Category: Covid-19 Vaccine

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The Biomedical Advanced Research and Development Authority (BARDA) and Snapdragon Chemistry are teaming up to develop a continuous manufacturing platform to produce a specific raw material for COVID-19 vaccines.

They are developing ribonucleotide triphosphates (NTPs), a critical raw material for COVID-19 vaccines that use messenger RNA technology. The project includes a scalable, continuous manufacturing process for the purification of NTPs.

Messenger RNA (mRNA) is present in all living cells and carries instructions from the DNA of one cell to another. Right now, one of the COVID-19 vaccines being developed with federal funding use mRNA technology and rely on NTPs.

With a small footprint and low capital cost, multiple identical platforms can be deployed to vaccine manufacturing facilities in the United States. This provides a more reliable way of producing the NTP component of some COVID-19 vaccines.

This project is one component of BARDAs rapidly expanding COVID-19 medical countermeasure portfolio.

Snapdragon Chemistry, based in Waltham, Mass., is a chemical technology company focused on the design and development of manufacturing processes for chemicals and pharmaceuticals.

As part of the governments Operation Warp Speed initiative, BARDA is working to remove any barriers to vaccine production and provide the services and expertise private sector partners need to accelerate development and manufacturing.

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BARDA teams up with Snapdragon to develop materials for COVID-19 vaccine - Homeland Preparedness News

The average times of the fastest sprinters in the 100-metre dash are in the ballpark of 10 seconds. So, what would you think if someone promised to run the race in one second?

It typically takes a minimum of 10 years for a vaccine to complete the three consecutive phases of the clinical research pipeline. This is because of the scope and length of the experiments, the need to critically assess the results at each stage and the mountains of paperwork that are involved.

What are the chances that this can be reduced to 12 months? Indeed, it has been implied that this process can be accelerated to warp speed.

We contend that a safe and effective vaccine against severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), which is the causative agent of coronavirus disease COVID-19, most likely cannot be made available to the public in time to make a substantial difference to the natural outcome of this pandemic. People often cling to hope even when prospects of success are low. However, this can have negative consequences if that hope is not realized.

We are academic scientists who manage vaccine research programs. In fact, Dr. Bridle received COVID-19-focused funding to develop a novel vaccine platform. Although many of us are working hard towards developing vaccines against SARS-CoV-2, we worry that some in the scientific community have offered too much hope for this to be accomplished in a timely fashion. Sometimes these promises are used by politicians and governments to inform public policies. As a result, the integrity of the scientific community is now in the limelight and, arguably, at risk.

Vaccines are an effective way for a population to achieve what is known as herd immunity. This is the concept that the pandemic will end once approximately 60-70 per cent of people become immune to SARS-CoV-2. An alternative is to let SARS-CoV-2 run its natural course until herd immunity is achieved. With physical distancing, some epidemiologists argue this could take two years, during which time a vaccine could be developed.

However, vaccinating at the tail end of a pandemic when disease incidence is very low and declining may be of little utility, hence the race to develop a vaccine for COVID-19. If one is not in widespread use within the first half of 2021, it will probably be too late to have a meaningful impact on control of COVID-19.

Educators often rely on past performance to predict the future performance of students. In this respect, how was the performance of the scientific community in the wake of the original SARS-CoV, or Middle East respiratory syndrome (MERS)-CoV? The fact is, no vaccine against a coronavirus has successfully navigated the rigours of clinical testing, despite having up to 17 years to do so.

The same applies to other dangerous respiratory pathogens, such as respiratory syncytial virus. Whether enough has been learned from these past experiences to get the design of COVID-19 vaccines right remains to be seen, and still does not negate the need for a rigorous testing process that will take time.

One concern is that some vaccines can protect against disease (that is, the outcome of an infection) but not against infection (the ability of the virus to get into the body). In this scenario, vaccinated individuals could potentially become asymptomatic carriers of SARS-CoV-2, thereby spreading COVID-19. For this and many other reasons, a cautious approach must be taken to developing COVID-19 vaccines.

What about the fact that there are front-runner vaccines already in human clinical trials? First, many of the vaccine technologies that can most readily make it to the front of the line are not necessarily the best quality. The easiest way to make a vaccine is to inactivate the pathogen or use pieces of it, and mix them with an adjuvant, which tells the immune system that the pathogen is dangerous and worth responding to.

