Category: Covid-19 Vaccine

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Infecting volunteers with Covid-19 might speed up the race for a vaccine. But it could be risky – CNN

July 29, 2020

Usually, vaccines are developed over the course of several stages, starting with testing in petri dishes and animals. The small fraction of these that show some promise then enter several phases of human trials, where researchers administer the vaccine to an increasing number of people while monitoring the dosage and assessing side effects and efficacy.

In Phase 3 (the last phase before FDA approval), researchers separate the participants into two groups, and administer the vaccine to one group while giving the other a placebo.

Researchers typically wait several months as the participants lead their lives, going to work, seeing family members or taking public transportation. If fewer people who received the vaccine than those given the placebo end up getting infected, it is deemed effective.

Because doctors have an ethical duty to minimize harm, they generally avoid purposely infecting people with a virus. But the usual process of waiting to see how many of the participants are naturally infected takes a long time.

And if the trials are being conducted in a place where community spread is low, participants in both groups may never be exposed to the virus, and researchers would have a hard time determining whether the vaccine works.

An organization called 1Day Sooner, which advocates for the use of "human challenge" trials in the development of a Covid-19 vaccine, asks people (especially those who are young and have no underlying health conditions) to enter their names online and state that they are willing to volunteer to take part in such a trial.

On paper, this approach seems straightforward and full of potential, given that the world is desperate to develop a Covid-19 vaccine. But it is critical that the process -- along with the final product -- is as safe as possible, especially given the mistrust of science in this country and the growing anti-vaxxer movement. This novel study design raises several significant problems that have not yet been resolved.

It remains unclear whether controlled infection trials will be implemented, or how. Proponents of these trials say they might need about 100 participants for each study. If researchers took this approach for 20 studies, 2,000 people would be infected with Covid.

Most vaccine trials are designed to test whether the product leads people to develop antibodies, not whether the vaccine actually prevents infection. Even if an experimental vaccine causes someone to develop antibodies, they might not successfully trigger all the components of the body's immune system to effectively attack the virus.

A vaccine may also only be partially effective and could cause significant side effects. It might, for instance, create antibodies only in perhaps 50% or 60% of participants, and cause serious illness in 10%.

The incident has helped fuel the anti-vaxxer movement ever since.

Unfortunately, given the ever-rising costs of drugs in the US, pharmaceutical companies that end up developing a successful vaccine may charge a significant amount of money for it.

Proponents of challenge studies have also largely ignored the question of whether participants (or their family members) will be compensated if they end up with long-term medical problems or die as a result of the trial.

While we shouldn't automatically reject the possibility of human challenge trials, given the number of lives that could be saved with an early vaccine, we need to proceed very cautiously.

If we do embark on these trials, researchers should be even more selective about which experimental vaccines to use. Drug companies should also commit to making the vaccine, if it is approved, affordable for millions of people.

Researchers, should they embark on controlled infection trials, should administer the vaccine and infect only a handful of participants at a time, and check whether it's effective before giving it to additional subjects to minimize any potential damage.

Informed consent and robust guidelines for all participants is crucial, and researchers should quiz each participant to guarantee that he or she fully understands the potential risks.

We all want a safe, effective and widely available vaccine, but researchers need to ensure that participant safety is also thoroughly considered.

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Infecting volunteers with Covid-19 might speed up the race for a vaccine. But it could be risky - CNN

Family Healthcast: Progress being made toward COVID-19 vaccine – WSYR

July 29, 2020

Posted: Jul 28, 2020 / 06:00 PM EDT / Updated: Jul 28, 2020 / 06:00 PM EDT

(WSYR-TV) Hopes are high for a coronavirus vaccine early in the new year. Whether that happens depends on testing being done right now.

In fact, 27 vaccines are being tested on people right now.

The largest study took a huge step forward this week when the experimental shot was given to the first of 30,000 people at 89 sites around the country.

Half of the people will receive two shots of the vaccine, 28 days apart, and half will receive two shots of a saltwater placebo. Neither the volunteers nor the medical staff giving the injections will know who is getting the real vaccine.

Researchers will then monitor the subjects, looking for side effects and waiting to see if significantly fewer vaccinated people get COVID-19, indicating that the vaccine works.

The main goal is to determine whether the vaccine can prevent the illness.

The study will also try to find out if it can prevent severe COVID-19 and death, if it can prevent infection entirely based on lab tests and if just one shot can prevent the illness.

