt an arms race, Price said.
Quite often in vaccine development, the frontrunners arent the most ideal. For instance, they may require one or more booster doses. They may need to be refined to create a stronger immune response. And, in the meantime, its important for researchers to understand the vaccines effects.
Let Dean introduce you here to the concept of antibody-dependent enhancement. Sometimes, Dean said, a vaccine can induce the body to produce antibodies that actually help the virus gain entry into human cells.
If you think of a lock-and-key metaphor, viruses contain keys that allow them to unlock human cells. Antibodies grab hold of those keys and block them. But what if another part of that antibody is itself a key that can unlock a cell? Its been a persistent problem in work to develop a vaccine for feline coronavirus, he said.
Its a normal part of the immune system, he said. But in this case, the virus can take advantage of that and use it to sneak into those cells using a different receptor.
So, taking this measured approach, all of the Colorado research teams are still relatively early in the development timeline.
Goodrichs team, which includes veteran infectious disease researcher Dr. Richard Bowen, is about halfway through a 10-week test of its candidate in hamsters. Dean and MacNeill are working to construct their vaccine candidates before moving into tests in animals.
Greffex is the furthest along, with Price saying that his team is about eight to 10 weeks away from entering clinical trials with a target date of completing its work by the end of the year. But Price reiterated the first across the finish line isnt the prize here.
It doesnt matter, he said. Get them all successful and make sure you know how to manufacture them.
Even if the Colorado vaccines arent first heck, even if they turn out not to work each of the research teams say there is still value in the work.
Theres still a lot we dont know about the coronavirus and how the immune system responds to it. That makes every study and every vaccine project currently underway valuable, Goodrich said.
If the problem gets solved before we get to the finish line and I hope it does all of the knowledge that were gaining, all of the experience were gaining is going to be useful when another pandemic arrives, he said. Maybe that knowledge will help us not only respond to the next pandemic but will help us prevent the next pandemic from occurring.
MacNeill said the research being done by one team will help inform the work of other teams. Vaccines could eventually be combined in a single dose to enhance efficacy. And its not just humans who could benefit from a vaccine with evidence growing that some animals can also be infected by SARS-CoV-2.
Maybe my vaccine will never go into people but it will be the one that gets all cats vaccinated, she said.
So, to the big question: Can we actually develop a successful vaccine for COVID-19? Every one of the Colorado researchers says yes.
I honestly believe were still on target, Price said of his companys candidate.
Dean talked about the massive coming together of the scientific community to focus on this one virus. Literally all of the worlds best minds in medicine and biology are currently working on vaccines or treatments to stop the pandemic.
What I see is that scientists are doing everything they can to work together and quickly share information, he said.
Goodrich pointed to promising results from a team at Oxford University that inoculated a half dozen rhesus macaques with their vaccine candidate and then bombarded the monkeys with live coronavirus to no avail.
And MacNeill noted promising research recently published on vaccines for MERS, a respiratory disease caused by a different coronavirus. Somebodys going to figure this out, she said. This is within human capability.
I think that we can get it done and I think we can get it done much more quickly because of what we know from similar coronaviruses, she said. I think, with what we know about the biology of the virus and how it gets into cells, we should be able to stop that.
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Coronavirus vaccine likely by Sept-Oct: Indias role in COVID-19 fight and how to prevent a second wave | Photo Credit: iStock Images
New Delhi: The COVID-19 caused by the novel coronavirus has been rapidly spreading across the world, claiming thousands of lives. Yet, no specific antiviral drug or vaccine is currently available due to the novelty of the virus now called the SARS-CoV-2. Raising hopes of a cure for the dreaded respiratory disease, a team of Italian scientists on Wednesday claimed that it has successfully developed the worlds first COVID-19 vaccine that can neutralise the coronavirus.
