Category: Covid-19 Vaccine

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‘I think it’s safe’: Brandon attorney part of Pfizer’s COVID-19 vaccine study – Clarion Ledger

November 27, 2020

Pfizer says its potential COVID-19 vaccine was 95% effective in final results. It will submit the candidate for approval from the FDA within days. Video Elephant

Brandon attorney Bill Blair is normally trying to win cases in a courtroom, but now he is hoping tohelp society win against the coronavirus.

Blair is one of nearly 50,000participants acting as humanguinea pigs for Pfizer's experimental coronavirus vaccine.

Pfizer and BioNTech have said data from their Phase 3 study in which Blair is a participant demonstrated the vaccine candidate was 95% effective in helping to prevent COVID-19.

Pfizer said Friday on its website that a request has been submitted tothe U.S. Food and Drug Administration for emergency use authorization of their COVID-19 vaccine.

If authorized by the FDA, then the investigational vaccine could be used in high-risk populations in the U.S. by the end of December, Pfizer said. At least two other companies have announced possible COVID-19 vaccines with high success rates for preventing the virus.

"There is so much negativity in this country, we need to be doing things to help each other," Blair said.

Attorney Bill Blair, a participant in Pfizer's vaccine study(Photo: Special to Clarion Ledger)

"My childrendidn't want me to do it; they wereconcerned for my safety," he said Wednesday. "My wife didn't want me to do it. She was concerned with myhealth issues that it might not be safe."

At 67, Blair said he was in the high risk category for COVID-19 due to his age and a damaged heart from a heart attack two years ago. He also suffers from hypertension andasthma.

COVID-19 on the rise: UMMC official calls for statewide mask mandate as COVID-19 cases rise

"I honestly had no fear about it and I guess you could say I was stupid about it;" Blair said. "I was just not concerned about it."

Blair said he was more concerned about a COVID-19 test swab stuck up his nose hurting than problems with the vaccine.

Blair said he wanted to be part of the historic study, but also had a selfish reason because of his health problems. It wasn't easy to become a participant in the program, he said.And Blair said he must drive three hours each way to the Mississippi Gulf Coast asaparticipant, a trip he has to make a total of six times over the two-year period.

Pfizer and BioNTech released early study results indicating that their vaccine prevented more than 90% of infections with the virus that causes COVID-19.(Photo: Getty)

When he got the first shot, Blair said he felt a little tired while driving home from the coast. The second time, he started to feel a little sick to his stomach. There was no question in his mind that he got the actual vaccine the second time. He believes the first shot was a placebo, but doesn't know for sure, since the participants aren't provided info on the shots.

That night after getting the second shot, Blair said he developed astrong case of what felt like the flu, withbad chills,a low-grade temperature of 100 and anachy body feeling. That next day, he had started feeling better but stillwent to health clinic.

"I would tell people who take the vaccine to be prepared to take off the next day because it might make you a little sick," Blair said.

After getting what he believes was the vaccine, Blair said he has a growing feeling of ease about getting the virus.

"I would tell anyone on the fence to go ahead and do it," Blair said. "I think it's safe. I would do it again and if it's (a) manual shot, I wouldbe the first in line."

Blair said he has an 8-year-old granddaughter who spends a lot of her time with. He said her life has been interrupted by COVID.

He said: "I wanted her to feel pa paw was doing whatever he could to help out."

Contact Jimmie E. Gates at 601-961-7212 or jgates@gannett.com. Follow @jgatesnews on Twitter.

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'I think it's safe': Brandon attorney part of Pfizer's COVID-19 vaccine study - Clarion Ledger

COVID-19 vaccine to roll out in four phases, starting with health care workers – NewsChannel5.com

November 27, 2020

NASHVILLE, Tenn. (WTVF) With the announcement that vaccines may be in Tennessee for initial distribution soon, Tennessee Department of Health Commissioner Dr. Lisa Piercey explained how the plan will work.

The earliest distribution is expected on either December 14 or 15. It's 24 to 48 hours after the FDA is expected to approve the Pfizer vaccine.

"As soon as the FDA gives that decision, the federal government has committed to allocating it and shipping it to states within 24 hours," said Dr. Piercey. "We have committed to, as soon as we get it in hand, to start deploying that immediately."

The state's plan involves four phases. The first phase involves the front line against the fight against COVID-19.

