Category: Covid-19 Vaccine

This summer, Jonathan Penman, 24, a college student at the University of Nebraska Omaha, enrolled in a clinical trial of an experimental vaccine for COVID-19.

The virus, he said, was a wake-up call.

I did the vaccine trial because I have a couple of grandmothers who live at our familys home, and my mom works in a preschool, Penman told Healthline. There are people close to me who are susceptible to the virus.

Penman is a participant in the phase 3 trial of mRNA-1273, a vaccine candidate from Moderna, a pharmaceutical company in Cambridge, Massachusetts.

Penman had to drive only a few minutes from his apartment in Omaha to take part in the trial at Meridian Clinical Research.

He received the second of two vaccine injections 2 weeks ago.

I was the first one in the Omaha area to do this trial, he said. So far, so good. Im a little tired from the second injection. Theres a little malaise, but thats about it.

Penman thinks that no matter what happens, he made the right decision.

I think its certainly possible that this could save my life. But we, of course, have no way of knowing, he said.

Penman is grateful that his girlfriend, Morgan, and his friends were supportive of his decision to enter the trial.

I ran this by my girlfriend, who is in nursing school, and she was like, Yeah, if you think you should, do it, go for it, he said.

We have had lot of discussions about this. A few people we know and in my family are anti-vaccine. So, it is a conflict, but not anything major, he added.

Penman said he has friends whove had COVID-19.

I have encouraged people on my Facebook page to do the trial because its the right thing to do. I also encourage them to please wear a mask, he said.

Penman said that thankfully, no one close to him has died from the virus.

I have no idea if I have been exposed or not, he said. But as part of the trial, they have done the swabs. Had I been exposed, that would have showed up there.

The first COVID-19 test he took was before the vaccination, just to make sure he didnt have it.

It came back negative, so I took the first shot, he said. They did my vital signs, it was all good. Then a month later, we did the same thing, and again it was negative.

Penman said the trial wasnt intrusive. But he checked it out before he went through with it.

I Googled it, and the whole concept of the trial works. It makes sense, he said. Its not just a typical vaccination. It attacks the RNA and DNA structure of the virus. That is serious bioengineering. Thats pretty cool.

Moderna is deploying its so-called mRNA platform to develop its vaccine.

While most vaccines use injected viruses to initiate an antibody response, Modernas technology uses viral genetic material RNA to produce the antigens that allow the body to learn to respond to the novel coronavirus.

Moderna is testing to see if its vaccine can help the immune system produce effective antibodies against the virus so that, in case of infection, the virus doesnt cause illness.

As of September 11, more than 23,000 people were enrolled in Modernas phase 3 trial.

All participants will be given an injection half of them with the vaccine, half of them with a placebo. Each group is given a second injection 28 days later.

The total participant enrollment plan for the trial is 30,000.

Why has Moderna been able to make it to a phase 3 trial with relative speed compared with some of the larger U.S. pharmaceutical companies?

Our mRNA platform was already built. It gave us speed, Ray Jordan, Modernas chief corporate affairs officer, told Healthline.

We began making doses for 30,000 participants when we were still in a phase 1 trial, Jordan said. It looked like it was not smart fiscal management. But you take that risk so you can move that much more rapidly.

Jordan explained that the company has been working on vaccines using this technology for a decade. The company has nine vaccine candidates in development against everything from respiratory infections to infections transmitted from mother to baby.

Jordan noted that more than 1,900 participants have been enrolled in Modernas infectious disease vaccine trials in the United States, Europe, and Australia. These are trials other than the one for the novel coronavirus.

People say that we got the virus into the clinic in 63 days. But its really been 10 years and 63 days, Jordan said.

When it comes to the development of a COVID-19 vaccine, no one knows for sure what will happen in the coming months or even years.

But theres increasing though guarded optimism in the scientific community that there will be a vaccine or more than one thats effective.

President Trump has said he wants to develop a vaccine as soon as possible, even if the phase 3 trials arent completed. In early August, Trump said he was optimistic that a vaccine would be ready by Election Day on November 3.

Late last month, Dr. Stephen Hahn, the commissioner of the Food and Drug Administration (FDA), said his agency could consider emergency use authorization or approval for a COVID-19 vaccine before phase 3 trials are complete.

But the chief executive officers at nine of the largest Western pharmaceutical companies with a vaccine being studied wrote a letter pledging that in their efforts to develop a COVID-19 vaccine, they wont take shortcuts and will adhere to the scientific process.

We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles, the pledge reads.

