US Company to Begin Second Phase of Human Trials in South Africa for COVID-19 Vaccine – Voice of America

US Company to Begin Second Phase of Human Trials in South Africa for COVID-19 Vaccine – Voice of America

When Will a Covid-19 Vaccine Be Available for Everyone in the World? Analyst Says by The End of 2021. – Barron’s

When Will a Covid-19 Vaccine Be Available for Everyone in the World? Analyst Says by The End of 2021. – Barron’s

August 18, 2020

Text size

The U.S. now has a half-dozen purchasing agreements with vaccine makers. And there are enough committed doses to immunize 75% of the population in 2021even assuming 40% of the them fall through, according to Bernstein analyst Ronny Gal.

Even if (say) two vaccines fail/underperform in trials or manufacturing issues cause only 60% of the promised dose to be delivered, HHS [the Department of Health and Human Services] would have enough to vaccinate [about] 85% of the U.S. population on the existing commitment alone, Gal wrote in a note on Friday.

In short, as long as the entire field does not fail, vaccines will available for the U.S. to be immunized in 2021.

Gal and his colleagues wrote that there appears to be enough data on timing, volumes, and prices to take a swing at modeling the Covid-19 vaccine market. So they did just that.

Once the developed world approaches vaccination rates of 50%, demand will slow down and substantial volume will be shifted towards emerging markets, they wrote. Assuming volume in line with projections of companies to date, there would be enough capacity by [year-end] 2021 to vaccinate everyone.

In terms of revenue, Gal and team note that revenue in the initial wave is mostly predetermined due to purchasing agreements. They model for roughly $20 billion in worldwide revenue for Covid-19 vaccines in 2021, the largest portion of which will be sold by Pfizer [ticker: PFE]. Again, the dynamics here are largely driven by the Pfizers relatively higher price point and the fact that they will begin delivering doses somewhat earlier.

Beyond 2021 is a fog, according to Gal. They note it would be hard to model without, some indication of relative efficacy/safety, durability, and how much demand will exceed supply in the developed world.

For now, they assume six players will be viable competitors for some time, a booster dose will be needed every two years, and prices will decline gradually. That all considered, they project a global market of between $5 billion to $6 billion in future years. In terms of market share, the Bernstein analysts assign a higher share to Sanofi (SNY) and GlaxoSmithKlines (GSK) candidate because our expectation [is a] recombinant protein vaccine will be preferable in most instances.

Johnson & Johnson (JNJ) gets the second highest share for similar reasons, with the analysts noting its platform has already been validated through the Zika vaccine.

Among the remaining players, we assign equal share ...given the uncertain nature of the vaccine data to-date, they added.

Write to Connor Smith at connor.smith@barrons.com


See more here:
When Will a Covid-19 Vaccine Be Available for Everyone in the World? Analyst Says by The End of 2021. - Barron's
What are the risks of taking part in COVID-19 vaccine trial – WESH 2 Orlando

What are the risks of taking part in COVID-19 vaccine trial – WESH 2 Orlando

August 18, 2020

In Central Florida, WESH 2 News has heard from people enthusiastically participating in a clinical trial to test a COVID-19 vaccine.Dr. Archana Shah, a local physician, spoke with reporter Dave McDaniel about how much of a risk these volunteers are taking.Shah is on the front line of the fight against the coronavirus, managing ventilator patients. She battles to save lives daily, knowing how many have been taken by the coronavirus already.We have 167,000 dead so far in the United States, Shah said.Her mission is treating the sick but she stresses the massive importance of disease prevention.We need some good vaccination prevention strategy, Shah said.A big part of battling COVID-19 is coming up with a safe and effective vaccine. That requires clinical trials.Elaine Jenkins and her fiance are both are participating in a local clinical trial to test a vaccine. Shah said the risks in taking part of a trial are low. She says labs are carefully selected and the process is approved and heavily scrutinized.Vaccination development is being very closely monitored by the scientific community, Shah said.For our local volunteers, that means filling out a diary and follow up visits. Any side effect or any change in even routine should be reported, Shah said.Its all to reduce the threat we are now desperately trying to slow.We do not know what percentage it will be effective, but even if it's 60 to 70% effective, we'll take it right now with all the challenges we're facing right now, Shah said. Don't have to live your lives in a mask, like we are right now, and then preventing all the deaths that we're facing right now."

In Central Florida, WESH 2 News has heard from people enthusiastically participating in a clinical trial to test a COVID-19 vaccine.

