Category: Covid-19 Vaccine

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Billions of dollars worth of coronavirus vaccine contracts have avoided usual mechanisms of transparency and regulatory oversight with Operation Warp Speed - the Trump administrations project to develop a Covid-19 vaccine - which is funneling money through a nongovernmental intermediary, a move that is likely to reignite worries over the projects opaque nature.

Operation Warp Speed has billions in secret Covid-19 vaccine contracts

Rather than entering into contracts with vaccine makers directly, NPR reports that more than $6 billion in Operation Warp Speed funding has been routed through an intermediary nongovernmental firm, thereby avoiding the usual requirements for regulatory oversight and transparency that accompany federal contracting as well as many public records request requirements.

NPR reports that funding is directed through the defense contract management firm Advance Technologies International, Inc., (ATI) who go on to award contracts to companies developing vaccines for Covid-19.

Some of the contracts for the most high-profile vaccine candidates have been awarded by ATI in this way, including $1 billion for Johnson & Johnson, $1.79 billion for Sanofi, $1.6 billion for Novavax, and $1.95 billion for Pfizer.

Since its inception, Operation Warp Speed has repeatedly come under fire over its opaque nature, including from Senate critics who accused officials of making major decisions behind closed doors; it is likely that the revelation in the way the project issues its contracts will reignite this debate.

Operation Warp Speed is the Trump administrations project to deliver a vaccine as fast as possible. The project has come under fire on numerous fronts, including from politicians slamming the organization's opaque nature and Dr Anthony Fauci raising concerns that the projects name could stoke public fears of a vaccine rushed through development for political purposes.

The organizational makeup of Operation Warp Speed has remained, along with many other aspects of the organization, relatively opaque. Stat News recently shed light on this with an organizational chart showing a highly structured organization dominated by military personnel.

How Operation Warp Speeds big vaccine contracts could stay secret (NPR)

Operation Warp Speeds opaque choices of COVID-19 vaccines draw Senate scrutiny (Science)

New document reveals scope and structure of Operation Warp Speed and underscores vast military involvement (Stat News)

Full coverage and live updates on the Coronavirus

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Operation Warp Speed Has Over $6 Billion In Secret Covid-19 Vaccine Contracts Evading Scrutiny - Forbes

NEW YORK CITY: As the death toll continues to climb in the latest violence between Armenia and Azerbaijan over the separatist territory of Nagorno-Karabakh, diplomatic efforts to find a solution to the decades-old rivalry have intensified.

Russia, France, and the US co-chairs of the OSCE Minsk Group created in 1992 to encourage a negotiated resolution to the conflict have called for an immediate cease-fire and a return to negotiations without delay.

Russia has offered to host talks between the foreign ministers of the warring countries, insisting there is no alternative to political and diplomatic methods for resolving the crisis.

The UN Security Council has issued a similar call to urgently resume talks without preconditions, backing an earlier appeal by UN Secretary-General Antonio Guterres to de-escalate the conflict and return to meaningful negotiations.

Armenia never refused to sit for peaceful negotiations, said Mher Margaryan, Armenias permanent representative to the UN, in an interview with Arab News. But it doesnt seem to be the intention of Azerbaijan to follow the calls for peace.

At the onset of the coronavirus disease (COVID-19) pandemic, Guterres made an appeal for a global cease-fire to help stem the spread of the virus.

Azerbaijan not only refused to unconditionally support the secretary-generals appeal, but also resorted to a large-scale military intervention, added Margaryan.

The (Azerbaijani) offensive comes amid a global crisis caused by the COVID-19 pandemic, when the international community is focused on fighting the disease.

Azerbaijan has decided to take advantage of these global vulnerabilities caused by the pandemic. So, this is not just an attack against Armenians but (also) an attack against the basic norms of humanity, an attack against what the UN stands for.

French President Emmanuel Macrons office said he and his Russian counterpart Vladimir Putin also shared their concern regarding the sending of Syrian mercenaries by Turkey to Nagorno-Karabakh.

Margaryan said Armenia was very concerned by the alleged involvement of foreign fighters. These foreign mercenaries are actually being recruited and transported with the support and encouragement of Turkey. We have to name the names: (The Turks) have been a very destructive element in this conflict. They need to be encouraged to stop.

The envoy said Azerbaijans actions, while they took the world by surprise, had been preceded by years of dangerous rhetoric, hate speech and Armeniaphobia,embraced and promulgated at the highest political level.

The leadership of Azerbaijan has been promoting hate crimes and glorifying hate criminals. At the same time, they have been spending billions of dollars to acquire deadly offensive weaponry and openly threatening the people of Armenia and Nagorno-Karabakh with promises to use force.

This section contains relevant reference points, placed in (Opinion field)

This much was clear, Margaryan said, from the Azerbaijan presidents recent speech at the 75th session of the UN General Assembly. It was not only a textbook manifestation of a hate speech but also we have come to realize now (a) declaration of war against the people of the Nagorno-Karabakh with a clear genocidal intent.