Health care workers and first responders will be the first people in the state to be immunized. Eighty-thousand units of the vaccine are expected in the first shipment. The state's priority is keeping health care workers in the fight against the virus.

"When you move into phase two, that's essentially the essential worker category or critical infrastructure. And then phase three is more of a broad or general public and phase four is everybody," said Dr. Piercey.

She said she doesn't expect to reach the final phases until the late spring or summer. However, the timeline could change if more vaccine brands become available.

In the short term, the Moderna vaccine is expected just a week after Pfizer becomes available. Then, in early 2021, Astrazeneca and a Johnson and Johnson vaccine could be ready.

"We're all tired. We're tired of living this. We're tired of living in all of these restrictions. And from a health care standpoint, we're tired of feeling helpless. And so, this vaccine is just a ray of hope," said Dr. Piercey.

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COVID-19 vaccine to roll out in four phases, starting with health care workers - NewsChannel5.com

Using a Cancer Therapy Platform as a Potential COVID-19 Vaccine – Contagionlive.com

November 27, 2020

OncoSec recently received an FDA IND clearance to begin a phase 1 trial.

Biotech company OncoSec has secured an IND clearance from the US Food and Drug Administration (FDA) to begin a phase 1 trial to study their CORVax12 vaccine. This is the first DNA vaccine candidate for COVID-19 to deliver the spike protein from SARS-CoV-2 and the immune-activating cytokine interleukin 12 (IL-12).

The vaccine combines OncoSecs immuno-stimulant IL-12 expression platform, TAVO (tavokinogene telseplasmid), with NIHs DNA-encodable stabilized trimeric SARS-CoV-2 spike glycoprotein to treat COVID-19.

The CORVax vaccine is designed to drive a coordinated long-term anti-viral response, capable of activating both cellular and humoral immune responses. The companys TAVO IL-12 expression platform stimulates immunity in immunocompromised cancer settings and could be particularly relevant for patients at highest risk from COVID-19.

The Providence Cancer Center in Oregon is collaborating with OncoSec, and the former will be a trial site. BernardFox, PhD, chief, Laboratory of Molecular and Tumor Immunology, Earle A. Chiles Research Institute at Providence Portland Medical Center is the principal investigator for the trial.

I think one of the advantages we bring to the trial from a cancer perspective is we are used to doing sophisticated immunological monitoring, and we have standards in place that have been broadly accepted, Fox stated.

Fox spoke to Contagion recently about the vaccines platform, how adding IL-12 can potentially help augment responses in older patients, the trials parameters and insights on long-term immunity.

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Using a Cancer Therapy Platform as a Potential COVID-19 Vaccine - Contagionlive.com

COVID-19 vaccine trials exhibit early success – University of Miami

November 27, 2020

Physicians at the Miller School of Medicine say that data show vaccines are highly effective against the coronavirus.

As they finish inoculating local volunteers for the Moderna COVID-19 vaccine trial and continue recruitingfor a new vaccine trial, doctors at the University of Miami Leonard M. Miller School of Medicine are elated by early indications that the Moderna vaccine and another one are extremely effective in preventing the spread of COVID-19.

Its incredibly exciting, said Dr. Susanne Doblecki-Lewis, clinical director for the Miller Schools Division of Infectious Diseases and the principal investigator of the Moderna trial. This shows we can have vaccines for COVID-19 that are highly effectiveand hopefully, well have several because they will make an incredible difference in the course of the pandemic.

Last week, Moderna announced that preliminary data shows its two-dose vaccine is 94.5 percent effective in the prevention of symptomatic COVID-19, the infectious disease caused by the novel coronavirus. Just days earlier, pharmaceutical giant Pfizer announced that its vaccine was more than 90 percent effective. Both companies are now in the process of mass producing the vaccines, although the vaccine trials continue to follow patients for two years after inoculation.

If it was not for the willing participants in Greater Miami and elsewhere, Doblecki-Lewis, an associate professor of clinical medicine, said the Moderna vaccine trials would not have generated positive results so quickly.

Our participants should be really proudwithout them we would not have this data, and I think well need a lot more volunteers in the future because its important that we have multiple vaccine candidates that are tested, she said. At this time in the pandemic, volunteering is a really positive thing to do to make sure we have the best possible vaccine and enough of it.