The executives who signed the pledge are from Moderna, AstraZeneca, BioNTech, Pfizer, Novavax, Sanofi, GlaxoSmithKline, Johnson & Johnson, and Merck.

Explaining why they wrote the letter, Pfizer CEO Albert Bourla, DVM, PhD, told NBC News, We saw it as critical to come out and reiterate our commitment that we will develop our products, our vaccines, using the highest ethical standards and the most scientific processes.

COVID-19 vaccine clinical trials are also being run by such companies as CanSino Biologics, Inovio, Sinovac, Gamaleya Research Institute of Epidemiology and Microbiology, CureVac, and Clover Biopharmaceuticals.

Russia and China are also developing vaccines.

Penman is optimistic about the possibilities of having a COVID-19 vaccine relatively soon.

Meanwhile, his eyes are firmly focused on the future.

Penman wants to get a federal emergency management position. He plans to join the National Guard and is trying to get a commission through the Reserve Officers Training Corps (ROTC).

Im going to try to get an officer position in the government. I would like to work in Homeland Security. But honestly, whatever is available, he said.

Penman has developed an interest in the concept of government intervention and public health since he decided to enroll in the clinical trial.

Im just curious about it, he said. Will the vaccine be mandatory? And what does that say about civil liberties? To what extent will government make it mandatory?

Penman said he has been reading lately about how the United States is one of the only countries where people are protesting the wearing of masks.

Its interesting. We are pretty defensive in this country about our liberties, he said.

But I encourage people to do the right thing. I encourage people to wear a mask. I have been exposed. Ive had friends around me who have gotten it. But some people just dont take it seriously.

Continued here:

COVID-19 Vaccine Trial Participant: 'It's the Right Thing to Do' - Healthline

The Microsoft cofounder and cochair of the Bill & Melinda Gates Foundation is spending much of his prodigious fortune trying to change the worldby tackling the diseases that hurt the poorest of the poor. But this year, a generations worth of progress is being threatened by a once-in a-century pandemic. Can an all-in bet on science and innovation set us back on course?

This edited Q&A has been condensed for space and clarity.

Since 2017, the Bill & Melinda Gates Foundation has issued an annual scorecard, called the Goalkeepers Report, on how were doing in the fight against global poverty and disease. In the latest assessment, you began with words Im guessing youve never uttered before: This progress has now stopped.

Gates: Yes, the United Nations developed these goals for humanity, which are about basic needs: getting rid of extreme poverty, providing access to education and health care. And so that creates a framework for us to do a report card every year and try to highlight the countries that are doing things wellwe call them exemplarsso that we can get others to adopt best practices. The visibility of gradual progress is very low: Since 2000, weve cut childhood death rates in half, for example, but the progress is mostly invisible to people.

This years report, however, is quite a contrast. Due to the direct effects of the pandemic, in terms of the deaths it has caused, but also due to its gigantic indirect effects on fragile health systems in the developing countries, weve regressed. So routine immunization rates, which weve worked to raise to 84% over the last 25 years, are down 14 percentage points in the past year. The pandemic has pushed almost 37million more people into extreme povertyuntil 2020, that number had been going down every year for two decades. So the call here is to say, Hey, weve got to bring this pandemic to an end. And then we have to work to catch up and get back to where we were at the start of 2020 on things like vaccination and education, so that we can resume that positive trajectory.

One opportunity for optimism, perhaps, is what seems to be a new wave of collaboration among companies in the wake of COVID-19. Is this new sense of shared purpose in the private sector real?

Well, the pharma industry is certainly stepping up to play their role. A lot of the big companies are agreeing to put their best people on both therapeutics and vaccines, so thats pretty spectacular. And thats why we have six vaccine constructs [methods of building vaccine], each of which could possibly be through an FDA Phase III clinical trial and receive an emergency-use license by early next year. The likelihood is that at least two, three, or four of those will probably prove to be both safe and efficacious. Then well be faced with the challenge of scaling up manufacturing to a completely unheard-of level. The form of cooperation thats never been done before is having a company that did not invent the vaccine provide its factories so that they can scale up that manufacture. Serum Institute of India, for example, has deals with AstraZeneca and [Maryland-based vaccine maker] Novavax. So were facilitating those pairings because the Indian manufacturers are much higher volume. Theyve got 5,000-liter tanks and huge built-in extra capacity.

The Gates Foundation has also invested heavily in possible medicines to treat COVID-19. What progress are you seeing there?

