Category: Covid-19 Vaccine

Nearly a year into a global pandemic the world is still on the back of its heels. In the face of ever increasing infection rates, world economies have slowed rapidly and unemployment has increased significantly, and now governments are reconsidering shutting down entire countries once again.

At the same time, the federal government has failed to pass a second stimulus package to prop up individuals who have lost their jobs and may be facing homelessness, as well as the need to help state and local governments provide a backstop against their own losses.

Given this backdrop, there is a lot riding on a potential vaccine and/or cure for COVID-19. There are many approaches that a lengthy list of varying companies are taking to bring their respective product to market.

Any company that does successfully bring a product to market that helps in the fight against the virus may see a significant increase in revenues as well as an in-kind increase in profits.

B. Riley Securities has highlighted three biotech companies that are approaching the virus from different directions. We ran the trio through TipRanks database to see how B. Riley's recent analysis compared to other analysts projections.

Altimmune Inc. (ALT)

Altimmune is a biopharmaceutical company that develops vaccines and immune modulating therapies. Fighting the virus is likely to need both approaches, a vaccine as well as an immune therapy. With this kind of focus, Altimmunes fortunes changed quickly with the onset of the COVID pandemic.

Altimmune produces AdCovid, a single dose, intranasal vaccine to protect against COVID-19. As B. Riley analyst Mayank Mamtani points out, Altimmunes products stands out in regards to lung specific IgA and CD8+ T-Cell responses and further states that In our view it blocks the virus at the source within the nose and respiratory tract." AdCovids preclinical data shows a great deal of promise.

ALT stock was trading around $2 per share back in January. Once the company got involved in the fight against COVID-19, the stock jumped up to a high of $33.00 per share, but is now trading at $11; still, this is a move of +450% year-to-date.

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Given what Altimmune has going for it, and the potential upside, this prompted Mamtani to give Altimmune a Buy rating in his recent analysis. The analyst has a price target of $31, suggesting a potential upside of 182% from current levels. (To watch Mamtanis track record, click here).

As it turns out, there are 4 Buy ratings equating to a Strong Buy on ALT with a low price target of $31 (coming from B. Riley), an average Price target of $49 and a high price target of $80. The average Price Target equates to a potential upside move of 345%. (See ALT stock analysis on TipRanks)

Arcturus Therapeutics (ARCT)

Arcturus Therapeutics focuses on RNA medicines with a focus on respiratory diseases. COVID, as it may be, is a virus that attacks the respiratory system.

Arcturus has a proprietary LNP delivery system that enables a safer, more deliverable method of bioavailable therapy. Regarding this method and Arcturus product advancements to this, B. Riley's Mayank Mamtani noted, Along with the proprietary LNP delivery platform, rapidly biodegradable LUNAR, alongside self-transcribing and replicating mRNA (STARR) technology, implies significant safety and durability advantage."

Arcturus has a strong collaboration with Duke University and the Singapore Economic Development Corp to develop LUNAR-Cov19 (ARCT-021) -- a self-replicating mRNA vaccine the might be sufficient to address the Coronavirus outbreak. The potential COVID-19 vaccine is now in a Phase 1/2 trial, and upcoming clinical results are expected in 4Q20. Given the backing and the product development, there appears to be significant potential with this product.

ARCT stock started the year at $10 per share but since has jumped to todays price of $53 this is a 430% year-to-date increase.

Considering the potential for the drug making it to market, Mamtani gives ARCT a Buy rating along with an $82 price target. This equates to an upside potential of 52% from current levels.

Overall, what does the street have to say about ARCT? There are a total of 6 Buy ratings and all add up to a Strong Buy consensus rating. With an average price target of $75.17, the stock is expected to rise nearly 39% over the next months. (See ARCT stock analysis on TipRanks)

Heat Biologics Inc (HTBX)

Heat Biologics is a biopharmaceutical that develops immunotherapies. In development is a T-Cell activation platform that is proprietary and is a strong contender in the fight against COVID-19.

There are similarities to SARS-Cov-1 from 2003 and todays COVID-19. As it turns out, and as bad as it sounds, having previously contracted the original SARS-Cov-1 in 2003 would have been a good thing. Patients that recovered from the original SARS-Cov-1 and contracted the current COVID-19, are seeing long-lasting T-Cells memory and are generally asymptomatic or have mild symptoms. Given this, Heat Biologics is using an approach to mimics the original SARS-Cov-1 to provide immunity against COVID-19.

Heat Biologics is in collaboration with Waisman Biomanufacturing to manufacture COVID-19 and are preparing to deliver its products to market. As B. Riley's Mamtani points out in his recent analysis, we view single-dose format of gp96-IgG to serve as complementary to advanced C-19 vaccine candidates in developing combination-based approaches aimed at enhancing T cell immunity."

