A COVID-19 vaccine this year? It's a long shot, but it's possible. Memphis Business Journal
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A COVID-19 vaccine this year? It's a long shot, but it's possible. - Memphis Business Journal
Investors are growing more convinced Covid-19 vaccines will work.
They arent as sure shares of vaccine companies can keep soaring.
The investors, along with analysts and others scrutinizing the results from early trials, say the most advanced vaccine candidates didnt cause serious side effects and helped produce antibodies that may be sufficient...
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Covid-19 Vaccine Front-Runners Impress Investors, but Concerns Exist - The Wall Street Journal
The National Governors Association says the availability of a future COVID-19 vaccine will likely be limited due to manufacturing constraints.
The NGA issued a memorandum Monday tellingstate leaders that difficult decisions concerning vaccine allocation and prioritization will occur.
Immunizing the U.S. population against COVID-19 will likely require the single largest vaccination campaign ever undertaken.National Governors Association
Meanwhile, shortages of the antiviral drug remdesivir may give an early indication of how prioritization could work.Some states have shifted to a weighted lottery system to determine who does and does not get the potentially life-saving medication.
Remdesivir has shown promising results treating COVID-19 in laboratory studies but hasnt been validated on a wide scale for patients.
Central Valley hospitals are running low on remdesivir as the state grapples with how much to send each county weekly.
Who might first get a COVID-19 vaccine?
U.S. public health officials on Friday charged a group of independent scientists and ethicists with developing guidelines to determine who should get the first doses of a COVID-19 vaccine, once one becomes available.
Lucky Malhi at Community Medical Centers says hes been preparing for a COVID-19 surge since February. He says that surge is happening now.
Currently we have enough remdesivir to treat about 30 patients after getting an emergency shipment last week and we are hoping for an additional delivery this week, said Malhi, who is CMCs vice president of supply chain management, in a statement.
As recently as a week and a half ago, Community Medical Centers went 24 hours without remdesivir until the emergency shipment arrived.
Malhi says as patient volumes continue to rise and stay at historic highs, the hospital is struggling with three main resources: staff, supplies, and beds.
CMC currently has 179 positive COVID-19 patients in their hospitals, and 119 CMC staff members either have the virus or are in self-isolation.
Related Story: County Has Unchecked Community Spread, ICU Beds Below 10%
Laura Florez-McCusker, director of media relations for Kaweah Delta Medical Center, tellsGV Wire by email the hospital does have remdesivir and is expecting another shipment.
But, she said, Our demand has consistently been greater than our allotted supplies of the medication and it is not uncommon for our supply to be depleted before the next allotted amount arrives.
The hospital has 74 COVID-19 patients and 97 employees out with the virus.
Photo: Shutterstock
Thus far, the allocations we have received have not provided enough of the medication to all of our hospitalized patients who may benefit from it. Kaiser Permanente of Northern California
Kaiser Permanente of Northern California responded toGV Wires questions about remdesivir and allocations in an email response.
In clinical trials, remdesivir has proven of some value in reducing length of hospitalization for people with COVID-19, and we wish there were more of it available for use in our hospitalized COVID-19 patients. With the number of confirmed cases of COVID-19 rising quickly in many states, the demand for remdesivir exceeds the supply available across all states, said Kaiser Permanente of Northern California.
The federal government is making remdesivir allocation decisions to states based on hospitalized COVID-19 census data. Each state then further allocates within its borders, and sends hospital allocation decisions to its contracted distributor, who in turn sends remdesivir to the selected hospitals. The current process is anticipated to provide distributions to allocated hospitals every two weeks.
Immunizing the U.S. population against COVID-19 will likely require the single largest vaccination campaign ever undertaken and governors will play a key role in bringing together leaders from their state public health, immunization, and emergency management systems to design and execute the operation, says the NGA.
The U.S. Department of Defense will assist with the vaccines distribution and administration.
The NGA also says, Additionally, state leaders, in coordination with local health authorities, will also play a role in determining when to begin offering vaccines to persons outside the initial target groups, a decision made based on local situations.
