Speed is of the essence as governments and companies rush to develop a COVID-19 vaccine that will end the pandemic and help the world return to normal.
Its also the focus of suspicion as some people wonder whether the rapid pace also means researchers are cutting corners during the process.
Overall, about half of Americans, 49%, said they planned to get vaccinated if a COVID-19 vaccine became available, 20% would refuse and the rest werent sure, according to a recent poll from The Associated Press-NORC Center for Public Affairs Research.
Among those who said they wouldnt get vaccinated, 7 in 10 worried about safety.
Experts understood why some people might be hesitant right now.
I think its reasonable to be skeptical about a vaccine that doesnt exist yet to prevent a virus that has been elusive and difficult to characterize, Dr. Paul Offit, an infectious disease physician and director of the Vaccine Education Center at Children's Hospital of Philadelphia, told TODAY. He himself wants to see the data before getting a vaccine.
Offit also didnt think it was helpful for the government to use Operation Warp Speed as the name for its goal to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.
I can promise you a scientist did not come up with that phrase. I think its terrible, Offit said.
Even Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, last month admitted he "flinched a little" at the name, fearing that some people may think it implies the fast-track process is reckless when it isnt. Researchers are not compromising the safety at all, nor is there compromise of scientific integrity," he noted.
What should people know about the vaccine process now? We asked Offit and Dr. Daniel Kuritzkes, chief of the division of infectious diseases at Brigham and Women's Hospital in Boston and professor of medicine at Harvard Medical School.
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Obviously, the goal here is to get as many people protected against COVID-19 because you never know if youre going to be one of those unfortunate people who has a more severe case and because the more people who are protected, the less spread there will be in the community, just like with measles, mumps and all the other viral illnesses that we vaccinate for, Kuritzkes said.
Its estimated about two-thirds of the population needs to be immune to COVID-19 to achieve herd immunity. Getting there depends on a vaccines effectiveness.
If its 80% effective meaning 8 out of 10 people who were inoculated would not get COVID-19 if exposed to it then about 80% of the population would need to get the vaccine, Kuritzkes said. If its 50% effective, more than 90% of people would have to be vaccinated to get to herd immunity.
Phase 3 trials where the vaccine is given to thousands of people and tested for efficacy and safety will be critically important, both experts said.
One U.S. company will start this phase of testing on July 27 with 30,000 adults who will either receive the vaccine or a placebo. Theyll be tracked for two years to see whether they get COVID-19 or have any adverse reactions.
That gives you a very good safety database on which to base a decision on whether or not to approve a candidate vaccine, Kuritzkes said.
Assuming that we can reasonably mitigate risk in a phase 3 trial meaning test it in at least 20,000 people so you can say it doesnt have an uncommon side effect problem and show that its, lets say, 70% effective for at least four to six months then I think we can convince the public that this is worth getting, Offit added.
The government is looking for volunteers to take part in the trials.
Kuritzkes called it highly unlikely based on everything researchers know about vaccines and how they work. When people experience symptoms, theyre all short-lived, like local inflammation, a sore arm, and occasionally muscle aches, fatigue and low-grade fever, he noted.
Still, while 20,000 people is a reasonable number of humans to test, its not 20 million people, Offit said. Thats why the government maintains programs like the Vaccine Safety Datalink and PRISM to monitor the safety of vaccines after their approval.
The typical time for vaccine development is 15-20 years, while this vaccine will probably become commercially available within a year-and-a-half of the virus emerging, Offit said.
Are there steps that are being compressed, skipped or overlapping? Yes, but as long as you do the phase 3 trials, then youre fine, he noted. Theres a fragile vaccine confidence in this country, which is why we cant release these vaccines before phase 3 trials. That would be a dreadful mistake.
Much of the speed is due to efforts to reduce the purely bureaucratic barriers for getting the clinical trials underway quickly, Kuritzkes added. Similar efforts were made to develop a vaccine for Ebola.
Yes, both experts said. The key part will be the large phase 3 trials.