Margaryan believes the people of Nagorno-Karabakh have all the rights to live in their ancestors historical land without fear of foreign collision.

He added: At the core of the (Karabakh) issue is the right to self-determination which is enshrined in the UN Charter, and they have exercised this right by way of a referendum back in December 1991 in accordance with the applicable Soviet laws at the time, and also international law.

Nagorno-Karabakh broke away from Azerbaijan during the 1991-94 war, which left 30,000 people dead and displaced more than 1 million others. However, it has never been internationally recognized as an independent republic.

Armenia as a guarantor of the security of the people of Karabakh will take every measure to defend their inalienable rights. Armenians around the world are very strongly united on this matter, Margaryan said.

We as Armenians cannot allow another genocide to be perpetrated against the Armenian population in the course Azerbaijans military aggression (that is) encouraged and supported by Turkey.

Ankaras expansionist and imperialistic policies were an attempt to sow instability in the region, he said.

While it is hard to say who is benefiting from this war, those who instigated this conflict (are) very well known not only to the expert community, not only with us who mediate in this conflict, but to the larger international society as well, Margaryan said.

The international community should send a stronger message to those engaged from the outside and encourage Azerbaijan itself to come to its senses and stop military aggression.

The resumption of this frozen conflict which dates back to the collapse of the Soviet Union has raised concerns about stability in the South Caucasus, a corridor for pipelines carrying oil and gas to world markets, and has even raised fears that regional powers Russia and Turkey could be drawn in.

What we are observing now is already a large-scale escalation with the use of the heaviest weaponry in their arsenal, Margaryan said.

It should come as no surprise that if the aggression continues then it might have a dangerous spillover effect. If Azerbaijan and Turkey are not contained, the consequences can have a devastating impact on the entire region and beyond.

Azerbaijan and Turkey must come to their senses and heed the call of the international community to commit to peace and good faith, he added.

The US, which co-chairs the OSCE Minsk Group, has not considered Nagorno-Karabakh a foreign policy priority since 2001.

We hope (Karabakh) is on the (American) list of priorities and we hope that the groups co-chair countries will continue to have a unified position as to the principles of the resolution of the conflict, Margaryan said.

He directed the same message at the Azerbaijan President (Ilham Aliyev) that Nikol Pashinyan, Armenias prime minister, has been emphasizing since he came to power in 2018.

The message to the Azeri president is: Any solution to this long-standing conflict must be acceptable to the people of Armenia, NK and Azerbaijan. And it should be without prejudice to all people who are concerned, Margaryan added.

So, the international community should use all means (to have) external actors withdrawn from the conflict zone.

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Twitter: @EphremKossaify

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COVID-19 vaccine will not end the pandemic on its own, experts warn - Arab News

The government has drafted scenarios and prepared logistical needs necessary to distribute COVID-19 vaccine across the archipelago, to make sure it can be evenly disbursed once available.

The scenarios were discussed in a coordination meeting led by Coordinating Maritime Affairs and Investment Minister Luhut Binsar Pandjaitan on Wednesday.

The vaccine is necessary for us now. Our main priority is preparing vaccination logistics, targets and mechanisms, the minister said.

Read also: Jokowi gives committee two weeks to draft COVID-19 vaccination plan

In order to distribute the vaccine evenly across the country, the government plans to procure cold chain equipment to store and distribute hundreds of millions of doses of COVID-19 vaccine from other countries.

State-Owned Enterprises Deputy Minister Budi Gunadi said two state-owned pharmaceutical firms, Bio Farma and Kimia Farma, currently only had the capacity to store 123 million out of 352 million vaccine doses.

Indonesia has forged cooperation with several countries regarding the supply of potential vaccines.

Chinese biopharmaceutical company Sinovac Biotech partnered with Bio Farma to launch the late-stage human trials of a candidate vaccine in Bandung, West Java. The trial involved some 1,620 volunteers since August.

Kimia Farma struck a deal with Group 42 (G42) Healthcare, an artificial intelligence company in the United Arab Emirates, to develop a potential vaccine.

The Research and Technology Ministry is also leading a national consortium, comprising research bodies and universities, to develop the Merah Putih vaccine.

The Health Ministry also signed an agreement with UNICEF to procure COVID-19 vaccine through COVAX, a global vaccine allocation plan co-led by the World Health Organization aiming for even distribution of the vaccine.

Read also: Indonesia secures massive supply of potential COVID-19 vaccine until end of 2021

During Wednesdays meeting, Indonesian Food and Drug Monitoring Agency (BPOM) head Penny Kusumawati Lukito said the agencys technical team would check laboratories designated to mass produce the vaccine as well as the ongoing clinical trials.