Will hospitals have a role in deciding the rollout of a vaccine?
When we speculate about the distribution of a future vaccine, that distribution model would be determined by federal, state, and local authorities, David Bacci, regional vice president of the Northern and Central California Hospital Council told GV Wire by email.
I see no indication that individual hospitals would determine the order in which to vaccinate people they would vaccinate according to the regulations that would be developed.
The NGA is also concerned there may be some vaccine hesitancy by people with skepticism towards vaccines in general. The group urges a multifaceted communications strategy to address these concerns.
Recent polling cited by the NGA indicates that only half of Americans reported that they intended to get a COVID-19 vaccine, with 31% reporting that they were not sure if they would get vaccinated and 20% saying that they will refuse.
Gilead says that making remdesivir is a complicated process. (Gilead Sciences)
The typical timeline for manufacturing a drug like remdesivir at scale is nine to 12 months; we have reduced that period to six to eight months. Gilead Sciences
Gilead Sciences, headquartered in Foster City, California said in a statementthat the process of making remdesivir is complicated.
The typical timeline for manufacturing a drug like remdesivir at scale is nine to 12 months; we have reduced that period to six to eight months, the company explained.
Related Story: UCSF Fresno Doctor: Remdesivir Should Be Given to Anyone to Fight ...
The California Department of Public Health states on its website, For each new (remdevisir) allotment received from the federal government, CDPH will use the most recent hospital data for patients with confirmed COVID-19 to proportionately distribute remdesivir . .
On June 8, CNN reported the federal supply of remdesivir would run out at the end of the month. Dr. Robert Kadlec, a U.S. Department of Health and Human Services official told the cable network thatGilead had given a general range of product delivery for July and August, which then significantly expands beginning in September, October, and through the fall as they kind of open the spigot of their production and processing.
The New York Times reports, one solution for a future COVID-19 vaccine that is starting to attract the attention of public health experts is a so-calledweighted lottery, which gives everyone a chance at access, although some get a better shot than others.
Doctors and ethicists rank patients, deciding which groups should be given preference and how much. First-responders, for example, might be weighted more heavily than, say, very sick patients who are unlikely to recover.
The goal is to prevent the haphazard or inequitable distribution of a treatment or vaccine when there isnt enough to go around. Such a system is being used toallocate remdesivir.
This is all very new, said Dr. Douglas White, an ethicist and vice chairman of the department of critical medicine at the University of Pittsburgh, which began using a weighted lottery last month to distribute remdesivir.
Patients have accepted the results, even when they lost in the lottery and ended up being denied the drug, he said.
To allocate the drug, Pittsburgh doctors decided that the lottery would give preference to health care workers and emergency medical workers. The doctors also weighted the odds to favor people from economically disadvantaged areas, who tend to be mostly Black and Hispanic.
People with other illnesses and limited life spans, like end-stage cancer patients, had the odds weighted against them, giving them a smaller chance to win in the lottery. The system did not consider age, race, ethnicity, quality of life, ability to pay, or whether a patient has a disability.
The lottery began in early June. We had 64 patients. We had to make the supply of remdesivir last at least two weeks. We only had enough to treat one in four patients, White said.
(Reuters and the New York Times contributed to this story.)
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Who Will Go to the Front of the Line for COVID-19 Vaccine? - gvwire.com
Axel Lehrer is an assistant professor at the John A. Burns School of Medicine working on the vaccine. (PC: UH-Mnoa)
A University of Hawaii at Mnoa researcher, in collaboration with a pharmaceutical company, has developed a vaccine candidate that shows promise in rapidly inducing immunity to the novel coronavirus in pre-clinical trials.
Axel Lehrer, an assistant professor at the John A. Burns School of Medicine, is leading a team of scientists in the Department of Tropical Medicine, Medical Microbiology and Pharmacology, that is collaborating with New Jersey-based Soligenix, Inc. on this project.