Both doctors also emphasized it was critically important for the government to get the process right so that only a vaccine thats proven to be safe and effective will be eventually approved.
If the first impression of this vaccine is that its in any sense unsafe or untested or ineffective, then I think its going to be hard to regain the trust of the American public, Offit noted.
A. Pawlowski is a TODAY contributing editor focusing on health news and features. Previously, she was a writer, producer and editor at CNN.
According to a new study, a Chinese phase II clinical trial of a COVID-19 vaccine candidate has shown that it is safe and induces an immune response.
With over 15 million confirmed cases of the new coronavirus, SARS-CoV-2, and more than 624,000 COVID-19 deaths globally, scientists around the world are competing against time to fast-track the development of new treatments to combat the disease.
Globally, scientists are developing about 250 candidate vaccines against SARS-CoV-2 infection. Of these, to date, at least 17 are under evaluation in clinical trials.
Stay informed with live updates on the current COVID-19 outbreak and visit our coronavirus hub for more advice on prevention and treatment.
The authors of the recent study aimed to evaluate the safety and efficacy of a vaccine candidate called adenovirus type-5-vectored COVID-19 vaccine (Ad5-vectored COVID-19 vaccine).
They also wanted to determine the most appropriate dose for a phase III trial in the coming months. They published their results in The Lancet.
The Beijing Institute of Biotechnology in Beijing, China, and CanSino Biologics developed the Ad5-vectored COVID-19 vaccine. It uses a weakened human common cold virus (adenovirus) that produces an immune system response, including antibodies, to fight off the coronavirus.
Danny Altmann, Professor of Immunology at Imperial College London in the United Kingdom, who was not involved in the study, told the Science Media Centre in London:
The Beijing approach is based on the backbone of a conventional human, common cold virus to which some people have preexisting antibodies, and they, therefore, make a lower response in some people to the vaccine because people have preexisting antibodies to their vector, so may clear it before it has a chance to work properly.
For the randomized controlled study, which took place in Wuhan, China, the researchers recruited and screened participants for eligibility in April 2020. In total, 508 participants (50% male) were eligible. The average age of the participants was 39.7, with 61% of them aged 1844, 26% aged 4554, and 13% aged 55 or older.
Of the 508 participants, 253 received a high dose of the vaccine, 129 received a low dose, and 126 received a placebo. The researchers observed the participants for 30 minutes after the injection to check for immediate adverse reactions and then followed them for any injection site or systemic adverse reactions within 14 and 28 days of the injection.
Additionally, the scientists took blood samples immediately before the treatment and at days 14 and 28 afterward to measure antibody responses.
The results revealed that 95% and 91% of those in the high dose and low dose groups, respectively, demonstrated either T cell or antibody immune responses 28 days after vaccination.
Specifically, at day 28, the team discovered T cell responses in 90% and 88% of the participants receiving the vaccine at a high and low dose, respectively.
Furthermore, both doses of the vaccine induced significant neutralizing antibody responses (in 59% and 47% of participants in the high and low dose groups, respectively) and binding antibody responses (in 96% and 97% of participants in the high and low dose groups, respectively) by day 28.
Participants in the placebo group, however, showed no antibody increases from baseline.
Although more people in the vaccine group experienced adverse reactions compared with those in the placebo group, most of the adverse reactions were mild or moderate. Adverse reactions included fatigue and pain at the injection site, and the most common severe reaction was fever.
Among the participants, 52% had high preexisting immunity to the Ad5 vector, and 48% had low preexisting immunity. Those with low preexisting anti-Ad5 immunity had neutralizing antibody levels that were approximately two times higher than those of the participants with high preexisting anti-Ad5 immunity.
Moreover, participants aged 55 or older had a significantly lower immune response than younger participants but higher tolerability to the Ad5-vectored COVID-19 vaccine.
Since elderly individuals face a high risk of serious illness and even death associated with COVID-19 infection, they are an important target population for a COVID-19 vaccine. It is possible that an additional dose may be needed in order to induce a stronger immune response in the elderly population, but further research is underway to evaluate this, states senior author Prof. Wei Chen, of the Beijing Institute of Biotechnology.