Given the potential of the immunotherapies and T-Cell activation Platform and the partnership with Waisman Biomanufacturing, this prompted Mamtani to place, once again, a Buy rating on Heat Biologics shares. The analyst suggests that if everything goes as planned, HTBX will be a $4 stock in the next 12 months, implying nearly 245% return.

As for other Wall Street analysts, there is only one additional rating on HTBX, which is also bullish. The average price target among the two stands at $4.50, which suggests a potential upside of a whopping 288%. (See HTBX stock analysis on TipRanks)

To find good ideas for coronavirus 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.

Continued here:

3 Biotech Stocks in the Hunt for COVID-19 Vaccine; One Analyst Calls Them a Buy - Yahoo Finance

Cross-posted from the CMS.gov Newsroom

Under President Trumps leadership, the Centers for Medicare & Medicaid Services (CMS) is taking steps to ensure all Americans, including the nations seniors, have access to the coronavirus disease 2019 (COVID-19) vaccine at no cost when it becomes available. Today, the agency released a comprehensive plan with proactive measures to remove regulatory barriers and ensure consistent coverage and payment for the administration of an eventual vaccine for millions of Americans. CMS released a set of toolkits for providers, states and insurers to help the health care system prepare to swiftly administer the vaccine once it is available. These resources are designed to increase the number of providers that can administer the vaccine, ensure adequate reimbursement for administering the vaccine in Medicare, while making it clear to private insurers and Medicaid programs their responsibility to cover the vaccine at no charge to beneficiaries. In addition, CMS is taking action to increase reimbursement for any new COVID-19 treatments that are approved or authorized by the FDA.

Under President Trumps leadership, we have developed a comprehensive plan to support the swift and successful distribution of a safe and effective vaccine for COVID-19, said CMS Administrator Seema Verma. As Operation Warp Speed nears its goal of delivering the vaccine in record time, CMS is acting now to remove bureaucratic barriers while ensuring that states, providers and health plans have the information and direction they need to ensure broad vaccine access and coverage for all Americans.

To ensure broad access to a vaccine for Americas seniors, CMS released an Interim Final Rule with Comment Period (IFC) today that establishes that any vaccine that receives Food and Drug Administration (FDA) authorization, either through an Emergency Use Authorization (EUA) or licensed under a Biologics License Application (BLA), will be covered under Medicare as a preventive vaccine at no cost to beneficiaries. The IFC also implements provisions of the CARES Act that ensure swift coverage of a COVID-19 vaccine by most private health insurance plans without cost sharing from both in and out-of-network providers during the course of the public health emergency (PHE).

In anticipation of the availability of new COVID-19 treatments, the IFC also establishes additional Medicare hospital payment to support Medicare patients access to these potentially life-saving COVID-19 therapies. In Medicare, hospitals are generally reimbursed a fixed payment amount for the services they provide during an inpatient stay, even if their costs exceed that amount. Under current rules, hospitals may qualify for additional outlier payments, but only when their costs for a particular patient exceed a certain threshold. Under this IFC, hospitals would qualify for additional payments when they treat patients with innovative new products approved or authorized to treat COVID-19 to mitigate any losses they may experience from making these therapies available, even if they do not reach the current outlier threshold. The IFC also makes changes to reimbursement for outpatient hospital services to ensure payment for certain innovative treatments for COVID-19 that occur outside of bundled arrangements and are paid separately. In addition, CMS released information to prepare hospitals to bill for the outpatient administration of a monoclonal antibody product in the event one is approved under an emergency use authorization (EUA).

This rule also allows states to employ a broad range of strategies - based on local needs - to appropriately manage their Medicaid program costs. The guidance and flexibility provided to states in the IFC will help them maintain Medicaid beneficiary enrollment while receiving the temporary increase in federal funding in the Families First Coronavirus Response Act (FFCRA).

CMS is also taking continued steps to ensure that price transparency extends to COVID-19 testing during the PHE. Provisions in the IFC require that any provider who performs a COVID-19 diagnostic test post their cash prices online. Providers that are non-compliant may face civil monetary penalties.

In addition to these provisions, the IFC:

Along with these regulatory changes, CMS is issuing three toolkits aimed at state Medicaid agencies, providers who will administer the vaccine, and health insurance plans. Together, these toolkits will help ensure the health care system is prepared to successfully administer a safe and effective vaccine by addressing issues related to access, billing and payment, and coverage.