The agency would also discuss with Sinovac regarding the vaccines delivery. After the vaccine arrived in Indonesia, BPOM would submit a halal certification for the substance to the Indonesian Ulema Council (MUI).

In the meantime, the Health Ministry is training medical workers for the vaccination program. Two community health centers (Puskesmas) in Badung, Denpasar, Bali as well as Bogor, West Java would become the locations for vaccination simulation.

Health Minister Terawan Agus Putranto said medical personnel and other workers in health facilities would be vaccinated first. The second group [to be vaccinated] would be workers aged 18 to 59, which is a high-risk group."

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Govt gears up for future COVID-19 vaccination - The Jakarta Post - Jakarta Post

In a U.S. pandemic response dominated by missteps, the effort to develop vaccines to prevent Covid-19 has so far been a triumph. Vaccines against the coronavirus that causes the disease are now racing through giant clinical trials as a result.

Its a terrible irony, then, that the Trump administrations statements have resulted in an erosion of public trust, with the percent of Americans who tell pollsters they would take a Covid-19 vaccine dropping and experts worrying the president could compel the Food and Drug Administration to approve a vaccine before one is ready. (Spoiler: No vaccine will likely be ready by Election Day.)

When the the president comes out and says, by a very special day, we might have a vaccine, the whole thing blows up, Ashish Jha, the dean of the Brown School of Public Health, said at a session focused on Covid-19 at the STAT Health Tech Summit. In some ways, weve got to get the politicians to shut up and let the scientists talk about this and drive this process.

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The process of deciding when a vaccine appears to be safe and effective isnt as straightforward as the general public might believe. But its important to understand it if we are to have confidence in these critical tools for helping to curb the pandemic.

Here, then, is a rundown of the science that goes into the decision-making process, what it tells us about when results could realistically be available, and when vaccines could start to be administered. This story is based on interviews as well as on documents the drug makers have released detailing their clinical trial plans.

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A clinical trial is typically sponsored by a company making a vaccine candidate or an academic institution, or a partnership of both. But it is actually monitored by what is known as a data and safety monitoring board, or DSMB, a group of independent experts hired to make sure volunteers in the study are safe. In many studies, the DSMB has the ability to recommend stopping a study not only if a treatment is unsafe, but also if it is so clearly effective that continuing just wouldnt be ethical.

In the case of the vaccine trials, the studies being run by Moderna, AstraZeneca, and Johnson & Johnson with the National Institutes of Health share a common DSMB. The study being run by Pfizer and its partner BioNTech has its own.

The DSMBs will conduct whats called an interim analysis after a certain number of people have been infected with Covid-19 and shown symptoms. Each of these cases is considered an event, and each vaccine maker has set a different number of events as a threshold to conduct an interim analysis as part of their trial protocols.

The study being run by Pfizer and its partner BioNTech, frontrunners in the race for a vaccine, is conducting its first interim analysis after 32 events, and would consider the vaccine effective if 26 people in the placebo group and six in its vaccine group had Covid. A study of Modernas vaccine, another frontrunner, is waiting until there are 53 cases of Covid.

In the case of Pfizer and BioNTech, an interim analysis could happen in October.

Should a vaccine be approved, potentially for millions of people, after its efficacy has been shown based on 32 cases of Covid-19?

Some experts say no. Eric Topol, the director of the Scripps Research Translational Institute, has been fervently saying that all the trials should continue beyond even their designed ends when there are about 150 cases of Covid saying that even the 150 number may make statistical sense, but it defies common sense. This could be particularly true if efficacy is limited, given that all the vaccines frequently cause side effects like fever.

Others say that while making a decision based on an interim analysis is fine, the first Pfizer analysis, in particular, seems to set a relatively low bar for efficacy given the small number of events.

The numbers are in line with past vaccine studies. Prevnar 13 was approved to prevent pneumonia in adults based on a study of 84,000 people that detected 139 cases of pneumonia, 90 of them in the placebo group.

But theres also a precedent for keeping such studies going to collect more safety data. Researchers studying RotaTeq, a vaccine to prevent a virus that causes childhood diarrhea, collected data from 70,000 patients to rule out a potential side effect which had been seen with a previous vaccine.

If and when a company believes its vaccine is safe and effective, it will then submit its data to the Food and Drug Administration.

No Covid-19 vaccine is likely to be fully approved by the FDA in the near term, because of requirements for manufacturing and follow-up that could take years. The FDA is expected instead to use a different authority by granting what is known as an emergency use authorization, or EUA.

The bar for an EUA is low, and past EUAs have seemed unwise in hindsight. A drug, peramivir, was authorized on an emergency basis to treat hospitalized patients during the H1N1 swine flu in 2009; the drug later failed to be shown effective in a clinical trial of such patients. Hydroxychloroquine was given an EUA to treat Covid-19 in hospitalized patients; that authorization was later rescinded once further study showed the drug did not benefit them. The EUA for convalescent plasma involved data that would never pass muster for an approval. These later examples are precisely why many experts are so worried that the FDAs decision-making is politicized.