University doctors are now recruiting participants for a one-dose vaccine developed by Janssen, a subsidiary of Johnson & Johnson. They have just a few weeks to wrap up enrollment by the end of the year and hope to get close to 1,500 participants.

At the moment, the trial is going very well, and the patients we have had so far have very few side effects, said Dr. Dushyantha Jayaweera, principal investigator for the Janssen trial and a professor of medicine in the infectious disease research unit at the Miller School.

Jayaweera noted that both the Janssen study, as well as the Moderna one, are double-blind, placebo-controlled studies. This means that half of the participants get the vaccine, while the other half will not. But both the doctors and patients are unaware of who is getting the vaccine and who is getting a placebo.

So far, the Janssen study has garnered 110 participants in the first two weeks of recruitment, but Jayaweera, and one of his co-investigators, Dr. Olveen Carrasquillo, said they need many more, particularly minority candidates. Right now, he is happy to report that more than 60 percent of candidates are Black or Hispanic, but Jayaweera and Carrasquillo said that just last week they were on a conference call with Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID), who emphasized the need for minority groups to participate in vaccine trials. That way the results will represent all of the people who are suffering from COVID-19. Data from the beginning of the pandemic has shown that Black, Hispanic, and Native American people are much more likely to be affected by COVID-19, and often face more dangerous outcomes.

Everything, so far, suggests positive things. But we need brave people to make sure the vaccine is safe and effective for everyone, said Carrasquillo, chief of the division of general internal medicine and a national expert on health disparities.

Physicians are optimistic about the vaccines being tested in upcoming trials because most share a critical element, Doblecki-Lewis said. All of the vaccines they are testing at the University so farand most under clinical trials in the U.S.operate by attacking the diseases spike protein, which is how COVID-19 enters into the bodys cells and replicates. But until there were some results from these first two trials, no one knew if that was the right approach to provoke an immune response. A similar method is used to create synthetic monoclonal antibodies, which are present in the Regeneron treatment that is the subject of another clinical trial at the University, she added.

When COVID-19 came about, many thought that the spike protein was the best target, but until now we werent sure that was the right focus, Doblecki-Lewis explained. It turns out that it was a good bet.

The data released about the effectiveness of the Moderna and Pfizer vaccines was also encouraging because respiratory vaccines are often much less effective, Doblecki-Lewis added. In comparison, the flu shotwhich she highly recommendsis only 70 percent effective.

Still, University physicians recognize that more than two vaccines will be needed to help immunize the nation and the world against COVID-19.

We need more than 300 million vaccines for the U.S. alone, so even if the Moderna and Pfizer vaccines are ready, you need more than two, Jayaweera said. Even more important is that the public understands how rigorous we are testing these vaccines, so that they will hopefully get immunized after the trials are over. Whats the point of having all these vaccines if people do not use them?

Toward that goal, there will likely be more COVID-19 vaccine trials coming to the University, Doblecki-Lewis said. Thats because the Miller School of Medicine is part of the National Institutes of Health COVID-19 Prevention Trials Network, which is spearheading the nations vaccine efforts. Since the Miller School was already a part of the HIV Vaccine Trials network, the existing partnership made it a logical place to test COVID-19 vaccines, according to Doblecki-Lewis.

At the same time, the University is also working to:

All of these treatment efforts will help physicians continue to advocate for their patients during what will likely be a challenging winter, said Carrasquillo, who has treated many people suffering from COVID-19.

Over the past several months, we learned a lot more about how to treat these patients. We had a lower mortality in July than we did in April, and every little bit helps, he said. But for prevention there was no hope, yet listening to the data from Pfizer and Moderna, I can see a light at the end of tunnel. A vaccine is not going to happen immediatelywe are still months awaybut I am hopeful that by next summer we will be in a different place than we are now.

To participate in the Janssen vaccine trial, or any of the ongoing COVID-19 clinical trials at the University, visit https://umiamihealthresearch.org and click on the COVID-19 icon.

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COVID-19 vaccine trials exhibit early success - University of Miami

Vaccine Expert: Once A COVID Vaccine Is Available, ‘Don’t Overthink It. Don’t Wait’ – NPR

November 25, 2020

A lab technician sorts blood samples for a COVID-19 vaccination study at the Research Centers of America in Hollywood, Fla., on Aug. 13. Chandan Khanna/AFP via Getty Images hide caption

A lab technician sorts blood samples for a COVID-19 vaccination study at the Research Centers of America in Hollywood, Fla., on Aug. 13.