Increasing Access to Vaccines for Medicare & Medicaid Beneficiaries

The toolkits issued today give health care providers not currently enrolled in Medicare the information needed to administer and bill vaccines to Medicare patients. CMS is working to increase the number of providers that will administer a COVID-19 vaccine to Medicare beneficiaries when it becomes available, to make it as convenient as possible for Americas seniors. New providers are now able to enroll as a Medicare mass immunizers through an expedited 24-hour process. The ability to easily enroll as a mass immunizer is important for some pharmacies, schools, and other entities that may be non-traditional providers or otherwise not eligible for Medicare enrollment. To further increase the number of providers who can administer the COVID -19 vaccine, CMS will continue to share approved Medicare provider information with states to assist with Medicaid provider enrollment efforts. CMS is also making it easier for newly enrolled Medicare providers to also enroll in state Medicaid programs to support state administration of vaccines for Medicaid recipients.

Coverage

As a condition of receiving free COVID-19 vaccines from the federal government, providers will be prohibited from charging consumers for administration of the vaccine. To ensure broad and consistent coverage across programs and payers, the toolkits have specific information for several programs, including:

Medicare:Beneficiaries with Medicare pay nothing for COVID-19 vaccines and their copayment/coinsurance and deductible are waived.

Medicare Advantage (MA):For calendar years 2020 and 2021, Medicare will pay directly for the COVID-19 vaccine and its administration for beneficiaries enrolled in MA plans. MA plans would not be responsible for reimbursing providers to administer the vaccine during this time. Medicare Advantage beneficiaries also pay nothing for COVID-19 vaccines and their copayment/coinsurance and deductible are waived.

Medicaid:State Medicaid and CHIP agencies must provide vaccine administration with no cost sharing for most beneficiaries during the public health emergency. Following the public health emergency, depending on the population, states may have to evaluate cost sharing policies and may have to submit state plan amendments if updates are needed.

Private Plans:CMS, along with the Departments of Labor and the Treasury, is requiring that most private health plans and issuers cover a recommended COVID-19 vaccine and its administration, both in-network and out-of-network, with no cost sharing. The rule also provides that out-of-network rates cannot be unreasonably low, and references CMSs reimbursement rates as a potential guideline for insurance companies.

Uninsured:For individuals who are uninsured, providers will be able to be reimbursed for administering the COVID-19 vaccine to individuals without insurance through the Provider Relief Fund, administered by the Health Resources and Services Administration (HRSA).

Billing and Payment

The toolkits also address issues related to billing and payment. After the FDA either approves or authorizes a vaccine for COVID-19, CMS will identify the specific vaccine codes, by dose if necessary, and specific vaccine administration codes for each dose for Medicare payment. CMS and the American Medical Association (AMA)are working collaboratively on finalizing a new approach to report use of COVID-19 vaccines, which include separate vaccine-specific codes. Providers and insurance companies will be able to use these to bill for and track vaccinations for the different vaccines that are provided to their enrollees.

Medicare Payment

CMS also released new Medicare payment rates for COVID-19 vaccine administration. The Medicare payment rates will be $28.39 to administer single-dose vaccines. For a COVID-19 vaccine requiring a series of two or more doses, the initial dose(s) administration payment rate will be $16.94, and $28.39 for the administration of the final dose in the series.These rates will be geographically adjusted and recognize the costs involved in administering the vaccine, including the additional resources involved with required public health reporting, conducting important outreach and patient education, and spending additional time with patients answering any questions they may have about the vaccine.Medicare beneficiaries, those in Original Medicare or enrolled in Medicare Advantage, will be able to get the vaccine at no cost.

CMS is encouraging state policymakers and other private insurance agencies to utilize the information on the Medicare reimbursement strategy to develop their vaccine administration payment plan in the Medicaid program, CHIP, the Basic Health Program (BHP), and private plans. Using the Medicare strategy as a model would allow states to match federal efforts in successfully administering the full vaccine to the most vulnerable populations.

The IFC (CMS-9912-IFC) is scheduled to display at the Federal Register as soon as possible with an immediate effective date, and a 30-day comment period. It can be downloaded from the Federal Register at:https://www.cms.gov/files/document/covid-vax-ifc-4.pdf

Additional information on this IFC can be found in the fact sheet here:https://www.cms.gov/newsroom/fact-sheets/fourth-covid-19-interim-final-rule-comment-period-ifc-4

The COVID-19 vaccine resources for providers, health plans and State Medicaid programs can be found here:https://www.cms.gov/covidvax

The FAQs on billing for therapeutics can be found here:https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf

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Cross Post: Coverage of Life-Saving COVID-19 Vaccines & Therapeutics - AIDS.gov blog

PIERRE, S.D. South Dakota health officials said a COVID-19 vaccine is expected to become available in mid-November, though that timeline isnt set in stone.