Perhaps, its not just Italy, but other countries such as Israel, the US and the UK are claiming to have discovered vaccines and crucial drugs that can help treat COVID-19. More than 100 vaccines are currently being tested across the world as scientists speed up the race for coronavirus disease cure. In an Exclusive Interview with Times Now Digital, Dr Inder Maurya, Consultant -Emergency Medicine - CEO and Founder, Foreign OPD, discussed Indias role in coronavirus vaccine and how countries can help prevent or tackle a second wave of an outbreak among many others.
Below are excerpts from the Interview.
Will we have a vaccine for COVID-19 by September/October this year?
Dr Inder Maurya: Yes. Italy and Israel are already at the forefront of it. The vaccine is already in phase 3 trials and is being tested in humans. Having said that, the world has got together to defeat coronavirus. We are at the peak of science and technology. We have a high-end AI and its system which can help accelerate the process and were not available a decade before. Hence, I have a firm belief that we would see a fully functional vaccine by then.
Why are so many vaccines being tested/developed for COVID-19?
Dr Inder Maurya: Well, desperate time, desperate measures. Multicentric multinational clinical trials are going on as the world unites to fight covid war together. Oxford has already started the largest clinical trial in Europe with more than 800 volunteers participating in the trials. Australia too has finished with successful animal trials and has begun human trials.
How do scientists measure how well a vaccine will work?
Dr Inder Maurya: Vaccine works on the principle of immunology. When we suffer some infection, say SARS-CoV-2, the immune system release antibodies (IGM) against this virus. They (antibodies) fight off the infection. And once the infections get defeated, the body memory cells get stimulated and protective antibodies (IGG) are stored. So next time, when the virus (SARS- CoV-2) infects, these protective antibodies will immediately rise and destroy the infection. This is the whole principle behind the vaccine as well. We inject sufficient antigen (attenuated) to elicit an immune response but not cause infection, thereby helping the body forms protective antibodies.
Will the COVID crisis end if a vaccine is found?
Dr Inder Maurya: It depends, if the virus undergoes genetic mutations then we would have to develop a new vaccine for that strain. But not to worry, since in case of influenza A (swine flu) we are every year injecting new vaccine depending upon the new viral strain.
What are Indian drugmakers doing in the fight against coronavirus disease? Please elaborate Indias role in COVID-19 vaccine research and treatment.
Dr Inder Maurya: India has been at the forefront in fighting the COVID war. But you do realise that you need more government funding towards healthcare research - we contributed less than 1% of GDP to the healthcare segment. After the Narendra Modis government came to power, we started concentrating more on healthcare research. Newer guidelines were framed, the number of PhD students increased, more funds are allocated to research, etc. International collaborations are being done at top Israeli and American institutes.
A top Indian pharmaceutical company has recently sought ICMRs nod for the clinical trial of pegylated interferons alfa 2b against coronavirus disease. The antiviral drug is used in Hepatitis B and C Rx.
Research has warned that the COVID-19 is likely to last 2 years and return with a vengeance. Do you think will there be a second wave of coronavirus? How do we stop or tackle a second outbreak?
Dr Inder Maurya: Yes, there will be a second wave, perhaps, thats how a pandemic works. However, the severity will be much lesser. Since by then we shall be very well equipped to handle the second wave with drugs like remedisivir showing promising results. Also, we might have a vaccine by then.
However, people must adhere to the guidelines such as - social distancing, wearing masks, regularly washing hands, or using hand sanitiser, effective communication strategies, etc.
Mass awareness about the prevention of the COVID-19 will go a long way in preventing the spread of the killer SARS-CoV- 2 virus.
The views expressed by the author are personal and do not in any way represent those of Times Network.
A new study has sparked fears that the coronavirus has mutated to become more contagious, but experts say there is no evidence these changes make it any more dangerous or transmissible than it already is.
"Viruses mutate all the time, [and] most mutations have no significance even if they spread," said Adriana Heguy, director of the Genome Technology Center at New York University, who was not involved with the research.