The current trial does have certain limitations. For instance, the team did not expose any of the participants to SARS-CoV-2 after vaccination.
Consequently, it is not possible for the current study to determine whether the vaccine candidate successfully protects against SARS-CoV-2 infection or whether there are any associated risks when the antibody (that the vaccination induces) encounters the new coronavirus.
Also, the trial only followed participants for 28 days. Therefore, the study has no data available about the resilience of the vaccine-induced immunity.
The authors conclude, the results of this trial have extended our knowledge of the immunogenicity and safety of the Ad5-vectored COVID-19 vaccines. They also add, We are planning an international multicenter, randomized, double-blind, controlled phase III effectiveness trial to further evaluate the efficacy of the vaccine.
For live updates on the latest developments regarding the novel coronavirus and COVID-19, click here.
Clinical trials for a number of coronavirus vaccines are underway, and the hope is to have one available for the public by 2021, but many are pushing to make sure speed and safety go hand-in-hand.
Patients are asking me, 'How effective is it going to be?' and, 'Is it safe for me to get? Is it safe for children? Is it safe for pregnant women? Is it safe for elderly seniors?' said Dr. Andrew Carroll.
Dr. Carroll expects these questions to continue as the world creeps closer to a vaccine to fight the coronavirus.
He says transparency from all the players, the drug companies, the FDA and CDC is crucial.
And that means the good -- is it 50 percent effective? Is it 90 percent effective? Will it require one shot or two shots? Thats another question, that being answered right now, and what are the side effects, said Dr. Carroll.
These are questions that look to be answered as three vaccines enter phase three of clinical trials.
Theres no use having a vaccine thats effective if no one wants to take it, said FDA Commissioner Dr. Stephen Hahn.
He says while the timeline for a vaccine has been compressed significantly, its still facing the same rigorous process.
We will not cut corners, we realize that the American people put their faith in the FDA, we have the world's best experts looking at this, said Dr. Hahn.
He says manufacturers are already making the vaccines in huge quantities.
So that if, not when, but if the FDA decides a vaccine based upon the data and science is safe and effective, they can have vaccine ready to go, said Dr. Hahn.
Moderna, in partnership with the Hope Research Institute, is lining up volunteers from across Arizona for their phase three trial.
Weve had several thousand people reach out to us, said Hope Research Institute CEO Dr. Nathan Alderson.
Dr. Alderson says they hope to enroll as many local participants as they can for the Moderna trial.
We do need more people that are at higher risk, so healthcare workers, first responders, grocery store clerks, explained Dr. Alderson.
They also need more volunteers from minority communities.
Enrollment continues until August, and they hope to inject their first volunteer next week.
Both Pfizer and AstraZeneca are expected to begin their own phase three vaccine trials in the state within the next few weeks.
To volunteer for the clinical trial visit http://HRIAZ.com/COVID or call 602-288-HOPE
One of the first Chinese projects to start testing its Covid-19 vaccine candidates overseas said it would have a vaccine ready for the public before the end of the year.
Liu Jingzhen, chairman of state-owned China National Pharmaceutical Group, also known as Sinopharm, said on state broadcaster CCTV on Tuesday that clinical trials that began in Abu Dhabi last week should be completed in roughly three months, paving the way for a vaccine to go to the market this year.
When will we have a Covid-19 vaccine? Live Q&A Financial Times
As manufacturers around the world race to develop Covid-19 vaccines, a parallel effort has begun to figure out who in the United States should get them first and how those doses should be distributed.
But already the effort is being complicated by tensions over who gets to make those critical decisions, with some groups feeling sidelined and multiple new actors crowding the stage.
On Tuesday, the National Academy of Medicine, tasked by top U.S. health officials, named an expert panel to develop a framework to determine who should be vaccinated first, when available doses are expected to be scarce. But that panel is ostensibly encroaching on the role of the Advisory Committee on Immunization Practices, a panel that has made recommendations on vaccination policy to the Centers for Disease Control and Prevention for decades, including drawing up the vaccination priority list during the 2009 H1N1 flu pandemic.
