Category: Covid-19 Vaccine

Health Matters is a biweekly opinion column. The views expressed are solely the authors.

A vaccine that nobody wants to take is not very useful.

If there were a safe and effective vaccine against COVID, why wouldnt people take it? After all, the virus has claimed 200,000 American lives, shut down schools and businesses and affected almost every aspect of our lives. The fact that scientists have been able to develop vaccine candidates in mere months after sequencing SARS-CoV-2s genetic code is nothing short of a medical marvel. However, our countrys hyper-polarizing climate has thrust the rapid vaccine progress into the political ring, resulting in rising public distrust.

Theres a reason progress on the vaccine has been so fast. The Trump administration implemented Operation Warp Speed (OWS) five months ago, which aims to produce 300 million doses of vaccines by January 2021 with an approved budget of $10 billion.

So far, OWS results seem promising. There are nine vaccines in phase 3 trials, the final phase before submitting for FDA approval. For details on how clinical trial phases work click here. Frontrunners include Moderna and Pfizer, which use inactivated coronavirus fragments to induce an immune response, and AstraZeneca, which uses an adenovirus to carry coronavirus genes into cells, provoking an immune response.

Even with promising results, the public remains nervous. A new Kaiser Family Foundation (KFF) poll showed 62% expressing concern that political pressure from Trump would force the FDA to approve a vaccine without ensuring safety and efficacy. Less than half (46%) would get vaccinated if a vaccine were approved by the FDA before the election. Another poll from STAT echoed the KFF poll, with 78% worried that vaccine approval is driven by politics more than science.

The integrity of the FDA has been put in question, catching the ire of administration, scientists and the American public. On one hand, Trump has claimed an FDA deep state that is committed to thwart his reelection by delaying a vaccine until after the election. On the other hand, scientists and the public are increasingly skeptical of the FDA, as the agency pushed out Emergency Use Authorization (EUA) for hydroxychloroquine after Trump touted it. The EUA was later rescinded.

More recently, the day after Trump called convalescent plasma a medical breakthrough the FDA gave plasma an EUA. It was promptly pointed out that misleading statistics overdramatized plasmas benefit and the statement was later rescinded via Twitter.

The mounting criticism of the FDA being controlled by the White House reached such a fever pitch that last week, in an opinion column in USA Today, eight career scientist at the FDA made a pledge that their work would continue unimpeded and independent of political influence. They stated if the agencys credibility is lost because of real or perceived interference, people will not rely on the agencys safety warnings and later adding We and our career staff do the best by public health when we are the decision makers, arriving at those decisions based on our unbiased evaluation of the scientific evidence.

Big Pharma is far from exempt. Many scientists say these vaccine makers need to be more transparent about how vaccine trials are run and reporting adverse events. In normal circumstances, drug companies hold clinical trial results precious in order to guard intellectual property and maintain competitive advantage. However, critics say that American taxpayers are entitled to know the details since the federal government has spent nearly $10 billion as part of OWS.

The most recent example of transparency (or perhaps lack thereof) is the incidence of a rare but lethal spinal inflammatory disorder called transverse myelitis in AstraZenecas Phase 3 trial, which immediately halted the trial. Trial shutdowns are common, and perhaps this instance demonstrates that drug companies are willing to slow down warp speed for the sake of patient safety. However, many are upset is that the shutdown was announced in a closed private meeting with investors and was actually leaked by STAT News.

The drug companies know that gaining public trust will lead to more vaccinations. In fact, in an unprecedented move amongst competitors, nine pharmaceutical companies including all the heavyweights pledged to stand with science by promising to submit for EUA only after ensuring safety and efficacy. Of course, these are things we already expect from a drug company. Even more so from the FDA.

All these factors make it challenging to follow the science. I believe in vaccines, but for me (i.e., this is not a medical recommendation but a personal choice), I think I will wait several months and continue to be vigilant with masks, hand-washing and distancing. These trials typically take years (the quickest vaccine developed in history took 5 years) to demonstrate safety and Im uncertain how efficacious the vaccine will be since antibody tests, one of the measures showing if a vaccine works, are not where they need to be.

Im also concerned about logistical compliance of the vaccine, since it is two parts and the second dose is time-dependentwhat if people dont get the second dose or they take it too late? I also think that more time and money should be put towards a COVID countermeasure. As it stands, only a small fraction of the $10 billion is going towards therapeutics. Many lives could be saved if we had a Tamiflu equivalent for treating COVID.

So back to the starting quote A vaccine that nobody wants to take is not very useful, which was from AstraZeneca CEO Pascal Soriot. Increased scientific knowledge, transparency on all sides and less scientific missteps with political leanings are key to gaining my trust in taking the vaccine.

Inside information on Arlingtons COVID vaccine plan is hard to find, but I do know that plans are in motion to prepare for imminent distribution. While this article is pertinent to all Americans, it will be interesting to hear what Arlingtonians think regarding the vaccine.

Dr. George C. Hwang, known to his patients as Dr. Chaucer, is a practicing anesthesiologist who also helps to runMind Peace Clinicsin Arlington. He has written for multiple journals, textbooks and medical news outlets, and has been living in Arlington for the past 15 years.