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The study was posted on the preprint server bioRxiv on April 30. Preprints are studies that have not undergone the rigorous peer-review process required for publication in medical or scientific journals. In the rush to share new research on COVID-19, many scientists have been sharing their work online before undergoing the full review process.
The authors, who included researchers from the Los Alamos National Laboratory in New Mexico, analyzed the genetic sequences of samples of the virus gathered worldwide, zeroing in on a mutation called D614G.
"We were concerned that if the D614G mutation can increase transmissibility," the study authors wrote, "it might also impact severity of disease."
The corresponding author at the Los Alamos National Laboratory did not respond to an interview request from NBC News.
The hypothesis is concerning for a virus that has already infected millions and is responsible for more than 260,000 deaths worldwide.
But outside experts were quick to point out that changes in viruses especially coronaviruses are common, and may mean nothing at all.
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Dr. Gregory Poland, director of the Mayo Clinic's Vaccine Research Group in Rochester, Minnesota, explained viral mutations using the analogy of an automobile.
"If the mutation takes out your carburetor, the car can no longer operate," Poland said. "On the other hand, if the mutation changes one spark plug, the car can still operate."
What's unclear is whether the D614G mutation slows or speeds the viral "car" or, in fact, does nothing.
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Heguy said the D614G mutation had already been identified in viral sequences from around the globe, particularly in Europe.
The researchers "used that for their model to see if there was an indication that this particular mutation ... would make it more transmissible. According to their model, it is possible," Heguy said. "Having said that, it is only a model."
That is, models only reflect what could possibly happen in the future. Scientists have not found the virus has evolved to become any more dangerous or deadly in people.
Mutations are common in viruses, but the coronavirus "so far has been pretty darn stable with little mutations around the edges," Dr. William Schaffner, an infectious diseases expert at the Vanderbilt University Medical Center in Nashville, said.
"That's what these investigators are looking at," Schaffner said. "They're trying to determine whether these little mutations have implications for how well it's transmitted." But, there is "no evidence that this is happening that I can see clinically," he added.
Dr. Robert Gallo, the co-founder and director of the Institute of Human Virology at the University of Maryland School of Medicine, said "the paper, I believe, is a strong paper by a quality group."
But, he said, "no conclusions can be made about biology or functionality" of the virus based on this study.
While the research may not be reflective of any impact on patients, scientists say it's still incredibly useful as a way to track how the virus acts over time.
Poland noted that experts tracking the virus through its genetic sequencing have found that while it is changing, it's not doing so very quickly.
"Unlike influenza, this virus accumulates mutations more slowly, which is a good thing," he said. "It gives us time to track it and to understand what's happening."
Rapidly mutating viruses make it more difficult for researchers to develop vaccines. Flu vaccines, for example, are notoriously difficult to get right because the various strains of influenza have a tendency to change and mutate quickly.
If this virus were to follow suit, it might mean trouble for ongoing COVID-19 vaccine research.
"It's possible that you'll get vaccines early enough and quick enough to prevent [a person's] first infection with the coronavirus," Gallo said. "We may look like heroes that stop this early on."
But, if the virus mutates too much, and the vaccine proves to be a poor match to future strains of the coronavirus, "we may be chasing our tail like with influenza. And that's not a bright prospect with a virus that is already so infectious."
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Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY."
Tonya Bauer and Judy Silverman contributed.
In 2016, Dr Peter Hotez and his team were working on a coronavirus vaccine in Texas. The next step would have been to begin trials on people. Instead, he had to pull the plug due to a lack of interest and funds.
In March this year Hotez, the co-director of the Center for Vaccine Development at Texas Children's Hospital and Dean of the National School of Tropical Medicine in Houston, testified before the US House Committee on Science.
His team's vaccine had been created in response to the SARS outbreak over a decade earlier.
"We had the vaccine ready to go," Hotez told the committee. "But by then nobody was interested in a coronavirus vaccine."