However, an inactivated virus or its components do not behave like the live virus, so the immune system sometimes responds to these vaccines in a way that is ineffective or sometimes even dangerous. For example, no vaccine based on the genetic material, known as ribonucleic acid or RNA, from a virus like SARS-CoV-2 has ever been approved. Further, some vaccines developed against the original SARS-CoV, after the epidemic was over, exacerbated the disease in mice.

A vaccine for COVID-19 does not have to be the best one, but it does need to be good enough to accelerate a populations progression to herd immunity. As experienced peer reviewers, we have some concerns about the rigour of some of the science surrounding COVID-19 vaccines.

Some vaccines are fast-tracking through the regulatory system before studies are completed and with minimal details of experimental results being released. Executives of a big pharmaceutical company whose vaccine is among those closest to the finish line recently sold their stocks after releasing positive results that were superficial, partial and that included three of eight healthy young volunteers experiencing severe adverse events.

Events like this are causing the public to become skeptical. A promising vaccine should have solid data to back it up. Those touting vaccines against COVID-19 that are in clinical trials should be asked to provide comprehensive details and results of their study. This enables objective and rigorous evaluations by the broader scientific community. A lack of complete transparency would be cause for concern.

Assuming a vaccine succeeds in human trials, it then needs to be manufactured in massive quantities at an affordable price, undergo quality control testing and be distributed worldwide. Even if by some miracle this spectrum could be bridged at warp speed, one then needs to wonder if up to 70 per cent of individuals can be effectively vaccinated.

Uptake of a vaccine could be compromised by anti-vaxxers, as well as by perceptions that warp-speed manoeuvring might be the result of cutting too many corners and compromising safety. Then there are those who simply do not respond as well to vaccines, which includes the elderly who are in the greatest need of protection.

Considering what we now know about SARS-CoV-2 vaccines, we need to take a more cautious approach and one could question if any of the vaccines that are now in pre-clinical testing can possibly help with the current pandemic. We sincerely hope that our pessimism about vaccines currently in clinical trials being ready in time is soundly proven wrong.

Even if a vaccine doesnt get developed in time, not all is lost. The array of vaccines being engineered will help with outbreaks beyond COVID-19. They can be vetted by scientists and the best technologies and associated research teams could be shortlisted to be called upon for future outbreaks. Although clinical research likely cannot be shortened to 12 months while maintaining integrity of the science, the current attempt to do so will build new and reasonable efficiencies into health regulatory policies. This will facilitate getting a wide variety of future health solutions to patients faster, but not at warp speed.

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Fast COVID-19 vaccine timelines are unrealistic and put the integrity of scientists at risk - The Conversation CA

COVID-19 (coronavirus) vaccine: Get the facts

A vaccine to prevent coronavirus disease 2019 (COVID-19) is perhaps the best hope for ending the pandemic. Currently, there is no vaccine to prevent infection with the COVID-19 virus, but researchers are racing to create one.

Coronaviruses are a family of viruses that cause illnesses such as the common cold, severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). COVID-19 is caused by a virus that's closely related to the one that causes SARS. For this reason, scientists named the new virus SARS-CoV-2.

While vaccine development can take years, researchers aren't starting from scratch to develop a COVID-19 vaccine. Past research on SARS and MERS vaccines has identified potential approaches.

Coronaviruses have a spike-like structure on their surface called an S protein. (The spikes create the corona-like, or crown-like, appearance that gives the viruses their name.) The S protein attaches to the surface of human cells. A vaccine that targets this protein would prevent it from binding to human cells and stop the virus from reproducing.

Past research on vaccines for coronaviruses has also identified some challenges to developing a COVID-19 vaccine, including:

Global health authorities and vaccine developers are currently partnering to support the technology needed to produce vaccines. Some approaches have been used before to create vaccines, but some are still quite new.

Live vaccines use a weakened (attenuated) form of the germ that causes a disease. This kind of vaccine prompts an immune response without causing disease. The term attenuated means that the vaccine's ability to cause disease has been reduced.

Live vaccines are used to protect against measles, mumps, rubella, smallpox and chickenpox. As a result, the infrastructure is in place to develop these kinds of vaccines.