Dr. Archana Shah, a local physician, spoke with reporter Dave McDaniel about how much of a risk these volunteers are taking.

Shah is on the front line of the fight against the coronavirus, managing ventilator patients.

She battles to save lives daily, knowing how many have been taken by the coronavirus already.

We have 167,000 dead so far in the United States, Shah said.

Her mission is treating the sick but she stresses the massive importance of disease prevention.

We need some good vaccination prevention strategy, Shah said.

A big part of battling COVID-19 is coming up with a safe and effective vaccine. That requires clinical trials.

Elaine Jenkins and her fiance are both are participating in a local clinical trial to test a vaccine. Shah said the risks in taking part of a trial are low.

She says labs are carefully selected and the process is approved and heavily scrutinized.

Vaccination development is being very closely monitored by the scientific community, Shah said.

For our local volunteers, that means filling out a diary and follow up visits.

Any side effect or any change in even routine should be reported, Shah said.

Its all to reduce the threat we are now desperately trying to slow.

We do not know what percentage it will be effective, but even if it's 60 to 70% effective, we'll take it right now with all the challenges we're facing right now, Shah said. Don't have to live your lives in a mask, like we are right now, and then preventing all the deaths that we're facing right now."


Here is the original post: What are the risks of taking part in COVID-19 vaccine trial - WESH 2 Orlando
Novavax to deliver 60 million doses of COVID-19 vaccine candidate to UK – Reuters

Novavax to deliver 60 million doses of COVID-19 vaccine candidate to UK – Reuters

August 18, 2020

(Reuters) - U.S. drug developer Novavax Inc said on Friday the UK would buy 60 million doses of its coronavirus vaccine candidate, NVX-CoV2373.

FILE PHOTO: A woman holds a small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/Illustration/File Photo

The company and the UK government will collaborate for a phase 3 clinical trial to assess the efficacy of the vaccine in the UK population, Novavax said in a statement, but did not disclose any financial details of the agreement.

The trial will be a study in about 9,000 adults between 18 years and 85 years of age.

Novavax would partner with Fujifilm Diosynth Biotechnologies for manufacturing the antigen component of its COVID-19 vaccine candidate in the UK, it added.

The company is also gearing up to deliver 100 million doses to the United States by January after it was awarded $1.6 billion to cover testing and manufacturing of its potential vaccine in the country.

Novavax has received $2 billion in funding so far for its coronavirus vaccine, including $384 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

Novavax will supply the NVX-CoV2373 doses to the UK beginning as early as the first quarter of 2021, while phase 3 trial is expected to begin in the third quarter of this year, the company said.

The Fujifilm Diosynth Biotechnologies site in the UK is expected to produce about 180 million doses annually, it added.

The United States and United Kingdom are leading a rush to strike deals with drugmakers to reserve supplies of experimental coronavirus vaccines, as the race to develop a safe and effective vaccine reaches the final stages of testing.

There are currently no approved vaccines for COVID-19, with over 25 candidates being studied in humans.

In an early-stage trial, Novavaxs vaccine candidate, NVX-CoV2373, has produced higher levels of antibodies in healthy volunteers after two doses than those found in recovered COVID-19 patients and the vaccine was well tolerated overall.

(This story corrects headline and first paragraph to drop reference to phase-3 trial)

Reporting by Kanishka Singh in Bengaluru; Editing by Rashmi Aich


Visit link:
Novavax to deliver 60 million doses of COVID-19 vaccine candidate to UK - Reuters
Life will never be the same for people over 60 even with a COVID-19 vaccine – MarketWatch

Life will never be the same for people over 60 even with a COVID-19 vaccine – MarketWatch

August 18, 2020

Imagine this scenario, perhaps a year or two in the future: An effective COVID-19 vaccine is routinely available and the world is moving forward. Life, however, will likely never be the same particularly for people over 60.

That is the conclusion of geriatric medical doctors, aging experts, futurists and industry specialists. Experts say that in the aftermath of thepandemic, everything will change, from the way older people receive health care to how they travel and shop. Also overturned: their work life and relationships with one another.

In the past few months, the entire world has had a near-death experience, said Ken Dychtwald, CEO of Age Wave, a think tank on aging around the world. Weve been forced to stop and think: I could die or someone I love could die. When those events happen, people think about what matters and what they will do differently.

Older adults are uniquely vulnerable because their immune systems tend to deteriorate with age, making it so much harder for them to battle not just COVID-19 but all infectious diseases. They are also more likely to suffer other health conditions, like heart and respiratory diseases, that make it tougher to fight or recover from illness.

