Category: Covid-19 Vaccine

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Latest on global search for coronavirus vaccine: Oxford vaccine may protect monkeys from COVID – USA TODAY

May 17, 2020

As coronavirus spreads, people are getting more cautious and creative with their social interactions. USA TODAY

Anall-out global race to develop a safe vaccineagainstcoronavirus is underway. The stakes couldn't be higher: an effective vaccine or treatment against the virus that causes COVID-19 is necessary to fully restart economies and resume civic life.

As the pace accelerates, USA TODAY is rounding up some of the week's most notable vaccine developments.

Here's what we know about Oxford University's most promising vaccine candidate, which many consider to be ahead in the race, international funding for a Maryland vaccine possibility and how people opposed to vaccines could keep COVID-19 circulating.

A single dose of a vaccine being developed by Oxford University in England caused six rhesus macaque monkeys to develop antibodies to coronaviruswithin 28 days.

The vaccine, called ChAdOx1, alsoappears to have prevented pneumonia and lung inflammatory disease when the animals were exposed to SARS-CoV-2, the virus that causes COVID-19.

The Oxford vaccine is based on a vaccine platform researchers at the universitys Jenner Institute adapted for SARS-CoV-2.

White House hopes for COVID-19 vaccine for all Americans by January(Photo: ap)

The tests on the macaques were conducted at the U.S. National Institute of Allergy and Infectious Diseases Rocky Mountain Laboratories in Hamilton, Montana.

The infected monkeys were compared with three control monkeys that did not receive the vaccine. Two out of three control monkeys developed pneumonia after being exposed to the virus.

The findings were in a preprint paper posted Thursday on the preprint server bioRxiv. Preprints are studies that have not undergone the normal peer-review process required for publication in medical or scientific journals. However, during the coronavirus emergency many researchers are releasing their results as soon as they are available.

Health and Human Services Secretary Alex Azar talked about a timeline for a COVID-19 vaccine. USA TODAY

Despite the Oxford news, British Prime Minister Boris Johnson acknowledgesits possible a vaccine for COVID-19 may never come.

The statement came as the United Kingdoms government published a detailed 50-page three-stage COVID-19 recovery plan that launched on Wednesday with a partial relaxation ofthe nations lockdown restrictions.

Johnson said the only feasible long-term solution was in a vaccine or a treatment, but while the nation hoped for a breakthrough, hope is not a plan.

A mass vaccine or treatment may be more than a year away. Indeed, in a worst-case scenario, we may never find a vaccine. So our plan must countenance a situation where we are in this, together, for the long haul, even while doing all we can to avoid that outcome, he said.

Vaccines: Trump announces 'Operation Warp Speed,' says UScould have coronavirus vaccine by January

Maryland-based vaccine company Novavax will receive up to $388 million from the International Coalition for Epidemic Preparedness (CEPI) to continue development and manufacturing of NVX-CoV2373, Novavax'COVID-19 vaccine candidate.

The company said the possible vaccine has shown success in animal models. It hopes to begin Phase 1 human clinical trials in May in Australia.

CEPI, based in Norway, is a partnership between public, private, philanthropic, and civil society organizations. It was launched in 2017 to develop vaccines to stop future epidemics and to insure access to those vaccines in low- and middle-income countries. It has so far begun nine partnerships to develop vaccines against SARS-CoV-2.

The World Health Organizations list of vaccine candidates for COVID-19 stayed steady at eight possible products in early-stage human trials. Those include four from China, two from the United States, one from the United Kingdom and one from Europe.

The list also includes possible vaccines that are in pre-clinical evaluation, meaning theyre still being tested in the lab either in cell cultures or in animals. This week the number increased by eight, going up from 102 possible candidates on May 11 to 110 on May 15.

When the list was first published, on April 20, it contained five candidates in early human trials and 71 still in the lab.

Most Americans are eager for a vaccine against SARS-CoV-2, the virus that causes COVID-19.

But among the minority who distrust vaccine safety, many say they would not. A poll by Yahoo News/YouGov found that 19% of Americans said they wouldnt get immunized against SARS-CoV-2. Another 26% said they werent sure.

A poll conducted by Morning Consult found that 64% of Americans said they would get vaccinated while 14% wouldnt. The rest were undecided.

This could block efforts to lower the spread of the disease in the country, especially if a second wave comes in the fall.

Infections rates alone are nowhere near high enough to bring about herd immunity,where enough people in the population are immune that the virus can no longer spread freely.

In France, an estimated 4.4% of the population is believed to have beeninfected with the disease as of May 11, according to a paper in the journal Science. A national infection rate for COVID-19 in the United States has not yet been determined.

The scientists' models estimate that 65% of the population would need to be immune to establish herd immunity and stop the spread of the disease.

The researchers' concluded, "Population immunity appears insufficient to avoid a second wave if all control measures are released at the end of the lockdown."

To submit adevelopment for the weekly roundup, orshare other vaccine news, please email Elizabeth Weise at eweise@usatoday.com

More on the coronavirus from USA TODAY

To find a vaccine, can we ethically infect people with a disease with no cure?

Editorial: Let's say a vaccine proves safe and effective. Then what?