So far, in the way of therapeutics, theres dexamethasone [a steroid hormone first approved by the FDA in 1958], which is the only treatment that has significant impact. Even [Gilead Sciences antiviral agent] remdesivir, right now, is still showing pretty modest results. But theres a pipeline of things being tested, including a number of monoclonal antibodies [lab-produced proteins that act like human antibodies, homing in on specific targets], which have the best chance of having fairly dramatic outcomes. We dont know for sure, but the cure rates could be very high, like 70% or 80%. Some of that data will start being published in the next month or two. The Gates Foundation reserved capacity at a factory owned by Fujifilm to manufacture an antibody product. We have to provide them with the thing by sometime in October, so were scrambling. If the antibodies dont work out or if we dont have the right ones, then well lose some of that money. But thats fine, because the potential impact of having that capacity, which is significant, would let us get it out to developing countries without having just the rich countries take all that capacity just for their usage.

Story continues

Peoples attitudes towards masks and the vaccine, will, in a concrete way, help determine how quickly we bring this pandemic to an end.

The Gates Foundationin a similar vein as BARDA, the U.S. governments Biomedical Advanced Research and Development Authorityde-risks a lot of the riskier investments that private companies make for the common good. How else can governments encourage innovation on the more revolutionary fronts of science and medicine?

The U.S. is exemplary in this. Weve got $42billion a year of NIH money that often lays the research foundation for understanding the biology so that the product innovation can go on and companies can then develop medicines based on that biology. There is all sorts of friction about what drug prices should be, which is a big, complex topic, but the U.S. systemin terms of creating high-paying jobs and leading companies here and in getting the availability of new medicines to the U.S. very quicklythats working pretty well.

You mentioned drug pricing. Can these COVID-19 vaccines and medicines be made cheaply enough that the world can afford them?

I have a regular discussion with the pharma CEOs. Their response to the pandemic and this great work that pharma people are doing has reminded many of their capacities and how they can be helpful to the worldas opposed to the industry being viewed as kind of selfish and uncooperative. In the last big, big health crisis we had, when the HIV epidemic came along, the industry didnt have a willingness initially to do tiered pricing, to get the drugs out to the developing countries [at prices they could afford], and they ended up in a lawsuit with former South African President Nelson Mandela. Eventually, they did the right thing. And thats why I think the commitment today by some of these companies to put resources into the vaccine manufacture, and to do it on a nonprofit basis, is pretty valuable.

Its hard enough producing enough safe and effective vaccines against COVID-19. Persuading billionsof people to take them may be harder yet.

The issue is just basic trusthow do people think about vaccines? With all the conspiracy theories out there, you know, weve got a challenge with thatnot just in the developing countries, but everywhere. The most extreme example was where the polio vaccine was said to be a plot to sterilize women in Nigeria in 2003. And sadly, that led to cases spreading to a dozen countries where the disease had been eliminated.That was a huge setback. But there we got the trusted religious leaders to get the message out and give the vaccine to their children, and so, eventually, we overcame that. Today, peoples attitudes towards masks and the vaccine, will, in a concrete way, help determine how quickly we bring this pandemic to an end.

Speaking of conspiracy theories, there was an insane one floating on social media about youthat you had somehow created this pandemic. Youre arguably the best-known champion of public health on the planet. How do you get past that sort of crazy?

Well, its a new phenomenon. So I cant say I have some great solution or expertise. And even though its so extremeyou could almost say its humorousit is potentially a real problem, particularly when you have some people turning it into a political thing and even talking about taking violent action. So, Im just learning about this. And, Im certainly surprised that the organization thats done more to save lives with vaccines is now being treated as though our goals are kind of the opposite.

The likelihood is that at least two, three, or four [vaccines] will probably prove to be both safe and efficacious.

Strangely, this is happening at a time when vaccine science in general seems to be advancing at breakneck speed. Can the race to create COVID vaccines help us develop one against, say, malaria?

We actually have a concrete project with Moderna to do a malaria vaccine construct using the messenger RNA platform [a method also being used for some COVID vaccine candidates]. That is somewhat interrupted by the pandemic, but it is an approach that we funded. We started backing these mRNA vaccines almost a decade ago. They are very promising and could be used potentially for HIV and tuberculosis as well.

The legendary investor Warren Buffett, who just turned 90, has entrusted much of his own fortune to your foundation. What have you learned from him in your long friendship?