Read: Yes, you may still be able to retire one day

So its no surprise that even in the future, when a COVID-19 vaccine is widely available and widely used most older adults will be taking additional precautions.

Before COVID-19, baby boomers those born after 1945 but before 1965 felt reassured that with all the benefits of modern medicine, they could live for years and years, said Dr. Mehrdad Ayati, who teaches geriatric medicine at Stanford University School of Medicine and advises the U.S. Senate Special Committee on Aging. What we never calculated was that a pandemic could totally change the dialogue.

It has. Heres a preview of post-vaccine life for older Americans:

Also see: Social Security could be vulnerable under President Trumps plan for payroll taxes


More here:
Life will never be the same for people over 60 even with a COVID-19 vaccine - MarketWatch
No to Expanded HHS Surveillance of COVID-19 Patients – EFF

No to Expanded HHS Surveillance of COVID-19 Patients – EFF

August 18, 2020

The federal government plans to process more of our personal data, in the name of containing COVID-19, but without showing that this serious privacy intrusion would actually do anything to protect public health. EFF filed comments in opposition to these new plans from the U.S. Department of Health and Human Services (HHS).

The U.S. Centers for Disease Control (CDC) leads our nations efforts to contain infectious diseases. Thus, CDC for decades has managed the federal governments processing of personal data about infection. It did so during the early months of the COVID-19 outbreak. But in July 2020, HHS stripped this tracking authority from the CDC, and transferred it to a new program called HHS Protect.

HHS issued two new Systems of Records Notices (SORNs) about this new HHS program. The federal Privacy Act requires federal agencies to issue SORNs to advise people about personally identifiable information that the government maintains about them.

Unfortunately, HHS Protect poses a grave threat to the data privacy of all Americans. As set forth in the SORNs, it would greatly expand how the federal government collects, uses, maintains, and shares all manner of personal information. We highlighted the following ways that HHS Protect would substantially burden privacy without a necessary or proportionate benefit to protecting public health.

New data collection. The SORNs would allow collection of personal information about physical and psychological health history, drug and alcohol use, diet, employment, and more. Data collected would also include geospatial records, which countless research has shown is difficult to de-identify. Data would be collected not just about people who test positive, but also about their family members, as well as people who test negative, and perhaps people who have not tested at all. Data would be collected from countless different sources, including federal, state, and local governments, their contractors, the healthcare industry, and patients family members.

New data sharing. The SORNs would allow sharing of these vast sets of data with additional federal agencies, unspecified outside contractors, and even student volunteers. These additional federal agencies would be allowed, in turn, to share the data with their contractors. Patient consent would not be required for this sharing.

New data use. The SORNs would allow use of this data in litigation and other proceedings whenever the federal government has an interest in them (such use now is allowed only when HHS is a defendant in litigation).

New data storing. The SORNs would allow permanent retention of data with significant historical and/or research value (retention now is limited to four years).

No doubt, the ongoing COVID-19 crisis requires a coordinated governmental response, which in turn requires robust data concerning the spread of the disease. But HHS has made no showing that CDCs existing epidemiological data systems are not up to the task.

Thus, EFF filed comments with HHS, asking the agency to withdraw these two SORNs. They violate the Privacy Act and create new threats to privacy without any showing of public health benefit.


See the original post:
No to Expanded HHS Surveillance of COVID-19 Patients - EFF
COVID-19 UPDATE: Gov. Justice announces adjustments to West Virginia School Re-entry Metrics and Protocols – West Virginia Department of Health and…

COVID-19 UPDATE: Gov. Justice announces adjustments to West Virginia School Re-entry Metrics and Protocols – West Virginia Department of Health and…

August 18, 2020

FREE COVID-19 TESTING Gov. Justice also updated the schedule of upcomingfree community COVID-19 testingevents taking place over the next several weeks at various dates and times in multiple counties across the state.

The effort is part of a plan to provide free optional testing to all residents in several counties that are experiencing higher rates of COVID-19 transmission. It targets residents who have struggled to be seen by a physician or do not have insurance to pay for testing. However, other residents, including those who are asymptomatic are welcome to be tested.