Twenty years have passed since the outbreak of SARS, yet the pharmaceutical industries haven't considered infectious diseases a matter of priority because they are not as profitable as chronic diseases, Massimo Florio, professor of public economics at the University of Milan, told Euronews.
Analysis by Bloomberg intelligence has shown that the world's 20 largest pharmaceutical companies operated around 400 new research projects over the past year. Roughly half were devoted to tackling cancer, while only 65 dealt with infectious diseases. Of those 20 big firms, only four had special vaccine units.
"The current research system is the victim of an incurable contradiction between the priority of science for health and that of science for profit," Professor Florio says.
As countries around the world race to find a COVID-19 vaccine, governments and the European Union are being called upon to guarantee that once one becomes available, it will be accessible and economically affordable for all countries even the poorest.
On April 17 the European Parliament passed a resolution insisting that any publicly funded research for a coronavirus vaccine must stay in the public domain.
This is a powerful statement, Belgian Green Party MEP Petra De Sutter told Euronews. The idea that the market solves everything is fake. In a time of crisis, governments have to face the issue.
Before the resolution was voted, she was one of the signatories to a letter from a cross-party group to the European Commission, demanding urgent action to ensure the economic affordability of any COVID-19 vaccine funded by the European Union. The letter expressed alarm that no such provision had been included in publicly-funded research projects.
The pharmaceutical one is not like a common industry. Its not about buying a new television set. Consumers have no choice when they are ill and in need of a specific drug, De Sutter explained.
Right now, its the market that sets the agenda on the development of new drugs. Yet, the market would never invest in something that doesnt appear to be profitable. Moreover, some highly expensive drugs are developed also thanks to public funding. For this reason, we need to rethink a European-led research on health and drugs in accordance with peoples needs, De Sutter said.
According to the World Health Organization, 62 research programmes are currently underway in laboratories around the world to find a vaccine for COVID-19.
Recently, Costa Rica asked the WHO to create a voluntary pool to collect patent rights, data and other information so as to widen access to medical products for combating the coronavirus.
In response, the world health body launched a global project named Access to COVID-19 Tools Accelerator to ensure worldwide access to resources, although the extent to which the project will include a pool to collect patent rights remains unclear.
In Europe, although there is a European Patent Office whose monopoly patents generally last 20 years each country independently negotiates the cost of a drug with the pharmaceutical industry.
In Germany, the Protection against Infection Act has been recently amended to give the Federal Health Ministry additional powers including the competence to order limitations on patents when the Bundestag finds there is an epidemic situation of national significance.
Outside the EU, Canada has amended its laws amid the COVID-19 emergency to gain easier access to compulsory licenses, a mechanism which enables governments to pay a set fee for an intellectual property without seeking the rights holders consent.
In the past, some developing countries used similar strategies to treat their citizens. In 1997 South Africa passed a Medicines Act to obtain patented HIV life-saving medicines from countries where they were sold more cheaply. At the time some of the worlds largest pharmaceutical companies took the South African government to the Pretoria High Court before backing down in the face of overwhelming public pressure.
On April 15 more than 20 organisations wrote to the UK government asking that any COVID-19 vaccine or treatment obtained with public funds be made available for all.
Without such safeguards, there may be stark global inequality in access to new COVID-19 technologies, as was experienced during the H1N1 flu outbreak in 2009 where the wealthiest countries bought up most of the vaccines first, the letter says.
The patient campaign Just Treatment, which has been demanding fair access to medicines for years, is among those who signed the document. A year ago the group supported the campaign to made Orkambi, a drug to treat cystic fibrosis, available to all patients.
While today the deadlock has been resolved, at the time the NHS said it couldnt afford the high prices of the new drug to make it available. As a result, some parents of children with the disease clubbed set up a buyers club to buy a generic version of the medicine from Argentina at a more affordable price.