The challenge for the FDA will be to make sure that it brings its usual standards for a vaccine to the much more flexible emergency use authorization process.

Reviewing data on a drug candidate normally takes a year, six months if it is fast, and three months at the fastest. Even a truncated review should take weeks. So even if data on Pfizers vaccine are available in mid-October, an emergency authorization by Election Day is difficult to imagine. The same is true if data emerge from one of the studies of AstraZenecas vaccine being conducted outside the U.S.

That assumes, of course, that politics are not at play.

In the interim analyses that most people who follow medicine are used to, as soon as there is a clear result, the trial stops. But the plan for Covid-19 vaccines is different: Data from an interim analysis may be released if a vaccine is deemed inarguably effective but volunteers may not be immediately told whether they are receiving vaccine or placebo. In other words, the study will remain blinded. Participants receiving a placebo will not be switched immediately to the vaccine.

The protocol is designed in a way that even if we would be able to file after an interim analysis, the protocol is designed to move on, at least for a certain amount of time, said Kathrin Jansen, Pfizers head of vaccine research, on a recent call with reporters. The reason is that there is a need to assess efficacy in smaller groups, such as teenagers, the elderly, and people with HIV, she said. Jansen said that Pfizer and BioNTech hope to gather information about severe infection, too.

Keeping a trial going after an interim analysis can be difficult, so much so that Thomas Fleming, one of the top minds in clinical trial statistics, co-authored a 2008 paper on why it should be avoided.

In a conference call with reporters to discuss the start of the study for Johnson & Johnsons vaccine, Anthony Fauci, who heads research on infectious disease at the NIH, said that the other trials will continue in a blinded fashion until half the volunteers in the study have been followed for at least two months, in order to collect more data on efficacy and safety.

The J&J study requires only 20 cases of Covid-19 before an interim analysis is conducted. But Paul Stoffels, Johnson & Johnsons chief scientific officer, told STAT that his company will wait to even conduct an interim analysis until after half the participants in its 60,000-volunteer study, started this month, have been followed for two months. Such an analysis will also require enough data in other populations, including the elderly. After the data are interpreted, the DSMB might recommend stopping the study.

Generating enough data is also where we take our responsibility, because in the end we will be liable for the product getting into the market, Stoffels said.

You know, we go from a thousand people, to 60,000, to probably 100 million to 500 million people, Stoffels said. The information we generate has to be very solid.

Thats the point that regulators and, especially, politicians need to remember no matter how eager they are to have a vaccine in hand.

Link:

A guide to how and when a Covid-19 vaccine could be cleared - STAT

Scientist Drew Weissman's research is the basis for several vaccines being developed to fight the pandemic.

It is no exaggeration to say that Drew Weissman '81, MS '81, is among a handful of scientists whose research may save the world from COVID-19.

Now his findings and the system he developed for delivering mRNA into cells underpin two of the most promising candidates for a coronavirus vaccine, one being developed by Pfizer and BioNTech and the other by Moderna.

Drew Weissman

Weissman, a professor of medicine at the Perelman School of Medicine at the University of Pennsylvania, is also working with the government of Thailand on a COVID-19 vaccine for the developing world. It is expected to be more affordable and easier-to-produce than the vaccines being created by drug companies.

A biochemistry major at Brandeis, Weissman worked in professor Gerald Fasmans lab.

"He definitely gave me insights on how to develop hypotheses how to think about them, how to develop new lines of research," said Weissman, who wrote his master's thesis on acetylation of DNA, part of the process of gene regulation.

Messenger molecules, mRNA transport instructions from DNA to the ribosomes in our cells for the production of proteins.

In a traditional chickenpox, polio, flu or rabies vaccine, a weakened or killed version of the virus is injected, fooling the immune system into fighting the disease.

But manufacturing a virus is a lot more expensive than synthesizing mRNA. And it isnt necessary to create an entirely new vaccine for each disease using mRNA since the mRNA can be reprogrammed to fight the target illness.

Many researchers gave up on mRNA, but Weissman and Karik persisted. "We were getting interesting results, so they just kept leading us on," Weissman said.

They replaced one of mRNAs four chemical building blocks, a nucleoside called uridine, with a slightly modified nucleoside called pseudouridine. This enabled the mRNA to skirt the body's immune system.

In the late 2010s came several more major breakthroughs. The researchers used mRNA to immunize mice against genital herpes (which is caused by the herpes simplex virus), influenza, Zika and HIV.

If it works, a COVID-19 mRNA vaccine will spur human cells to produce the spike-shaped protein found on SARS-CoV-2, the virus that causes the illness, and will trigger the immune system to produce protective antibodies.

Weissman is now focusing on an even more ambitious project developing a vaccine for all coronaviruses. Besides SARS-CoV-2, two other lethal varieties of coronavirus SARS and MERS have spread among humans in recent years.