However, live virus vaccines often need extensive safety testing. Some live viruses can be transmitted to a person who isn't immunized. This is a concern for people who have weakened immune systems.

Inactivated vaccines use a killed (inactive) version of the germ that causes a disease. This kind of vaccine causes an immune response but not infection. Inactivated vaccines are used to prevent the flu, hepatitis A and rabies.

However, inactivated vaccines may not provide protection that's as strong as that produced by live vaccines. This type of vaccine often requires multiple doses, followed by booster doses, to provide long-term immunity. Producing these types of vaccines might require the handling of large amounts of the infectious virus.

This type of vaccine uses genetically engineered RNA or DNA that has instructions for making copies of the S protein. These copies prompt an immune response to the virus. With this approach, no infectious virus needs to be handled. While genetically engineered vaccines are in the works, none has been licensed for human use.

The development of vaccines can take years. This is especially true when the vaccines involve new technologies that haven't been tested for safety or adapted to allow for mass production.

Why does it take so long? First, a vaccine is tested in animals to see if it works and if it's safe. This testing must follow strict lab guidelines and generally takes three to six months. The manufacturing of vaccines also must follow quality and safety practices.

Next comes testing in humans. Small phase I clinical trials evaluate the safety of the vaccine in humans. During phase II, the formulation and doses of the vaccine are established to prove the vaccine's effectiveness. Finally, during phase III, the safety and efficacy of a vaccine need to be demonstrated in a larger group of people.

Because of the seriousness of the COVID-19 pandemic, vaccine regulators might fast-track some of these steps. But it's unlikely that a COVID-19 vaccine will become available sooner than six months after clinical trials start. Realistically, a vaccine will take 12 to 18 months or longer to develop and test in human clinical trials. And we don't know yet whether an effective vaccine is possible for this virus.

If a vaccine is approved, it will take time to produce, distribute and administer to the global population. Because people have no immunity to the COVID-19 virus, it's likely that two vaccinations will be needed, three to four weeks apart. People would likely start to achieve immunity to the COVID-19 virus one to two weeks after the second vaccination.

A lot of work remains. Still, the number of pharmaceutical companies, governments and other agencies working on a COVID-19 vaccine is cause for hope.

Until a COVID-19 vaccine is available, infection prevention is crucial. The Centers for Disease Control and Prevention (CDC) recommend following these precautions for avoiding infection with the COVID-19 virus:

If you have a chronic medical condition and may have a higher risk of serious illness, check with your doctor about other ways to protect yourself.

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COVID-19 (coronavirus) vaccine: Get the facts - Mayo Clinic

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LAURAN NEERGAARD AP Medical Writer

June 11, 2020, 6:19 PM

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The first experimental COVID-19 vaccine in the U.S. is on track to begin a huge study next month to prove if it really can fend off the coronavirus, while hard-hit Brazil is testing a different shot from China.

Where to do crucial, late-stage testing and how many volunteers are needed to roll up their sleeves are big worries for health officials as the virus spread starts tapering off in parts of the world.

Moderna Inc. said Thursday the vaccine it is developing with the National Institutes of Health will be tested in 30,000 people in the U.S. Some will get the real shot and some a dummy shot, as scientists carefully compare which group winds up with the most infections.

With far fewer COVID-19 cases in China, Sinovac Biotech turned to Brazil, the epicenter of Latin America's outbreak, for at least part of its final testing. The government of So Paulo announced Thursday that Sinovac will ship enough of its experimental vaccine to test in 9,000 Brazilians starting next month.

If it works, with this vaccine we will be able to immunize millions of Brazilians, said So Paulos Gov. Joao Doria.

Worldwide, about a dozen COVID-19 potential vaccines are in early stages of testing. The NIH expects to help several additional shots move into those final, large-scale studies this summer, including one made by Oxford University that's also being tested in a few thousand volunteers in Brazil.

There's no guarantee any of the experimental shots will pan out.

But if all goes well, there will be potential to get answers on which vaccines work by the end of the year, Dr. John Mascola, who directs NIHs vaccine research center, told a meeting of the National Academy of Medicine on Wednesday.

Vaccines train the body to recognize a virus and fight back, and specialists say it's vital to test shots made in different ways to increase the odds that at least one kind will work.