Excerpt from:

Health Matters: Will You Trust a COVID-19 Vaccine? - ARLnow

Without masks and a vaccine, we could reach Herd Immunity from COVID-19, but deaths would skyrocket. We break down the science of it. USA TODAY

I'm USA TODAYeditor-in-chief Nicole Carroll, and this is The Backstory, insights into our biggest stories of the week. If you'd like to get The Backstoryin your inbox every week,sign up here.

Bottom line: "You've got to be patient," said Jennifer Portman, USA TODAY's health editor.

This week, Pfizer, one of the companies developing a vaccine, said its test looks safeand plans to releasedata for approval at the end of October. It is expanding its Phase 3trial from 30,000 to 44,000 people, another sign that things are going well.

USA TODAY patient safety reporter Karen Weintraubexplains the phases, which start after a vaccine has been tested in a labon mice and on monkeys.

Phase 1, she said, "is a very small trial wherethey're trying to make sure they're not killing anybody. There arehints at effectiveness in Phase 1but not a lot of data. Phase 2 is a bigger trial phase. Phase 3 is the big trial."

The vaccine will be approved if on average, it is at least 50% effective in Phase 3. "Then there will be a Phase 4," she said, "which is once it's on the market, they're going to continue these trials for some time andmake sure there are no side effectssix months down the line."

Once the vaccine is approved at the end of Phase 3,there's a regulatory process. The U.S. Food and Drug Administration reviews the data,then the U.S. Centers for Disease Control and Prevention determineshow the vaccine will be distributed. Most vaccine candidates will require two doses to be effective.

"It will first go to health workers in hospitals or clinics who aretreating COVID patients," said Elizabeth Weise, a USA TODAY health and science reporter. "Maybe front-line providers, police, firefighters, the military will probably have its own section. And then it'll start coming down to people, if they got COVID, probably at highest risk of getting very sick or dying. It depends on which vaccine and whoit works best on."

The vaccine can be distributed quickly after approval because companies are already manufacturing iton the assumption theirs will be approved. If they do not get approval,they'll have to destroy all the vials waiting for distribution.

From left, USA TODAY's Karen Weintraub, Jennifer Portman and Elizabeth Weise.(Photo: USA TODAY)

The CDC document released this week says the vaccine might be available by early November but "significantly more COVID-19 vaccine may be available for distribution" beginning in January 2021.

But wide distribution?

"I definitely think that's a huge issue on people's minds," Weintraub said."When can life resume?And I think it's sometime next summer to fall."

A day later, on Wednesday, that'sexactly what CDC DirectorRobert Redfield told the Senate. Any vaccine available in November or December would be very limited and prioritized, he said.If youre asking me,When is it going to be available to the American public so we can begin to take advantage of vaccines to get back to our regular life? I think were probably looking at late second quarter, third quarter 2021.

We ask this question ofour own experts each month as well. USA TODAY created a panel of leaders in medicine, virology, immunology, logistics and supply chain issues to estimate how close we are to a vaccine.We plot their answers on a USA TODAY vaccine clock, on which midnight is the day the pandemic began and noon is the day that a vaccine is freely available to whomever wants it.

Right now, on average, our experts say we're at 7 a.m., up from 4 a.m. in June.Our panel this month was concerned about making sure that data fromthe vaccine trials is transparent, openly released to the scientific community and thoroughlyvetted.

It's a shared concern. On Sept. 3, the Biotechnology Innovation Organization issued a public letter reiterating the strict standards its members follow. Trusting science and the scientific process is the best way out of this pandemic, said Dr. Michelle McMurry-Heath, BIO's president and CEO.

Race to the vaccine:The sprint to create a COVID-19 vaccine started in January. The finish line awaits.

Fighting COVID-19: How the CDC failed public health officials fighting the coronavirus

A USA TODAY/Suffolk Poll released this month showed two-thirds of U.S. voters say they won't try to get a coronavirus vaccine as soon as it becomes available,and one in four say they don't want to ever get it.The poll, taken Aug. 28-31, surveyed registered voters.

"We know what needs to be done. And we'll tell you if it's being done or ifit's not being done," Weise said. "And then when we actually get a vaccine, we should have enough information to saythere's great data, this vaccine is safe and effective, or there was not great data and there are many questions about this vaccine.

We are not political. We'rescience writers who arejust going to say, This is what we know. This is the data we have.

Portman says the most important thing we can do, as journalists and as citizens, is follow the science,"and it's just going to take a little bit longer than any of us want."

The Backstory: Covering the record-setting wildfires that have wracked Western states

The Backstory: Our journalists' top takeaways from the Democratic and Republican conventions

You can reach Nicole Carroll at EIC@usatoday.com orfollow her onTwitterhere.Thank you forsupporting our journalism.You cansubscribe to ourprint edition, ad-free experienceor electronic newspaper replica here.