Department of Health Secretary Kim Malsam-Rysdon said when the vaccine arrives it will be administered to vulnerable populations, such as health care personnel, other essential workers, people with underlying medical conditions, those over the age of 65, racial and ethnic minority groups, tribal community members, incarcerated individuals, homeless shelters, colleges and universities, persons living in or working in congregate settings, rural communities, persons with disabilities and uninsured or underinsured people, according to the states distribution plan.

South Dakota reported nine more deaths on Wednesday, Oct. 28, bringing the death toll to 384.

The deaths included one person in their 50s, one in their 60s, one in their 70s and six over age 80.

Current hospitalizations increased to 412, up 17 from Tuesday.

That leaves 31% of hospital beds and 34 % of intensive care unit beds available.

An additional 745 active cases were reported on Wednesday, for a total of 11,933 active cases in the state.

As a public service, weve opened this article to everyone regardless of subscription status. If this coverage is important to you, please consider supporting local journalism by clicking on the subscribe button in the upper righthand corner of the homepage.

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COVID-19 vaccine expected to reach South Dakota by mid November - INFORUM

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Kathy Strauss has always pretty good at math and science. But the 1974 Pine-Richland graduate didnt necessarily envision a career in the medical profession or ever imagine that she would someday work on groundbreaking research in the mission to find a vaccine for the coronavirus.

But Strauss, 64, recently was asked to serve as one of the laboratory specialists working with researchers at the University of Maryland School of Medicine who are conducting covid-19 vaccine trials on behalf of the pharmaceutical company Pfizer.

Before entering my senior year of high school I was planning on getting into something related to biology, but I didnt have anything specific in mind, said Strauss, who lives in the Baltimore area. I thought maybe I would become a veterinarian. But honestly, I was more interested in having fun my senior year, so I took some art courses and played flute and drums in the marching band.

Those art courses helped Strauss uncover a hidden talent and a burning passion that she pursues today.

While studying at Westiminster College, a professor suggested that Strauss consider pursuing a career in art.

My immediate response was that my mom will hand me my head if I major in art, she said. So I studied biology and art with the thought that I could get into illustrating medical books and publications as a way to earn a living.

While Strauss has found success in the medical profession since relocating to the Baltimore area, her initial reasons for going there had nothing to do with the type of work she would do.

Baltimore is a lot like Pittsburgh, and I had friends from up there who were teaching sailing, she said. So I decided to come here to do that until I found a real job.

Strauss mathematics studies at the University of Marylands University College helped her land a job in a laboratory classifying nuclear waste from chemical plants.

Strauss said her entry into the medical field was something I totally lucked into when she was hired by the University of Marylands pediatrics department.

That post was followed by a five-year stint in the epidemiology department, which studies the spread and control of diseases.

Before joining the covid research team, Strauss worked for scientists developing a malaria vaccine at the universitys Center for Vaccine Development.

Strauss said she just happened to be at this place with the right skills when the invitation came to join Dr. Kirsten Lykes covid vaccine research team.

I worked for Dr. Lyke for years and would have been devastated if I hadnt been asked to join her, Strauss said. You have to be as hard-charging and focused as she is, which is one of the reasons I love working for her.

Strauss said while there are similarities between the covid vaccine trials and the work she did on the development of a malaria vaccine, there is one major difference that cant be overstated, she said.

With malaria, if we catch it, we can treat it, she said. Theres no threat of death hanging over you like there is with covid.

An in-depth story about the team working on the vaccine trials recently was published in Rolling Stone magazine.

Strauss said her role in the covid trials is to test people before they receive the vaccine to ensure that they are not infected with the coronavirus and are simply asymptomatic.

We cant give the vaccine to people if they already have the virus, she said. It has to be perfect, so Ive never known such pressure.

To help deal with the stress, Strauss turns to her art.

Its saving my life, she said. It helps me calm down and deal with the excess energy that builds up from working on the trials.

Strauss works have been displayed in a number of Baltimore area venues, including Maryland Art Place, the Creative Alliance, and at Baltimores annual arts festival ArtScape. She has also exhibited work in Pittsburgh, Washington, D.C., and New York. She has produced art for textbooks and publications that are in the permanent collections at the Institute for Genome Sciences and Notre Dame of Maryland University.

Strauss also has demonstrated and lectured on fiber art techniques for the staff at the Baltimore Museum of Art and the Textile Museum in Washington, D.C.

Some of the pieces she has created can be viewed on her website.

While Strauss no longer has close family ties to the Pittsburgh area, she has returned a number of times for class reunions and holds fond memories of growing up here.

My experiences at Pine-Richland were great and Ive enjoyed visiting the area and seeing how much it has changed over the years, she said.

Pine-Richland spokeswoman Rachel Hathhorn said sharing stories about district graduates is a great way to connect with the districts past while highlighting the success our future graduates can obtain.