Sinovac's vaccine is made by growing the coronavirus in a lab and then killing it. So-called whole inactivated vaccines are tried-and-true, used for decades to make shots against polio, flu and other diseases giving the body a sneak peek at the germ itself but growing the virus is difficult and requires lab precautions.

The vaccine made by the NIH and Moderna contains no actual virus. Those shots contain the genetic code for the aptly named spike protein that coats the surface of the coronavirus. The body's cells use that code to make some harmless spike protein that the immune system reacts to, ready if it later encounters the real thing. The so-called mRNA vaccine is easier to make, but it's a new and unproven technology.

Neither company has yet published results of how their shots fared in smaller, earlier-stage studies, designed to check for serious side effects and how well people's immune systems respond to different doses.

Even before proof that any potential vaccine will work, companies and governments are beginning to stockpile millions of doses so they can be ready to start vaccinating as soon as answers arrive.

In the U.S., a program called Operation Warp Speed aims to have 300 million doses on hand by January. Under Brazil's agreement with Sinovac, the Instituto Butantan will learn to produce the Chinese shot.

AP journalist Marcelo Silva de Sousa contributed to this report.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education. The AP is solely responsible for all content.

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Final tests of some COVID-19 vaccines to start next month ...

As the world waits for a coronavirus vaccine, some scientists are proposing that existing vaccines could give the bodys immune system a much-needed temporary boost to stave off infection.

Its still unclear whether such an approach would work, and some experts are skeptical. Others including researchers in Israel, the Netherlands and Australia are already investigating whether a tuberculosis vaccine could help jump-start the immune system and make COVID-19 less deadly, though the World Health Organization strongly advises against using that vaccine until its proven effective against the coronavirus.

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In the U.S., several big names in virology including Dr. Robert Gallo, the director of the Institute of Human Virology at the University of Maryland School of Medicine and one of the scientists who discovered HIV are turning their attention to another existing vaccine, the oral poliovirus vaccine. It hasnt been licensed or available in the U.S. since 2000, but is still used in other countries where poliovirus still circulates, according to the Centers for Disease Control and Prevention. (Polio was eradicated in the U.S. in 1979.)

In a perspective piece published Thursday in the journal Science, Gallo and other experts from the Baltimore-based Global Virus Network outline why this particular polio vaccine might hold potential and why the group is seeking funding and approval to start clinical trials to test their hypothesis.

The polio vaccine in question is a live vaccine meaning it uses a weakened form of the live virus.

Live vaccines trigger a general immune response that helps the body fight off invaders until the immune system has time to develop specific antibodies. In theory, scientists believe that this temporary immune boost could provide protection for viruses the vaccine was not designed to prevent, such as the coronavirus, said a co-author of the Science piece, Dr. Konstantin Chumakov, a member of the Global Virus Network, an international coalition of virologists aimed at preventing and eradicating virus disease.

(Chumakov is also associate director of research at the U.S. Food and Drug Administrations Office of Vaccines, but spoke to NBC News on behalf of the Global Virus Network, not the FDA.)

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Using existing live vaccines, including the oral poliovirus vaccine, would not be a permanent solution, but rather a temporary fix that may buy time until a coronavirus vaccine hits the market, Chumakov said.

The protection would wane with time, but the beginning of an outbreak is an important time to keep the virus from spreading, said Chumakov, noting that unlike the vaccine for tuberculosis, there are three types of oral poliovirus vaccine that could be administered back-to-back as soon as the immunity-boosting effects of one wears off, potentially extending such temporary protection.

The potential protection from the vaccine remains hypothetical, however, which is why Chumakov and others are calling for clinical trials.

In places where its still used, the oral poliovirus vaccine is typically administered to babies and not adults, so scientists cant simply look at whether it already works to boost the immune system against other viruses in adults in these populations.

Chumakov referred to a three-year controlled trial conducted in Russia in the 1960s as the strongest evidence in support of using disease-specific vaccines to broadly ward off other viruses. In the study, which was conducted by Chumakovs mother, researchers concluded that giving adults doses of the oral poliovirus vaccine cut deaths due to seasonal influenza and acute respiratory diseases three-fold.