We are facing a new wave of patent-protected drugs, mostly cancer drugs, at a very high price in the European market. We are likely to see monopolies leading to restrictions on access, based largely on price, Diarmaid McDonald, Just Treatment's lead organiser, told Euronews.
Right now, we have a global pandemic and the response also should be global. This is the moment to clear conditions about public funding.
Just Treatment supported also hepatitis C patients to obtain the drug they needed. When Sofosbuvir came to the market, in 2015, the high price of the medicine had been a barrier to access it. The NHS rationed it so that the drug was immediately available only to the sickest patients: others were forced to wait for months and years to access the treatment, McDonald explained.
This must not happen again, Simon Brasch, a Just Treatment leader and a former hepatitis C patient told Euronews. I clearly remember I went through a medical examination to learn whether or not I could access the treatment. The doctor told me my liver hadnt deteriorated enough, so I had to wait. I couldnt believe it. I said to myself: maybe I should drink a couple of vodkas every night till my liver gets worse, so that finally I could be treated.
Finally, I accessed the medicine, but what about the next expensive drug that wont be available in the future? Its the entire system of the pharmaceutical market that has to change, Brasch said.
Doctors Without Borders has also signed the letter to the UK government. Since 1999, when the NGO won the Nobel Peace Prize, it has been fighting for the affordability of medicines, through its Access campaign. We know too well from our work around the world what it means to not be able to treat people in our care because a needed drug is just too expensive or simply not available, the NGO said in a public statement.
A year ago, for the first time in Europe, Doctors Without Borders and other NGOs used a new humanitarian mechanism to vaccinate refugee children in Greece against pneumonia at an affordable price. Thanks to this mechanism the vaccine has a special reduced price of about US$9 (8.23). Without that safeguard, the price of the vaccine in Greece would have been US$168 (153.80) per child.
While the Humanitarian Mechanism has been useful in protecting children in crisis, countries at all income levels continue to struggle to access the pneumonia vaccine at an affordable price, the NGO said on a statement.
Approximately one-third of countries globally have not been able to include the pneumonia vaccine in their standard vaccination package due to the exorbitant price charged by Pfizer and GSK, Doctors Without Borders announced, referring to the two pharmaceutical producers of the vaccine. Pneumonia remains the single largest killer of children under five worldwide, the organisation went on to say.
According to a WHO report, in 2017 more than 800,000 children under five died due to pneumonia, accounting for 15% of all deaths of children in that age group.
The emergency we are experiencing must be an opportunity to rethink the rules that have defined the pharmaceutical market in recent decades, says Professor Massimo Florio of the University of Milan.
Various surveys have shown that in recent years pharmaceutical companies tend to invest only in the final stages of research when the profit appears assured, while the initial steps are carried out thanks to the resources of universities or associations.
This pandemic highlights the failure of the current pharmaceutical market. For this we need a European public structure that produces the drugs that the private sector does not care about or that exist on the market only at exorbitant prices, Professor Florio says.
Today we cant believe that developed countries like ours woke up without a vaccine and drugs to fight COVID-19, and even without masks. This must not happen again.
This is not how vaccines are normally tested. What usually happens is that after a vaccine is deemed safe in Phase 1, vaccinated subjects in Phases 2 and 3 carry on with their day-to-day lives. Months later, scientists check to see whether the vaccinated group as a whole got fewer infections than a group that got a placebo. This is safe, but takes time. In a challenge study, there is no waiting around. Vaccinated volunteers would be exposed to or injected with live virus in a controlled setting.
With limited treatments for COVID-19, such an experiment would obviously be risky. Even so, I would be willing to sign up if conditions were right.
I do not consider myself a big risk-taker. I am a teetotaler, I follow speed limits, and my last broken bone was in middle school. I did not sign up to be in a Phase 1 study because I do not care about my health; I did it because by taking on a small amount of risk, I might be able to help many others. Im not alone in this thousands applied to be in the study I am in, though just 45 volunteers were needed for this stage of this particular trial.