As coronavirus cases continue to surge both in the U.S. and around the world, there's promising news on the vaccine front. Pharmaceutical companies Pfizer, Moderna and, more recently, AstraZeneca have all announced that their vaccines have shown better-than-expected results.

Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital, says that a vaccine release could begin for selected populations by the middle of December and that a broader vaccination effort could soon follow.

"By the early part of next year, we're going to move pretty quickly, I think, in vaccinating a significant percentage of the [U.S.] population," Hotez says.

Hotez says that at present, all the vaccines in development work similarly, by inducing an immune response to the spike protein of the virus.

"One of the questions that I'm asked all the time is, 'Hey, doc, which vaccine are you waiting for?' And the answer is ... I'm going to take any of those vaccines that's made available to me that's authorized by the U.S. Food and Drug Administration," he says. "Don't overthink it. Don't wait. Get what vaccine you can."

Dr. Peter Hotez is co-director of the Center for Vaccine Development at Texas Children's Hospital. Some people in the global health sector call him "Bono with a bow tie." Katie Hayes Luke for NPR hide caption

Dr. Peter Hotez is co-director of the Center for Vaccine Development at Texas Children's Hospital. Some people in the global health sector call him "Bono with a bow tie."

For two decades, Hotez and his team have worked to develop low-cost global health vaccines. Now, with COVID-19, they're working on developing a vaccine that he hopes could be produced locally, so low- and middle-income countries aren't reliant on the U.S. or Europe for production.

"We signed an agreement with Biological E., based in India, in Hyderabad, and they are now scaling this up to 1.2 billion doses, testing it across India," Hotez says. "It's very exciting for us to make a contribution. We've never made a billion of anything before so that's pretty exciting also."

Despite this good news, Hotez urges people to continue physical distancing and wearing masks.

"Don't be lax with it now, especially with the holidays," he says. "It's especially tragic if one of your loved one loses their life or has permanent, long-lasting injury during this period because it's just a matter of staying disciplined for the next couple of months and getting them to the other side."

Hotez's forthcoming book is Preventing the Next Pandemic: Vaccine Diplomacy in a Time of Anti-Science.

On his advice for the holidays: telling loved ones that visiting isn't safe this year

It's not worth that short-term event, getting family together, in order to put them at risk and put yourselves at risk. Vaccines are coming.

Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital

Remember, this is a true gesture of love telling people not to come because right now ... COVID-19 [is] accelerating across the United States at this screaming-high level of approaching 200,000 confirmed cases per day, which really means about probably at least half a million new cases a day. Any airport right now, any bus terminal, any train station has lots of COVID-infected people in those venues. It's not worth it. It's not worth that short-term event, getting family together, in order to put them at risk and put yourselves at risk. Vaccines are coming. It's just a matter of recognizing we have to get everybody through to the other side.

On the U.S. pulling out of the World Health Organization and how vaccines have become nationalized

I think the scientists are still sharing information and communicating at an international level, so I don't think that's been too affected. The thing that I worry about now is people have tied national identities to vaccines. In fact, there's a new term that's been coined called "vaccinationalism." We talk about the Chinese vaccine, the Russian vaccine, the British vaccine, the American vaccine. We've never had that before. I think it's counterproductive. And so by the U.S. pulling out of the World Health Organization and refusing to be a part of the COVAX sharing facility, which is our new mechanism that's been put in place to provide global equity for vaccines, I think this has been counterproductive and could hold us back.

We also now have this unfortunate situation where countries that don't have full access to vaccines are now making one-off deals with the Russians, the Chinese, and [it] has kind of a Cold War smell to it. We have to fix that as well. I've been devoted my whole life to this concept of vaccine diplomacy, sharing vaccine development practices between countries. And I served that role as U.S. science envoy in the Obama administration. I think we have to get back to that.

On the vaccine development he's working on and why he hopes it will reach low- and middle-income countries

Medical staff along with volunteers from the Hindu hard-line group Rashtriya Swayamsevak Sangh walk through a market for a door-to-door medical screening in Mumbai, India, on June 17. Indranil Mukherjee/AFP via Getty Images hide caption

Medical staff along with volunteers from the Hindu hard-line group Rashtriya Swayamsevak Sangh walk through a market for a door-to-door medical screening in Mumbai, India, on June 17.