Tony LaRussa is a Tribune-Review staff writer. You can contact Tony at 724-772-6368, tlarussa@triblive.com or via Twitter .

Categories:Allegheny | Coronavirus | Local | Pine Creek Journal | Top Stories

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Pine-Richland alum working on team searching for covid-19 vaccine - TribLIVE

The oil company worker wondered why he had to keep his vaccination a secret. Questions raced through his head as he read the confidentiality agreement, which threatened he would be disciplined if he told anyone outside company management about the COVID-19 shot he was waiting to get.

What if something went wrong? Who would take responsibility? The worker knew the vaccine maker, China National Biotec Group part of the state-owned pharmaceutical group Sinopharm was conducting trials of this vaccine on hundreds of thousands of volunteers in the United Arab Emirates, Peru, Morocco and other countries.

At least theyre in a monitored, controlled situation, he said of those trials, watching as hundreds of his co-workers lined up around him to get their injection at a clinic in Beijing. But for us, they cant make any guarantees. This is us making a sacrifice for the nation.

The employee who did not give his name for fear of reprisal is one of hundreds of thousands of Chinese citizens who have received COVID-19 vaccines before they have been proved safe in clinical trials. Chinas military began getting vaccinations in June. Medical workers and employees of state-owned companies working abroad were soon included in an emergency use program. In September, a China National Biotec executive said 350,000 people outside clinical trials had already received the vaccine.

Early vaccinations of high-profile people have become a way to show trust in Chinas medical system after a 2018 scandal in which children were exposed to faulty vaccines for diphtheria and tetanus.

In March, images of Chen Wei, a military general and epidemiologist leading one of the coronavirus vaccine efforts, were widely shared by social media users, praising her for receiving an injection before it had been tested on animals. Yin Weidong, chief executive of biopharmaceutical company Sinovac, told reporters last month that he was one of the first to take the vaccine after it passed the first two trial phases. About 90% of Sinovacs employees have voluntarily taken the vaccine early, the company said.

This month, China National Biotec Group reportedly began offering free vaccines to Chinese students planning to go abroad, according to a company website that was later taken down. More than 93,000 people had signed up for the free vaccine, the website said. Students who had been vaccinated also spoke to local and foreign media about their experiences. But state media later reported that the free vaccine offer was not real.

Several cities in Zhejiang province have also reportedly begun offering vaccines made by Sinovac. In Yiwu city, Chinese media found a clinic offering vaccination shots for about $30 each on a first come, first served basis. Most of those receiving shots were people planning international travel, though they did not have to prove it, according to local reports.

A technician works in a lab at Sinovac Biotech in Beijing on Sept. 24, 2020. The lab is working on a potential coronavirus vaccine.

(Kevin Frayer / Getty Images)

None of the vaccines have completed Phase 3 trials, which often catch rare side effects that go undetected in earlier phases.

Chinese health authorities have said that the vaccines are safe, with no severe adverse effects, and that their emergency use is justified to protect against imported infections or a domestic resurgence of COVID-19. But health experts outside China are questioning the safety and ethics of such a strategy, especially when China has largely contained the COVID-19 pandemic.

Its a huge gamble, because youre giving the vaccine to people who are healthy, said Lawrence Gostin, director of the ONeill Institute for National and Global Health Law at Georgetown University.

Such a risk might make sense in a country where the virus was rapidly spreading and front-line workers were constantly exposed to COVID-19 as in in the United States but Western health experts and vaccine makers have been wary of prematurely rolling out a vaccine.

I would not expect a country with a highly developed regulatory and safety system like the United States, the European Union [states] or Japan to allow that kind of wide access to an unproven vaccine, Gostin said. Its unethical, and its dangerous.

The oil company worker, who is usually based in a Persian Gulf country but has been stuck in Beijing since January, sent copies to The Times of the consent forms and confidentiality agreement he had to sign before receiving the vaccine. He also provided screenshots of WeChat discussions about vaccinations among his colleagues.

The worker said he received the vaccine in September as a requirement for all staff working abroad. He worried about the lack of transparency or scrutiny in Chinas mass vaccination of state-owned company employees and other citizens. There was no written document forcing them to receive the vaccine, he said, but workers were not being cleared to return to their jobs abroad unless they were vaccinated.

Are you afraid of the vaccine? Of course. But are you afraid of getting the sickness? Yes, youre always afraid, the oil company worker said.

It was politically incorrect to question the vaccine at his company, he said. Most of his colleagues were eager to get it. They were more afraid of catching COVID-19 abroad than of safety concerns with the vaccine.