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The Brandeis alum whose research may lead to a COVID-19 vaccine - Brandeis University

At least one late-stage clinical trial will likely provide data to support the safety and efficacy of an emerging coronavirus disease 2019 (COVID-19) vaccine candidate by the end of this year, but there are concerns that the lack of long-term safety data and the rush to approve a vaccine before November could pose potential health risks to the public.

This is according to Barry Bloom, Ph.D., research professor of public health and former dean at the Harvard T.H. Chan School of Public Health, who participated in an online forum titled The Coronavirus Pandemic: Global Race for a Vaccine held September 15.

Even if results are able to support an emergency use authorization (EUA) for a COVID-19 vaccine by the end of 2020, Bloom noted, there will be a limited supply. Manufacturers, he argued, do not currently have the capacity to produce all the vaccines necessary for the U.S and the world at large.

By January 2nd, there will not be enough vaccines to protect everybody, and that leads to some critical decisions of who will be prioritized to get the first vaccines, Bloom said.

Forum moderator Michele Gershberg, the U.S. health editor for Reuters, asked Bloom whether it was realistic for a potential COVID-19 vaccine, once proven safe and effective in Phase III trials, could be considered or authorized for some people by as early as October 2020. Bloom responded that the decision as to whether a vaccine is protective and safe will depend on the studys statistical data.

Gershberg also asked Bloom about pauses in COVID-19 trials, for which he responded: It is unlikely that I think a vaccine will be so spectacular that there would be reason to stop the trial, but I would point out the pause in one of the vaccine trials from AstraZeneca was because of two patients that had potential serious adverse effects.

This response was in reference to AstraZenecas decision earlier this month to pause a U.K. trial studying COVID-19 vaccine candidate AZD1222. While the company has since resumed the trial, it hasnt yet released specifics on the adverse effects the two patients experienced.

Now we know generally in clinical trials [that] this information does not have to be disclosed to the public, but I'm wondering under these circumstances, with everybody watching this race so closely, do you think that vaccine developers should think a little bit more differently about how quickly they disclose issues like this for the sake of transparency? Gershberg asked.

Bloom responded that most late-stage trials, including those which enroll up to 30,000 people or more, expect to see at least one adverse event during the study period. Likewise, making interim data available during a non-pandemic era isnt mandatory or always considered. This is a very special situation, he added, in which every country in the world (and their political parties) are involved in the COVID-19 vaccine race.

I think your point is well-taken that the companies and the government should be as transparent as possible, [while] still protecting individual personal privacy and rights, to tell what they know at the earliest possible point, he said.

When asked about the lack of U.S. involvement in a World Health Organization (WHO) initiative to raise money to create an equitable distribution network of vaccines around the world, Bloom noted that it is very sad to see the U.S. withdraw from the WHO at exactly the time in the middle of a unique pandemic [and] when developing countries that do not have the capacity for the science or developing industrial production of vaccines are increasingly vulnerable and not willing to have us participate in a formal way.

The U.S. has been seen as the leader in global health, the leader in science, the leader in the commitment of science for the benefit of people around the world, Bloom added. We have withdrawn from that role, and I think that's bad for the U.S. and certainly not good for the people in low- and middle-income countries.

Gershberg proceeded to ask Bloom about the potential of a government granting an EUA for a COVID-19 vaccine in children prior to adequate testing being conducted. Bloom responded that this will be highly unlikely considering most trials are restricted to adults and people with the highest risk of COVID-19-related mortality are over the age of 60.

I would hope if the results [of adult COVID-19 studies] are so spectacularly clear that the injuries are minor that there will be studies immediately after approvals to show that it's safe in children, he said. We're lucky with COVID-19 in that children seem to be the most resistant to the adverse, serious consequences of hospitalization and death of any age group, so they're not the most vulnerable which they would be for many other infectious diseases.

Bloom added that COVID-19 vaccines will likely face opposition by some groups of people.

The first anti-vaccine organized society was in 1886, and it has persisted in many, many vaccines that were developed after smallpox, he said. There's always been a small group who preserve and fight for their independence to make decisions, rather than believe it's worth the public good to have everybody protected.

Whats different now, he suggested, is that social media has provided these groups a pervasive platform capable of spreading disinformation and misinformation on a more massive scale.

And we now know from other countries [that] misinformationmakes it only more difficult for people to get the information they need to make a decision, he added.

Despite the possible backlash, Bloom stated he and his colleagues in the scientific community are optimistic that several of these vaccines, and there are many more behind them, are going to be found to be safe and effective and be made available. He estimated that approximately 5.6 billion doses will be required for the world population, or 200 to 250 million for the U.S.

Read the rest here:

Experts Hope COVID-19 Vaccines Will Prove Safe and Effective, Yet Concerns Over Long-Term Effects Linger - BioSpace

The coming months are going to be crucial for vaccine development and decisions around how we distribute COVID-19 vaccines equitably, who gets them first and how to gain the publics trust.