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There is also the matter of Operation Warp Speed, the governments vaccine fast-tracking program that has claimed authority over, among other things, distribution decisions when it comes to Covid-19 vaccines.
Amid so many players, public health experts are expressing concern and confusion.
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It seems to me like weve just assigned four different air traffic control towers to land the same plane, said Michael Osterholm, director of the University of Minnesotas Center for Infectious Diseases Research and Policy. Between ACIP, and this new committee, the group working within Operation Warp Speed and just in terms of input from the general community, its not clear to me who will make the final decision and how that process will unfold.
The health of untold numbers could hang in the balance, given that initial batches of vaccine are likely to be available only for a sliver of the population. Additionally, most vaccines will probably be given in two-dose regimens, meaning any figure of available doses would have to be divided in half to see how many people could be vaccinated.
There is no doubt that health care workers will be offered vaccines first. But after that, tough decisions will have to be made about the order in which other frontline workers which? how many? are offered priority access to vaccine and who will follow, in what order.
Normally, such decisions would fall to ACIP, which months ago set up a working group to monitor the evolving science on Covid-19 and the vaccines being developed to protect against it. But its not clear what task ACIP will be handed here.
We havent been given a firm answer as to what our role will be. We are continuing with our routine planning and discussion, and we will come up with what we think are appropriate guidelines for prioritization. But that weve not been given assurances that we will actually be contributing to that, said Jos Romero, the panels chairman.
Romero told STAT he even had applied to be on the National Academys panel after the academy urged people who were interested to nominate themselves. Romero said he never heard back. The agenda for the first public meeting of the panel, scheduled for Friday, states Romero has been invited to speak to the kickoff session. He said late Monday he hadnt received an invitation.
ACIP member Beth Bell, who chairs its Covid-19 vaccines work group, is also concerned about the National Academy panel working on vaccination priorities before ACIP.
Hopefully it wont be a parallel process and itll be something which can complement the work of the ACIP, said Bell, a professor of global health at the University of Washington and a former director of the CDCs national center for emerging and zoonotic infectious diseases.
She seemed to take some solace from the fact that former CDC director Bill Foege one of the architects of the smallpox eradication program and a revered figure in public health circles has been named co-chair of the new panel.
Foege will share chairing duties with Helene Gayle, president and CEO of Chicago Community Trust. Gayle previously worked at the CDC for 20 years on HIV/AIDS and at the Bill and Melinda Gates Foundation. In addition to the co-chairs, the 15 panelists include vaccine experts, ethicists, experts in vaccine hesitancy, global health, health policy, risk communications, and the delivery of health care to low-income populations.
Francis Collins, director of the National Institutes of Health, first asked National Academy of Medicine President Victor Dzau to create the new panel, even though setting vaccination priorities is a public health role traditionally on the CDCs turf, not the NIHs. Later a letter formally requesting that the panel be struck came from Collins and Robert Redfield, the CDC director.
In an interview, Collins seemed puzzled as to why ACIP members might be concerned about the creation of the expert panel. He said the decision-making framework the panel designs will make their job, I think, a lot more straightforward and less likely to be attacked as being capricious.
This is a discussion which is potentially going to be contentious and we want to try to minimize that, Collins told STAT.
There are certainly parts of society that are suspicious of what the government is doing, no matter what it is, he added. And this takes it out of that framework and provides an opportunity for whose sort of wisest big thinkers to gather and make this kind of a judgment about what those priorities ought to look like, he said.
Whats not to love about this? he said.
Some vaccine developers have embraced the idea of the National Academys involvement, which the body suggests will set a priorities framework that can be used in the United States and beyond.
It is the CDCs responsibility, the ACIP that makes decisions about allocation, but in this very special case, I have personally and I think many of us have called for the National Academy of Medicine to create a mechanism to look at health equity and make sure that the allocation is fair, Julie Gerberding, the chief patient officer at Merck, told a House subcommittee on Tuesday.