The vaccine injection could have caused an immediate allergic reaction. I had no issues. It may cause my body to produce antibodies that make later coronavirus infection more likely, as has rarely happened with other experimental vaccines. But I am 29 years old and in good health. Even if my odds of catching COVID-19 go up, I would likely have mild illness and then fully recover.
Which brings me to challenge studies.
The idea of exposing volunteers to an infectious agent to definitively assess whether a vaccine is working is not new. It has been done in the United States for influenza and typhoid fever, yielding approved vaccines, and across Africa for malaria, though that parasitic infection can be managed with known antibiotics, which lowers risk for volunteers. All told, more than 6,500 people have participated in challenge studies for diseases other than COVID-19.
Not all challenge studies are ethically equivalent. For each, potential benefit must be weighed against potential harm. A planned challenge study for Zika virus was called off in 2018 in part over objections from a panel of bioethicists who found substantial uncertainty about the risks to would-be volunteers. These concerns extended to those in the community where such a trial might take place. Zikas spread is difficult to detect and is linked with birth defects. Can a challenge study be ethical if it puts additional children at risk?
There is a lot we do not know about SARS-CoV-2, the virus behind COVID-19. A challenge study would clearly need to omit pregnant women and people most likely to die from infection. Volunteers would have to be kept in strict isolation, potentially for weeks or months. Experts estimate that 100 healthy subjects would be needed.
A growing number of bioethicists argue that we should seriously consider COVID-19 challenge studies. The public health and economic burden of the pandemic is extraordinary. Even one day shaved off vaccine testing could save many lives.
I would agree to participate in such a challenge trial if three conditions were met.
First, the Food and Drug Administration would have to sign off. This would signify both that the conditions for preparing and handling the virus are up to par with other approved challenge studies and that the countrys chief regulatory body is willing to accept the results.
Second, it would need to be clear that no matter the outcome, the experiment would have value. If all the subjects in a challenge avoid infection, then clearly the vaccine should be fast-tracked. If they all get sick, it should be scrapped. But what if protection is only partial, as is the case with many vaccines? Would traditional testing of the vaccine resume? If so, what really would have been gained by the challenge trial? The answers to these questions would need to be decided ahead of time.
Third, I would need to know that I had a good chance of avoiding infection altogether. As of today, I am making no assumption that I am immune. My experimental vaccine, made by Cambridge-based Moderna, may not produce any effect. But if laboratory testing could indicate before a challenge trial that my immune system is already producing neutralizing antibodies as a result of the vaccination, I would consider the personal risk low enough. I know lab testing isnt foolproof, but it would at least put my mind at ease.
You might disagree with the moral calculus Ive laid out. To some, human challenge trials are clearly too dangerous, making informed consent impossible. To others, the need to act swiftly even if it means that exposing 100 volunteers to the coronavirus leads to 100 more COVID-19 cases makes human challenge studies the obvious choice. In the end, its a judgment call.
Though no human challenge studies are being planned at the moment, the organization 1DaySooner has begun soliciting volunteers online. More than 10,000 people have said that if enough precautions were in place, they would be willing to sign up including me.
Ian Haydon is a press officer at the University of Washington in Seattle. Follow him on Twitter @ichaydon.
COVID-19 vaccines are in development, but to meet the demand of over 300 million doses, the ... [+] government is spending big on needles and syringes.
The U.S. government is getting its vaccine supplies ready in anticipation of a working cure. Two separate orders signed off on May 1, 2020, total $100 million and specify needles and syringes for a COVID-19 Mass Vaccination Campaign.
One $27.5 million order went to Colorado-based Marathon Medical, the other $83.7 million to Texan business Retractable Technologies. The orders were placed by the Health and Human Services (HHS) departments Office of the Assistant Secretary for Preparedness and Response (ASPR).
The orders come as a raft of different vaccines are under development and testing. The U.S. government has backed a handful, including a $450 million deal with Johnson & Johnson arm Janssen Pharmaceutical for its COVID-19 cure. That vaccine could be ready by early 2021.