These were some of the challenges discussed in two sessions at the World Economic Forum's Sustainable Development Impact Summit.

With 42 vaccine candidates in clinical trials on humans, scientists are working hard to fast-track the development of a safe and effective vaccine that would typically take decades work.

We are at the beginning of the beginning, said Sai Prasad, President of the Developing Countries Vaccine Manufacturers Network.

We are just at the end of the first year, and we have a few candidates that are moving forward. None of them are successful yet. Time will tell the next three to four months as to which one of these candidates will be successful.

Thats the end of the beginning, because once you know whats successful, you have to manufacture that at scale. The devil is in the detail. After you manufacture, you have to get these products approved and then distribute them.

How close is the world to finding a coronavirus vaccine?

Image: Statista

In the first six months of the pandemic, more than 700 products for treatment or prevention of COVID-19 went into the pipeline, which is unprecedented, said Julie Gerberding, Executive Vice-President of pharmaceuticals company Merck.

She compared the response speed with that of the AIDS epidemic: It was several years before there was even a test and it was 15 years before a highly active antiviral remedy. Were living in an era where the science has brought possibilities.

Antivirals, which Merck is also working on, will help. If we can take mortality down, it buys us time... I dont think we should put all our eggs in the vaccine basket, but clearly its a huge component of securing global protection and we have to prioritize it.

Once a vaccine is successful, how can world leaders ensure against vaccine nationalism and make sure its distributed fairly across the globe?

Gavi, The Vaccine Alliance, along with the World Health Organization and the Coalition for Epidemic Preparedness Innovations (CEPI), have created the COVAX Facility, a global initiative that brings together governments and manufacturers to ensure eventual COVID-19 vaccines reach those in greatest need.

So far, a total of 156 economies, representing nearly two-thirds of the global population, are now committed to or eligible to receive vaccines through the Facility.

Responding to the COVID-19 pandemic requires global cooperation among governments, international organizations and the business community, which is at the centre of the World Economic Forums mission as the International Organization for Public-Private Cooperation.

Since its launch on 11 March, the Forums COVID Action Platform has brought together 1,667 stakeholders from 1,106 businesses and organizations to mitigate the risk and impact of the unprecedented global health emergency that is COVID-19.

The platform is created with the support of the World Health Organization and is open to all businesses and industry groups, as well as other stakeholders, aiming to integrate and inform joint action.

As an organization, the Forum has a track record of supporting efforts to contain epidemics. In 2017, at our Annual Meeting, the Coalition for Epidemic Preparedness Innovations (CEPI) was launched bringing together experts from government, business, health, academia and civil society to accelerate the development of vaccines. CEPI is currently supporting the race to develop a vaccine against this strand of the coronavirus.

"A vaccine is the way we're going to get out of this pandemic that is the best way we have to go back towards normal, said Seth Berkley, Chief Executive Officer of Gavi.

Our belief in a fast-moving pandemic is youre not safe unless everyone is safe. What the COVAX Facility is trying to do is to get a vaccine out to all countries, rich and poor, at the same time.

Initially, he said, this would be frontline health workers and those most at risk and then the broader population.

Gavi is working with the pharmaceutical industry to scale up production and it is looking to have 2 billion doses available by the end of 2021.

Before COVAX, countries didnt have the option of working together, said Richard Hatchett, Chief Executive Officer of CEPI.

They were behaving in their own rational self-interest, which would have been inequitable and resulted in a perpetuation of the pandemic.

We have had to devise institutional arrangements in real time to develop and create a space for international collaboration in development, procurement and delivery. Designing a system to solve all those at one time is a huge challenge.

He said its encouraging to see emerging momentum around global solidarity and collaboration and willingness to work with us.

Global coverage, local plans

Companies need to look at the issues of the developing world during product development, said Prasad of the Developing Countries Vaccine Manufacturers Network, particularly around vaccine storage temperature, transportation and biomedical waste disposal.

Many companies are doing that. But if they only have a US focus, they might not see the needs of the middle-income and low-income countries.

Gavi's Berkley said each country would need a bespoke plan for who to vaccinate first.

In the US, it might be [people in] prisons or meat-packing plants, the elderly, but in developing countries, you might not have a high elderly population, but you might have urban slums and displaced people, so you really have to understand the local situation even though we can have global guidelines.

Johnson & Johnson's candidate is the latest to go into Phase 3 clinical trials and will now be studied as a single-dose vaccine on 60,000 people.

The pharmaceutical company says its on track to meet its goal of providing 1 billion doses of an affordable vaccine each year. It anticipates the first batches to be available in early 2021, if proven to be safe and effective.

Paul Stoffels, Johnson & Johnson's Chief Scientific Officer, said the first vaccines would be ready early next year and explained the trial size was determined by transmission rate.