Fact check: China doesn't own patent for coronavirus treatment remdesivir

Read or Share this story: https://www.usatoday.com/story/money/2020/05/16/coronavirus-vaccine-updates-oxford-covid-19-vaccine-protects-monkeys/5202831002/

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Latest on global search for coronavirus vaccine: Oxford vaccine may protect monkeys from COVID - USA TODAY

What Is the World Doing to Create a COVID-19 Vaccine? – Council on Foreign Relations

May 15, 2020

A global race is underway to develop and mass-produce an effective vaccine to counter the new, deadly, and highly infectious coronavirus disease, COVID-19, which has brought much of the world to a standstill. Many governments have warned that daily life cannot return to normal until their populations have built up antibodies to fend off the virus. Some clinical trials are already underway, but vaccine development often takes years.

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Developing a successful vaccine is not enough. Many countries also face the looming challenge of producing quantities necessary to provide immunity to all their citizens, and competition is already emerging over who will have access once a vaccine is ready.

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There are more than one hundred vaccines in preclinical development by pharmaceutical companies, academic institutions, government agencies, and others. More than seventy of these are being tracked by the World Health Organization (WHO) [PDF]. Eight vaccine candidates, across four countries, are already undergoing clinical trials. While several of these candidates are already spurring hope, experts warn that its too early to determine if any will be successful in later-stage trials.

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A summary of global news developments with CFR analysis delivered to your inbox each morning.Most weekdays.

United States. Two candidates are being tested in the United States. The first human trial in the country began in Seattle in March with a vaccine developed by Moderna Inc. The trial is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). In early April, trials began in Philadelphia and Kansas City for a second candidate, which is being developed by American biotech firm Inovio Pharmaceuticals and funded by the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI).

China. Trials for four other candidates are taking place in China. The biotech firm CanSino Biologics and the medical research arm of the Peoples Liberation Army started trials in mid-March for a potential COVID-19 vaccine. The Beijing and Wuhan Institutes of Biological Products, arms of state-run Sinopharm, are carrying out trials on another two candidates, and trials for a vaccine developed by biotech firm Sinovac are also underway.

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United Kingdom. The University of Oxford started human trials for a candidate in late April, with $25 million in funding from the UK government.

Germany. Pharmaceutical giant Pfizer is working together with German firm BioNTech and Chinese firm Fosun Pharma on a vaccine that began human trials in the European country in late April. Trials are expected to soon be expanded to the United States.

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Dozens of treatmentswhich would not prevent someone from being infected with COVID-19 but could help reduce the severity and duration of illnessare being developed to mitigate the health crisis in the interim. Among the most promising treatment candidates is the antiviral drug remdesivir, which was developed by U.S.-based Gilead Sciences and is already in advanced trials. Preliminary results from an NIAID trial that involved dozens of sites in the United States, Europe, and Asia showed faster rates of recovery from the virus.

Vaccines are frequently collaborative efforts across sectors of society, with private pharmaceutical firms teaming up with public health agencies or university labs. For instance, a recently approved Ebola vaccine was ultimately developed by multinational pharmaceutical company Merck but also involved Canadian and U.S. public health agencies, a tiny Iowa-based biotech firm, U.S. Defense Department researchers, and the WHO. Here are snapshots of some of the major players in the COVID-19 race.

Governments. Public health agencies play critical roles in vaccine research, supplying funds to develop a COVID-19 vaccine. For example, the U.S. Biomedical Advanced Research and Development Authority (BARDA), an agency of the U.S. Department of Health and Human Services (HHS), pledged hundreds of millions of dollars to assist the development of vaccines by Moderna and Johnson & Johnson. And the NIH, also within HHS, has partnered with more than a dozen major pharmaceutical companies to coordinate accelerated COVID-19 vaccine research. The European Commission is also funding several candidates [PDF]. In China, the government is closely overseeing efforts on its territory, with state-owned firms making up about two-fifths of the countrys vaccine industry.

International institutions. The WHO and other multilateral institutions such as the World Bank are focused on financing and manufacturing a COVID-19 vaccine for global use, in particular to ensure fair allocation among all countries. Also at the forefront of multilateral efforts is CEPI, a global alliance that was founded by Norway, India, the Gates Foundation, the UK-based Wellcome Trust, and the World Economic Forum. Gavi, the Vaccine Alliancealso founded by the Gates Foundationis a public-private partnership; it focuses on improving vaccine access for lower-income countries.

Private sector. The pharmaceutical industry is driving much of the push toward a vaccine. Companies ranging from biotech start-ups to giants such as Johnson & Johnson, Pfizer, and Sinopharm are rapidly shifting their research and development (R&D) efforts to focus on COVID-19. While early research into a vaccine candidate typically receives government funding, such as NIH grants in the case of the United States, the bulk of financing for clinical development generally comes from private sources.

Research institutions and nonprofits. The majority of COVID-19 vaccine candidates involve a university or college assisting in preclinical research or clinical trials. In the case of the University of Oxfords candidate, the research team was already working on vaccines for an unknown disease that could cause a pandemic. In January, the group zeroed in on COVID-19, and now they are conducting phase-one trials with one thousand volunteers. The Gates Foundation has been the leading nonprofit funding COVID-19 vaccine efforts.

Traditionally, vaccines are dead or weakened virus moleculesknown as antigensthat trigger defensive white blood cells in the immune system to create antibodies that bind to the virus and neutralize it.