Im talking to Warren actually more regularly this year than at any time during our friendship, which is almost 30 years now. And its because of his ability to look at whats going on in the world and be fascinated and surprised. He and I sit and marvel over the unexpected things that are going on in many frameworks: political, macroeconomic, and in the world at large. He knows so much more about business, and he sees so much. Talking about, Okay, are people buying furniture this year? And the answer is yes, actually its at higher levels than last year. And going through each of his businesseswhere has he seen the demand, and why he thinks that is? Or talking about an Austrian 100-year bond selling at 88 basis pointsand what that means. He hears a little bit from me on the digital realm, or about some of this health-related innovation, particularly related to the pandemic. But, you know, we never run out of things to talk about. He just brings such a sophisticated frameworkand he always has this humility that goes with it, which makes it so much fun because hes having fun. Hes also very careful about what he claims to know. You know, Id rather talk to him about business and the economy than anyone else.

Youre known for clearing time on your calendar for Think Weeks, where you hole up in a cabin, read books, and ponder the world. Why is this so essential?

Adult life is so easy to fill up with activities. The ability to step back and read deeply or think deeply or write up thoughts is largely missing. And so I work hard on my schedule to make sure Im not filling it up with too many things. Its been a little bit easier with no travel this year. So I think of myself as a student where I need almost like a reading period to consolidate my knowledge. It was particularly challenging when I was CEO of Microsoft. Eventually, I got to two weeks a year that I was setting aside. Since I retired from Microsoft in 2008, I dont have to do it necessarily as one block, a week at a time, but I do set aside lots of days, and then I say, Did I write the memo that I intended to write? The act of writingwhen you try to explain it to someone elseis where you really are forced to think things through and not be sloppy in your thinking.

Newsletter-Red-Line-15

(1) Black check: Since 1994, the Bill & Melinda Gates -Foundation has awarded $54.8billion in grants (through Q4 2019).

(2) Projected change in people earning less than $1.90 per day (intl. poverty line):2018: -1.2%2019: -1.5%2020: +7.1%Source: Gates Foundation

(3)Fast lane for meds: In March, the Gates Foundation partnered with the U.K. foundation Wellcome and Mastercard in a COVID-19 Therapeutics Accelerator designed to speed upand scale upthe development of treatments.

(4) PR nightmare: In 1998, 39 multinational drugmakers sued the South African government (and Mandela, its former President) for circumventing patent protections on exorbitantly priced medicines for HIV/AIDS. The pharma companies would ultimately lose their legal battleand much of their reputation.

(5) Rich and poor alike: AstraZeneca and Johnson & Johnson have promised to deliver vaccine on a nonprofit basis through the pandemic. More than 170 nations have signed on to a GAVI-led compact called the COVAX Facility, whose aim isto ensure thatvaccines are distributed equitably around the world.

Death averted, compared with a no-vaccine scenario:When a vaccine is distributed to high-income countries first: 33%When a vaccine is distributed to countries according to their population size: 61%Source: Gates Foundation

(6)Ending a scourge: The Gates Foundation has committed $5.5billion to the global polio eradication effort.

(7)Give it away now: In addition to committing 10million shares of Berkshire Hathaway stock (in annual payments) to the Gates Foundation, Buffett joined with Bill and Melinda to launch the Giving Pledge, an effort to encourage fellow billionaires to commit to giving the majority of their wealth to philanthropy.

(8)Long-lasting bond: In June, the Austrian government issued more than $2 billion worth of century bonds, yielding just 0.88%. One hundred years may seem like a long time to wait for little gainbut with much of the world looking for safety, this auction was oversubscribed.

A version of this article appears in theOctober 2020 issueofFortunewith the headline The Conversation: Bill Gates.

This story was originally featured on Fortune.com

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When Bill Gates thinks well have a COVID-19 vaccineand why that wont be the end of the pandemic - Yahoo Finance

A professional society of Black physicians has formed a task force to assess COVID-19 vaccines and treatments, in light of concerns that federal agencies may approve vaccines and drugs without adequate proof that they work, Stat News reported.

The National Medical Association (NMA), which represents Black physicians and health professionals in the U.S., formed the task force following recent, controversial actions taken by both the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA). For instance, the CDC initially issued guidance that close contacts of infected people should only get tested for COVID-19 if they show symptoms, even though asymptomatic people can spread the virus; the FDA authorized the widespread use of plasma therapy for COVID-19 with little proof it works, and recently revoked its emergency authorization of hydroxychloroquine after patients developed serious heart, kidney and liver problems, according to the agency's website.