Workers package rabies vaccine at a lab at the Yisheng Biopharma company, where researchers are trying to develop a vaccine for the coronavirus, in Shenyang, China, on June 9, 2020. China has mobilised its army and fast-tracked tests in the global race to find a coronavirus vaccine, and is involved in several of the dozen or so international clinical trials currently underway.

(Noel Celis / AFP/Getty Images)

Some project managers were rushing the vaccinations, he said, by encouraging employees to receive two shots at once instead of waiting the recommended 14 or 28 days between injections.

I saw that some people got two shots together. But you have to say youre urgently departing the country, a colleague who appeared to be coordinating staff vaccinations wrote in one of the WeChat screenshots. Im thinking the three of you can save a trip and get back to the project earlier. Ask them if you can get both shots at once, the colleague said.

A consent form shared by the employee appears to verify this account: If you urgently need to go abroad and truly cannot complete the two-shot vaccination, you can consider receiving two injections at once, one each on the left and the right, the form says.

Although severe adverse effects had not been observed in this vaccine, the form warns of possible fever, fatigue, diarrhea and headaches. Other vaccines on the market sometimes caused severe reactions such as anaphylactic shock. If that happened to a vaccination subject, they should seek timely treatment, the form says.

Vaccine doses are usually spaced out so that the first priming dose sensitizes a bodys immune system to recognize a new pathogen, while the second booster dose stimulates higher antibody levels, said Keiji Fukuda, director of the University of Hong Kongs School of Public Health and a former World Health Organization official.

Giving two doses on the same day is an attempt to drive antibody levels higher by giving more vaccine, he said: The prime-boost approach takes advantage of how the immune system works naturally. The large dose approach is more like applying brute force.

Premature vaccine use can also create a false sense of safety, said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations. China calls its emergency use vaccines effective because they produce antibodies, he said: But that is a low threshold.

Syringes of the potential vaccine CoronaVac are seen at Sinovac Biotech.

(Kevin Frayer / Getty Images)

More testing is needed to show how effective the antibodies are, how long they last, and whether they can protect against different strains of the coronavirus questions that cannot be answered in China, where the lack of an active outbreak makes it hard to prove whether a vaccine is working.

A representative of the oil company said over the phone that he could not disclose any information regarding vaccinations. Sinopharm did not pick up phone calls or respond to faxed requests for comment.

A Times reporter visited the site where the oil company worker was vaccinated, a clinic near Beijings Olympic Park, in late September. Medical staff there confirmed that they were giving out coronavirus vaccines, but only to employees of designated state-owned enterprises, and said all their appointment slots for the coming month had been filled.

Sinovac, the company whose vaccines are reportedly being distributed in Zhejiang, did not pick up phone calls or respond to emailed requests for comment.

The opacity of Chinas vaccine experiments has sparked backlash. Papua New Guinea complained in August when China sent mine workers whod received vaccines to their country without fully disclosing whether they were part of a trial or the risks involved in receiving vaccinated workers.

But many countries are also clamoring for Chinas coronavirus vaccines, which Chinese President Xi Jinping has pledged to make a global public good. Brazils health regulator approved the import of 6 million vaccines from Sinovac this week. The United Arab Emirates approved its own emergency use of a Sinopharm vaccine in September. Sinovac has agreed to supply 40 million doses of its vaccine to Indonesia by March.

China announced this month that it was joining COVAX, a global initiative to ensure equitable distribution of vaccines to developing countries. Sinopharm also announced this month that it was preparing production lines in Beijing and Wuhan to produce 1 billion doses of its vaccines next year.

Such moves have bolstered Chinas soft power regardless of questions about vaccine transparency, especially in comparison to the United States, which has struggled to contain its COVID-19 outbreak, withdrawn from the WHO and refused to participate in COVAX.

We cannot claim that moral high ground when we accuse China of using the vaccine to achieve their foreign policy goals. No matter what they are doing, at least they benefit people in the developing world, Huang said. We like to talk about China exercising vaccine diplomacy, but the U.S. is not even part of the game.

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China has injected hundreds of thousands with COVID-19 vaccines - Los Angeles Times

U.S. military personnel won't be administering any COVID-19 vaccines to the American people once the vaccines are approved for use. But the U.S. military will lend it's experienced hand in logistics to ensure the vaccine is available across the nation, said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services.

"The overwhelming majority of Americans will get a vaccine that no federal employee, including the Department of Defense, has touched," Mango said during a Friday teleconference regarding Operation Warp Speed, the DOD and HHS effort to find a vaccine for COVID-19. "That said ... we have the best logisticians in the world at the Department of Defense, working in conjunction with the CDC, to guide ... every logistical detail you could possibly think of."

That effort, Mango said, involves things such as needles, syringes, swabs, adhesive bandages, dry ice and trucks, for instance.