According to a press release from UH-Mnoa, Lehrer and Soligenix have previously demonstrated the feasibility of developing a thermostable Ebola virus and multivalent filovirus vaccines and applied the same technology platform to rapidly develop a vaccine for the prevention of COVID-19, the infection caused by SARS-CoV-2.
Our work to date has demonstrated not only the feasibility of rapid and efficient manufacturing of the required vaccine antigens, but also the potential for a broadly applicable and easily distributed vaccine, Lehrer stated. We are delighted with our earlier successes on development of filovirus and flavivirus vaccines with this platform.
The release indicates that their vaccine candidate successfully demonstrates the ability to rapidly stimulate a balanced antibody response, which includes potent SARS-CoV-2 neutralization and cell-mediated immunity, a measure necessary to clear a viral infection. In addition, these results generated by Lehrer and his team in a well-defined mouse model using a prototype virus antigen display a rapid onset of immunity with antibody responses detected as early as 7 days after the first vaccination.
A manuscript presenting the data has been submitted for peer review to npj Vaccines and is available as a preprint on bioRxiv (https://biorxiv.org/cgi/content/short/2020.07.24.220715v1).
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UH-Based Research Develops COVID-19 Vaccine in Early Trials - Big Island Now
Trump Says Covid-19 Vaccine May Be Ready Far Before Year's End Bloomberg
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Trump Says Covid-19 Vaccine May Be Ready Far Before Year's End - Bloomberg
COVID-19 vaccine trials in the DFW area WFAA.com
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Introduction
One of the most argued topics of this downturn is whether the oil and gas supermajor Exxon Mobil (XOM) will reduce its dividend for the first time since the dark days of World War 2. Given Exxon's immense financial strength, it should be of little surprise that thus far the company has defied the downturn and sustained its dividend, but unfortunately, this now appears to be approaching its limits based on the latest commentary from management.
When a dividend is under pressure, management will always be facing questions probing for insights into any possible reductions, and thus, reviewing the way in which they speak is particularly interesting. They made numerous statements during the second quarter of 2020 results conference call, but the two quotes listed below are the most interesting:
Doing so will enable us to maintain the dividend and hold debt at its current level. Of course, this is a volatile market, and we can't know with certainty how the market will evolve from here. There are simply too many unknowns. While we're developing plans based on what we and other third parties can reasonably expect to happen, we have to maintain a certain degree of flexibility to be able to respond to potential improvement or further degradation.
But as I said, we don't plan to take on any more debt. We're now developing plans that will able us to maintain those capital allocation priorities over the near term, and that includes sustaining the dividend.
- Exxon Mobil Q2 2020 Conference Call
Similar to central bank press releases, management teams at massive companies walk a fine line between not misrepresenting their intentions, but at the same time, when discussing something undesirable, not being too straightforward. On the surface, they may appear to be remaining steadfast in their commitment to sustaining the dividend, however, they also appear to be flagging the limits to this commitment by stating that they do not plan to take on any debt.
I believe that this commentary indicates an intention to reduce their dividend once their current cash balance is depleted if operating conditions have not made a significant recovery and the future is more certain. Given the immense pressure that their entire industry is facing, it seems prudent for investors to assume that the countdown to a potential dividend reduction has begun. Although they can reduce their costs, the biggest factor that will determine whether they require more debt or not is always going to remain oil and gas prices.
Whilst every person is entitled to their own view, based upon how the last six months have transpired I believe that COVID-19 will continue significantly weighing down economic activity until such time as a viable vaccine is produced. It initially appeared that the world was starting to get the virus under control with the amount of new global cases remaining static throughout much of April and May, but this clearly proved short-sighted, as the two graphs included below display.
(Image Source: Google)
In my home country of Australia, we were quite fortunate initially and avoided seeing a massive surge cases, and thus, life began returning toward normal. Fast forward a few months, and one of our largest states, Victoria, has just imposed very strict lockdowns for at least the next six weeks that will slam economic activity, with other states also shutting their borders and imposing various other restrictions. Whilst this example alone does not materially impact global economic activity, it still provides a timely example of the difficulties that the entire world faces, since, being a developed island without extensive high-density living, we should fare better than many other countries.