There are four main types of conventional vaccines:

There are also several new types of vaccines that use the viruss genetic materialDNA or RNAto prompt the body to create antibodies. Scientists are still investigating these types for wide use in humans.

When most of a population has been vaccinated and is immune to a particular disease, even those who are not immune are considered protected because the likelihood of an outbreak is small. This is known as herd immunity. Chickenpox, measles, mumps, and polio are all examples of diseases for which the United States has achieved herd immunity due to vaccines.

There are many stages involved in the development and production of a vaccine, from initial academic research to distribution to hospitals and doctors offices.

Clinical trials are crucial indicators of whether a vaccine is effective. Potential vaccines, as with other drugs, are commonly tested in animals first. Human trials are broken up into three phases, progressively increasing the number of volunteers. If a vaccine candidate appears to be ineffective, has harmful side effects, or is too similar to existing vaccines, it wont move on. Trials are often carried out blind, by which some groups are administered the vaccine and some receive a placebo.

If a vaccine candidate is considered successful in human trials, the developers can seek approval by a national regulatory agency, such as the U.S. Food and Drug Administration or the European Medicines Agency. In the United States, less than 10 percent of all drugs that go into clinical trials make it past this part of the process. Additionally, while the WHO does not approve drugs, the vaccine maker can request prequalification by the WHOa process to determine quality assurance. Many low- and middle-income countries rely on WHO prequalification [PDF] when buying medicines. Finally, the vaccine must be approved by national regulators in other countries to be distributed abroad.

Following approval, the vaccine can be manufactured for broad use. However, with the need for billions of doses of a COVID-19 vaccine, experts warn that many more production plants will be needed to fulfill the global demand. CEPI has already raised roughly half of the $2 billion it is seeking for its coronavirus response, including building specialized production plants. BARDA has also pledged to help scale up manufacturing in the United States.

Many experts say that the timeline of twelve to eighteen months stated by U.S. officials for a COVID-19 vaccine is extremely optimistic. Under normal circumstances, during which the stages of vaccine development occur sequentially, a vaccine on average takes eight to fifteen years to get from the lab into the hands of health-care providers. The fastest a vaccine has ever been developed is five years.

However, many around the globe are seeking to accelerate the process for COVID-19 by initiating some stages of development simultaneously and by looking to new vaccine technologies. Whats different in this context is that you have such an enormous global effort being undertaken, says CFRs Thomas J. Bollyky. Any entity working in this field broadly is pursuing a COVID-19 vaccine.

In the United States, President Donald J. Trumps administration launched a project known as Operation Warp Speed aimed at manufacturing enough doses of an effective vaccine for all three hundred million Americans by early 2021. The project hinges on overlapping stages of development; mass production would begin for strong candidates even while clinical trials are still ongoing.

But clinical trials are difficult to speed up because antibodies take time to develop in the body. So-called challenge trials, in which patients are purposefully exposed to a disease, are another way to cut time out of the process, but they are ethically controversial. Typically, challenge trials are only done with curable diseases, such as typhoid fever, and there is no known cure for COVID-19 yet.

Another way researchers are seeking to quicken the process is by focusing on new vaccine approaches. RNA- and DNA-based vaccines can be developed far faster than conventional vaccines, which require months at a time of growing antigens in animal or insect cells. However, none has ever been approved for commercial use in humans. Three of the eight COVID-19 candidates in clinical trials are RNA- or DNA-based.

Public officials worldwide have stressed that the pandemic likely will not end until there is an effective vaccine. Even after a vaccine is approved, however, there remains the tremendous challenge of producing enough of it for the worlds population. An estimated one billion doses would need to be manufactured just to vaccinate workers in health care and other essential industries globally, and that is if only a single dose is required for each person.

This task has both motivated countries to prepare for large-scale production, as well as pitted them against one another amid fears of a potentially limited vaccine supply. While Brazil, China, and India all have large vaccine industries, they also have among the largest populations, and they could reserve their vaccine supplies for their own citizens before opening them up to others. Some countries are seeking to strike monopoly agreements with vaccine manufacturers to avoid domestic shortages. Experts including CFRs Bollyky have warned that bidding wars over a vaccine will lead to inequitable distribution and, ultimately, fail to eliminate the risk of new outbreaks.

Moreover, amid these extraordinary efforts to secure a vaccine, scientists are still investigating how this new coronavirus behaves and trying to answer the many questions people have about the risk it poses and how protected they will be. This includes how effective a vaccine will be against a mutating coronavirus, though researchers point out that mutations do not necessarily mean different strains of the virus or changes in its infectiousness or lethality. Uncovering such details about the virus, they say, will only help in the development of a successful vaccine.