"Gen. [Gustave F. Perna], and his team ... are guiding all of that with scores of folks from both the CDC and the DOD," Mango said. "We will have an operation center that will tell us at any given time exactly where every dose of vaccine is."

Those operations centers, he said, will be similar to those set up for things like hurricanes.

"We're going to have one just for vaccines that Gen. Perna, his team and the CDC are going to man 24 hours a day," Mango said. "They will know where every vaccine dose is. If a vaccine dose is at risk of expiring, they will guide the movement of that to someplace else."

What Mango also said, however, is that federal military personnel will not be involved in touching the vaccine or administering it to Americans. He did add that if state governors want their own National Guard personnel to be involved as part of a state-run effort, they will do that at their discretion.

"The federal military will not be involved in moving any doses or injecting any vaccines," he said.

Right now, there are six vaccine candidates that must be evaluated in clinical trials, and volunteers are needed to participate in those trials, said Dr. Matt Hepburn, vaccine lead for Operation Warp Speed.

"We are anticipating large-scale clinical trials 30,000 patients each for these products," Hepburn said. "Therefore, we do need more people to be willing to sign up... if people are looking for a way that they can help us, help us as a nation, fight this pandemic, one of the ways they can do that is volunteer for these clinical trials."

While more are needed to participate in trials for vaccine candidates, many have already signed up. Dr. Jerome Adams, the U.S. surgeon general, said he's been impressed, so far, with the diversity of the candidates who've volunteered, and he said such diversity is important in a vaccine trial.

Vaccine candidate developer Moderna, for instance, announced it had completed enrollment on its Phase 3 clinical trial. Of the 30,000 participants, 37% are part of minority populations, with over 10% from African-American communities, Adams said.

"We want to applaud the recruitment outreach that's been done by Moderna," Adams said. "They were able to turn around what were initially low minority participation rates by removing barriers and meeting folks where they are and by harnessing relations with researchers who have long-standing trust with minority communities. ... We need this to continue for other trials."

Adams said those wishing to participate in trials for one of the COVID-19 vaccines can do so by visiting coronavirus.gov.

Operation Warp Speed is a partnership between the DOD and HHS. Specific HHS components involved include the CDC, the Food and Drug Administration, the National Institutes of Health and the Biomedical Advanced Research and Development Authority.

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Military to Play Logistics-Only Role in COVID-19 Vaccine Effort - Department of Defense

GRAND RAPIDS, Mich. Cherry Health is conducting a vaccine trial for COVID-19, according to the health center.

The trial will be done under the Johnson & Johnson Vaccine Study, says Nate Shurlow, a research assistant for Cherry Health. They ask interested participants to visit this link to see if they qualify.

Were told that upon qualification, volunteers will be contacted by one of Cherry Healths research assistants to schedule a visit, where they will address any questions that volunteers may have.

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Cherry Health conducting COVID-19 vaccine trial - Fox17

1. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2  The Lancet
2. FDA COVID vaccine chief: We'll be independent, transparent, trustworthy  USA TODAY
3. States need billions to prepare for Covid-19 vaccines. The federal government isn't helping.  Vox.com
4. Schmidt '21: Get real the COVID-19 vaccine isn't coming soon  The Brown Daily Herald
5. AstraZeneca Says Covid-19 Vaccine Trials Are Encouraging for Older Adults  Barron's
6. View Full Coverage on Google News

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What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2 - The Lancet

After months of social distancing, mask wearing, and, increasingly, COVID-fatigue, a vaccine for COVID-19 is on the horizon. Dr. Anthony Fauci recently said one could be available as soon as the end of November or early December. Governor Andrew Cuomo has speculated this "winter."

The Guardians COVID vaccine tracker notes 11 vaccines are in phase-three trials to determine effectivenessincluding Pfizers vaccine, whose CEO had previously said the company could have a vaccine ready to seek approval by the end of October. On Tuesday, CEO Albert Bourla asked for patience, and pushed that timeline further out.

But developing a vaccine may ultimately be the easy part, compared to the complex challenge of injecting it into enough people.

I think there's going to be this interesting dance that happens with the vaccine availability and prioritization, said Rachael Piltch-Loeb, a preparedness fellow at the Harvard TH Chan School of Public Health and associate research scientist at NYU.

Healthcare workers and high-risk populations like older adults would be prioritized first, with varying layers of priority levels for other essential workers, non-essential workers, and everybody else, under frameworks laid out by Governor Andrew Cuomo and Mayor Bill de Blasio. It is unclear how many vaccines would be available for each state right away, or how allocation would work. President Donald Trump has previously claimed 100 million doses would be ready by the end of 2020.