Oxford Universitys vaccine could be given to millions of people even earlier. AstraZenecas chief executive, Pascal Soriot, suggested toward the end of last week that the cure could be ready for a limited rollout before the close of 2020. That would be a remarkable turnaround, given that vaccine testing and release can take over a decade.
Its unclear just how many needles and syringes have been ordered. Its estimated as many as 300 million will need to be inoculated in the U.S., but a report in the New York Times last week cited industry sources expressing concern about Americas urgency to produce the myriad parts required to deliver the medicine.
HHS announced at the end of March it was working with Janssen and Massachusetts-based Moderna on fast-tracking vaccine production. HHS said it would accelerate advanced clinical trials, regulatory support and large-scale manufacturing to produce up to 300 million doses of vaccine in the United States each year.
Neither HHS nor the manufacturers had responded to requests for more details on how many needles and syringes were being produced.
But the latest orders should go some way to alleviating concerns about preparedness to deliver vaccines to Americans.
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Posted: May 5, 2020 / 10:50 AM EDT / Updated: May 5, 2020 / 10:54 AM EDT
HARRISBURG, Pa (WHTM) Representative Seth Grove plans to introduce legislation that would allow pharmacists to administer COVID-19 vaccine once they become available.
Pharmacists are highly trained and are currently allowed to administer flu immunization shots, Grove said. My bill addresses the potential issue of long lines of people awaiting a COVID-19 vaccine at their doctors offices before the problem arises.
According to a press release from Groves office, the bill would allow pharmacists to administer a federally approved vaccine in a manner which complies with the rules and regulations established by the Center for Disease Control and Prevention.
By increasing the accessibility of a vaccine, once approved, the Commonwealth would be able to leverage skilled pharmacists as a force multiplier to save lives and improve public health according to Grove.
Grove says in order to immediately increase the Commonwealths testing capabilities during the time of a disaster declaration, the legislation would also allow pharmacists to conduct testing during a public health emergency, such as the COVID-19 pandemic.
Grove recently circulated the co-sponsorship memo for the bill.
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With a number of big pharma companies announcing efforts and partnerships to rapidly develop vaccines, hopes of an effective one emerging within the year is running high.
GlobalData, a data analytics company, conducted a poll asking its healthcare readership the likelihood of a vaccine being developed in the next 12 months, with 52% being very confident and a further 28% being somewhat confident.
With 80% of respondents optimistic about the potential for the successful development of a vaccine in the next year, Michael Breen, associate director of infectious diseases at GlobalData, moved to calm such expectations.
Part of the reason for such confidence is the number of developments that have moved rapidly into the clinic, he suggested.
For example, Moderna became the first company to administer a vaccine to a person, after only 63 days.
It was not long before Moderna was followed by the University of Oxford, which then saw AstraZeneca quickly move to partner on the vaccine.
Moving slightly slower, with a Phase I study slated for September 2020, was Johnson & Johnson however, the pharma giant subsequently backed its vaccine by announcing a number of partnerships to bolster vaccine capacity to ready it for commercialization, ahead of any in-human readouts.
Though these efforts are reasons for hope, Breen noted that they were running at substantially shorter R&D timespans than usual and have utilized new vaccine technology.
As a result, Breen cautioned that this technology is still in its infancy: No vaccine using these technologies has ever been commercialized and data supporting their efficacy is thin, thus enthusiasm surrounding their likelihood of success may be met with disappointment.
Further than this, there is still the issue of manufacturing at scale and then the difficulty in distributing the vaccine hurdles that Breen suggested could add further delays.
Ultimately, while it is technically possible for a COVID-19 vaccine to be available in 12 months, several factors portend this to be closer to wishful thinking than anything remotely certain, Breen concluded.
Donald Trump has said he is very confident there will be a vaccine for coronavirus by the end of the year, revising up his estimate of the final US death toll as several European countries prepare for a cautious easing of lockdowns.