This is a very traditional technology. The same technology used to make the recombinant hepatitis B vaccine used all over the world. And that's important for two reasons. One, many countries have the ability to make their own hepatitis B vaccine that includes Brazil and Cuba and Bangladesh and India and Indonesia so that potentially our vaccine could be made locally. It doesn't depend on it being made in Europe or the U.S. and then filtering to the low- and middle-income countries. And it could be made pretty inexpensively, we think. So the hepatitis B vaccine, in many cases, is made for under a dollar a dose, so we think our vaccine could come along in a similar cost structure. So we're looking potentially at using this to help fill the gaps where low- and middle-income countries don't have access to COVID-19 vaccines, and possibly even a strategy for the U.S. and Europe.

On the lack of communication among Operation Warp Speed, the pharmaceutical companies and the American public

I would have liked to see more of ... a communication strategy coming out of Operation Warp Speed. The communication has been very much left to the pharma CEOs, and I think overall they've not done a good job communicating to the American people. First of all, too much reliance on press releases that over this past year have been sometimes hard to decipher or understand. Too many leaked phone calls, too much weirdness about the stock trading and options. And I think that has undermined some confidence.

I would have liked to have seen government scientists out there communicating on a frequent, regular basis about Operation Warp Speed, very much like the way [New York Gov.] Andrew Cuomo did in March and April. It doesn't have to be every day, but on a regular basis. I've done what I can to fill in those gaps, being on the various cable news networks and podcasts, but at the end of the day, I'm not a government scientist.

On how 95% mask-wearing could prevent hundreds of thousands of deaths

We have new estimates now from the Institute for Health Metrics and Evaluation at the University of Washington, really looking at the number of deaths that are going to be projected to result from COVID-19. And they're pretty chilling numbers. And that says that unless we can get to 95% mask-wearing, we're looking at another 150,000 Americans who will lose their lives between now and a week or two after the inauguration. So we have the stunning number in a terrible way of 400,000 Americans losing their lives ... by a week or so after the inauguration. That's basically the number of American GIs who died in World War II. We're looking at those kinds of numbers.

For me, the tragedy is none of those people have to die if we adhere to 95% mask-wearing No.1. No. 2: social distancing, especially in times when there's a threat of a big surge on intensive care units, because, remember, that's when the mortality figures go way up. We saw this in New York in March and April. We saw it in southern Europe and Italy and Spain in March and April. The death rates really accelerate as ICU staff starts to get overwhelmed. And that's already starting to happen now in the northern Midwest and in Lubbock and El Paso here in Texas. So just by those straightforward measures, social distancing, being responsible, wearing masks, we can save tens of thousands of American lives between now and the time of the inauguration. And that has to be our big emphasis.

On the importance of a coordinated federal government response to the pandemic

What we saw all this year in the Trump administration was putting the states in the lead and the U.S. government would be responsible for backup supply-chain management and FEMA support and manufacturing ventilators and that sort of thing. And it didn't work. And this is why the U.S. has led the world in terms of COVID-19 deaths. And the reason it didn't work is the states never had the epidemiologic horsepower to even know how to conduct COVID control measures. And they also needed the political cover of the federal government to deflect from the attacks that they were getting from their own internal political opposition. I think having the federally coordinated response, which the Biden administration seems committed to, will make a big difference.

On the difficulty of achieving herd immunity when so many people believe anti-vaccine conspiracies

If we're going to really achieve that 70% herd immunity, which is what our estimates that we came up with, together with our colleagues at City University of New York ... we need to figure out ways to better communicate about vaccines and the importance of vaccines and really start doing something about this very aggressive anti-vaccine movement that's now morphed into a wide-scale anti-science machine or empire or confederacy that really dominates the Internet and dominates American life right now. We've got to figure out a way to begin dismantling that.

On going back to "normal" life

It's not going to be a light switch. It's going to be an evolving process. We will be in a much better place by the spring, and then by the summer we'll even be in a better place, and by a year from now, life, I don't know that will entirely return to normal, but it's going to be much better than it is now.