Read or Share this story: https://www.usatoday.com/story/opinion/2020/09/18/covid-19-vaccine-available-cdc-coronavirus-summer-fall-2021/5799327002/

See the original post:

The Backstory: What our health journalists want you to know about the coronavirus vaccine - USA TODAY

The headlines arent always kind to the National Security Agency, a spy agency that operates almost entirely in the shadows. But a year ago, the NSA launched its new Cybersecurity Directorate, which in the past year has emerged as one of the more visible divisions of the spy agency.

At its core, the directorate focuses on defending and securing critical national security systems that the government uses for its sensitive and classified communications. But the directorate has become best known for sharing some of the more emerging, large-scale cyber threats from foreign hackers. In the past year the directorate has warned against attacks targeting secure boot features in most modern computers, and doxxed a malware operation linked to Russian intelligence. By going public, NSA aims to make it harder for foreign hackers to reuse their tools and techniques, while helping to defend critical systems at home.

But six months after the directorate started its work, COVID-19 was declared a pandemic and large swathes of the world and the U.S. went into lockdown, prompting hackers to shift gears and change tactics.

The threat landscape has changed, Anne Neuberger, NSAs director of cybersecurity, told TechCrunch at Disrupt 2020. Weve moved to telework, we move to new infrastructure, and weve watched cyber adversaries move to take advantage of that as well, she said.

Publicly, the NSA advised on which videoconferencing and collaboration software was secure, and warned about the risks associated with virtual private networks, of which usage boomed after lockdowns began.

But behind the scenes, the NSA is working with federal partners to help protect the efforts to produce and distribute a vaccine for COVID-19, a feat that the U.S. government called Operation Warp Speed. News of NSAs involvement in the operation was first reported by Cyberscoop. As the world races to develop a working COVID-19 vaccine, which experts say is the only long-term way to end the pandemic, NSA and its U.K. and Canadian partners went public with another Russian intelligence operation aimed at targeting COVID-19 research.

Were part of a partnership across the U.S. government, we each have different roles, said Neuberger. The role we play as part of Team America for Cyber is working to understand foreign actors, who are they, who are seeking to steal COVID-19 vaccine information or more importantly, disrupt vaccine information or shake confidence in a given vaccine.

Neuberger said that protecting the pharma companies developing a vaccine is just one part of the massive supply chain operation that goes into getting a vaccine out to millions of Americans. Ensuring the cybersecurity of the government agencies tasked with approving a vaccine is also a top priority.

Here are more takeaways from the talk, and you can watch the interview in full (embedded above).

TikTok is just days away from an app store ban, after the Trump administration earlier this year accused the Chinese-owned company of posing a threat to national security. But the government has been less than forthcoming about what specific risks the video sharing app poses, only alleging that the app could be compelled to spy for China. Beijing has long been accused of cyberattacks against the U.S., including the massive breach of classified government employee files from the Office of Personnel Management in 2014.

Neuberger said that the scope and scale of TikToks apps data collection makes it easier for Chinese spies to answer all kinds of different intelligence questions on U.S. nationals. Neuberger conceded that U.S. tech companies like Facebook and Google also collect large amounts of user data. But that there are greater concerns on how [China] in particular could use all that information collected against populations other than its own, she said.

The NSA is trying to be more open about the vulnerabilities it finds and discloses, Neuberger said. She told TechCrunch that the agency has shared a number of vulnerabilities with private companies this year, but those companies did not want to give attribution.

One exception was earlier this year when Microsoft confirmed NSA had found and privately reported a major cryptographic flaw in Windows 10, which could have allowed hackers to run malware masquerading as a legitimate file. The bug was so dangerous that NSA reported the vulnerability to Microsoft, which patched the bug.

Only two years earlier, the spy agency was criticized for finding and using a Windows vulnerability to conduct surveillance instead of alerting Microsoft to the flaw. The exploit was later leaked and was used to infect thousands of computers with the WannaCry ransomware, causing millions of dollars worth of damage.

As a spy agency, NSA exploits flaws and vulnerabilities in software to gather intelligence on the enemy. It has to run through a process called the Vulnerabilities Equities Process, which allows the government to retain bugs that it can use for spying.

Read this article:

How the NSA is disrupting foreign hackers targeting COVID-19 vaccine research - TechCrunch

The past half year has proven without a doubt the critical importance of a well-functioning healthcare supply chain. It has also revealed many of the shortcomings and weak links in that chain. While the procurement, transport and distribution of such items as personal protective equipment (PPE) posed one of the greatest logistics challenges of our lifetime, this will pale in comparison to an even greater task ahead of us: vaccine logistics.

Luckily, all stakeholders in the supply chain, from suppliers, to governments and NGOs and onto logistics providers, have learned much since the pandemic began. Now is the time to put these lessons into practice and prepare for the huge challenge of getting life-saving vaccines to the people of this world. As the worlds largest logistics group, we are prepared to distribute the vaccines but it all depends when the vaccine will be ready, and how prepared governments are the world over to take all the necessary measures for the final delivery of the vaccine to their citizens.

Keeping vaccines cool along the supply chain will be a major challenge

Image: DHL

It is evident that we must act quickly. Currently, there are more than 250 potential COVID-19 vaccines in various stages of development around the world, with progress being made at unprecedented speed. It is not unlikely that we could see some vaccines ready for distribution before the end of this year.