The full enrollment of 30,000 people in the trial is expected to be completed by the end of the summer and results might be available by November.

At least three more so-called Phase Three trials will be starting soon, each also needing 30,000 patients.

A second company, Pfizer, announced late Monday afternoon that it had also begun a late-stage study of a coronavirus vaccine.

The first subjects in that study received injections at the University of Rochester on Monday.

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Family Healthcast: Progress being made toward COVID-19 vaccine - WSYR

Will People With HIV Be Excluded From COVID-19 Vaccine Trials? – POZ

July 29, 2020

As the world waits with baited breath for a safe and effective vaccine to prevent SARS-CoV-2, the new coronavirus that causes COVID-19, people living with HIV are concerned that they may be excluded from clinical trials testing these vaccines.

Following the publication this month of promising data from early-stage trials, two vaccine candidatesone being developed by the National Institute of Allergy and Infectious Diseases (NIAID) and the biotechnology company Moderna, the other by the University of Oxford and AstraZenecaentered the final stage of testing this week.

But the trial protocol for the NIAID-Moderna vaccine, available on ClinicalTrials.gov (study number NCT04470427), excludes people with an immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection.

This really stinks! What a great way to begin the U.S. Phase III vaccine effortlets exclude people with HIV, longtime advocate Lynda Dee of AIDS Action Baltimore told POZ. Apparently, the HIV exclusion was added to a new version of the protocol unbeknownstto many stakeholders. Were going to do our very best to make Moderna amend the HIV exclusion.

Dee and a growing group of advocates have issued a sign-on letter to the director of the National Institutes of Health (NIH), which oversees NIAID, demanding that they do not exclude people with HIV. A copy of the letter will be sent to pharmaceutical companies developing COVID-19 vaccines.

In the era of effective antiretroviral therapy, most HIV-positive people on treatment do not have immune suppression because the medications halt viral replication and allow CD4 T-cell counts to return to near-normal levels. Studies so far have found that people living with HIV are neither at greater risk for SARS-CoV-2 infection nor more likely to develop severe COVID-19 or to die from it.

The NIAID-Moderna trial protocol states that it will include healthy adults or adults with preexisting medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the three months before enrollment.

The Oxford-AstraZeneca trial protocol (study number NCT04400838) excludes people with any confirmed or suspected immunosuppressive or immunodeficient state but does not specifically mention HIV. All study sites for this vaccine trial are in the United Kingdom.

While most HIV-positive people on treatment fall into the stable disease category, advocates fear that the explicit HIV exclusion criterion in the NIAID-Moderna protocol will create confusion and be interpreted as taking priority.

And in fact, this has already happened. Jeff Taylor of the HIV+Aging Research Project, another longtime advocate, called a local study site listed in the trial description and was told that he could not enroll because he is HIV positive, even though he met all the otherstudy criteria."

I was shocked to see that HIV was specifically excluded, Taylor told POZ. "There is no need to exclude the 1.2 million people living with HIV from getting this vaccineespecially since more than half are older than 50 and at increased risk for severe illness or dying from COVID.

Decades of research have proven that HIV-positive people with undetectable viral loads and a safe CD4 count respond to vaccines, and are encouraged to receive all recommended vaccinations, he continued. It shouldgive us pause to see an inexperienced company with a lack of basic scientific knowledge is in charge of a hugely important vaccine trialat a huge cost to taxpayers.

Sign-On Letter

According to Dee, Carl Dieffenbach, PhD, director of NIAIDs Division of AIDS, said he would request an amendment to the protocol after the trial opens.

But advocates are in no mood to wait, concerned that HIV-positive people eager to participate in the study will be turned away, as Taylor was, before the amendment makes its way through the system and filters down to local study site coordinators.

In an effort to increase the pressure to change the NIAID-Moderna criteriaand to ensure that other companies developing COVID-19 vaccines do not make the same mistakeadvocates issued a sign-on letter to NIH director Francis Collins, MD, PhD.

We are extremely dismayed to learn that a COVID-19 vaccine candidate developed with significant contributions from researchers at the NIH excludes people with HIV with no scientific basis, reads the letter. We want to be sure you are aware of this situation, will do everything in your power to intercede with Moderna to reverse this exclusion and ensure that such an exclusion never happens again.