"There is a concern that some of the recent decisions by the Food and Drug Administration have been unduly influenced by politicians," Dr. Leon McDougle, a family physician and president of the National Medical Association, told Stat News. In addition, President Donald Trump has teased that a COVID-19 vaccine could be available before November 3, raising concerns that the vaccine approval process might be dangerously rushed before data shows the vaccine works, according to The New York Times. To address this growing uncertainty, the NMA task force plans to double-check that any approved drug or vaccine is truly safe and effective.

Related: 20 of the worst epidemics and pandemics in history

"I think this will help to increase uptake in the African American community, if members of our task force give it the green light," McDougle told Stat News. "What we've seen in terms of political interference in the FDA and CDC has really undermined what little trust the Black community had," added emergency physician Dr. Uch Blackstock, the founder and CEO of the consulting firm Advancing Health Equity, who is not a member of NMA.

In addition to reviewing the safety and effectiveness of approved vaccines and drugs, the task force will look at whether clinical trial participants accurately represent the demographics of the broader U.S. population, according to Stat News. If the FDA approves a drug or vaccine without releasing all the relevant data, McDougle told Stat News that he hopes that NMA members involved with federal agencies could still get access to those reports.

While some experts agree that the task force is greatly needed, others worry that it could undermine acceptance of COVID-19 vaccines, in general, if the NMA's assessments clash with the official guidance of the CDC and FDA.

The thought is that too much uncertainty could deter people from getting any approved vaccine, even if the panel confirms it's safe. Read the full story at Stat News.

Originally published on Live Science.

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Black doctors have created a task force to make sure COVID-19 vaccines are safe - Live Science

Safety and efficacy of the Russian COVID-19 vaccine: more information needed Authors' reply  The Lancet

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Safety and efficacy of the Russian COVID-19 vaccine: more information needed Authors' reply - The Lancet

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The federal government is spending millions to accelerate the production of a coronavirus vaccine. Though the rushed process may produce an ineffective vaccine, the benefits of mandating the vaccine outweigh the potential risks.

In July, the federal government announced it will invest over $2 billion in grants to companies that are trying to manufacture a vaccine or treatment for COVID-19. The grants went to companies such as Regeneron, which has had success in developing treatment drugs for Ebola, and Novavax, which has tried to produce many vaccines but has failed at getting the Food and Drug Administrations approval for any.

The government is investing so much money into these companies so that, when one of these manufacturers develops a vaccine that the FDA approves, it doesnt have to wait months for mass quantities of the vaccines to be produced. The government even wants mass quantities to be produced and has committed to buying them even before knowing the vaccines are effective, which is a risky strategy.

The rushed process for vaccine development, testing and approval has many Americansworried. But most of the vaccines that these companies are producing are completely harmless, showing your immune system something that looks like the virus to prepare your body to fight the actual thing.

The vaccines being developed are also modeled after knowledge of past vaccines that have been developed and have proven effective. The development and testing processes, although accelerated, are similar to ones implemented in the past for other viruses and are familiar to scientists and doctors.

Any vaccines that are developed in this shortened timeline will likely be pretty safe because that is one of the main concerns, said Brittany Kmush, an assistant professor of public health at Syracuse University who specializes in the study of vaccines, global health and infectious diseases. (Pharmaceutical companies) are doing a good job of evaluating safety and really looking at the short-term safety profiles, she said.

Though a vaccine for COVID-19 is likely to be very safe, it may not be entirely effective. If a vaccine is rushed but proves ineffective once given to people, or if its only effective for a limited amount of time, there are consequences.

If an ineffective vaccine is given to students, and they believe it works, the students put their guards down. If this does happen, people will likely become less cautious about practicing social distancing and wearing masks, which will likely cause another wave of COVID-19 infections and deaths.

However, this negative possibility does not outweigh the pros of mandating a vaccine that may not be entirely effective. If a vaccine does come out and is proven to work, countless lives will be saved. Schools will be able to return to some semblance of normalcy, and COVID-19 will mirror what happens to all deadly viruses once a vaccine or cure is found: the virus will infect fewer people, and the pandemic will tamper off.

Because a vaccine will not have been around for years or decades, there is no way we can know if there are some kind of very rare, long-term side effects, Kmush said. But thats not very likely because they are using the same technology as they used for other vaccines that have been around for decades.

Even with a possible vaccine on the way, students still have the responsibility to ensure that they are continuing to follow guidelines from the Centers for Disease Control and Prevention and practice social distancing until a vaccine is proven safe and effective. A new vaccine could be the first step in allowing students a normal college experience in the spring.Skylar Swart is a sophomore political science major. Her column appears bi-weekly. She can be reached at saswart@syr.edu. She can be followed on Twitter at @SkylarSwart.