It appears that until such time as a vaccine is invented and rolled out across the world, life will struggle to resemble normal, and thus, economic activity will continue being weighed down significantly. This means that a proper and sustained recovery in oil and gas demand, and thereby prices, within the short to medium term is also likely to be dependent on a vaccine, along with the dividend of Exxon Mobil. Whilst many people are hoping that a viable vaccine is only around the corner, until such time as one is definitively successful, investors would be well served to keep their expectations tempered.
This situation gives rise to the following question: how much longer does Exxon have before its cash balance is depleted and a dividend reduction becomes very likely? Whilst the volatility in oil and gas prices makes this impossible to know for certain, a reasonable estimation can be made using its guidance and recent cash flow performance, as the table included below displays.
(Image Source: Exxon Mobil Second Quarter 2020 Results Presentation)
It can be observed that Exxon ended the second quarter of 2020 with a sizeable $12.6 billion cash balance, but unfortunately, this could deplete quite quickly and may not last beyond the end of 2020. The company's dividend payments cost $3.7 billion every quarter, or $7.4 billion remaining to the end of 2020. Given its guidance for 2020 capital expenditure of $23 billion, it implies that Exxon still has $11.4 billion remaining for the second half of 2020, and thus, its total remaining cash outflows should be $18.8 billion. Whilst this was easy to estimate, the biggest question going forward is regarding the company's operating cash flow.
The prices of oil and gas are notoriously difficult to accurately predict, but given the current COVID-19 situation and resulting economic environment, at best it seems sensible to assume that operating conditions will average between those of the first and second quarters of 2020. I believe that a reasonable conservative assumption would be that the company's operating cash flow for the remaining two quarters of 2020 will average half that of the first quarter excluding working capital movements, thereby totaling $7.5 billion.
When this estimated operating cash flow is subtracted from Exxon's $18.8 billion estimated cash outflow, it indicates that the company would end 2020 with a cash balance of only $1.30 billion. This would clearly push Exxon towards making a decision to either increase debt or reduce its dividends, which I now believe management is seriously considering if operating conditions are still tough. Admittedly, asset divestitures, further capital expenditure reductions and favorable working capital movements may provide a sufficient temporary boost and thus buy the company another quarter or two.
Even though everyone remains hopeful that a viable vaccine will be rolled out soon, uncertainty still reigns supreme in a world that feels almost unrecognizable compared to only one year ago. It now appears that after fighting to sustain its dividend for years following the 2015-2016 oil price crash, the toll is starting to weigh on the company's resolve. Although shareholders should still expect to see Exxon's dividends flowing unchanged throughout the remainder of 2020, if a COVID-19 vaccine does not transpire by early 2021, it now appears that the company's dividend will be joining the long list of causalities. I will still be maintaining my Bullish rating, since Exxon still offer a way to capitalize on any eventual recovery in oil and gas prices, regardless of the dividend.
Disclosure: I am/we are long XOM. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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Exxon Mobil: COVID-19 Vaccine Needed To Save The Dividend - Seeking Alpha
Public health experts are raising red flags that the Trump administration could exert political pressure on the Food and Drug Administration (FDA) to approve a COVID-19 vaccine before one isready.
President TrumpDonald John TrumpWhite House sued over lack of sign language interpreters at coronavirus briefings Wife blames Trump, lack of masks for husband's coronavirus death in obit: 'May Karma find you all' Trump authorizes reduced funding for National Guard coronavirus response through 2020 MORE, searching for a political win just over three monthsfrom the election, has latched onto the push for developing a vaccine in record time and promoted it in anumber of recent appearances.
Trump spoke optimistically of the prospects for a vaccine during a visit to a biotech facility in North Carolina on Monday, despite experts cautioning one may not be widely available for another year.
The president made similar comments Thursday, touting progress without dwelling on the fact that more than 150,000 Americans have died due to the pandemic, a massive toll higher than any other country's.