Chumakov and his co-authors also cite other studies and anecdotes in which an oral poliovirus vaccine has effectively prevented another strain of poliovirus, which the vaccine was not specifically designed to treat.

However, other experts in the field are skeptical that the polio vaccine would provide the needed boost, and view the existing research as flimsy at best.

I do believe the oral polio vaccine would provide some protection against new viruses, but so would catching cold, said Rachel Roper, associate professor of microbiology and immunology at East Carolina Universitys Brody School of Medicine. Catching any virus, she said, would set up the antiviral state associated with enhanced immunity.

Roper also expressed concern that administering a live vaccine that does not specifically target COVID-19 could create competition called immunodominance that prompts the immune system to target the live vaccine while leaving few resources to fight off COVID-19.

We wont see safety concerns until we test it in large trials that include a lot of people, Roper said.

Indeed, the oral polio vaccine shouldnt be given in an attempt to prevent COVID-19 outside of a clinical trial.

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Adam Lauring, an associate professor of microbiology, immunology and infectious diseases at the University of Michigan, said that if the oral poliovirus vaccine is proven to be effective, everyone would need to get the vaccine at the same time for it to work as planned, which would require a coordinated response with its own logistical challenges.

Theres also the issue of some people already having immune responses against some vaccines, which means this could impede some of the antibody responses we would want, said Lauring. In other words, the oral polio vaccine may not boost the immune system, as the theory proposes, in people who have already received a polio vaccine.

Its a good idea, but we dont know how it would pan out. There is some epidemiological evidence that is a sign that its something worth looking into, he said.

Chumakov estimates that it would cost $13 million to vaccinate the entire U.S. population, a relatively cheap solution if it works, and could provide a leg-up on future pandemics.

This pandemic will go, but there will be another one. We will continue to get new and emerging diseases, and there will always be this dilemma of what do we do in the interim before we can develop a specific vaccine, Chumakov said. This is much bigger than just stopping COVID-19.

CLARIFICATION (June 12, 2020, 12:12 p.m. ET): A previous version of this article omitted Dr. Robert Gallo's title. He is the director of the Institute of Human Virology at the University of Maryland School of Medicine.

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Polio vaccine could give temporary protection against ...

You can count the R&D execs at AbbVie among the believers in Genmabs bispecific platform tech.

Moving beyond the Allergan buyout, AbbVie refocused on its cancer drug pipeline, shelling out $750 million in cash and promising up to $3.15 billion more in milestones 60% for development and regulatory goals to ally itself on a slate of 7 development and discovery programs.

At the front of the queue is the early-stage drug epcoritamab, a CD3xCD20 bispecific from its DuoBody collection. Theres also DuoHexaBody-CD37 and DuoBody-CD3x5T4. And then AbbVie gets to pick and choose from among the discovery work at Genmab for 4 more, with AbbVie adding in its own contributions in the pairing up to come.

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Moderna burnishes its PhIII-ready Covid-19 vaccine with promising mouse data which suggest one dose might be enough after all - Endpoints News

One plan for an efficacy trial that compares several COVID-19 vaccines calls for using mobile teams, rather than fixed sites, as was done in the Democratic Republic of the Congo with an experimental Ebola vaccine.

By Jon CohenJun. 12, 2020 , 1:35 PM

Sciences COVID-19 reporting is supported by the Pulitzer Center.

A Chinese company will turn to Brazil for help. The World Health Organization (WHO) is adopting a strategy forged in a war zone during an Ebola outbreak. And the Trump administration plans to lean on existing U.S. infrastructure for tackling HIV and flu. These are some of the disparate strategies about to be employed in the next and most important stage of the COVID-19 vaccine race: the large-scale, placebo-controlled human trials needed to prove which of the more than135 candidatesare safe and effective.

Two such efficacy trials plan to start next month, even as the United States and global initiatives struggle to answer major questions, from what it means for a COVID-19 vaccine to work to how to find enough people exposed to the virus so a candidate can be put to a real-world test. Populations that have high levels of viral transmission are a moving targetWuhan, China; Seattle; or Milan might once have been a good place to test the mettle of a vaccine, but no longer. And quickly enrolling tens of thousands of properly informed people who meet a trials entry criteria is a big lift, says Susan Buchbinder, an epidemiologist at the San Francisco Department of Public Health who runs vaccine trials.