There is no clinical justification for excluding people with HIV from COVID-19 vaccine trials. Thanks to the advent of triple combination antiretroviral therapy in the mid-1990s, HIV infection has not been synonymous with an immunodeficient state for over two decades, the letter continues. At most, CD4 T-cell threshold criteria might be employed if there are concerns about people with very low counts being able to mount insufficient vaccine responses. If there are concerns about a unique immune response for people with HIV, this can be studied through a subset analysis of participants with HIV. This approach should be considered for participants with other controlled comorbidities, and is especially important with respect to communities of color, who are disproportionately affected and suffer disparate outcomes from both HIV and SARS-CoV-2 infections.

Whats more, the NIAID-Moderna exclusion sets a terrible precedent, not grounded in any scientific data, the letter states. If the Moderna vaccine is approved by the [Food and Drug Administration], there will be no data on its safety or efficacy in people with HIV. Thus, there will probably not be an FDA indication for people with HIV or payer reimbursement as a result.

The FDA has been explicitlyclear that people living with HIV on sustained treatment should be treated as healthy volunteersfor clinical trials, Ace Robinson of NMAC told POZ. Furthermore, the racial and ethnic minority communities experiencing the worst HIV-related health outcomes are the exact same ones that are experiencing the worst COVID-19 health outcomes. We must do better to engender trust in these communities. This oversightby Moderna is yet another step backward in establishing medical trust between clinical development and communities of color. Moderna and other biotech firms must be held to the highest standards even when we are moving at warp speed.

Initial signatories on the letter include some of the big names in HIV advocacy, including Mark Harrington and Richard Jefferys of the Treatment Action Group, Guillermo Chacon of the Latino Commission on AIDS, Moises Agosto of NMAC, Murray Pennerof the Prevention Access Campaign, Mitchell Warren of AVAC and Bruce Richman of the Prevention Access Campaign.

Community members are encouraged to sign on to the letter as well.

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Will People With HIV Be Excluded From COVID-19 Vaccine Trials? - POZ

Virology Experts to Address Race for a COVID-19 Vaccine in Live Webinar – Pharmacy Times

July 29, 2020

MJH Life Sciences will host COVID-19: Race for a Vaccine, a free, live, 1-hour webinar, Thursday, July 30, at 6 p.m. EDT.

Investigators and scientists around the globe are racing the clock to develop a vaccine against SARS-CoV-2, the virus that causes COVID-19. With a handful of candidates entering phase 3 trials, huge investments from governments for the first 100 million doses, case counts continuously ticking upward and policymakers working to untangle the logistical knots of distribution, the race for a COVID-19 vaccine is one of the most urgent public health challenges in modern history.

This panel discussion will feature the top minds in infectious diseases, virology and vaccinology, who will give participants a breakdown of the top vaccine candidates and the latest information on clinical trials. They will also discuss how to combat logistical challenges associated with rolling out a vaccine in the middle of a global pandemic.

Expert panelists includeGregory A. Poland, MD,director, vaccine research group, Mayo Clinic;Walter A. Orenstein, MD,professor andassociate director, Emory Vaccine Center; andAngela Rasmussen, PhD,virologist, Columbia University Mailman School of Public Health.

With new data from clinical trials about a COVID-19 vaccine being released every day, more concerns and more questions have been raised, especially by clinicians, said Mike Hennessy Jr., president and CEO of MJH Life Sciences, in a prepared statement. As the pandemic continues to surge, our mission to improve quality of life through health care communications, education and research has become more relevant and urgent than ever. Our teams are working hard and fast to ensure that the medical community has access to critical, timely insights to allay the confusion that exists within the medical and public community.

During the webinar, the panelists will provide insight on the following:

To learn more about the webinar and to register, click here.

REFERENCE

MJH Life Sciences Hosts Virology Experts for COVID-19: Race for a Vaccine Live Webinar [news release]. Cranbury, NJ; July 28, 2020: MJH Life Sciences. https://www.businesswire.com/news/home/20200728005629/en/MJH-Life-Sciences%E2%84%A2-Hosts-Virology-Experts-%E2%80%9CCOVID-19 Accessed July 29, 2020.