"We are way ahead on vaccines, way ahead on therapeutics. And when we have it, were all set up with our platforms to deliver them very, very quickly," Trump said during a White House press conference. "Were all set to deliver them as soon as we have them, and thats going to be very soon."
The president has sought to take credit for "Operation Warp Speed," the administration's multibillion-dollar effort to fund the development and distribution of potential vaccines for COVID-19 and have them available as soon as they are found to be safe and effective.
The administration has been buoyed by some early success reports from top vaccine candidates, and political officials have confidently predicted a shotwill be available before the end of the year.
Anthony FauciAnthony FauciWhite House sued over lack of sign language interpreters at coronavirus briefings Fauci warns of 'really bad situation' if daily coronavirus cases don't drop to 10K by September Overnight Health Care: Trump criticizes Birx over Pelosi, COVID-19 remarks: 'Pathetic' | Democratic leaders report 'some progress' in talks with White House | WHO chief: There may never be 'silver bullet' for coronavirus MORE, thecountry's top infectious disease doctor,said Friday he is cautiously optimistic a vaccine will be ready by the end of 2020 and be widely distributednext year.
While there's almost no chance a vaccine would be ready for widespread distribution before Election Day in early November, some of the companies with vaccine candidates entering the phasethree clinical trial stages now might start to show initial results by then.
Researchers and experts said they are worried Trump could seize on those early results to pressure public health agencies into approving a vaccine before it is ready.
"You saw the issue of politicization around hydroxychloroquine and the pressure that was put on FDA then. There's a legitimate concern that does not happen again," said Jesse Goodman, a Georgetown University professor who was previously FDA's chief scientific officer.
Many outside observers felt the FDA bowed to political pressure earlier this year when the agency issued an emergency authorization for hydroxychloroquine, an anti-malaria drug that Trump, his allies and members of his administration have continued to tout as a miracle cure for COVID-19 despite evidence.
Rick Bright, an agency whistleblower, made similar accusations and said he lost his job for objecting to the drug's widespread promotion.
The FDA later revoked the authorization.
In another instance, the White House reportedly pressured the Centers for Disease Control and Prevention (CDC) to change its guidance on reopening schools in order to emphasize the importance of kids going to school while downplaying any potential risks.
Goodman said even if there is no political pressure on a COVID-19 vaccine, there's still "a legitimate problem in public perception" because of the administration's past actions in other areas of the crisis.
An ABC News/Washington Post pollreleasedin Julyfound that more than half the country distrusts Trump while six in 10 Americans disapprove of his handling of the virus outbreak overall.
A separate poll released this week found that 64 percent favor fully testing any potential vaccine, even if doing so delays its release and allows the disease to potentially spread further.
Health experts warn about the danger of a widespread portion of the population rejecting a vaccine once one is available.
Top administration officials are working hard to reassure the public that they will not be cutting any corners.
"Data and science. Those are what's going to guide us," FDA Commissioner Stephen Hahn said during a recent interview with the Journal of the American Medical Association. "We cannot have a situation where people lose trust in the FDA and the clinical trials process.
Hahn said the FDA's decisions have worldwide implications, beyond just a COVID-19 vaccine.
"America and the world's public trust in FDA is really important. It's worth a lot because people depend upon us every day in their lives, and we just cannot do anything that would break that trust, and that's a solemn promise," Hahn said.
FDA guidance requires any vaccine approved to be at least 50 percent more effective than a placebo in preventing the disease, among other criteria.
Drug executives have said they do not believe the FDA would lower its standards for approval.
Still, a potential workaround exists: theagency could issue an emergency use authorization, which requires less rigorous data than a full approval, as soon as officials are convinced a vaccine is safe and effective.
Goodman said all agencies involved in the decisionmaking need to be as transparent as possible.
"I don't think emergency use authorization should be trivialized on very limited data, and I thinkthe data need to be spelled out to people," Goodman said.
Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said he thinks there are enough outside players involved that the Trump administration would be hard-pressed to push a vaccine based on limited evidence.
"My confidence is not in the White House managing this, but in the pharmaceutical companies that have delivered hundreds and millions of doses of vaccines for many different problems over time," Adjala said.