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What Is the World Doing to Create a COVID-19 Vaccine? - Council on Foreign Relations

We May Never Have a COVID-19 Vaccine and Have to Live With The Disease Forever – India.com

May 15, 2020

Scientists around the world are in continuous fear that we may never be able to produce an effective vaccine against COVID-19 and have to live with the permanent risk of contracting the novel virus. Also Read - Coronavirus in Delhi: His Cook Positive, Supreme Court Judge Goes in Self-Quarantine With Family

Currently, more than 100 vaccines are undergoing pre-clinical trials and a few have entered the human trial stage. Still, the researchers fear that the vaccines may not be able to cross the last hurdle and be available for the common people. This is because of the nature of this new coronavirus. According to the scientists, COVID-19 virus may change its structure in a few months when we hopefully have a vaccine but the change in its anatomy can turn the entire development, scientific processes and result futile. Also Read - Coronavirus in Karnataka: Passengers Refuse Institutional Quarantine, 19 Sent Back to Delhi

According to a CNN report, in which Dr. David Nabarro, World Health Organizations COVID-19 special envoy was quoted saying, There are some viruses that we still do not have vaccines against. We cannot make an absolute assumption that a vaccine will appear at all, or if it does appear, whether it will pass all the tests of efficacy and safety. Also Read - Sri Lanka to Impose Nationwide Day-long Curfew Again on Sunday to Check Coronavirus Outbreak

Notably, vaccine development is a very long procedure. And as per reports, 37 per cent of vaccines fail in the first phase itself. Whereas 69 per cent fail in the second stage. And 42 per cent go futile in the third phase. Only 10 per cent of total vaccines manage to reach the last stage and get approval.

Even after the approval, we are not sure if a vaccine would be effective in the general population. One of the examples for this is the dengue vaccine that came in 2015. It was found out to have severe negative impacts on the people in the Philippines. Instead of providing immunity against the virus, the vaccine made people critically ill with severe symptoms of the disease.

Also, it has been nearly four decades now but we still do not have a vaccine against HIV, which has caused around 32 million deaths till now.

According to a statement given by the UKs Chief Medical Officer, Christopher Whitty to a Parliamentary committee, there is enough concerning evidence that shows, we may not able to develop a COVID-19 vaccine. One of the bases for this negative possibility is the reinfection. This means, getting the infection once is not making a person immune to it for a prolonged period.

Even the World Health organisation recently hinted towards the possibility of never be able to deal with the virus. If that happens, the only way the human race can survive is by developing herd immunity but in the process, a huge number of people will lost their lives.

With Inputs From IANS

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We May Never Have a COVID-19 Vaccine and Have to Live With The Disease Forever - India.com

Global COVID-19 Vaccines Pipeline 2020: 150 Organizations’ Vaccines for COVID-19, SARS and MERS – PRNewswire

May 15, 2020

DUBLIN, May 14, 2020 /PRNewswire/ -- The "Global Coronavirus Vaccines Pipeline 2020" report has been added to ResearchAndMarkets.com's offering.

COVID-19 vaccine development is proceeding at an unprecedented pace, achieving a substantially accelerated timeframe in comparison to the typical vaccine development process. Part of this rapid pace can be attributed to the prior work done with SARS and MERS and now is being used for COVID-19. The Global Coronavirus Vaccines Pipeline report features a comprehensive data analysis of over 150 organizations working on developing vaccines focused on the ongoing COVID-19 pandemic and the previous SARS and MERS outbreaks.

It provides market intelligence and pipeline analysis on the current available vaccines region-wise, specifically from the Americas, Europe, the Middle East and Africa (EMEA), and the Asia-Pacific region (APAC). It captures detailed profiles of these companies, the ongoing partnerships as well as growth and financial performance analysis. In addition, it pulls together insights from interviews and surveys with key opinion leaders who committed to developing an affordable vaccine for emergency pandemic use. The Global Coronavirus Vaccines Pipeline report seeks to holistically inform the community on the current status of coronavirus vaccine development and discover future opportunities for collaboration, technology transfer and co-development.

In addition, it gives readers access to company profiles, ongoing clinical trials and an assessment of the regulatory environment. Moreover, the report pulls together insights on funding and a swot analysis on the industry. Popular market sentiments derived through comprehensive primary research with key industry stakeholders have been compiled as well.

Key Topics Covered:

Section 1

Section 2: Covid-19 Pipeline Analysis

Section 3: SARS Pipeline Analysis

Section 4: MERS Pipeline Analysis

Section 5: Data Analysis & Intelligence Mapping

Covid-19 Vaccines Development

SARS Vaccines Development

MERS Vaccines Development

A selection of companies mentioned include:

For more information about this report visit https://www.researchandmarkets.com/r/33tnpz

About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Global COVID-19 Vaccines Pipeline 2020: 150 Organizations' Vaccines for COVID-19, SARS and MERS - PRNewswire

Under Trump, will the US corner the market on Covid-19 vaccine? – STAT

May 15, 2020

The United States is sprinting headlong toward the development and distribution of Covid-19 vaccines. But under an America First president, public health experts worry, the United States could seek to gobble up early supplies and set the stage for prolonged devastation in the rest of the world.

Under Operation Warp Speed, the Trump administration hopes to have 300 million doses of vaccine ready for domestic use by January 2021. That outcome would largely satisfy domestic needs in the United States, experts say, but it would mean prioritizing low-risk individuals in one the worlds richest countries over high-risk health care workers and other vulnerable populations elsewhere in the world.

Such concerns prompted more than 140 world leaders and other dignitaries on Thursday to sign an open letter to all governments demanding that Covid-19 vaccines be considered a global good to be shared equitably. The letter came just a day after Paul Hudson, CEO of pharmaceutical giant Sanofi, angered the French government by indicating the U.S. would have first access to his companys output.

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I do think that theres a significant risk, at least under the current plan, that the U.S. will vaccinate not only health workers and high-risk populations and priority populations for breaking transmission chains, but also low-risk individuals first, said Tom Bollyky, director of the global health program at the Council on Foreign Relations.