Others acknowledge there is confusion about who is doing what and most importantly, who will make the final decisions.
Osterholm, the University of Minnesota expert, called the composition of the National Academy panel outstanding. They couldnt find two better chairs than Bill and Helene.
But the excellence of the panel doesnt negate the fact there isnt much clarity about roles, he said.
Ultimately the administration in power when vaccine is approved for use will likely dictate who stands where in the vaccine priority line. The current administrations past decisions about distribution of desperately needed protective equipment for health workers and scarce supplies of the antiviral drug remdesivir dont instill confidence that the painstakingly crafted recommendations of the National Academy group, or of the ACIP, will be followed to the letter.
In the end it will be decided by the U.S. government, Osterholm said. Look at how the remdesivir situation unfolded nationally. That was a terrible situation.
The task of setting priority groups wont be an easy one.
Older adults are most at risk of dying if they become infected. But essential workers in food production and distribution may be at higher risk of contracting the virus. Who should move to the front of the line? Should the vaccination program prioritize people of color, who have contracted and died from Covid-19 in disproportion numbers? At the June meeting of the ACIP, at least one member suggested that should be considered. One of the charges to the National Academy panel is to advise on how communities of color can be assured equitable access to the vaccines.
Other questions asked of the National Academy panel include what criteria should be used to set priorities for equitable allocation of vaccines for example, how to weigh individual risk, due to age, underlying health conditions, or occupation, versus group risks posed by being in prison, being homeless or being a resident of a long-term care facility. The panel is also being asked to provide input on how to communicate vaccine priority decisions to the wider public, and how to address vaccine hesitancy, especially in high-risk populations.
Collins said the panel has been asked to come up with interim recommendations by Labor Day, which would then be subject to a short period of public comment. Dzau, the academy president, said last week that the final recommendations would probably take about three months to deliver, which would mean early October.
Dzau strenuously refuted the idea that the new panel might be driving in someone elses lane. The group will create scenarios, he said, of how to deal with the variety of circumstances the country might face, for instance starting to vaccinate with 10 million doses, or 60 million, or 100 million.
I think our job will be to look at the evidence and the strategy of who should get what and how. Some kind of priority list and the rationale for that, Dzau said.
The time frame he and Collins envisage may leave the ACIP with little time to fine-tune the framework the National Academy panel devises. Some of the most aggressive manufacturers have stated they may have enough evidence to support the issuance of an emergency use authorization from the Food and Drug Administration by October.
Beyond questions of priority-setting, there are also concerns about how vaccines will be distributed.
Those concerns were first triggered by the press release announcing the formation of Operation Warp Speed, which claimed distribution as one of the projects responsibilities.
Four organizations representing professionals who make up the last mile of a vaccines journey into arms in the United States wrote to the leaders of Operation Warp Speed on June 23, asking if the project intended to use existing vaccine delivery infrastructure to get Covid-19 vaccines into Americans. They still havent received a reply.
If your job is logistics and you dont know that theres a system out there already, it might be easy for you to start planning things down a different path, said Claire Hannan, executive director of the Association of Immunization Managers, one of the groups. And we dont want that to happen.
Another group that signed the letter, the Association of State and Territorial Health Officials, has since had a discussion with Lt. Gen. Paul Ostrowski, from Operation Warp Speed, said Jim Blumenstock, the organizations chief program officer for health security. Blumenstock said that after the conversation, he felt more confident that traditional vaccine distribution networks would play a part in the roll out of Covid-19 vaccines.
The proof is always in the pudding, he said, recounting that Ostrowski told him that micro-planning for vaccine distribution would start in the next two to three weeks.
STAT asked Operation Warp Speed for interviews about these issues. The requests were neither turned down nor granted they were merely acknowledged.
Hannan, who hadnt heard anything from Operation Warp Speed as of Monday, remains unsettled.