Still, he said public skepticism will be hard to overcome.
"If politicians get involved in vaccine decisionmaking, that is going to be tainted, because everything that politicians have touched so far in this pandemic has been compromised by their involvement in it," Adjala said.
"This is not a place that politicians really need to insert themselves. This is a medical decision between doctors and patients."
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Experts fear political pressure on COVID-19 vaccine | TheHill - The Hill
U.S. President Donald Trump delivers a speech during a visit to the Fujifilm Diosynth Biotechnologies' Innovation Center, a pharmaceutical manufacturing plant where components for a potential coronavirus disease (COVID-19) vaccine candidate are being developed, in Morrrisville, North Carolina, U.S., July 27, 2020.
Carlos Barria | Reuters
The hunt is on for a vaccine for Covid-19, which has killed more than 600,000 people.
The current frontrunners include an mRNA vaccine from Moderna; a candidate vaccine from AstraZeneca and Oxford University; a Chinese vaccine from the military and biotech company CanSigo Biologisc; and an mRNA-based vaccine from German company BioNTech and Pfizer.
While a candidate could be approved this year, it remains to be seen whether the vaccine will confer temporary or long-term immunity, or how many doses will be required, as doubling the number of jabs could complicate worldwide immunization efforts.
But bioethicists and public health experts all agree that manufacturing doses for 8 billion people quickly is an insurmountable challenge.
So someone will have to decide who should get the vaccine first and why.
In the United States, committees have begun to form to discuss this tricky issue.An advisory committee of external health experts is advising the Centers for Centers for Disease Control and Prevention on an equitable framework. The National Academies of Medicine announced earlier this month that its committee will "develop an overarching framework to assist policymakers in the U.S. and global health communities."
Some of the most challenging questions they face include whether pregnant women (normally the last to get a vaccine) should be higher up on the list, or whether Black and Latino people who have been disproportionately affected by the virus should get access to the vaccine before the rest of the population.
Then there are the global considerations. Task forces have formedto come up with a "fair and equitable" framework to distribute the vaccine between countries, but face numerous practical challenges.
Arthur Caplan, professor of bioethics at New York University Langone Medical Center, thinks some countries will have vaccines to spare, while others won't have access to many at all. Some nations could use their leverage over vaccines as a way to curry favor or to negotiate trade deals. Enforcing safety and efficacy is another sticking point because not every country has the same quality-control processes.
"Internationally, there's a lot of talk about how every life is valuable," he said. "But that doesn't address what you do in practical terms if there's a shortage."
Caplan is also concerned about the rise of black markets, which might allow rich people in certain countries to jump the line and buy vaccines for themselves and their families.
Other bio-ethicists note complicated questions around responsibility and need. For instance, countries like New Zealand have done a very good job at flattening the curve, while others like Brazil are struggling to contain active outbreaks. So should the countries that have largely stamped out Covid-19 vaccinate their populations last?
"We need to think through how to distribute vaccines to reduce harm internationally," saidEzekiel Emanuel, an oncologist and senior fellow at the Center for American Progress. "And some countries are really suffering more than others."
Within the U.S., bioethicists hope that vaccines are distributed in a centralized and coordinated way. Back in April and May, the lack of coordination from the federal government meant that states had to compete for supplies, including ventilators, and manufacturers were confused about where to send equipment.
"I'm worried that there will not be the kind of national leadership on the issue that we need to avoid fights from breaking out as people jockey to get access," said Michelle Mello, professor of law and medicine at Stanford University.
Even if the federal government steps up, there isn't yet consensus on who should get access to the vaccines first.
Most of the experts had a set of categories in mind.Lawrence Gostin,a professor of global health law and director of the O'Neill Institute for National and Global Health Law at Georgetown, helped draft policy papers on the issue for the Obama administration during the H1N1 crisis of 2009.
His strategy would be using the vaccine first to prevent further spread of the virus.
"That is, we might need a kind of ring vaccination strategy for major clusters of cases that don't we want to spread to other other cities or states," he said.