Bollyky warned any U.S. effort to inoculate its entire population could incentivize other countries to refuse to share peripheral materials needed for mass vaccination, including vaccine vials and syringes.

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While its impossible to know which, if any, of the current vaccine candidates in development will prove effective and reach the market, the United States, along with China and India, appear posed to perhaps have first access to vaccines, given the scale of vaccine production capacity in those countries. Furthermore, in the United States, President Trump could invoke the Defense Production Act, giving the administration broad power to force companies to manufacture vaccines for domestic purposes even against their will.

Pandemic planners for years have recognized that in the event of a dangerous pandemic, countries would be under pressure to nationalize essential products made within their borders. It happened in 1976, during the swine flu scare, when it was thought the world was on the brink of a 1918-like influenza pandemic. The United States intent on vaccinating every man, woman and child would not allow vaccine producers to export their product.

Determined to protect U.S. interests, the Biomedical Advanced Research and Development Authority, an agency under the Department of Health and Human Services, has spent billions of dollars to support the creation or expansion of vaccine manufacturing operations on U.S. soil, the agencys former director, Robin Robinson, told STAT recently.

While the U.S. is perhaps being the most forthright about its intent to meet domestic needs first, experts believe many countries may succumb to the same type of pressure, especially if vaccine becomes available when a resurgence of transmission is underway.

This may not be just a phenomenon of the U.S., said Bollyky, who noted several countries have barred exports of personal protective equipment worn by health workers and ventilators.

Scott Dowell, deputy director for surveillance and epidemiology at the Bill and Melinda Gates Foundation, said the foundation is working to try to ensure countries without production capacity have access to Covid-19 vaccine. One of its approaches is to support production capacity in small countries places like Singapore and Switzerland so that even if output is nationalized, local needs will be met quickly, after which, vaccine exports could begin.

Using the earliest available doses for health workers around the world would be in everybodys best interest, Dowell said, though he acknowledged that arguments of equity may not carry much water these days.

If you end up using your first 100 million or 300 million doses on low-risk teenagers in Switzerland, Singapore, the U.S., or other places that could be a years worth of vaccine, Dowell noted. So you could lose a year immunizing really low-risk groups rather than using your vaccine in the most effective way that you could.

Prioritizing vaccine in ways aimed at minimizing the impact of the pandemic globally would be to everyones advantage, experts argue. If Covid-19 is circulating in any country, were all still at risk, said Dowell.

Bollyky noted that the earliest vaccines to hit the market may not be the most effective ones, which would mean people vaccinated with them might still be susceptible to infection. Some vaccines that take longer to develop may actually produce a more robust immune response. And if the U.S. doesnt share in a timely manner initially, others will not either, he noted.

Vaccinating all the citizens of a few countries wont solve the economic problems of those nations. If the pandemic continues to rage in most parts of the world, global travel will remain disrupted, supply chains broken, economies in tatters.

This is a global problem. It requires a global solution, said Seth Berkley, CEO of Gavi, the Vaccine Alliance.

It is the job of countries and political leaders to protect their own people and I certainly understand that, Berkley added. But it is also the job to have a longer-term view and understand the global nature of infectious diseases, as well as the global nature of science.

If we nationalize science, we will not optimize science, he said.

Bollyky said there needs to be a public dialogue about how to deploy Covid-19 vaccines when supplies are scarce so that people can understand the consequences of the various approaches to their use.

At the end of the day if this comes across as some tree-hugging argument, its just not going to resonate, he said. And thats not just here in the U.S., its in other countries as well.

Dowell agreed, saying there are huge incentives for countries to maximize the impact of the rollout of Covid-19 vaccines.

In the big picture, Ill be surprised if we dont see a planetary public health intervention implemented more effectively and faster than weve ever seen before, Dowell said, though he acknowledged it will be messy, for sure.

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Under Trump, will the US corner the market on Covid-19 vaccine? - STAT

Trump Confident COVID-19 Vaccine Will Be Available by Year’s End – Voice of America

May 15, 2020

WHITE HOUSE - U.S. President Donald Trump is saying he is confident there will be a COVID-19 vaccine by the end of the year, and mass inoculations of the public will occur quickly. I think distribution will take place almost simultaneously because we've geared up the military, Trump explained on Thursday, adding that further details will be released on Friday.The presidents prediction contrasts with testimony heard on Capitol Hill shortly before Trump spoke on the White House South Lawn. The ousted director of the federal governments vaccine agency told lawmakers, We dont have a plan to mass-produce and distribute a coronavirus vaccine. Hope for such a vaccine within 12 to 18 months assumes "everything goes perfectly, Dr. Rick Bright testified. "We've never seen everything go perfectly. More than 90 vaccines for the novel coronavirus are in development around the world. German company CureVac said Thursday that one of its mRNA candidate vaccines has protected animals from the virus at low doses. Clinical trials are expected to begin next month. Bright was removed as the director of the Biomedical Advance Research and Development Authority (BARDA), which is under the Department of Health and Human Services, an action that prompted the immunologist to file a whistleblower complaint. Trump told reporters he watched some of Thursdays testimony by Bright and he looks like an angry, disgruntled employee who, frankly, according to some people, didn't do a very good job.