"To reach a statistically significant end point, we need to have significant numbers, so there's a lot of data science to see where we have to target people most at risk."

He said the company has learned from developing vaccines for the Ebola virus that single-shot vaccines are efficacious, but they will be testing booster shots at a later date.

All eyes are on the pharmaceutical companies during the development process, and once a vaccine is ready to be distributed, will the global public want to take it?

In a recent World Economic Forum-Ipsos survey of nearly 20,000 adults from 27 countries, 74% said they would get a vaccine for COVID-19.

This majority might still fall short of the number required to beat COVID-19, with just 37% strongly agreeing they would be willing.

Pascal Soriot, the CEO of AstraZeneca, said companies working on COVID-19 vaccines are looking at how to provide greater transparency without impacting on vaccine trials.

AstraZeneca, which is developing a vaccine with the University of Oxford, paused its Phase 3 trial earlier this month, after a patient became sick. The trial has now restarted in the UK, but in the US, it's waiting on the go-ahead from the FDA.

"Stopping a trial in a vaccine programme is not uncommon and if you place safety at the centre of what you do, you're going to have to stop and look at events.

"Typically, the clinical guidelines recommend you don't disclose patient-level information or much information at all because you could compromise the study.

"We're looking at how much transparency we can provide... as an industry without compromising patient privacy or the trial itself."

"At the end of the day, people have to accept that they have to trust someone... So many regulators will look at this data and these results with different eyes... Medicine shouldn't be practiced by the media, it should be practiced by experts."

Trust is everything, said Gerberding. We need to involve opinion leaders and trusted doctors at the local level to communicate the actual facts and stand strong.

Its an understandable concern that in our race to get additional population protection, safety shortcuts will occur. That is not the case. The major vaccine manufacturers recently signed a pledge promising that they would adhere to safety requirements of the regulatory agents and not jump ahead of the curve in an effort to win the race.

We are self-policing and making sure we dont overstep that confidence barrier.

Preparing for the next one

We cant afford to be short-termist while were focusing on COVID-19, Gerberding and Berkley also warned.

It is evolutionarily certain we will have more outbreaks, said Berkley. The way to build back better is to have routine systems and continued investment. The cost [of COVID-19] has been between $9 and $12 trillion. A little bit of investment in peacetime is exactly the right thing to do.

Gerberding added: "We have to make sure that while we're fighting this pandemic, we're preparing for the next, because I do believe it's only a matter of time before we face another of these situations or potentially something worse."

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What are the challenges to making a COVID-19 vaccine? - World Economic Forum

The coronavirus pandemic has turned markets upside down.

Sectors like financials, energy, and consumer discretionary have been hit hard as consumers have spent more time at home, and so-called "stay-at-home" stocks like Zoom Video CommunicationsandPeloton have soared along with e-commerce, benefiting from the shift in consumer behavior.

Image source: Getty Images.

No one knows when a COVID-19 vaccine will eventually come out, but when it does, it's a good bet that traditional consumer behavior will return. While some business leaders believe there will be a permanent shift to remote work and e-commerce, there will also be pent-up demand for pre-COVID ways of living, like socializing in large groups and, for many, returning to the office and the traditional way of life.

Keep reading to see whyDisney(NYSE:DIS),Planet Fitness(NYSE:PLNT), andLyft(NASDAQ:LYFT) all look like stocks poised to soar when a vaccine is released.

Image source: Disney.

Few large companies have been impacted by the pandemic as much as Disney. Nearly every component of its business, including its theme parks and resorts, movie releases, and live sports, has been upended by the crisis. Six months after the pandemic began, the company is still operating its parks at reduced capacity, and it just delayed a slate of blockbuster movies set to debut this year. Many of the challenges it's facing will endure until a vaccine is discovered and distributed.

Despite those headwinds, Disney actually managed to deliver a slight operating profit in its most recent quarter, a period that included the bulk of the lockdowns in the U.S. and Europe. Though it lost nearly $5 billion on a generally accepted accounting principles (GAAP) basis, the entirety of the loss was owed to restructuring and impairment charges as the company wrote down the value of assets like its international Disney Channels. The company posted an adjusted profit in part because of costs saved due to sports cancellations, but the results show the business is more resilient than investors thought.

There is one component of Disney's business that has shined during the pandemic: streaming, and in particular Disney+. The namesake service that the company launched last November has already racked up more than 60 million subscribers, and should help reinforce the strength of the brand at at time when other Disney experiences are unavailable.

Once a COVID-19 vaccine is fully deployed, Disney is likely to benefit from both the increased subscriber base in its streaming business, which also includes Hulu and ESPN+, and a surge of pent-up demand for its theme parks, as tourists and fans are likely to come flooding back. While that may not happen until 2022, when it does, it will almost certainly be Disney's best year ever, likely giving the stock a jolt.

Image source: Planet Fitness.