Next, he would prioritize health workers on the front lines of the pandemic. Once they're vaccinated inside hospitals, he would turn his attention to other essential workers, including police, sanitation workers, and workers who are critical to maintaining our food supply. Then he'd select the most vulnerable, including the elderly or marginalized populations or those with pre-existing conditions.
Other experts have different ideas.
Nisarg Patel, a surgeon at UC San Francisco and a co-author of an op-ed on the topic, would start with the people at highest risk, including health workers, essential municipal workers, vulnerable groups and the elderly.
But given that nearly half of Americans have at least one chronic illness, there might need to be some consideration about who gets prioritized within that group. For instance, should immunocompromised patients in the midst of cancer treatment get access to the vaccine before tens of millions of people with Type 2 diabetes?
"The way you think through them is to think through the outcomes," said Mello, although she notes the evidence is still accumulating on that. She also points out, however, that it might be the case that not everyone will want the vaccine immediately - so some might wait and see what happens with the first cohort.
Even then, it's not that simple.
Bioethicists point out that some of these decisions can only really be made once the specifics of the vaccine are better understood.
Vulnerable populations including the frail and elderly might not mount a robust immune response to the vaccine, for instance. The data on that from clinical trials is still limited. And health care workers might not get first dibs if they have sufficient PPE to protect themselves. The first round might be limited to those who treat Covid-19 patients specifically.
"A lot will depend on the vaccine, but also the modeling that we do," said Emanuel. "We might even find that the best way to reduce the spread of the virus is to vaccinate the most common transmitters, like grocery store workers or policemen," he said.
Another question that will need to be determined by committees: If sufficient people aren't willing to volunteer for a vaccine, should governments require that certain groups get vaccinated?
"Voluntary is always better," said Emanuel. "It's never the first option to mandate it, but it may be a necessary one."
Caplan agrees that discussions should be underway on this issue, as a lot of people might be reluctant to get vaccinated. Anti-vaccination sentiment is far from limited to the United States, he points out. In countries like France, surveys have shown that 1 in 3 people do not feel that vaccines are safe.
Caplan doesn't have a clear solution for hardline anti-vaxxers, who might never be willing to get the vaccine. But he does think that a lot can be done to sway those who are reluctant or hesitant by showing data from the first group that gets vaccinated. In the United States, he would message to the public that vaccination is required for certain freedoms, like travel or sending their kids to school. Emanuel suggests that public health workers might even consider teaming up with celebrities and influencers to help spread the word.
These challenges and many more surrounding vaccine allocation are surmountable with the right planning and coordination, Emanuel stresses.
"We shouldn't give up," he said.
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Who should get the Covid-19 vaccine first? It's way trickier than you might think - CNBC
At least 20 Boston researchers, technologists and science enthusiasts have tried a DIY vaccine developed by a group called the Rapid Deployment Vaccine Collaborative, or Radvac, according to the MIT Technology Review.
The scientists, many of whom are connected to Harvard University and MIT, include George Church, a celebrity geneticist from Harvard. While Church has not left his home in five months, he believes that the vaccine is extremely safe, as one of the developers is Preston Estep, a former graduate student of his at Harvard.
"I think we are at much bigger risk from COVID considering how many ways you can get it, and how highly variable the consequences are," said Church, according to the MIT Technology Review. "I think that people are highly underestimating this disease."
Radvac was formed in March, when Estep emailed a number of acquaintances wondering if a DIY project could develop a vaccine more quickly than ongoing projects, as he felt that "already sufficient information" had been published about the virus in order to guide an independent project.
We established a core group, most of them [from] my go-to posse for citizen science, though we have never done anything quite like this, explained Estep, a cofounder of Veritas Genetics, a DNA sequencing company.
The Radvac team went through reports on vaccines against SARS and MERS and worked in borrowed labs with mail-order ingredients in order to develop the vaccine. The team was looking for "a simple formula that you could make with readily available materials, Estep told the MIT Technology Review. That narrowed things down to a small number of possibilities.