This rapid rollout is only possible if special approaches in vaccine development, testing and stabilization are used. While traditionally, sufficient time is devoted to testing and developing vaccine stability, with the tremendous urgency to deliver a successful coronavirus vaccine, this might not be the case for all of the potential candidates.

A potential lack of stability data, in turn, could mean more stringent temperature requirements for the vaccine supply chain, with some vaccines needing to be kept at temperatures as low as -80 degrees Celsius. This poses challenges for the existing medical supply chain that conventionally distributes vaccines at +28C. While health authorities, producers and logistics providers would strongly prefer to begin large-scale transport and distribution under the less stringent conditions, one of the most promising vaccines that could be produced at high capacity is likely to require such extreme care, more akin to logistics used for medical trials a system created to cater to a much lower number of units than billions of doses of a COVID-19 vaccine.

The actual transport of these vaccines will also pose a huge challenge. Due to their urgency, it is probable that at least for longer distances air freight will be needed. If we want to achieve global coverage over the next two years, that means some 200,000 pallet shipments and 15,000 flights. In the final distribution we could potentially require nearly 15 million cooling boxes, with the corresponding amounts of cooling bricks or dry ice.

Data must be available for everyone

Due to the sensitivity of the shipments, technology will play a vital role in ensuring the smooth execution along every step of the supply chain, for example to ensure that vaccines have remained efficacious throughout the supply chain. At the same time, and as the initial scramble for PPE earlier this year showed, we will need to increase the overall visibility on relevant data for everyone involved. This is not only essential to properly judge supply and demand, but also to identify potential bottlenecks that slow the transport and distribution of the vaccines.

Currently, no platform exists that covers all those visibility needs, but a number of examples exist from other areas. Ecommerce-led platforms, for example, are able to provide near real-time shipment visibility, smart routing and demand forecasting. In the forwarding industry there are data sharing platforms that are able to monitor and predict potential risks, such as volatile transportation, distressed suppliers and other disruptions. Adapting existing solutions to emergency response management could greatly ease some of the challenges experienced in the past months.

Reaching billions of people

Geography will be a defining factor in how quickly and efficiently vaccines can be distributed, and here temperature requirements are likely to be the main challenge. If vaccines need to be distributed under the more stringent scenario, especially regions with a particularly warm climate and those with limited cold-chain logistics infrastructure will pose a huge challenge this is the case in large parts of Africa, South America and Asia. In other words, if the vaccine does need this extreme care, we are currently only able to (fairly) easily reach 2.5 billion of the worlds population.

Potentially, some of these challenges can be lessened if, in the end, the vaccines that go into mass production do not need such stringent care, but even then the logistical effort will be extraordinary.

We are all in this together

So what needs to be done in the short time we still have before the first vaccines arrive?

The world has learned a lot of lessons over the past few months of this health crisis. One of them is that sufficient planning and solid partnerships make a huge difference when it comes to meeting the surge in demand for medical supplies and ensuring their effective distribution. A network with both public-private and government-to-government partnerships will be essential going forward. Every one of us has an interest in ending this pandemic as quickly as possible.

Logistics companies such as Deutsche Post DHL Group and our peers in the industry are natural partners to ensure that the countries of the world will be able to source and distribute any vaccine as quickly as possible. We and they are working hard to set up the necessary infrastructure and have the teams in place to execute the moment a vaccine arrives. Global logistics players, working in tandem with governments, NGOs and health authorities, will be able to provide governments with access to a global shipping network at scale as well as local warehousing capacity and know-how with in-country logistics. But, as mentioned at the start, much will also depend on when the vaccines will be available and how well governments around the world have prepared for the distribution of the vaccine to their people.

As part of our contribution to this endeavor, but also to stress the critical urgency of this matter, Deutsche Post DHL Group also recently published a study in collaboration with McKinsey & Company that offers an in-depth look at what the logistics challenges for medical supplies, particularly vaccines, might look like in the coming months. The white paper offers a five-pillar strategy to help stakeholders prepare for and respond to the next public health emergency.

Included in the report are also a number of recommendations for governments to support them as they prepare not only for the requirements of a well-run vaccine supply chain, but also for future crisis. These measures could entail, for example, the creation of centralized special unit within the government that has the authority to quickly and effectively decide and respond to developments, that can act agilely to an ever changing and often complex situation, and possess credibility both within the government and the public sector.

Prepared for future crisis

COVID-19 is not the worlds first pandemic, and it likely will not be the last. By working together in strong partnerships and with careful and informed planning, we can establish comprehensive public health crisis management backed by safe and sophisticated supply chains. This will help us tackle the current challenges we face, and make sure that we are well prepared to deal with any large-scale health crisis that comes our way.

Read more here:

How to get billions of COVID-19 vaccines around the world - World Economic Forum

ROCHESTER, NY (WROC)Rochester Clinical Research is working to find an effective vaccine, by focusing on recruiting people of color, who are more impacted by the virus.

Adam Larrabee says Rochester Clinical Research is at the forefront of the search of a COVID-19 vaccine.