Testing details listed below in chronological order:

Lincoln County (1 of 2) Wednesday, August 19 10:00 AM 3:00 PM Harts PK-8: 1246 McClellan Highway, Harts, WV

Hancock County Friday, August 21 1:00 PM 7:00 PM Weir High School: 100 Red Rider Road,Weirton, WV Saturday, August 22 10:00 AM 4:00 PM Weir High School: 100 Red Rider Road,Weirton, WV

Boone County Tuesday, August 25 10:00 AM 6:00 PM Madison Civic Center: 261 Washington Avenue, Madison, WV

Lincoln County (2 of 2) Wednesday, August 26 10:00 AM 3:00 PM Alum Creek Church of Christ: 2368 Childress Road, Alum Creek, WV

Mason County Friday, August 28 & Saturday, August 29 9:00 AM 4:00 PM Webster County High School: 1 Highlander Drive, Cowen, WV

Webster County Saturday, August 29 9:00 AM 5:00 PM Webster County High School: 1 Highlander Drive, Cowen, WV

Nicholas County Thursday, September 17 12:00 PM 8:00 PM Nazarene Camp: 6461 Webster Road, Summersville, WV


See original here: COVID-19 UPDATE: Gov. Justice announces adjustments to West Virginia School Re-entry Metrics and Protocols - West Virginia Department of Health and...
COVID-19 Daily Update 8-16-2020 – West Virginia Department of Health and Human Resources

COVID-19 Daily Update 8-16-2020 – West Virginia Department of Health and Human Resources

August 18, 2020

The West Virginia Department of Health andHuman Resources (DHHR) reportsas of 10:00 a.m., on August 16, 2020, there have been 355,168 total confirmatory laboratory results receivedfor COVID-19, with 8,564 total cases and 160 deaths.

CASESPER COUNTY: Barbour (33), Berkeley (734), Boone (118),Braxton (8), Brooke (76), Cabell (450), Calhoun (7), Clay (18), Doddridge (6),Fayette (170), Gilmer (18), Grant (131), Greenbrier (96), Hampshire (88),Hancock (113), Hardy (63), Harrison (248), Jackson (168), Jefferson (305),Kanawha (1,080), Lewis (28), Lincoln (108), Logan (356), Marion (199), Marshall(130), Mason (73), McDowell (67), Mercer (240), Mineral (127), Mingo (201),Monongalia (989), Monroe (20), Morgan (33), Nicholas (39), Ohio (279),Pendleton (43), Pleasants (14), Pocahontas (42), Preston (130), Putnam (218),Raleigh (297), Randolph (214), Ritchie (3), Roane (19), Summers (19), Taylor(74), Tucker (11), Tyler (15), Upshur (40), Wayne (221), Webster (4), Wetzel(44), Wirt (7), Wood (283), Wyoming (47).

As case surveillance continues at thelocal health department level, it may reveal that those tested in a certaincounty may not be a resident of that county,or even the state as an individual in question may have crossed the stateborder to be tested. Such is the case of Wetzel Countyin this report.

Pleasenote that delays may be experienced with the reporting of information from thelocal health department to DHHR. Data is published daily at 10 a.m. on thedashboard located at www.coronavirus.wv.gov.


See the article here:
COVID-19 Daily Update 8-16-2020 - West Virginia Department of Health and Human Resources
Airlines, Airports Reportedly Push U.N. Body To Recommend Negative Covid-19 Tests As Alternative To Quarantine Requirements – Forbes

Airlines, Airports Reportedly Push U.N. Body To Recommend Negative Covid-19 Tests As Alternative To Quarantine Requirements – Forbes

August 18, 2020

TOPLINE

With countries starting to reopen their borders to travelers, airlines and airports will ask a U.N. task force on Tuesday to recommend countries accept a negative Covid-19 test result within 48 hours of travelers departure from countries with high infection rates as an alternative to mandatory quarantines that have decreased demand for travel, according to Reuters.

Mandatory quarantine rules are a deterrent for travelers.

If a task force set up by theU.N.s International Civil Aviation Organization agrees with the proposal, it is likely the guidelines will be accepted by the 193 member nations.

Requiring a negative Covid-19 test prior to departure will decrease the risk of importation by up to 90% and open up travel between a larger number of countries, according to the proposal from the Airports Council International and International Air Transport Association, according to Reuters.

The organizations are seeking to find a way around quarantine requirements that are a deterrent for travelers.

About 85% of people surveyed said they were concerned about needing to quarantine while traveling and only 17% said they were willing quarantine, according to a July IATA survey.

Quarantine is a demand killer. Keeping borders closed prolongs the pain by causing economic hardship well beyond airlines. If governments want to re-start their tourism sectors, alternative risk-based measures are needed, said IATA Director General and CEO Alexandre de Juniac.