A white paper detailing the vaccine was published by Radvac in early July for anyone to copy, with four authors named on the document and a dozen initials of participants who chose to remain anonymous.
The DIY vaccine is a "subunit" vaccine consisting of fragments of the virus. Radvacs virus is made from peptides, short bits of protein that match part of the coronavirus but can cause the disease itself. Subunit vaccines are used for some other diseases including hepatitis B and human papillomavirus (HPV). Novavax, a biotechnology company, is also working on a subunit vaccine for the coronavirus, and has secured a $1.6 billion contract from the Trump Administration's Operation Warp Speed.
The peptides in Radvac's vaccine were mixed with chitosan, a substance from shrimp shells, which coats the peptides in a nanoparticle which can pass the mucous membrane.
Nasal vaccines are easier to administer than injected ones, but only five out of about 199 COVID-19 vaccines are using nasal delivery.
A nasal vaccine could also create mucosal immunity, or immune cells present in the tissues of the airway, which could be important for defending against SARS-CoV-2. Mucosal immunity is harder to detect than antibodies that appear in the blood, however, and may require a biopsy to identify, according to the MIT Technology Review.
George Siber, the former head of vaccines at Wyeth, told Estep that short, simple peptides often don't cause much of an immune response and that he hasn't heard of any subunit vaccine delivered nasally. Siber also asked Estep if Radvac had considered a dangerous side effect, called enhancement, in which a vaccine can actually worsen the disease.
Its not the best idea especially in this case, you could make things worse, warned Siber. You really need to know what you are doing here.
Arthur Caplan, a bioethicist at New York University Langone Medical Center, called Radvac "off-the-charts loony," according to the MIT Technology Review, warning of a high "potential for harm" and "ill-founded enthusiasm."
Radvac still can't say whether or not the vaccine works. Church said that some studies are underway in his Harvard lab to see if the vaccine leads to antibodies against the virus and Estep hopes that mainstream immunologists will help the group. Concerning immune responses so far, Estep told the MIT Technology Review that its a little bit complicated, and we are not ready to report it.
Estep has continued to deliver the vaccine to a number of friends and colleagues. The materials for the vaccine have been delivered to 70 people, but since the vaccine must be mixed by the recipients, they're unsure about how many have actually taken it.
The US Food and Drug Administration requires authorization to test novel drugs in the form of an investigational new drug approval. Radvac did not request approval from the FDA and has not had any ethics board sign off on the vaccine plan.
Estep stated that he feels that Radvac is not subject to oversight because the group mixes and administers the vaccine themselves without any exchange of money. If you are just making it and taking it yourself, the FDA cant stop you, said Estep.
Estep explained that the group did seek legal advice and the white paper begins with extensive disclaimers, including that anyone who uses the vaccine takes "full responsibility" and must be at least 18-years-old.
What the FDA really wants to crack down on is anything big, which makes claims, or makes money. And this is none of those, said Church. As soon as we do any of those things, they would justifiably crack down. Also, things that get attention. But we havent had any so far.
Siber explained that self-experimentation with COVID-19 vaccines would never win ethics approval at any US university, but admitted that many vaccinologists had injected themselves as a quick and cheap way to get data. Siber himself has even done so, although not recently.
Rammensee said that he self-injected to avoid red tape and get preliminary results about a vaccine being developed at the university, adding that it was acceptable to do so because he is an expert in the field and understood the risks and implications.
"If someone like me who knows what he is doing [does it], its fine, but it would be a crime for a professor to tell a postdoc to take it, explained Rammensee.
Alex Hoekstra, a data analyst with training in molecular biology who previously volunteered on the Personal Genome Project staff, explained that the virus changed how he moved through the world, according to the MIT Technology Review.
I am not licking doorknobs, said Hoekstra. But its an amazingly surreal experience knowing that I may have an immunity to this constant danger [and] that my continued existence through this pandemic will be a useful data set. It lends a level of meaning and purpose.
Read more:
At least 20 Boston scientists tested DIY COVID-19 vaccine on themselves - The Jerusalem Post