The most important thing that we can do right now is find a vaccine for COVID-19 to help save lives, said Adam Larrabee, president of Rochester Clinical Research, Inc.

Multiple phase 1, 2, and 3 trials are taking place at Rochester Clinical Research, and they are hoping to recruit up to 5,000 people as paid volunteers to take place in COVID-19 Vaccine Studies.

It could be eight visits over two years, the first two visits may be within the first month and then they dont come back for another 3-6 months and then theres periodic phone calls, said Larrabee.

Volunteers can make up to $150 dollars per visit. Health requirements for some of the phases are low, and researchers say they work with volunteers providing transportation and compensation for their time.

To make sure the vaccine is most effective, researchers are targeting communities of color, who are most at risk for infection.

Those are the people that 3 times at risk of being infected and 7 times more likely to die, said Larrabee. We know right now that the communities of color are being infected the most. The only chance at prevention is with a vaccine.

To learn more, you can call585-288-0890 or visit their website here.

Read the original:

COVID-19 vaccine trials looking to target communities of color - WIVB.com - News 4

Thats not the case with Covid-19. So far, over 25.7 million people have been infected worldwide and 857,920 have died. With the prospect of many more infections ahead, the rapid deployment of a safe and effective vaccine is all the more urgent.

The Centers for Disease Control and Prevention told public health agencies last week that limited doses of a vaccine may be available beginning in late October or November, although that would only be if a vaccine is shown to be safe and effective. According to the documents the agency sent to the public health offices, two million doses of what the C.D.C. labeled Vaccine A most likely the Pfizer vaccine may be available by the end of October, with 10 to 20 million doses possibly available by November, and 20 to 30 million by the end of December.

The C.D.C. said the other potential vaccine, Vaccine B which matches the details of the Moderna vaccine could have about 1 million doses available by October, 10 million by November, and 15 million by December. Each of the vaccines would require two doses to be effective.

Pfizer and Moderna did not respond to questions about the C.D.C.s recent guidelines.

In the documents sent to public health agencies, the C.D.C. said certain groups would have priority, beginning with health care workers, essential workers (like police officers or those who work in critical industries like food production), national security populations, and workers and residents of long-term care facilities like nursing homes.

Those priority groups include millions of people. At a meeting last week of the Advisory Committee on Immunization Practices of the C.D.C., an agency official presented a slide showing that in the United States, there are about 17 to 20 million health care workers, 60 to 80 million essential workers and about 53 million people older than 65.

On Wednesday, the National Academies of Sciences, Engineering and Medicine unveiled a 114-page plan, sponsored by the C.D.C. and the National Institutes of Health, that proposed a complicated four-phase system for priority.

Probably not. Aside from Moderna and Pfizer, there are 34 other vaccines in clinical trials worldwide. There are over 90 more vaccines confirmed to be in active preclinical testing. Over the next year, 69 of them are slated to go into clinical trials.

Read this article:

What We Know About the C.D.C.'s Covid-19 Vaccine Plans - The New York Times

TipRanks

Did the stock markets epic rally just need a little breather? The last few weeks have seen stocks experience their first meaningful correction since the bull market kicked off in March. Now, the question swirling around the Street is, will the rally pick back up again, or is more downside on the way?According to Morgan Stanleys chief U.S. equity strategist Mike Wilson, uncertainty regarding the presidential election and stalemate on the next stimulus package could lead to declines in September and October. On the correction, there's still downside as markets digest the risk of congressional gridlock on the next fiscal deal. While we think something will ultimately get done, it will likely take another few weeks to get it over the goal line, he noted.However, Wilson argues the recent volatility in no way signals the end of the current bull market. We think this correction is just that, a correction in a new bull market. It's normal for markets to pullback after such an incredible run like we've experienced since March. Furthermore, when a new bull market coincides with a new economic cycle, the bull market usually runs for years, not months, the strategist explained.Taking Wilsons outlook to heart, our focus shifted to three stocks getting a thumbs up from Morgan Stanley. As the firms analysts see over 50% upside potential in store for each, we used TipRanks database to get the full scoop.Akero Therapeutics (AKRO)With its innovative medicines designed to restore metabolic balance and halt the progression of NASH, a severe form of nonalcoholic fatty liver disease, Akero Therapeutics wants to address the unmet medical needs of patients from all over the world. Based on the strength of its lead candidate, Morgan Stanley is pounding the table.Representing the firm, 5-star analyst Matthew Harrison tells clients that AKROs treatment for NASH, efruxifermin (EFX), has a best-in-class profile. EFX is the companys lead asset and was designed to mimic the biological activity of fibroblast growth factor 21 (FGF21), which regulates multiple metabolic pathways and cellular processes, to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins.According to Harrison, NASH is a complex disease, with patients usually having multiple co-morbidities like obesity, type-2 diabetes, increased triglycerides, increased LDL cholesterol and low HDL cholesterol. A promising therapeutic solution would not only treat the multiple components of NASH but would also have an acceptable side effect profile given the potential co-morbidities, the analyst explained.Thats where AKROs therapy comes in. In June, Akero presented best-in-class data from its Phase 2a study. This data indicates that EFX improved the two liver histological endpoints recommended by the FDA along with resulting in weight loss, improving cardiovascular health (increasing good HDL cholesterol, decreasing triglycerides, not raising bad LDL cholesterol), and improving factors related to controlling blood glucose levels. This benefit/risk profile beats the competition, Harrison stated.Looking at the indication as a whole, Harrison views NASH as a very large opportunity given that roughly 20 million people in the U.S. suffer from the condition.The analyst, however, acknowledges there are commercial hurdles. One of these is the fact that NASH is currently undiagnosed in all but a very small percentage of the prevalent pool since diagnosis currently requires an invasive liver biopsy. Therefore, along with demonstrating a positive benefit/risk profile, AKRO will need to find patients and secure payer support should the candidate receive FDA approval, in Harrisons opinion.That said, Harrison believes AKRO is up for the task. We believe that given EFXs clean safety profile and broad-based effects, Akero will likely largely overcome these commercial hurdles, he commented.Harrison added, Importantly, since Akeros treatment is injectable, we only assume the drug will penetrate into the population of the most sick patients where there are currently at least 400,000 patients diagnosed and seeking treatment in the U.S. To this end, he assigns a 60% probability of success, and estimates unadjusted peak sales for the U.S. and the EU will land at $4.5 billion.Based on all of the above, Harrison rates AKRO an Overweight (i.e. Buy) along with a $70 price target. Should his thesis play out, a potential twelve-month gain of 93% could be in the cards. (To watch Harrisons track record, click here)Are other analysts in agreement? They are. Only Buy ratings, 6, in fact, have been issued in the last three months. Therefore, the message is clear: AKRO is a Strong Buy. Given the $58.50 average price target, shares could rise 61% in the next year. (See AKRO stock analysis on TipRanks)TransDigm Group (TDG)Next up we have TransDigm Group, which is one of the top producers, designers and suppliers of highly engineered aerospace components, systems and subsystems. Its products are used on nearly all commercial and military aircrafts in service today. Given its ability to weather the COVID-19 storm, Morgan Stanley sees a bright future ahead.Morgan Stanley analyst Kristine Liwag stated, We view TransDigm as the most defensible business model in commercial aerospace. However, this is not to say the company hasnt been confronted with serious challenges.Over the past few years, management has had to grapple with how to price its defense business, the sustainability of its pricing strategy in aerospace, the durability of its levered balance sheet and the ability to weather a downturn. That said, Liwag remains optimistic going forward. TDG has overcome short thesis after short thesis in the past few years and we do not expect these concerns to repeat, she noted.According to Liwag, TDGs ability to hold on to margins during a global pandemic conveys its operating strength. To this end, her estimate for EBITDA margins is well above the rest of the Streets. The analyst also points out that the company cut its SG&A expense by $89 million year-over-year in fiscal Q3 2020. We assume the company will retain at least half of those savings, with the remainder returning in the form of variable selling expenses, she said.Liwag added, We are positive on TransDigm, particularly as recovery in global air traffic would be favorable for TransDigms core profit maker, the aftermarket. Additionally, we view it positively that TDG has the means to acquire weaker players.Back in April, management raised $1.5 billion of additional debt to trim liquidity risks and provide an extra cushion. A large debt load is part of managements strategy to provide private equity like return for its shareholders. Historically, the company has used debt to acquire businesses with similar attributes to TDGs portfolio of 90% proprietary products and 75% sole sourced. If passenger air traffic continues to normalize, we would expect TDG to use its incremental capital to acquire struggling businesses that fit its strategy, Liwag commented.All of this prompted Liwag to leave her bullish call and $772 price target unchanged. This target conveys her confidence in TDGs ability to climb 48% higher in the next year. (To watch Liwags track record, click here)Looking at the consensus breakdown, 7 Buys and 5 Holds have been published in the last three months. Therefore, TDG gets a Moderate Buy consensus rating. Based on the $500.58 average price target, shares are poised to stay range-bound for now. (See TDG stock analysis on TipRanks)Cemex SAB (CX)Cemex counts itself as one of the leading players in the building materials industry, with the company manufacturing and distributing cement, ready-mix concrete and aggregates. As its risk/reward profile has just gotten more positive, now could be the time to snap up shares, so says Morgan Stanley.Covering the stock for Morgan Stanley, analyst Nikolaj Lippmann believes that CXs bullish guidance for the third quarter and FY20, which was significantly ahead of consensus, was the catalyst that builds a bridge to a favorable risk-reward shift. On top of this, the stock is trading at 6.4 2020e EV/EBITDA, which is cheap compared to its historical performance and its peers, according to the analyst.That being said, Lippmann argues CX is mainly a good, strong deleveraging story with a call option on what could be an exceptional U.S. cement market if the U.S. Congress approves an infrastructure package in 2021... If we get a U.S. infrastructure package beyond 2020, it would add icing to the cake, we think, and take the market from good to possibly great.Although a large multi-year package is dependent upon the outcomes of the U.S. presidential and congressional elections, even in the base case, Lippmann expects cement to show pricing power in the U.S.It should be noted that Lippmann thinks its possible the next year will be relatively uneventful, but in that case, he expects the industry to pause at 90% capacity utilization and grow from there. On top of this, pricing in Mexico has been holding up. This limits the downside risk materially and helps skew the risk-reward positively, in Lippmanns opinion.What else is working in CXs favor? The cement demand year-to-date has pleasantly surprised Lippmann, with upside seen during the first stage of the pandemic. He points to DIY and Department of Transportation maintenance work during periods of low traffic, and strong residential construction as the drivers of this demand.Everything that CX has going for it convinced Lippmann to rate the stock an Overweight (i.e. Buy). Along with the call, he attached a $6 price target, suggesting 50% upside potential. (To watch Lippmanns track record, click here)Turning to the rest of the analyst community, opinions are split almost evenly. 6 Buys and 5 Holds add up to a Moderate Buy consensus rating. At $4.16, the average price target implies 4% upside potential. (See Cemex stock analysis on TipRanks)To find good ideas for stocks trading at attractive valuations, visit TipRanks Best Stocks to Buy, a newly launched tool that unites all of TipRanks equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