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Virology Experts to Address Race for a COVID-19 Vaccine in Live Webinar - Pharmacy Times

Researchers Identify Potent Infection-Blocking Antibodies In Race For COVID-19 Vaccine – PRNewswire

July 29, 2020

PALM BEACH, Fla., July 28, 2020 /PRNewswire/ -- As the global pandemic caused by the coronavirus SARS-CoV-2 continues, researchers are working at unprecedented speed to produce new treatments and vaccines. Much work has focused on studying antibodies from the blood of people who have recovered from COVID-19,the disease caused by SARS-CoV-2. Antibodies are molecules that are produced by the immune system to fight infection. Some research teams are testing whether antibodies against SARS-CoV-2 could be isolated and given as a treatment to others who are infected. Others are studying the structure and function of different antibodies to help guide the development of vaccines. A recent articlefrom the National Institutes of Health discussed this issue saying: "SARS-CoV-2 particles have proteins called spikes protruding from their surfaces. These spikes latch onto human cells, then undergo a structural change that allows the viral membrane to fuse with the cell membrane. The viral genes then enter the host cell to be copied and produce more viruses. Several potential vaccines now under development are designed to trigger the human body to produce antibodies to the SARS-CoV-2 spike protein. Antibodies that recognize and bind to the spike protein will hopefully block the virus from infecting human cells." Active biotech companies with recent developments include: Nascent Biotech, Inc. (OTCQB: NBIO), MediciNova, Inc. (NASDAQ: MNOV), OPKO Health, Inc. (NASDAQ: OPK), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Ampio Pharmaceuticals, Inc. (NYSE: AMPE).

The article continued: "To better understand antibodies against the spike protein that are naturally produced after an infection, a team led by Drs. Davide Robbiani and Michel Nussenzweig at the Rockefeller University studied 149 people who had recovered from COVID-19 and volunteered to donate their blood plasma. The participants had started experiencing symptoms of the virus an average of 39 days before sample collection.The study was funded in part by NIH's National Institute of Allergy and Infectious Diseases (NIAID). Results were published on June 18, 2020, inNature."

Nascent Biotech, Inc.(OTCQB: NBIO) BREAKING NEWS:Nascent Biotech Announces Collaboration with Syracuse University - Advancing COVID-19 Research - Nascent Biotech (the "Company" or "Nascent") announced today it has entered into a research collaboration with Syracuse University to further the development of Pritumumab, a unique monoclonal antibody that binds to cell-surface vimentin, for potential use in COVID-19 treatment.

Alison Patteson, an assistant professor of physics at Syracuse University, will test to see if Pritumumab has the potential to block SARS-CoV-2 (SARS2), the virus responsible for COVID-19, from entering cells. According to Patteson, research shows that SARS2 may be traveling into cells by way of a receptor known as cell-surface vimentin (CSV).This ia a protein found on the cell surface, similar to vimentin, which is a key internal structural protein present in many cell types. Vimentin is known for its cage-like structure which protects the cell against damage..

"Our hope is that when we treat cells with Pritumumab, it will bind to CSV, and effectively block the SARS2 virus from entering the cell," says Patteson. "An antibody that could block the entry of SARS2 into the cell could be a monumental step in the fight against COVID-19."

Patteson will test the hypothesis on mouse embryo fibroblast cells and lung airway epithelial cells to determine if the antibody will block the uptake of SARS2. Using a cell in which vimentin has been knocked out, the results will provide an important control of Pritumumab effects.

Nascent Biotech Chief Medical Officer over Viral Research, Dr. Navpaul Singh said, "This collaboration will determine if Pritumumab can effectively block SARS2 in an animal mouse model. It will also gauge Pritumumab's ability to bind vimentin in a live model." Read this entire press release and more news for NBIO at: https://www.financialnewsmedia.com/news-nbio

Other industry developments from around the markets include:

MediciNova, Inc. (NASDAQ: MNOV)recently announced an agreement with BioComo (President: Masayuki Fukumura, Mie prefecture, Japan) and Mie University (Mie prefecture, Japan) for joint development of a SARS-CoV-2 vaccine using BC-PIV, a human parainfluenza virus type 2 vector developed by BioComo and Tetsuya Nosaka, M.D., Ph.D., professor of the Department of Microbiology and Molecular Genetics, Mie University Graduate School of Medicine.MediciNova has been granted exclusive worldwide development rights to use BC-PIV for SARS-CoV-2 vaccine development from BioComo and Mie University.