Bright told a House health subcommittee that higher officials, including those at the White House, ignored his early warning about COVID-19, and the federal government was ill-prepared to respond to a pandemic.The current administration blames any shortcomings on plans and supplies left by the previous administration of Barack Obama, who turned the presidency over to Trump in January 2017. White House press secretary Kayleigh McEnany said this would be explained line by line in a briefing for reporters on Friday. The president, prior to visiting a medical supply distributor in Pennsylvania, returned to his previous controversial promotion of an unproven malaria drug for treatment of the novel coronavirus. Weve had tremendous response to the hydroxy(chloroquine), asserted Trump, who also criticized Bright for fighting it when he was running BARDA. Bright and others cautioned about the need for scientific studies about using the drug for COVID-19 treatment and warned of its dangers, including the possibility it could kill people. Asked by a reporter if the Centers for Disease Control and Prevention is over-counting U.S. deaths from the coronavirus, Trump replied, I don't know how they're counting. I never discussed it with them. Death is death. We don't want people dying in this country. And we've done a great job. The United States has recorded the most deaths and most COVID-19 cases of any country. As of Thursday afternoon EDT, according to records compiled by Johns Hopkins University, 1.4 million people had tested positive for the virus and more than 85,000 had died in the country.

At a Thursday afternoon event, partly resembling a campaign rally, at a medical supply distribution company in the election battleground state of Pennsylvania, the president promoted the replenishment of the strategic national stockpile.

Trump linked the high rate of COVID-19 cases in the United States to the country's having conducted the most tests.

When you test, you have a case, the president said. If we didnt do any testing, we would have very few cases.

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Trump Confident COVID-19 Vaccine Will Be Available by Year's End - Voice of America

Global Vaccine Development and Production Trends for COVID-19 and WHO Vaccine Pipeline Tracker – GlobeNewswire

May 15, 2020

Dublin, May 15, 2020 (GLOBE NEWSWIRE) -- The "Vaccine Development and Production Trends, COVID-19 and Other Vaccines Pipeline" report has been added to ResearchAndMarkets.com's offering.

The vaccine market is poised for a rather substantial increase in the next five years due to the number of vaccines in development and the push for a COVID-19 vaccine. As the COVID-19 outbreak advanced worldwide, companies stepped up to the challenge, scrambling to provide a potential vaccine. In addition to discussion of COVID-19 vaccine development as it stands currently, this report examines the market for human vaccines used to prevent various types of disease, focusing on commercialized vaccines and developmental vaccines for diseases that are already vaccine-preventable, with a discussion of the demanding tasks that are facing vaccine manufacturers.

Vaccine Development and Production Trends, COVID-19, and Other Vaccines Pipeline provides the following market data:

This report examines the current global market for vaccines, including discussion of prevailing issues:

Vaccination has played an enormous role in the prevention of disease, having had the greatest impact on human health of any medical intervention to date. As a result, vaccine-preventable diseases and their resulting deaths are now relatively rare in the developed world. However, developing nations have not benefited as much from the introduction of vaccines.

Vaccine Development and Production Trends, COVID-19, and Other Vaccines Pipeline outlines the issues and trends affecting the vaccine industry, including:

The report also reviews the history and lines of business, strategic alliances, and vaccine products of market participants:

Also included as an appendix is the WHO Vaccine Pipeline Tracker, a listing of WHO vaccine candidates for HIV, Ebola/Marburg, Zika, Malaria, TB, and Dengue - over 400 vaccines in development.

Key Topics Covered:

Chapter 1: Executive Summary

Chapter 2: Introduction to Vaccine Industry

Chapter 3: Production and Challenges of Vaccine Development

Chapter 4: Issues and Trends of the Vaccine Industry

Chapter 5: Market Participants

Appendix: WHO Vaccine Pipeline Tracker

For more information about this report visit https://www.researchandmarkets.com/r/istjv7

About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Global Vaccine Development and Production Trends for COVID-19 and WHO Vaccine Pipeline Tracker - GlobeNewswire

Coronavirus Updates: Whistleblower Says COVID-19 Vaccine Unlikely in 18 Months – The Weather Channel

May 15, 2020

A whistleblower who was ousted as head of a federal agency involved in developing a coronavirus vaccine, told a U.S. House committee on Thursday he doesn't think a vaccine can be ready as quickly as some in the Trump administration have suggested.

A lot of optimism is swirling around a 12 to 18 month timeframe, if everything goes perfectly, said Dr. Rick Bright, who was director of the Biomedical Advanced Research and Development Authority in the Department of Health and Human Services. Weve never seen everything go perfectly. My concern is that if we rush too quickly, and consider cutting out critical steps, we may not have a full assessment of the safety of that vaccine.

In prepared testimony to a subcommittee of the House Energy and Commerce Committee, Bright said, Our window of opportunity is closing. If we fail to develop a national coordinated response, based in science, I fear the pandemic will get far worse and be prolonged, causing unprecedented illness and fatalities.

He said the country faces the darkest winter in modern history if the administration does not act.

Bright has said he was removed from BARDA after he objected to the wide distribution of the malaria drug hydroxychloroquine that President Donald Trump had promoted as a treatment for COVID-19, the New York Times reported.

Dr. Rick Bright, former director of the Biomedical Advanced Research and Development Authority, testifies before a House Energy and Commerce Subcommittee on Health hearing to discuss protecting scientific integrity in response to the coronavirus outbreak on Thursday, May 14, 2020, on Capitol Hill in Washington.