Whether the federal government will seek uniformity between states is unknown. Vaccine hesitancy could also stoke fears or delay widespread distribution. And vaccines may not be a cure-all, in which case mask-wearing would supplement moderately effective vaccines. As the director of the Vaccine Research Group at the Mayo Clinic, Dr. Gregory Poland, told the NY Times, chaos and confusion can be expected. Vaccine storage requirementssome of which may call for ultra-cold storage at 80 degrees below zero Celsiusare another challenge, CBS News reported.

Some of this is not about epidemiology, said Dr. Jessica Justman, associate professor of medicine in epidemiology at Columbia Mailman School of Public Health. Some of this is about what do people want.

The Pew Research Center found the percentage of U.S. adults who would get a vaccine if it were available today dropped from 72% in May to 51% in September.

Justman is optimistic that those prioritized under NYs early broad strokes plan will be early-adopters, and even if just half the state wants the vaccine, vaccinating 10 million people would be daunting.

Piltch-Loeb, who's researching vaccine hesitancy at Harvard, added: Never before have we had such varied reasons why people are hesitant to take a vaccine. Previously, NYC faced a measles outbreak largely concentrated in the Orthodox Jewish community, where parents were skeptical of vaccinating their children on religious grounds.

What's fascinating this time around is that we're not necessarily talking about parents making a decision about vaccinating their child, we're talking about adults making a decision around taking a vaccine for themselves, Piltch-Loeb said. Cuomo has created a task force that will explicitly determine safety and efficacy of a virus, but people who are fearful of vaccines may not be persuaded by scientific assurances.

Donna Hallas, the director of the Pediatrics Nurse Practitioner Program at NYU Rory Meyers College of Nursing, added vaccine hesitancy differs from vaccine refusal, which she says the governors plan doesnt fully address.

I think what's missing is they do talk about vaccine hesitancy, but they don't talk about vaccine refusers, Hallas said. Someone who's a refuser, no matter what, they're going to just refuse. Messaging between informing people about how a vaccine works versus for groups that outright refuse vaccines has to be clear, she added.

Cuomo has compared the vaccine rollout to COVID-19 testing, which he described as an operational nightmare at a recent press conference.

New York has so far conducted about 13 million tests for COVID-19. Thats a far cry from vaccinating the entire state population of 20 million. A vaccine requiring two doses would mean 40 million doses have to be administeredensuring each person vaccinated gets the proper vaccine as various companies race to test different vaccines each with different protocols.

"I really worry about complexity of second doses, and especially if we have more than one vaccine product out there, I just think it will be really hard to keep that straight," Justman said.

How the federal government will or will not create consistency between states remains an unanswered question.

The states are operating a little bit in the dark, said Piltch-Loeb.

Cuomo, on behalf of all governors, sent a list of 36 questions to the Trump administration on funding, vaccine allocation, and ultra-cold storage concerns. In an op-ed in the New York Daily News this week, Cuomo said the administration hadnt yet answered those questions. Whether President Donald Trump or former Vice President Joe Biden wins the election could also change any future COVID response.

Ideally, the role of the federal government would be to guide this kind of harmonization, Justman said. Certainly, that's the kind of thing that you'd hope for.

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Developing An Effective COVID-19 Vaccine Is One Thing. Getting It To Enough People Is Another - Gothamist

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The government is reportedly set to announce this week that Medicare and Medicaid will cover the out-of-pocket costs for Covid-19 vaccines that have received emergency use authorization from the Food and Drug Administration, as well as permit greater flexibility for patients seeking Covid-19 treatment, Politico reports.

Medicaid and Medicare will reportedly cover Covid-19 vaccines

The new regulations, which have been under development for weeks, are likely to be announced on Tuesday or Wednesday by the Centers for Medicare and Medicaid Services, Politico reports, citing four sources with knowledge of the matter.

Current policies dont cover the costs of vaccines that have received emergency use authorization, which allow unproven medicines to be used in an emergency.

The changes would mean patients could receive a Covid-19 vaccine at no cost.

Two producers of leading candidates, Pfizer and Moderna, have said they plan to apply for emergency use authorization by the end of 2020.

Given the speed and circumstances behind the race to develop a Covid-19 vaccine, any successful candidate will very likely be approved on an emergency basis first. The reported changes to Medicaid and Medicare will help ensure the high levels of vaccination required to tackle the pandemic.

Medicare and Medicaid to cover early Covid vaccine (Politico)

Pfizer Reportedly Manufactures Several Hundred Thousand Covid-19 Vaccines Anticipating November Regulatory Approval (Forbes)

Pfizer Will Seek Emergency Approval For Covid-19 Vaccine In November, After Election (Forbes)

Full coverage and live updates on the Coronavirus

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Report: Covid-19 Vaccine Will Be Covered By Medicaid, Medicare - Forbes