BC-PIV, an innovative non-transmissible viral vector co-developed by BioComo and Mie University, is derived from the recombinant human parainfluenza virus type 2 (hPIV2). It is highly efficient in its ability to transfer multiple foreign proteins to recipients and has a strong safety profile as no secondary infectious virus is produced. BC-PIV is designed to display not only the gene but also the foreign protein itself on the surface and inside of the viral membrane. Therefore, it can carry the large membrane proteins of viruses and signal transduction receptors/ligand proteins on the viral surface. BC-PIV is able to carry the proteins that require a proper three-dimensional structure or multimeric structure while maintaining the structure.BC-PIV elicits good immunogenicity against antigen proteins without adjuvants. The SARS-CoV-2 vaccine prototype has been developed to include the specific SARS-CoV-2 antigen protein in order to express maximum antigenicity. To date, BioComo has succeeded in producing a recombinant Ebola virus vaccine and a Respiratory Syncytial virus prefusion F vaccine (unpublished data) using this BC-PIV platform technology.

OPKO Health, Inc. (NASDAQ: OPK)recently announcedit will accept an Indefinite Delivery Indefinite Quantity (IDIQ) contract award to provide Commercial Surge Capacity Testing for COVID-19 Emergency Response to the Centers for Disease Control and Prevention (CDC).

Under the contract with the CDC, BioReference will perform antibody testing to determine COVID-19 seroprevalence, and will provide results with key demographic information and analysis in collaboration with the CDC. The agreement's period of performance beganJuly 20, 2020, and is ongoing throughNovember 19, 2020.

Inovio Pharmaceuticals, Inc. (NASDAQ: INO)recently announced positive interim clinical data of INO-4800, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase 1 clinical trial cohorts. In addition, INO-4800 has been selected to participate in a non-human primate (NHP) challenge study as part of the U.S. government's Operation Warp Speed, a new national program aiming to provide substantial quantities of safe, effective vaccine for Americans byJanuary 2021. Furthermore, INOVIO has expanded its Phase 1 trial to add older participants in additional cohorts and plans to initiate a Phase 2/3 efficacy trial this summer upon regulatory concurrence.

Dr. J.Joseph Kim, President and CEO of INOVIO, said, "INOVIO would like to thank all of the trial participants and the investigator staff who have made this trial possible. We are very encouraged by the positive interim safety and preliminary cellular and humoral immune response results to date as well as the inclusion of INO-4800 in Operation Warp Speed. We are also pleased that INO-4800 vaccination abrogated viral replication in the lungs of mice challenged with SARS-CoV-2.We look forward to urgently advancing INO-4800, as it is the only nucleic-acid based vaccine that is stable at room temperature for more than a year and does not require to be frozen in transport or for years of storage, which are important factors when implementing mass immunizations to battle the current pandemic."

Ampio Pharmaceuticals, Inc. (NYSE: AMPE) is actively working on the development of therapies for patients infected with the SARS-CoV-2 virus ("COVID-19"). Patients are being dosed in a Phase 1 United States based clinical trial evaluating a 5-day intravenous ("IV") Ampiontreatment for COVID-19 patients requiring supplemental oxygen. The primary endpoint for this randomized, controlled study will evaluate the safety and tolerability ofIVAmpion treatment in adult COVID-19 patients requiring oxygen supplementation.

Ampion is an immunomodulatory anti-inflammatory agent that has been shown to inhibit the expression of proinflammatory cytokines, including tumor necrosis factor alpha (TNF), by repressing their transcription. Proinflammatory cytokines like TNF are believed to play a key role in the overactive inflammatory response, or cytokine storm, in the lungs of COVID-19 patients who require supplemental oxygen. Ampion may be effective in interrupting the inflammatory cascade associated with COVID-19 and improve the clinical course and outcome of patients. A manuscript detailing this mechanism of action titled, "The novel immunomodulatory biologic LMWF5A (Ampion) for pharmacological attenuation of the 'cytokine storm' in COVID-19 patients: a hypothesis", has been published in a peer-reviewed journal.

DISCLAIMER:FN Media Group LLC (FNM), which owns and operates Financialnewsmedia.com and MarketNewsUpdates.com, is a third- party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels.FNM is NOT affiliated in any manner with any company mentioned herein. FNM and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security.FNM's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material.All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release.FNM is not liable for any investment decisions by its readers or subscribers.Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed FNM was compensated forty six hundred dollars for coverage of news issued by Nascent Biotech, Inc. by a non-affiliated third party.