I am still very concerned about how distribution will be carried out and about the lack of planning with state and local public health agencies, she told STAT. We have received no assurance that existing vaccine allocation, distribution, and tracking systems will be used.
Damian Garde contributed reporting
ClinEdge, BTC Network and GuideStar Research, portfolio companies of ClinX, provide consulting, financial, marketing, advertising, enrollment, patient travel, and trial management solutions to the clinical research industry.
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View source version on businesswire.com: https://www.businesswire.com/news/home/20200724005011/en/
Moderna Inc's (NASDAQ: MRNA) coronavirus vaccine in development mRNA-1273 continues to inspire confidence among sell-side analysts.
The Moderna Analyst: SVB Leerink analyst Mani Foroohar initiated coverage of Moderna with a Market Perform rating and $65 price target.
The Moderna Thesis: The intense unmet need and the political will to get one or more vaccines approved are likely to sway regulators into showing substantial flexibility for vaccine candidates against SARS-CoV-2, the virus that causes COVID-19, Foroohar said in a Thursday initiation note. (See his track record here.)
"As a result, odds of approval for MRNA-1273 and competing therapies are high, even if pivotal clinical datasets show some inadequacies or inconsistencies," the analyst said.
Initial demand for the vaccine should be robust, he said.
SVB Leerink's base case estimates are modestly above the consensus for2021.
Medium- and long-term expectations are unlikely to be met unless Moderna shows a best-in-class profile, Foroohar said.
This is an unlikely proposition for Moderna, given its many competitors, including big biopharma players pursuing mRNA strategies similar to Moderna's, the analyst said.
SVB Leerink also sees commoditization risk even in the face of excellent data, as many companies are entering the market in a short time and considering the early price point implied by Pfizer Inc. (NYSE: PFE)/BioNTech SE's ADR supply agreement with the U.S. government.
This scenario impliesa price target of $19 per share attributable to Moderna's vaccine program, Foroohar said.
While being optimistic aboutModerna's mRNA-1273, the analyst said he's uncomfortable with Moderna's valuation,even after ascribing value to a dozen programs, many of which are quite early.
"Without major pipeline catalysts to counterbalance competitive risk to MRNA-1273, we view risk/reward as unappealing at this valuation."
MRNA Price Target: Moderna shares were trading down 3.17% at $80.59 at last check Thursday.
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WHO CHIEF SCIENTIST SAYS WHILE SPEED IS IMPORTANT IN COVID-19 VACCINE DEVELOPMENT, IT CANNOT BE AT THE COST OF SAFETY OR EFFICACY - "THERE WILL BE NO CORNERS CUT" Marketscreener.com
Birminghams Southern Research is collaborating with a company to study responses to the virus that causes COVID-19 as part of a broader program to develop a vaccine.
Southern Research, an independent nonprofit scientific research organization, announced today an expansion of an existing collaboration with Tonix Pharmaceuticals Holding Corp. The two back in February began developing and conducting testing of Tonixs TNX-1800, a potential vaccine designed to protect against COVID-19. Results from this testing are expected in the fourth quarter of this year, followed by human trials.
In addition, the two groups will focus specifically on T cell immune responses by volunteers who have recovered from the disease or who remain asymptomatic after exposure to COVID-19. T cells are a central part of the immune system. Raj Kalkeri, a senior scientist with Southern Researchs Infectious Disease Research Group, said the most successful vaccines mimic how the immune system responds to an invader.
By collecting data from recovered or asymptomatic volunteers, researchers hope to provide the same type of protection for those who take the vaccine as those who have actually recovered from COVID-19.
Tonix CEO and President Seth Lederman said TNX-1800 is designed to elicit a predominant T cell response, along with some antibody response. Three other early candidates in the companys vaccine portfolio are designed to elicit an almost pure T cell response.
We are looking forward to a timely completion of this study, utilizing readouts from a variety of assays that can provide information about TH1 or other types of immunity, Kalkeri said.
As of today, more than 15 million people have been infected with COVID-19, with more than 618,000 deaths.