There's no question that the pandemic has been a disaster for the gyms and the fitness industry in general. Gyms have been closed in many states as part of restrictions aimed at slowing the spread of the coronavirus, and even when they've reopened, many gym-goers are reluctant or fearful of contracting the virus. They'd rather work out in their own homes, where they don't have to wear a mask or follow other safety protocols.

Planet Fitness saw revenue decline 78% in the second quarter and posted a loss of $29.2 million, and though most of its fitness centers have now reopened, the company faces stiff headwinds as many people simply don't feel comfortable exercising in a gym. Still, Planet Fitness is in a much stronger financial position than many of its competitors, including independent gyms and exercise studios, and chains that have declared bankruptcy like Gold's Gym and 24-Hour Fitness. Planet Fitness finished the second quarter with $423 million in cash, giving it a sufficient safety net to survive the crisis.

Once a vaccine comes on the market, people are likely to return to gyms and fitness classes, eager to resume their old workout routines. Additionally, the return of social events will be another incentive for many people to get back in shape. Workout options like Peloton have thrived during the pandemic, but Planet Fitness competes for a much different customer, offering memberships at just $10/month compared to an exercise bike that costs about $2,000. Many of its customers have no other good, similarly priced option for accessing the kind of gym equipment available at Planet Fitness because they don't have space in their homes to install a home gym, and workout classes or something like Peloton is too expensive. That should help drive Planet Fitness' comeback when it's safe to return.

Image source: Lyft.

Ridesharing companies like Lyft are in a difficult position these days, as nearly all of the major use cases for such transportation, including commuting, going home after a night out, and traveling to the airport, have significantly declined. However, the company has cut costs sharply and kept its adjusted EBITDA loss to $280.3 million in the second quarter, better than the company's expectations, as revenue tumbled 61% to $339.3 million. Lyft also laid off 17% of its workforce at the end of April, which should help streamline the business once it returns to full health.

While the company's results will continue to be ugly during the pandemic, Lyft has enough cash on its balance sheet to make it through the crisis with nearly $3 billion in cash and short-term investments, and just $623 million in debt.

The company was previously targeting profitability on an adjusted EBITDA basis by the end of next year, and is still on track, provided a vaccine comes out between now and then. In its August earnings call, the company said it had achieved $300 million in annual savings, which would allow it to be profitable with 20% to 25% fewer rides, or annual revenue of around $5 billion. By comparison, the company had $3.6 billion in revenue last year.

Unlike most of the stocks that have suffered during the pandemic, Lyft was delivering high growth in pre-COVID days. Revenue jumped 68% in 2019, and the company was calling for 27% to 29% growth in 2020. Once a COVID-19 vaccine is available, Lyft rides should surge as Americans return to old habits, and pent-up demand for social events and travel should drive the company's revenue back to all-time highs.

Lyft shares are now down 37% year to date, giving significant upside to a recovery.

Link:

3 Stocks That Will Only Get Stronger After the COVID-19 Vaccine - Motley Fool

As scientists around the world race to find a vaccine for COVID-19 and even a cure, a drug heavily pushed by the president doesnt seem to be a front runner.

Back in March, we met an infectious disease doctor from North Dakota on the frontlines looking for a cure to coronavirus, studying the drug hydroxychloroquine and its effects on people that contract the virus.

Since March we completed two randomized controlled trials. One was hydroxychloroquine being able to treat COVID-19 disease and the other was looking at hydroxychloroquine as post-exposure prophylaxis, meaning trying to prevent developing disease after getting exposed, said Dr. Caleb Skipper, University of Minnesota.

President Donald Trump has been a long time supporter of the drug, even after some of the countries top health experts said otherwise, like Dr. Anthony Fauci.

Hydroxy has tremendous support, but politically its toxic because I supported it. If I would have said, Do not use hydroxychloroquine under any circumstances, they would have come out and they would have said, Its a great its a great thing,' said Trump.

Dr. Fauci recently shared that a study using hydroxychloroquine at The Henry Ford Hospital, and many others have not shown success. The same is for Dr. Skipper and his team at the University of Minnesota.

Dr. Skipper added, Both trials found essentially the same thing. Hydroxychloroquine was not able to effectively either prevent the progression of the disease, compared to placebo or prevent disease after exposure.

Dr. Skipper says that doesnt mean the drug cant be used to fight the virus at all, just not on a universal scale. Instead, it may be effective in certain populations, like healthcare workers who could take the drug and it would prevent them from ever getting it.

He says although they werent able to find a cure, others are working hard for vaccines to end the pandemic.

Dr. Skipper says other medications are being looked at that could cure COVID-19.

The rest is here:

Doctor from Rugby says the race to find a COVID-19 vaccine or cure is still on, despite failed studies - KX NEWS

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COVID-19 Vaccines: HHS Advisory Committee Urges 'Great Caution' On Use Of EUA - Pink Sheet