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Researchers Identify Potent Infection-Blocking Antibodies In Race For COVID-19 Vaccine - PRNewswire

Novavax coronavirus vaccine will be made at Texas facility if successful – The Texas Tribune

July 28, 2020

Need to stay updated on coronavirus news in Texas? Our evening roundup will help you stay on top of the day's latest updates. Sign up here.

A biotech production facility in College Station could begin manufacturing hundreds of millions of doses of a COVID-19 vaccine as early as next year.

As part of a $265 million contract with the federal government, the Texas A&M University System Center for Innovation in Advanced Development and Manufacturing which is owned and operated by Fujifilm Diosynth Biotechnologies has been tapped to mass-manufacture a vaccine candidate that is still undergoing testing. That vaccine, which is being developed by the little-known Maryland company Novavax, is one of six candidates the federal government has put billions of dollars behind as part of its Operation Warp Speed, which is pursuing an aggressive timeline for mass-distributing a coronavirus vaccine.

President Donald Trump, appearing Monday afternoon at a North Carolina Fujifilm facility where the vaccine candidate is being developed for clinical trials, praised the progress of the Novavax vaccine and of other therapeutics.

We will have it delivered in record time, he said.

If clinical trials for the Novavax vaccine prove successful, the bulk production will be moved to the College Station facility which is quite the place, the president said Monday starting next year. The federal dollars will pay for equipment to significantly expand the facilitys production capacity. As many as 80 new hires are also expected.

W. Jay Treat, Texas A&Ms chief manufacturing officer for the Center for Innovation in Advanced Development and Manufacturing, said although the federal contract does not specify a certain number of doses that his facility must produce, he is optimistic that the figure could be in the hundreds of millions. And if Novavax doesn't prove successful in clinical trials, he expects the facility could pivot to begin producing a different vaccine.

If all goes well, Treat said, "I think we might have the capacity here to provide enough [doses] for the U.S. There may even be excess capacity."

Novavax, which has never brought a vaccine to market, received the federal governments largest-yet vaccine contract of $1.6 billion earlier this month. A total of about $4 billion has been invested in companies pursuing vaccines.

According to the World Health Organization, Novavaxs vaccine is still in relatively early stages compared with competitors. Researchers began testing the vaccine in 130 humans in May and expect to report preliminary results by the end of this month. By contrast, Moderna has already found promising results from its early phase trials and launched a trial this week that will enroll 30,000 human participants across the country.

Researchers across the globe are pursuing 166 COVID-19 vaccine candidates, but only about two dozen vaccines are currently being tested in humans, according to the World Health Organization. The U.S. Food and Drug Administration approves less than 10% of drugs that undergo clinical trials for public use.

And developing a vaccine against any new infectious disease is a challenging, time-consuming project. Researchers have outlined an optimistic 12- to 18-month timeline on developing a vaccine against the new coronavirus; that would mark the fastest vaccine development in history.

Officials with the A&M System, as well as Fujifilm, praised the federal governments decision to entrust production to the Texas facility, which was founded with such a project in mind.

John Sharp, chancellor of the Texas A&M University System, called the project a triple win: for the A&M System, for Fujifilm and for the nation.

The A&M System facility was founded in 2012 as one of the U.S. governments three national biosecurity centers, intended to develop and produce drugs that would fight pandemics and bioterrorist threats. The U.S. government decided to make an investment in domestic production facilities in the wake of the 2009 H1N1 influenza, not wanting to be reliant on other countries for vaccines in times of crisis.

Fujifilm, a photography, medical equipment and biotech corporation, now owns and operates the facility, but the federal contract runs through the A&M System as part of its long-standing partnership with the federal government on such projects.

The facility has done some work for the government, on drugs for Zika and other diseases, but the coronavirus vaccine will be its first large-scale government contract, Treat said.

Disclosure: The Texas A&M University System has been a financial supporter of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribune's journalism. Find a complete list of them here.

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Novavax coronavirus vaccine will be made at Texas facility if successful - The Texas Tribune

To beat the pandemic, we need outreach about a Covid-19 vaccine – STAT

July 28, 2020

Americans anxiously await two key benefits that a Covid-19 vaccine will deliver: freedom from fear and a return to normal.

No single vaccine is likely to offer a panacea for this pandemic. And even if it did, it might not accomplish its job if we dont deal with hesitance to get vaccinated and counter vaccine disinformation. By failing to do these things, we risk a perpetual cycle of infectious disease coupled with persistent economic decline.