Excerpt from:

Vaxart Can Still Be a Major Force in the COVID-19 Vaccine Landscape, Says Analyst - Yahoo Finance

Utah County is developing a vaccination scheduling tool to prevent long lines at health clinics and limit physical human interaction once a COVID-19 vaccine becomes available to the public.

During a Utah County Commission work session on Wednesday, Eric Edwards, director of health promotion at the Utah County Health Department, told the commissioners that, in the beginning of the swine flu pandemic in 1999, health clinics experienced the huge long lines and there were frustrations about the supply and demand needs of vaccines.

It just wasnt well coordinated because we werent prepared at that point for anything like that, Edwards said. We hadnt experienced it before.

One of the greatest lessons learned from the swine flu pandemic, Edwards said, is the need to have some way of organizing appointments for individuals so that they could come and receive in a systematic way rather than having the Disneyland line effect.

After being instructed by the Utah Department of Health in April that it should start preparing for the eventual arrival of a vaccine for COVID-19, the county health department began working with Utah County Information Systems on a web-based application that would allow patients to schedule vaccination appointments online.

Such a tool would address the greatest challenges of large-scale vaccination, he said, including massive lines, physical distancing needs and appropriately vaccinating priority populations.

Allowing users to download and fill out their form beforehand speeds up the vaccination process and prevents the Health Department from having crowded waiting areas wherein patients are filling out forms, according to a health department presentation.

IS Director Patrick Wawro said the tool would help the health department administer vaccinations in a safe way during the pandemic, noting that patients dont have to come in contact with anyone to make this appointment, at all, until its time to actually come in and get their shot.

It really speeds up the process for the health department, Wawro said. And no longer do you have to come in and have them fill out a form at the side table or anything like that, theyve already done all that. So the idea here is that we dont have groups of people. Pretty much, as soon as you arrive, youre going to be ushered in in the next few minutes, which is what were after.

County programmers developed a prototype of the tool and did a soft launch with county employees, Edwards said. On Sept. 9, 56 county employees successfully set flu shot appointments using the tool, while 72 employees successfully registered the next day.

Weve actually already begun testing this application in a real way, said Wawro. Any county employee(s) last week were able to register to get their first flu shot of the year using this application because we wanted to test our capability and performance.

The next step, Edwards said, will be testing the tool with the public at community flu clinics, including at an upcoming drive-thru flu clinic in Spanish Fork.

But doing this, I dont think we can test it enough so that we truly can be prepared for whatevers to come with the eventual arrival of the COVID-19 vaccine, Edwards acknowledged.

Centers for Disease Control and Prevention Director Robert Redfield told a United States Senate panel on Wednesday that he predicted a coronavirus vaccine would be generally available to the American public in the late second or third quarter of 2021.

Connor Richards covers government, the environment and south Utah County for the Daily Herald. He can be reached at crichards@heraldextra.com and 801-344-2599.

See more here:

Utah County develops online scheduling tool in preparation for COVID-19 vaccine availability - Daily Herald

In recent days, the President has accused Democratic nominee Joe Biden of being mentally "shot" and "on drugs," and implied that the 77-year-old will not be fit to serve within a month of taking office -- a crude attack on a rival only three years his elder. His disparagement of Democratic vice presidential nominee Kamala Harris has taken an increasingly racist and sexist tone. And during a riotous campaign swing, he claimed Democrats generally want to "lock law-abiding Americans in their homes."

Trump is also escalating false claims that the election will be rigged, claiming that mail-in voting is "unconstitutional" an outright lie. And he's resorting to ever-more inflammatory rhetoric to scare up the votes of White suburbanites: "Does anybody want to have somebody from Antifa as a member, as a resident of your suburb? I don't think so," Trump said Thursday, conjuring a fantasy of picket-fenced suburbs under invasion.

What is he up to? Of course, Trump loves saying outrageous things to get a rise from crowds. But he also needs to win over more voters than the typical 42% or so who think he's doing a great job. And his turn toward the unhinged reveals a huge bet at the center of his reelection bid.