At the hearing Thursday, Bright said, There were some attempts to bypass that rigorous vetting process that caused me great concern.

Before Bright testified, Trump tweeted that he had never met or even heard of Bright. But to me he is a disgruntled employee, not liked or respected by people I spoke to and who, with his attitude, should no longer be working for our government, he tweeted.

In a statement Thursday, HHS said Bright had pushed for quick and serious consideration of hydroxychloroquine, celebrated acquisitions of the drug, and considered chloroquine and hydroxychloroquine possible treatments for COVID-19, the Washington Post reported. The department also criticized him for not taking the new position he was assigned at the National Institutes of Health.

Bright also testified that his superiors were indifferent to his warnings about scarce supplies. He said he pushed warnings from mask manufacturer Mike Bowen that N95 mask supplies were decimated to the highest levels of HHS.

From that moment, I knew that we were going to have a crisis for our health-care workers because we were not taking action. We were already behind the ball," Bright said. "That was the last window of opportunity to turn on that production, to save the lives of those health-care workers, and we didnt act.

Nearly 85,000 people in the United States have died because of COVID-19, according to data compiled by Johns Hopkins University. More than 1.4 million coronavirus infections have been confirmed in the U.S. Worldwide, there have been more than 4.4 million confirmed infections, and over 300,000 people have died.

United States:

-Fourteen testing sites in Florida will be closed from Friday to Monday due to a threat of high winds, the state Department of Health announced Thursday. The 10 drive-thru and 4 walk-up sites are located in Volusia, Brevard, Palm Beach, Broward and Miami-Dade counties. The gusty weather is forecast to come from a low pressure system that could become the first named storm of the year. The system has already dropped several inches of rain in the Florida Keys, but isn't expected to have major impacts on land.

-New Jersey Gov. Phil Murphy announced the Jersey Shore will be reopened in time for Memorial Day weekend. Shore towns must set occupancy limits, require 6 feet of space between beachgoers except family members or couples, and prohibit groups of 10 or more from congregating on the beach. Showers, changing pavilions and rest rooms should be open, but amusement rides and arcades will remain closed and beach fireworks are prohibited.

-Florida Gov. Ron DeSantis announced Miami-Dade and Broward counties, the two Florida counties most affected by the coronavirus outbreak, can start reopening under phase one of the state's reopening plan starting Monday.

-The Mall of America, the largest shopping and entertainment complex in North America, will partially reopen June 1, mall management announced. The mall, which is in Bloomington, Minnesota, south of Minneapolis, has more than 520 stores and restaurants. All dining venues and attractions, including Nickelodeon Universe, will remain closed until the state provides more guidelines.

-North Carolina Republican Sen. Richard Burr is temporarily stepping down as chairman of the Senate Intelligence Committee. The FBI is investigating whether Burr sold hundreds of thousands of dollars worth of stocks using nonpublic information about the coronavirus. The agency served Burr with a warrant Wednesday to seize his cellphone.

-Mar-a-Lago, President Trump's club in Palm Beach, Florida, has told members its Beach Club restaurant an oceanfront building and outdoor patio, separate from the main clubhouse would reopen Saturday for lunch service, according to the Washington Post.

-The U.S. Labor Department announced about 36 million people have filed for unemployment benefits in the two months since the coronavirus first forced millions of businesses to close their doors and shrink their workforces. Last week nearly 3 million more people filed claims for jobless help.

-A study from the National Institute of Diabetes and Digestive and Kidney Diseases and the University of Pennsylvania has found that ordinary speech can emit small respiratory droplets that linger in the air for at least eight minutes and potentially much longer. The new study did not involve the coronavirus or any other virus, the Washington Post reported, but the authors said the small droplets they studied still could potentially contain enough virus particles to represent an infectious dose. The study was published in the Proceedings of the National Academy of Sciences.

Worldwide:

-The director of the World Health Organization's emergencies program said the new coronavirus may never go away, the BBC reported. "It is important to put this on the table: this virus may become just another endemic virus in our communities, and this virus may never go away," Dr. Mike Ryan said during a briefing Wednesday. "HIV has not gone away but we have come to terms with the virus," said Ryan, executive director of the WHO Health Emergencies Program. He said he doesn't think "anyone can predict when this disease will disappear," and he noted that other diseases, such as measles, still haven't been eliminated despite there being vaccines for them.

For the latest coronavirus information in your county and a full list of important resources to help you make the smartest decisions regarding the disease, check out our dedicated COVID-19 page.

The Weather Companys primary journalistic mission is to report on breaking weather news, the environment and the importance of science to our lives. This story does not necessarily represent the position of our parent company, IBM.

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Coronavirus Updates: Whistleblower Says COVID-19 Vaccine Unlikely in 18 Months - The Weather Channel

The Answer to a COVID-19 Vaccine May Lie in Our Genes, But … – Scientific American

May 15, 2020

The coronavirus, as we all know, has brought our economy to its knees. As the search for vaccines and treatments accelerates, geneticists are now looking to our genes to understand why some recover quickly or show no symptoms, while others die. To do so, they are searching DNA databases and cross-referencing them with COVID-19 cases. This research holds great promise for addressing the pandemic.