Competition among trial efforts could hinder the global push, says Wayne Koff, who heads the nonprofit Human Vaccines Project and formerly led the HIV vaccine program at the National Institute of Allergy and Infectious Diseases (NIAID). Its absolutely extraordinary how much has been done in 6 months, but theres an old adage that everybody loves to collaborate unless they want to win. Others, however, dont anticipate conflicts, noting that scientists and officials are sharing information about trial designs and plans. Each one will contribute differently, says Ana Maria Henao Restrepo, the lead representative of WHOs vaccine effort, Solidarity. I dont see competition.

Winning, one of U.S. President Donald Trumps favorite terms, is the clear goal of Operation Warp Speed, the U.S. project that aims to start to vaccinate millions of Americans in October and offer shots to 300 million people in the United States by January 2021. After winnowing down vaccine candidates in an opaque process over the past month and committing what could be more than $2 billion to its top choices, Warp Speed plans to enter three to five of them into efficacy trials that will have harmonized protocols to streamline oversight and will run analyses in central labs so data can more easily be compared.

The first Warp Speed candidate to launch is Modernas vaccine, composed of messenger RNA encoding the spike protein of SARS-CoV-2, the virus that causes COVID-19. The candidates efficacy trial, announced by the company on 11 June, will enroll 30,000 people and take place primarily at U.S. hospitals and universities long used for HIV and flu vaccine testing and now overseen by Warp Speeds COVID-19 Prevention Network. But which of those brick-and-mortar sites will have enough SARS-CoV-2 circulating near them to quickly produce an efficacy signal is uncertain given the shifting distribution of new cases in the United States.

China has an even starker problem: Theres currently no transmission to speak of in the country, which has forced Sinovac Biotech, a company based in Beijing, to stage efficacy trials of its vaccine candidate in Brazil, where the COVID-19 epidemic is now raging. With a product composed of the entire virus that the company has inactivated with chemicals, Sinovac announced this week it is collaborating with the Butantan Institute, a major research institution in So Paulo that manufactures vaccines. We are working very hard to start the trial in July, says Sinovac Senior Director Meng Weining.

WHO proposes a different solution for Solidaritys efficacy trials. The agency hasnt yet announced which candidates Solidarity will test, but, unlike Warp Speedwhich wont consider Chinese-made vaccinesit is open to products from every country and has made public detailed criteria for how it will prioritize vaccines. To cope with the patchiness of the pandemic, Solidarity will adopt a strategy Henao Restrepo helped develop for Ebola vaccine trials in Guinea in 2015 and, 3 years later, in the Democratic Republic of the Congo (DRC): setting up vaccination teams that can quickly mobilize to localized outbreaks.

We did this in Congo despite the war, Henao Restrepo says. Its not the traditional way, and some people think that we are crazy, but we have done it not once but twice. In the DRC, about 20 teams with 15 members each drove around the affected regions and set up temporary sites, vaccinating and following more than 300,000 people.

Warp Speed, which could if needed expand its trials to international sites used for HIV drug and vaccine testing, also plans to form surge clinics to quickly recruit people in rural U.S. areas with big outbreaks or industrial pockets of high transmission such as meat-packing plants. Models driven by machine learning will help Warp Speed forecast where infection will be highest, says Peter Gilbert, a University of Washington, Seattle, biostatistician. There are risk predictors that account for space and geography and features that are more constant like race, ethnicity or preexisting conditions, Gilbert says. Its really complicated.

One of the trickiest issues for trial designers is deciding what, exactly, represents success for a COVID-19 vaccine. Is it an infection endpoint, a transmission endpoint, preventing moderate disease, or preventing severe disease? Koff asks.

There was a lot of debate on that question, for Warp Speed, notes John Mascola, who heads NIAIDs Vaccine Research Center and contributes to the project. A COVID-19 vaccine that fails to prevent infection might still provide great benefit if it reduces symptomatic disease, so Warp Speed and Solidarity both ultimately chose that as the primary endpoint of the trials. Trial volunteers who develop fever, headache, dry cough, or other symptoms linked to COVID-19 will be tested for SARS-CoV-2, to see whether more people with confirmed infections develop symptomatic disease in the placebo arm of the trial than among those who received the vaccine.