We'll find out in 50 days.

'Now I can be really vicious'

Despite his flame-thrower rhetoric, Trump says it's Democrats who've crossed the line. On the campaign trail this weekend, the President complained that Democrats had been unfair to him by seizing on his reported remarks that US war dead in France were "losers" and "suckers." "Pathetic Joe, he's a pathetic human being to allow that to happen," Trump said at a rally in Nevada Saturday night, concluding: "Now I can be really vicious."

Spot the difference

'The last vestiges of the Flat Earth Society of this generation'

First in line for a jab?

"No, I will not get in the line for a coronavirus vaccine," writes Damien in Paris. "Vaccines take years to research and more years to test. Rushing science is not a good idea. We must learn, as a society that lives increasingly in tight packed cities, to adopt hygenic practices in our daily lives. When and if there is a vaccine, I will wait a few years to see if it seems efficient and harmless."

In Pennsylvania, Kathy seemed to agree: "With virtually EVERYTHING being politicized by Trump who would feel safe taking some half-baked vaccine!? NO WAY!!!!!"

Guy in Belgium said that he would happily volunteer to take it if it would help advance the science. "As I am 67 and fit, I could be a good test person for the study here in Belgium."

We got a conditional yes from Alan in South Africa. "It would depend on the supplier of the vaccine and who endorses it. A vaccine released by Trump -- I would be at the end of the queue. Endorsed by Faucci and/or created, tested and released by other Western nations, I would be at the front of the line," he said.

And Carolyn said she would trust a vetted vaccine -- but would wait for the most exposed members of society to get the jab first.: "I'm a 68-year-old White female Democrat. I think essential workers should be first in line. Then the most vulnerable. Then those over age 65 followed by the young and healthy. Finally at the end of the line all those who are not practicing social distancing or wearing masks. I think that would serve some justice to all those who could have easily helped their fellow man but refused."

Visit link:

Trump turns 'vicious' and readers debate the Covid-19 vaccine - CNN

In the past 25 weeks, the COVID-19 pandemic has reversed 25 years of progress in global vaccine distribution. Immunization coverage, a good barometer for how health systems are functioning, has plummeted to levels last seen in the 1990s, according to the Bill & Melinda Gates Foundations fourth annual Goalkeepers Report.

Now, the unequal distribution of vaccines stands to do even more damage as countries with greater financial resources preemptively stockpile limited doses of future COVID-19 vaccines, a move that Northeasterns MOBS Lab determined could cause almost twice as many coronavirus deaths than if vaccines were equally distributed once available.

We believe global collaboration is the most effective way forward. Businesses and governments must understand that the future is not a zero-sum contest in which winners win only when someone else loses. It is a co-operative endeavor in which we all make progress together, said Bill and Melinda Gates in a recent op-ed in the Financial Times.

Matteo Chinazzi is a senior research scientist in Northeasterns Network Science Institute. Photo by Matthew Modoono/Northeastern University

The Bill & Melinda Gates Foundation asked a team of researchers at the MOBS Lab, led by Alessandro Vespignani, director of the Network Science Institute and Sternberg Family distinguished university professor of physics, and Matteo Chinazzi, senior research scientist, to estimate the outcomes for two different vaccine scenarios.

In one scenario, approximately 50 high-income countries monopolize the first 2 billion doses of the COVID-19 vaccine. In the other, doses are distributed everywhere based on each countrys population, not its ability to afford the vaccine.

The models found that 61 percent of deaths could be averted if the vaccine was distributed to all countries proportional to population, while only 33 percent of deaths would be averted if high-income countries got the vaccines first.

Thats quite a difference, says Vespignani. You see immediately that, on the global level, the second scenario is far superior, and not even just for ethical reasons.

To avoid making unpredictable assumptions about the future course of the pandemic in their models, the team of researchers instead examined what would have happened if a vaccine had been available mid-March when the virus started spreading worldwide.

Using this framework, the researchers modeled the evolution of the pandemic based on its previous trajectory and considered interventions adopted by each country concerning travel restrictions and non-pharmaceutical public health policies such as school closures.

Without an actual vaccine, researchers also had to make assumptions about its efficacy. The model considers estimates for 80 and 65% percent efficacy in a single dose two weeks after administration with 3 billion doses administered in total.

But while these models can simulate how vaccine deployment would have panned out this spring, will these same estimates and patterns hold true for vaccine deployment against a potential second wave of COVID-19?

This is only the first step, says Vespignani. There are still lots of unknown factors that go unaccounted for in this model, for example, how many people will be immune in the next months, how efficient will the vaccine actually be, and even if countries have the means to acquire enough doses, will they have the resources and coordination to distribute them?

In any case, decisions about how countries allocate vaccines cant be made based on only one model, Chinazzi says. But for now, the results from the model are clear. When countries cooperate, the number of deaths is cut in half.

For media inquiries, please contact j.hair@northeastern.edu.

Continued here:

If rich countries monopolize COVID-19 vaccines, it could cause twice as many deaths as distributing them equally - News@Northeastern