Many airlines do not think demand will return to 2019 levels until 2023 or 2024, de Juniac said. A 58% majority of the people who responded to the July IATA survey said they have avoided air travel and 33% said they will avoid travel in the future to reduce the risk of catching Covid-19. When asked to rank the top three measures that would make them feel safer, 37% said Covid-19 screening at departure airports, 34% agreed with face-covering mandates and 33% said social distancing measures on the plane.

$365 billion. That is the maximum potential loss for passenger operating revenues for airlines in 2020, according to an August 12 ICAO report. The organization predicts an overall reduction of 2.86 billion travelers.

Airlines, airports to push for COVID testing as quarantines hit traffic (Reuters)

Effects of Novel Coronavirus (COVID-19) on Civil Aviation: Economic Impact Analysis (ICAO)

Traveler Survey Reveals COVID-19 Concerns (IATA)

Full coverage and live updates on the Coronavirus


Visit link:
Airlines, Airports Reportedly Push U.N. Body To Recommend Negative Covid-19 Tests As Alternative To Quarantine Requirements - Forbes
McKesson signs up with Warp Speed to distribute COVID-19 shots in U.S. – FiercePharma

McKesson signs up with Warp Speed to distribute COVID-19 shots in U.S. – FiercePharma

August 18, 2020

The U.S. government has placed a series of multibillion-dollarbets on potential COVID-19 vaccines. But actually getting those vaccines to patients is another story, and now the government has picked a distributor to aid that effort.

The Trump administration has tapped Dallas-based distribution giant McKesson to partnerwith the Centers for Disease Control and Prevention (CDC) as a national distributor for COVID-19 vaccines.

Under a 2016 childhood vaccine deal, the CDC had an option to draftMcKesson to distributevaccines in case of a pandemic, according to a Department of Defense release. While financial terms of the option weren't disclosed, Bloomberg reported the overall deal could be worth up to $300 million.

DEVELOP A UNIFIED SCIENTIFIC VOICE

Learn how to streamline medical communications and align tactics and objectives within your organizations by attending the virtual Medical Affairs Strategic Summit (MASS).

McKesson, perhaps best known in recent years for its legal troubles over the nation's opioid epidemic,is familiar with pandemic scenarios. In 2009, the Obama administration brought the company in to handle national distribution of H1N1 flu vaccines.

RELATED:States reject drug wholesalers' $18B opioid settlement offer: WSJ

McKesson and the nation's largest drug distributors, including Cardinal Health and Walgreens, have been locked in thousands of lawsuits over their roles in fueling the U.S. opioid crisis.

In February, a suite of state attorneys general shot down a class settlement of roughly $18 billion from McKesson and others, saying a fair deal would lie in the $22 billion to $32 billion range, The Wall Street Journal reported.

The distributor's board in January reached a $175 million settlement with investors over claims it didn't adequately flag suspicious opioid shipments that may have helped add fuel to the crisis.

RELATED:After nearly $1B in research funding, Moderna takes $1.5B coronavirus vaccine order from U.S.

McKesson's Warp Speed pact comes as the Trump administration looks to flesh out a production and distribution framework for one or more approved vaccines by the end of the year.

Last week, the government reached a $1.5 billion work order with Moderna for 100 million doses of itsmRNA-based COVID-19 shotafter spending almost $1 billion in development costs for the vaccine.The pact also includes an option for an additional 400 million doses.

The Moderna order follows a suite of Warp Speed deals in recent weeks:Sanofi and GlaxoSmithKline scored $2.1 billion to develop and deliver100 million doses; Pfizer andBioNTechs would rake in $1.95 billion for its shot; and Novavax snared$1.6 billion from the initiative. Johnson & Johnson also locked in a deal for $1 billion for 100 million doses of its shot, and AstraZeneca is on the hook for300 million doses ina $1.2 billion deal.


See the original post: McKesson signs up with Warp Speed to distribute COVID-19 shots in U.S. - FiercePharma
Sharon Stone shares sisters battle with COVID-19, blaming non-mask wearers and urging followers to vote to – WBTV

Sharon Stone shares sisters battle with COVID-19, blaming non-mask wearers and urging followers to vote to – WBTV

August 18, 2020

"Also, the people that they came in contact with, like my mother, who's had two heart attacks, five stents, and a pacemaker in the last five months, couldn't get a test because she wasn't symptomatic even though she could have been their asymptomatic contact that gave them COVID," she continued. "The nurses in the hospital that are taking care of them can't get tested because they don't have tests to test them with."


Read the original post:
Sharon Stone shares sisters battle with COVID-19, blaming non-mask wearers and urging followers to vote to - WBTV