To detect an efficacy signal, both Warp Speed and Solidarity estimate they will need to give each vaccine to 15,000 to 20,000 people in a population that has a 1% incidence of SARS-CoV-2 infection. If the vaccine prevents COVID-19 symptoms at least 50% of the time, its efficacy should be clear in 6 months, after about 150 infections have accumulated in the trial.

Both efforts will pit multiple vaccine candidates head to head. One difference is that Solidarity plans to compare all its vaccines against a shared placebo group, an approach that reduces the number of volunteers the researchers need to recruit and follow. In the Solidarity trial, the philosophy is we have to make this thing really simple, says Gilbert, who has worked with this effort, too. Solidarity trial sites have the option to do substudies of more detailed questions, but those are built into Warp Speeds trials. Specifically, Warp Speed will do repeated blood draws and nasal/throat swabs to evaluate immune responses and viral levels to better understand why vaccines succeed or how they might affect transmission.

In addition to Solidarity, WHO is helping the Access to COVID-19 Tools (ACT) Accelerator, another global effort that may stage its own vaccine efficacy trials if companies do not want to participate in Solidarity. Companies may or may not be very enthusiastic about head-to-head comparisons, explains Soumya Swaminathan, WHOs chief scientist and top liaison to the ACT Accelerator. And the ACT Accelerator has pockets as deep as Warp Speed: Countries and philanthropies in May pledged $8 billion, with a commitment that it would equitably distribute any proven COVID-19 productsvaccines, treatments, diagnosticsto rich and poor alike.

Buchbinder is impressed by the speed at which these massive efforts have gotten underway. Its unlike any other research Ive undertaken, she says. But she and others are careful to temper expectations. Even though she will oversee a Warp Speed trial site, for example, she doubts the U.S. effort will meet Trumps goal of having a proven vaccine by October. Koff agrees; the failures of so many HIV vaccine trials have sobered him, he says. We need to be really careful how we manage expectations, he concludes.

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'It's really complicated.' United States and others wrestle with putting COVID-19 vaccines to the test - Science Magazine

WASHINGTON--(BUSINESS WIRE)--The Milken Institute, the nonprofit, nonpartisan think tank, and First Person, a San Francisco design and storytelling company, together tell the urgent story of the global race for a COVID-19 vaccine in a newly released interactive experience at: https://www.covid-19vaccinetracker.org/.

Developed by First Person, the web-based tool is the culmination of a nearly three-month long effort tracking treatment and vaccines candidates for COVID-19 undertaken by FasterCures, a center of Milken Institute. When it first launched, FasterCures identified 38 vaccine candidates. As of today, there are 161 vaccines in development, with 10 in clinical trials.

Developing a safe vaccine that can be widely accessed is both necessary and extraordinarily complex, said Esther Krofah, Executive Director at FasterCures. We are thrilled that First Person has been able to bring our comprehensive vaccine tracker to life in a way that educates the public and gives the medical research community a new tool to better understand the race toward a COVID-19 vaccine.

The interactive platform is updated regularly and takes the viewer through a narrative including:

"Our intent with this project was to answer the question of how long it would take to develop a COVID-19 vaccine, said Drew Fiero President and CEO of First Person. The comprehensive, neutral, and consistently updated data from FasterCures allowed us to leverage our storytelling capabilities to do just that through a visually compelling, interactive experience.

Compiled from more than 30 publicly available data sources, the COVID-19 Treatment and Vaccine Tracker is updated daily by FasterCures. The nonprofit welcomes input on new treatments and vaccines in development. Please email COVID19@milkeninstitute.org with tips.

About FasterCures

FasterCures, a center of the Milken Institute, is working to build a system that is effective, efficient, and driven by a clear vision: patient needs above all else. We believe that transformative and life-saving science should be fully realized and deliver better treatments to the people who need them.