Now is the time to make sure that all residents of the U.S. understand the value of a Covid-19 vaccine and the necessity of getting one.

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Since the start of the Covid-19 pandemic, vaccination conspiracy theories have flourished, fueled by a potent combination of fear, misinformation, and social media amplification. According to new polling data, among adults who have heard of one or more Covid-19 conspiracy theories, 36% believe it to be probably or definitely true.

At first, many health professionals dismissed vaccine conspiracy theories as outlandish and unbelievable. Yet additional polling data indicates 20% of Americans would outright refuse a Covid-19 vaccine and 31% are unsure as to whether they would get vaccinated.

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In essence, conspiracy theories and anti-vax sentiment have reached the American mainstream, even as researchers and health care professionals are making progress toward effective treatments, with some Covid-19 vaccine candidates already showing positive results.

Our nation is hurtling toward a future where our scientific prowess makes preventing Covid-19 possible yet a substantial proportion of Americans may be unwilling to accept or avail themselves of these scientific breakthroughs, thereby continuing to fuel the global pandemic. We are already witnessing this problem with the refusal of a significant number of Americans to wear face coverings to reduce the transmission of Covid-19.

To effectively beat Covid-19 we will need solutions beyond those furnished by science.

Most Americans have a high level of trust in their personal medical providers, whether they are doctors, nurses, or physician assistants. These medical professionals should proactively reach out to their patients and discuss the potential benefits and risks of a Covid-19 vaccine before one becomes publicly available. This personal touch could go a long way in helping patients make a more informed and balanced decision with input from a trusted medical expert.

This could take many forms. It could become a standard and essential part of clinicians telehealth or in-person visits. Clinicians could reach out by email or letter to explain the benefits of vaccination against Covid-19, while addressing any potential concerns that patients may have about potential side effects. In addition to engaging individual patients, we encourage healthcare providers to seek out venues in which larger groups could be better informed about the benefits of a Covid-19 vaccine. In particular, local parent-teacher association meetings, town halls, or other virtual gatherings are opportunities to provide up-to-date and scientifically sound advice. These messages should highlight that vaccines benefit not only the individual but also family and friends, a message that preliminary evidence has been shown to be effective.

We must also invest in grassroots public outreach campaigns to communities in which vaccine hesitancy and skepticism are prevalent. On social media, false information spreads faster than true information. Coupled with public skepticism of government and public health officials, that poses a big challenge.

Heavy-handed, dry, and regulated government messaging wont be effective in a world where public opinion is ruled by tweets and sound bites. The messaging must be designed specifically for social media and carried by nontraditional messengers, like local and national celebrities, religious leaders, and other influencers with broad reach. These messengers would serve as an important counterpoint to some of the unfounded conspiracy theories that have propagated online.

On top of these efforts, social media companies must partner with public health experts to curb the spread of misinformation, expose the falsehoods driving vaccine hesitancy, and stop groups that incite attacks or violence directed at public health officials. Partnering with expert reviewers has been leveraged by Wikipedia via trusted editors. Others have suggested crowdsourcing approaches to help ensure the veracity of online claims. Social media has given us wondrous new, lightning-fast communication tools, and these assets need to drive evidence-based messaging that advances public health and ultimately, helps save lives.

With the surge in Covid-19 cases, its clear that we need to rewrite the pandemic strategy and playbook. Federal and state governments should do more to partner with the private sector to help America achieve community immunity. We simply cannot get there without investing in targeted, grassroots outreach campaigns to encourage the uptake of a Covid-19 vaccine while at the same time moderating purveyors of disinformation.

Beating Covid-19 will require nontraditional partnerships and new communication styles that will resonate with the American public and, at the end of the day, win hearts and minds.

Bill Frist is a physician, former Republican Senate majority leader from Tennessee, chairman of the executive council of the health care investment firm Cressey & Company, senior fellow at the Bipartisan Policy Center, and a co-chairman of the centers work on health innovation. Richard Pan is a pediatrician representing Sacramento in the California State Senate and chairs the Senate Committee on Health. Max G. Bronstein is the founder of the Journal of Science Policy & Governance. He was previously senior director of health policy and corporate affairs at Audentes Therapeutics and chief advocacy and science policy officer at the EveryLife Foundation for Rare Diseases.

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To beat the pandemic, we need outreach about a Covid-19 vaccine - STAT

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