Peter Hotez

It's not going to be a light switch. It's going to be an evolving process. We will be in a much better place by the spring, and then by the summer we'll even be in a better place, and by a year from now, life, I don't know that will entirely return to normal, but it's going to be much better than it is now. And the reason I say [life] may not entirely return to normal is we don't exactly know the performance of these vaccines in terms of reducing the amount of virus shed from our nose and mouth. ... So there still could be a fair bit of virus circulating. And that means there could be still some need for masks and social distancing and contact tracing. But, no question, life will be so much better in the next few months than it is right now.

Lauren Krenzel and Seth Kelley produced and edited this interview for broadcast. Bridget Bentz, Molly Seavy-Nesper and Marc Silver adapted it for the Web.

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Vaccine Expert: Once A COVID Vaccine Is Available, 'Don't Overthink It. Don't Wait' - NPR

COVID-19 Vaccines To Be Allocated Based On Population : Shots – Health News – NPR

November 25, 2020

A flu vaccine is administered at a walk-up COVID-19 testing site, in San Fernando, Calif. Emergency use authorization is expected soon for vaccines for COVID-19. Robyn Beck/AFP via Getty Images hide caption

A flu vaccine is administered at a walk-up COVID-19 testing site, in San Fernando, Calif. Emergency use authorization is expected soon for vaccines for COVID-19.

Top officials from Operation Warp Speed, the government's program to fast-track the development and delivery of COVID-19 vaccines, announced they've allocated 6.4 million doses of COVID-19 vaccines to states based on their total populations.

Once a COVID-19 vaccine is authorized by the Food and Drug Administration, allocations will be made based on the total number of adults in the state. "We wanted to keep this simple," Alex Azar, secretary of Health and Human Services, said at a media briefing Tuesday. "We thought it would be the fairest approach, and the most consistent."

The allocation-by-population policy is a departure from earlier distribution plans, and it downplays the role of the Advisory Committee on Immunization Practices. The independent vaccine advisory group for the Centers for Disease Control and Prevention has proposed allocations based on high-risk groups. The CDC advisory committee had previously been central to the government's vaccine distribution plans.

At a briefing on October 23, top HHS official Paul Mango told reporters that Operation Warp Speed would send vaccines out to states based on the number of people in high-risk groups, such as health care workers, nursing home residents and factory workers, who had been identified by the CDC advisory committee.

The committee is currently working on guidelines for prioritizing these groups, which will be finalized once a vaccine is authorized by the FDA. Operation Warp Speed officials had previously said they would wait for these guidelines to be completed.

Now government officials say that's changed. Instead of waiting for the advisory committee's recommendations, they've gone ahead and allocated the first 6.4 million doses to states, based on overall population. "I finally made the decision, late Friday night," said Gen. Gustave Perna, head of logistics for Operation Warp Speed, at the briefing Tuesday. "So states could prioritize based on [their] amount," meaning how many doses of vaccine each state will receive.

HHS Secretary Azar says the way vaccines are allocated will not change once the advisory committee makes its recommendations. "At the end of the day, that is a decision of the U.S. government's to make." He added that states would get the final say in whether to abide by the government's recommendations.

Still, many states intend to follow the committee's guidance on how to prioritize limited doses, according to plans submitted to the CDC. States are currently enrolling local hospitals, doctors offices and pharmacies to be eligible to give COVID-19 shots when they're available and providers are signing agreements saying they will follow the CDC's advisory committee guidelines.

There may be valid reasons why Operation Warp Speed has changed the way it's decided to allocate vaccines and it would be helpful for the public to see how their thinking evolved, says Dr. Grace Lee, an advisory committee member. "Transparency in the process is entwined with public trust," she says, "and that's so critical to the success of a COVID-19 vaccination program, especially in a pandemic." That's why the committee has been holding monthly public meetings where members openly air their considerations and concerns.

At one such meeting Monday, advisory committee members described the importance of prioritizing vaccines for groups that bear the highest risk burdens. "I think if we're serious about valuing equity, we need to have that baked in, early on in the vaccination program," said Dr. Beth Bell, who chairs the committee's COVID-19 vaccines workgroup.

They are weighing the relative benefits and risks of vaccinating specific populations such as health care personnel and essential workers, who are more likely to be exposed to the coronavirus because of jobs requirements; and people who are older and those with underlying health conditions, who are more likely to get severely ill or die from COVID-19.