About the Milken Institute

The Milken Institute is a nonprofit, nonpartisan think tank that helps people build meaningful lives, in which they can experience health and well-being, pursue effective education and gainful employment, and access the resources required to create ever-expanding opportunities for themselves and their broader communities. For more information, visit http://www.milkeninstitute.org

About First Person

First Person is a San Francisco design and storytelling company. We combine brilliant ideas with business insight to develop stories that leverage design and technology to deliver lasting value. The result is engaging media that informs, surprises and delights. For more information, visit http://www.firstperson.is

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Milken Institute Teams with First Person to Explain the Race to a COVID-19 Vaccine - Business Wire

Third of Americans Say They Won't Get a COVID-19 Vaccine, with Black Americans the Most Skeptical  Newsweek

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Third of Americans Say They Won't Get a COVID-19 Vaccine, with Black Americans the Most Skeptical - Newsweek

John Young, Pfizers chief business officer, was only about four minutes into a one-hour fireside chat at this years virtual BIO conference when he addressed a question thats been weighing on investors for several weeks now: If the company successfully develops a vaccine against COVID-19, what will the return on investment be?

When Pfizer began strategizing methods for addressing the pandemic back in January, we realized this is not a time to think about a typical ROI, Youngsaid. Frankly, the world needs a safe and effective vaccine, and the companys priority is to play our part in bringing forward vaccines and treatments that the world needs right now.

Pfizer has been working with Germany-based mRNA specialist BioNTech to develop a COVID-19 vaccine. The partners are now in clinical trials, assessing four variants of the vaccine. After testing the variants at different schedules and dose levels, they will select a vaccine candidate to move into larger trials.

RELATED: After Operation Warp Speed picks 5 finalists, experts question why some vaccines were left out

Pifzer is one of five finalists in Operation Warp Speed, the U.S. governments attempt to speed up the development of a COVID-19 vaccine. But unlike other contenders, it is not looking for federal funding to accelerate clinical development. Theres a reason for that, Young said at BIO.

We made an active decision not to seek government funding because we didn't want this to slow down our partnership with BioNTech and to slow the progress moving a vaccine construct into the clinic, Young said. Our focus was to move as quickly as possible and we really didn't want to spend a month negotiating with the U.S. government.

So how long will Pfizers development process take? Young was reluctant to make any hard predictions. Too few patients have been dosed in the clinical trials thus far, he said, and ultimately data should really drive the decisions that we make, along with regulators, as to which [candidate] has the potential to be the safest and most effective vaccine construct.

But Pfizer is thinking about how to tackle the challenge of manufacturing enough doses of a COVID-19 vaccine to meet the demandand investing plenty in that effort. The company said in May it would lean on its manufacturing sites in Michigan, Massachusetts and Missouri, as well as a fourth site in Belgium, to ramp up production of the vaccine.

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During the BIO chat, Young said Pfizer will handle the U.S. supply chain and BioNTech will develop a parallel supply chain for Europe and rest the world. Meanwhile, Pfizer will outsource production of some its other drugs to contractors to clear manufacturing space.

Despite its strong partner network, the manufacturing of a COVID-19 mRNA vaccine will be far from simple, Young said. Typically, Pfizer makes about 500 million vaccine doses per year, but this time around, the company has committed to make tens of millions of doses this year and hundreds of millions in 2021 if one of its vaccine candidates succeeds, he said. So we need to more than double down on our investments in our supply chain, and to make significant investments of capital, as well as investments in some very specialized raw materials.

Young emphasized that making an mRNA vaccine is a brand-new endeavor for the company. It involves combining nanoparticles with mRNA and using plasmids to produce the mRNA. We have not made one of those products before, so we really had to from scratch work with raw material suppliers and companies that make these very specialized products.

It all brought to mind that one pressing question: What will the ROI be for Pfizer? To answer that, the company would need to estimate its own costs, not to mention the price of the vaccineneither of which its ready to do, Young said.

Pfizer has done no modeling work to this point around the pricing, Young said, because were still in the process of figuring out where our supply chain is to know even what our cost of manufacturing is. So its really premature in our vaccine program to reach a point of view on pricing.

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The controversy over drug pricing continues to be a thorn in the side of the pharma industry, even amid thepandemic. Pfizer is well aware of the need to balance the need for an affordable COVID-19 vaccine with the demand from investors for ROIand the potential for its actions to help repair the industrys image, Young said.

We really need effective vaccines to get back to normal economic activity, Young said. So I hope, if we're successful in that mission the perception of our industry will reflect the efforts that we've made.

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BIO: What's the ROI on a COVID-19 vaccine? We have no idea, says Pfizer - FiercePharma