Yet if scientists do find answers in our genes, we need to consider the implications for genetic privacy. Armed with the ability to identify who is vulnerable and who is not, how will society proceed?

On the one hand, health care providers could use genetic testing to help vulnerable patients stay safe. But there would also be a temptation to use genetic testing in the workplace. Companies could use genetic test results to manage the risks for all employees, for example by controlling the activities of those who are most vulnerable. Businesses will also see opportunities to use genetic test results in the marketplace, for example by tailoring insurance offerings according to genetic risk. Currently, there are some limited legal protections against genetic discrimination and health privacy intrusions, but the pandemic has already led the federal government toscale backsome of those protections for the time being.

Although the rationale for expanded genetic testing is obviously meant for the greater good, such testing could also bring with it a host of privacy and economic harms. In the past, genetic testing has also been associated with employment discrimination. Even before the current crisis, companies like 23andMe and Ancestry assembled and started operating their own private long-term large-scale databases of U.S. citizens genetic and health data. 23andMe and Ancestry recently announced they would use their databases to identify genetic factors that predict COVID-19 susceptibility.

Other companies are growing similar databases, for a range of purposes. And the NIHs AllofUs program is constructing a genetic database, owned by the federal government, in which data from one million people will be used to study various diseases. These new developments indicate an urgent need for appropriate genetic data governance.

Leaders from the biomedical research community recently proposed a voluntary code of conduct for organizations constructing and sharing genetic databases. We believe that the public has a right to understand the risks of genetic databases and a right to have a say in how those databases will be governed. To ascertain public expectations about genetic data governance, we surveyed over two thousand (n=2,020) individuals who altogether are representative of the general U.S. population. After educating respondents about the key benefits and risks associated with DNA databasesusing information from recent mainstream news reportswe asked how willing they would be to provide their DNA data for such a database.

The results were surprising. Initially, we believed people would generally approve of donating their genetic data for altruistic reasons, such as for example, finding a vaccine for COVID-19, so we assumed they would be more willing to provide their data to a hospital or university compared with a tech company or pharmaceutical firm. But we found a fairly similar level of willingnessregardless of who owns the database. While 37 percent were unwilling to provide their DNA data to a technology company (like 23andMe), about the same percent were unwilling to provide it to a hospital (40 percent), a government health institute (37 percent), a pharmaceutical firm (40 percent) or a university (35 percent).

The most important thing our survey revealed was that the willingness of individuals to provide their genetic data depended greatly on the kinds of policies that would govern that data. Thus, in order to find a vaccine for COVID-19, we must have genetic data governance policies that inspire confidence and that will prompt the public to donate their genetic data. Willingness to provide genetic data increased the most when people were told they would have the ability to control how their stored data is reused or shared in the future. This willingness also increased when people were assured they could have their data deleted at any point.

Conversely, one of the policies that reduced willingness to contribute the most was the retention of data indefinitely without a specified date for destruction. These patterns held equally among people who were willing to provide their data as an altruistic donation and people who were only willing to provide their data in exchange for payment of some kind. The patterns also held regardless of the type of organization the respondent was being asked about, that is whether tech company, hospital, government, pharmaceutical firm or university.

Not surprisingly, we also found that willingness to provide genetic data increased greatly when contributors knew that the organization would be using state-of-the-art cybersecurity to protect their data.

Together, these findings indicate two principles to guide needed regulation and any code of conduct for genetic databases.

The first is personal agency and control. People want to know that they can control the end uses of their DNA data. This principle puts the burden on database owners to obtain additional permissions when they want to reuse or share data. It also means designing databases so each entry has an expiration date and can be selectively removed. Technologies exist to support this principle, and some organizations are using them.

The second is equal treatment of all organizations. The same rules should apply regardless of an organizations sector (e.g., for-profit, nonprofit, government); industry (health care, technology, consumer/lifestyle and so on); or size. Such distinctions make little sense in an era when data are routinely moved, shared and reused across organizations, sectors and industriesoftenwithout the full understanding of the peopleincluded in the data.

How can these principles be integrated with existing law and regulation? One approach would be to treat genetic sequence data as personal health information under HIPAA. This is consistent with the current understanding that genetic data can neither be truly de-identified nor completely stripped of sensitive informational content. Organizational policies for data access and cybersecurity can then follow health sector guidelines at a minimum.

Naturally, when biomedical researchers think about rules for genetic information databases, they want to avoid excessive limits on using the data. After all, such limits may slow scientific progress and reduce the societal benefits of the databases. But as suggested by the recent consumer genetics slowdown, without appropriate rules in place, the public may become wary of participating. Thus, it is imperative to consider public opinion of genetic data collection, the safeguarding of the data, and the use of DNA databases.

Our research suggestsour proposed principles for genetic database governance will help preserve the publics willingness to contribute their genetic informationwhich may be our only hope of defeating the coronavirus.

The authors are co-principal investigators on a grant by the Robert Wood Johnson Foundation to research the governance of genetic testing as part of corporate wellness programs. Their article Evolving public views on the value of ones DNA and expectations for genomic database governance: Results from a national survey, co-authored with Allison Gaddis and Jennifer McCormick, was published by PLOS ONE.

Read more about the coronavirus outbreak from Scientific American here, and read coverage from our international network of magazines here.

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The Answer to a COVID-19 Vaccine May Lie in Our Genes, But ... - Scientific American

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