At the meeting, the committee generally supported prioritizing vaccines for workers who keep our health, food and transport systems running, ahead of those with health issues. "These essential workers are out there putting themselves at risk to allow the rest of us to socially distance," Bell said.

No vaccines have been authorized yet, but the FDA has set a December 10 meeting to consider the first application for a COVID-19 vaccine co-developed by drug companies Pfizer and BioNTech. If the vaccine is given the OK by the FDA, the government expects to begin vaccine distribution in mid-December.

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COVID-19 Vaccines To Be Allocated Based On Population : Shots - Health News - NPR

The First U.S. Shipments of COVID-19 Vaccines Will Include 6.4 Million Doses – TIME

November 25, 2020

With three vaccine makers saying that their COVID-19 vaccines are at least 90% effective, the U.S. government is gearing up plans to distribute the shots across the country.

In a Nov. 24 briefing, members of the Department of Health and Human Services (HHS)which oversees the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)and Operation Warp Speed provided the latest information on the vaccine rollout. Most importantly, HHS Secretary Alex Azar said hes ready to work with the incoming Biden administrations transition team on vaccine rollout plans, following a decision by the General Services Administration to begin the handoff process.

I reiterated my firm commitment that the transition planning and execution will be professional, cooperative and collaborative in the best spirit of looking out for the health and wellbeing of the American people, Azar said during the briefing. He previously said that he would not initiate transition communications until the GSA decision.

Heres what the Operation Warp Speed team, which is tasked with supporting development, manufacturing and distribution of COVID-19 vaccines, revealed during the briefing:

A panel of independent experts convened by the FDA will review studies from each vaccine to determine if they are safe and effective enough to distribute to the public. First up are Pfizer and German biotech firm BioNTech, which filed an emergency use authorization (EUA) request for their COVID-19 vaccine on Nov. 20. The FDA group will meet to evaluate the shot, which the companies say is 95% effective in protecting against COVID-19, on Dec. 10.

Moderna is expected to submit a similar request to the FDA soon, and the committee will meet again to evaluate the Massachusetts-based companys application. AstraZeneca will likely follow as well.

Gen. Gus Perna, chief operating officer of Operation Warp Speed, said that he told state health departments on Nov. 20 that 6.4 million doses of vaccine will be available once the FDA issues the first EUA (at this point, Pfizers shots will most likely be the first to get the green light). What will happen if more becomes available after the initial push is, we will go out following a weekly cadence to distribute [doses] accordingly, with 40 million [doses] by the end of the year.

How much vaccine each state initially receives will be based on a rough per capita calculation.

Pfizers and BioNTechs vaccine, which is based on a new mRNA technology, needs to be kept at -70 C to -80 C. In the U.S., Pfizer has designed special thermal packaging to ship its doses. If replenished with dry ice, the doses can remain in those containers for 15 to 20 days. Once removed, the vials can be stored in a refrigerator for up to five days.

In order to train workers who are receiving the doses, Pfizer has conducted dry runs of shipping its vaccine to 10 locations. Perna said such trials would be done with all 64 public health jurisdictions receiving vaccines from the CDCmost of which are state health departmentsto make sure those administering the vaccine are comfortable handling it.

Ive personally gone through the process, put my hand in the box, pulled out trays, and timed myself in the execution, and its a very, very doable process, he said. The Pfizer containers will include 975 doses. We feel confident that if states plan dosages in the right locations, with the drumbeat and cadence of [regular manufacturing], administration of the vaccine to a minimum amount of 975 doses is very doable within 20 days, he added.

Once the first batch of vaccines are shipped, the next batch will be dispatched within 21 days for the Pfizer vaccine and 28 days for the Moderna vaccine, so people who received their first dose will be able to get their second shot. Once the manufacturing reaches a regular cadence, shipments will be distributed weekly. States will be able to order vaccines through a 24/7 system, and the doses will be shipped the following day.

Vaccine manufacturing will gradually increase as more shots are authorized by the FDA, and people will be vaccinated according to guidelines set by the CDCs Advisory Committee on Immunization Practices (ACIP), among others. The ACIP recently released principles that it says should guide who gets vaccinated first; these factors include risk as well as equity. Health care workers, first responders and others with essential jobs will be first in line, with the elderly and those with chronic health conditions next. It likely wont be until next spring or summer that the majority of the American public will be eligible to get vaccinated.