The president used a Fox News virtual town hall on Sunday night to repeat his regular virus talking points, including that a vaccine was not far away, Covid-19 was Chinas fault and the economy would not only recover but grow like crazy.
We are very confident we are going to have a vaccine by the end of the year, Trump said. Scientists have repeatedly warned that a vaccine may take 12-18 months or longer.
Trump in April predicted 60,000 American lives would be lost but on Sunday said: Were going to lose anywhere from 75, 80 to 100,000 people. Thats a horrible thing.
Trump indicated that intelligence agencies would release further information on Monday about the virus but failed to give details. Asked why he didnt act earlier on the epidemic, the president said that on 23 January he was in told in briefings there could be a virus coming, but it was of no real import.
In other words, it wasnt: Oh, weve got to do something, weve got to do something. It was a brief conversation.
His comments came amid reports that US officials believed China intentionally covered up the extent and severity of the virus while increasing its imports and decreasing exports of medical supplies.
The Associated Press said a four-page Department of Homeland Security intelligence report dated 1 May found China held off informing the World Health Organization (WHO) that the coronavirus was a contagion for much of January so it could order medical supplies from abroad, and that its imports of face masks and surgical gowns and gloves increased sharply.
Those conclusions were based on the 95% probability that Chinas changes in import and export behaviour were not within normal range, the report said.
Asked about the the viruss origins, Trump again suggested it came from a Wuhan lab. I think they made a horrible mistake and they didnt want to admit it, he said.
On Sunday the US secretary of state, Mike Pompeo, said there was enormous evidence the coronavirus outbreak originated in a laboratory in Wuhan, China, but did not provide evidence for his statement.
The presidents appearance came as several European nations cautiously prepared to ease lockdown restrictions. Italy, which reported its lowest daily toll since stay-at-home orders were imposed on 10 March, is set to follow Spain in allowing people outside. From Monday Italians will be permitted to go to parks and visit relatives. Restaurants can open for takeaways and some shops will be able to resume business, but there has been confusion over the rules.
On the one hand were super excited for the reopening, were already organising various activities the kids will be able to do with their grandparents outdoors, said Rome resident Marghe Lodoli, who has three children. On the other hand its disorientating. The rules are not clear and were not sure if just using common sense will do.
Italian authorities have said some preventative measures are still needed in a country that has the second-highest number of virus deaths.
Germany will continue its easing on Monday while Slovenia, Poland and Hungary will allow public spaces and businesses to partially reopen. In another sign of life returning, an influential German minister said on Sunday that he supported a resumption of the countrys football season this month as long as teams respected hygiene conditions.
Officials in Moscow, however, urged residents to stay home. With cases increasing by several thousand each day, Russia is now the European country registering the most new infections, with Moscow at the centre of the contagion.
The British government said the easing of coronavirus lockdown measures was likely to be gradual. The UK death toll had reached 28,446 according to the Johns Hopkins tracker, putting the UK just behind Italy on 28,884 and the US with 67,680 deaths.
In other developments:
Global coronavirus cases have surpassed 3.5 million with more than 247,000 deaths.
In New York, the centre of the US outbreak, an emergency field hospital erected in Central Park is set to close. Dozens of New Yorkers were fined for violating social distancing guidelines as they flocked to beaches and parks in balmy weekend weather.
China reported three new coronavirus cases, versus two the day before.
Japans state of emergency is expected to be extended until the end of the month.
France will not quarantine anyone arriving from the EU, the Schengen area or Britain due to the coronavirus.
New Zealand has reported no new coronavirus cases for the first time.
South Korea plans to ease a ban on some gatherings and events as long as they follow disinfection measures.
Brazil has become the first country in Latin America to report more than 100,000 cases.
The Iranian president, Hassan Rouhani, announced mosques will reopen across large parts of the Islamic republic after they were closed in early March.