We are bridging to when we have vaccines first for the most vulnerable like health care workers, first responders and eventually the broad American population, Azar said. [Until then] wash your hands, watch your distance and wear face coverings when you cant watch your distance, and stay out of settings where you cant do those things.

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The First U.S. Shipments of COVID-19 Vaccines Will Include 6.4 Million Doses - TIME

COVID-19 vaccine, ‘the one ray of hope,’ could reach Tennessee by mid-December – Chattanooga Times Free Press

November 25, 2020

Tennessee's first shipment of highly anticipated coronavirus vaccine is expected to arrive in about three weeks, according to the state's top health official.

Pfizer's COVID-19 vaccine will be the first shipped out across the United States and should reach Tennessee around Dec. 15. Dr. Lisa Piercey, commissioner of the Tennessee Department of Health, shared the news during a briefing Tuesday.

How many doses the state will receive is fluid, but Piercey said the ballpark for the initial shipment is between 80,000 and 100,000 doses. Each person will need two doses of vaccine spaced several weeks apart, meaning the first allotment will cover between 40,000 and 50,000 people.

"This is the one ray of hope that we've got, and so we are putting a ton of effort forth to make sure we get it to you as fast and as safely as possible," Piercey said, adding that all vaccine distribution plans are subject to change.

Pfizer's vaccine is reported to be 95% effective based on late-stage clinical trials. The U.S. Food and Drug Administration is scheduled to meet Dec. 10 to discuss Pfizer's trial data and will ultimately decide whether it receives emergency use authorization, according to The New York Times.

More vaccine from another leading drug manufacturer Moderna is expected to arrive a week after Pfizer's, Piercey said.

Although the initial shipments may seem small in the context of 6.8 million Tennesseans, she said, "We're going to start to see some measurable improvement in our case trends when we get some vaccines in arms."

The welcome news comes as Tennessee and the country continue to face record numbers of new COVID-19 cases and hospitalizations.

On Tuesday, the Hamilton County Health Department reported 264 new infections and five additional COVID-19 deaths, making November the deadliest month for the virus in the county, with 29 deaths so far and six days still remaining in the month.

Hamilton County is averaging 227 new COVID-19 cases in the past week, a record, and a positivity rate of 22% for new tests in the past week, another record. As of Tuesday there were 136 people hospitalized with the virus and 30 people in intensive care units, according to health department data.

Gov. Bill Lee said during Tuesday's news conference that vaccines will be "very important for us in this state to curb the spread of the virus and to ultimately really be able to handle it."

The state will follow its draft plan to determine vaccine distribution to at-risk groups first based on supply.

Front-line health care workers and first responders those most likely to come into contact with infected people or materials will be vaccinated first. Examples include emergency department and intensive care unit staff, people conducting mass testing events and first responders who arrive at scenes without knowing the status of those they're treating.

"We need to make sure that those folks are protected so we can keep our health care workers on the front lines," Piercey said, adding that she anticipates widespread vaccine availability sometime in summer 2021.

(READ MORE: What Chattanooga area nurses treating COVID-19 patients had to say after work)

Pfizer's vaccine must be stored at an ultra-low temperature, so the state will use special coolers filled with dry ice called "thermal shippers" that hold 975 vials each in order to distribute shipments faster, rather than relying on a large stationary freezer for storage.

Contact Elizabeth Fite at efite@timesfreepress.com or follow her on Twitter @ecfite.

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COVID-19 vaccine, 'the one ray of hope,' could reach Tennessee by mid-December - Chattanooga Times Free Press

While Connecticut officials urge more federal funding for COVID-19 vaccine distribution, Gov. Lamont says hes prepared to dip into the states rainy…

November 25, 2020

A volunteer participating in the AstraZeneca vaccine trial having blood drawn in Oxford, England, Nov. 19, 2020. AstraZeneca's new clinical trial results are positive but confusing, leaving many experts wanting to see more data before passing final judgment on how well the coronavirus vaccine will work. (Andrew Testa/The New York Times)

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While Connecticut officials urge more federal funding for COVID-19 vaccine distribution, Gov. Lamont says hes prepared to dip into the states rainy...

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