Published on September 20, 2020 at 10:34 pm

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Benefits of mandated COVID-19 vaccinations outweigh risks - The Daily Orange

Yahoo News Medical Contributor on life after a COVID-19 vaccine: 'We probably will be living with the virus for a while even after a vaccine'  Yahoo Finance

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Yahoo News Medical Contributor on life after a COVID-19 vaccine: 'We probably will be living with the virus for a while even after a vaccine' - Yahoo...

A surprising segment of the stock market will rally the most on a COVID-19 vaccine, Goldman Sachs says | Markets  Business Insider

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A surprising segment of the stock market will rally the most on a COVID-19 vaccine, Goldman Sachs says | Markets - Business Insider

With Covid-19 continuing to ravage communities, Americans are anxious to discover a vaccine. This week, President Donald Trump claimed we could have a vaccine as early as mid-October something directly contradicted by Centers for Disease Control and Prevention head Robert Redfield, who predicted we might see something by the end of the year, if that. On Friday, Trump predicted more than 100 million doses of a vaccine will be available by the end of the year.

Theres an obvious political reason why Trump or other lawmakers might wish to get our hopes up about a vaccine before the November election.

Theres an obvious political reason why Trump or other lawmakers might wish to get our hopes up about a vaccine before the November election. But based on my 35 years spent developing drugs for serious medical conditions, including AIDS and sepsis, this is unlikely to happen as quickly as some politicians have told us.

Importantly, creating the vaccine is just one step. We then need to distribute it. Because while vaccinating everyone is impossible, vaccinating enough people to create a protective herd immunity is not. This is really the key when we talk about returning to normal. Youre not hearing much about that from the president because its easier to just allude to a magical vaccination that will immediately fix everything. And there is no magical solution to this problem.

Until now, the federal government has eschewed a leadership role in pandemic response. The crew that tried to derail CDCs venerable Morbidity and Mortality Weekly Report and accused the CDC of sedition has not positioned itself to be a credible force for public health. An administration that has eliminated nonpartisan careerists throughout government in favor of politically favored but professionally naive opportunists is unlikely to pull off the most significant logistical challenge ever undertaken by the government within our borders.

Vaccines are generally safe and effective because to be approved, they must go through rigorous testing. This helps keep people safer and the drug companies that make those vaccines profitable.

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Drug companies dont make money by testing vaccines, but by selling them. When a drug company says vaccines take years to develop, thats because the company wants to get the vaccine right. Some vaccines may make the disease worse, at least in some people, so proper testing is essential to protect public health. If we cut corners on testing, the risk goes up that a vaccine may be unsafe or ineffective.

But before we reach that herd immunity, we will have to clear four hurdles: clinical trials, regulatory review, filling the supply chain and getting enough people to get vaccinated.

To adequately test a vaccine, the sample population must be large enough, which in the case of Covid-19 is about 30,000 people, which may seem like a lot. However, the more people you study, the faster you can get to an answer. Since Covid-19 began in the United States in earnest in March, more than 6 million people have been infected in a nation with 330 million people. Thats about 2 percent of the U.S. population in six months. If we apply this to a study of 30,000 people, that would be about 45 cases per month in the control group and hopefully half of that with the vaccine.

Thats not a lot of people to study.

Still, Pfizer seems to have done a good job, with over 29,000 people enrolled in its study. So far, most of the possible side effects have been mild. This is encouraging and supports the CEOs statement that it could have the results of interim analysis in late October. Moderna is not far behind. However, we must keep in mind that an early report does not guarantee there will be enough data to support even an emergency Food and Drug Administration authorization, much less full approval.

For the sake of discussion, lets imagine there is a positive result announced in late October and the vaccine not only decreases viral infections, but also reduces clinical symptoms like shortness of breath and fever.

While I have great respect for the scientific integrity of Pfizers research and development group, terrible things have happened when a federal agency took a manufacturers word that its product was safe.

Therefore, the FDA will need to get the relevant vaccine trial data (this will take time) and conduct its independent review. One month to review this volume of data would be record-breaking. However, given the novelty of the product (no mRNA vaccine has ever been approved) and the shortcuts being taken for Operation Warp Speed, an independent advisory committee of medical and statistical experts will also need to review the data. If all give up their holidays, a recommendation could be made at the end of December. However, if there are any hold-ups at all, there will be a further delay.

Then the supply chain needs to be filled and the drug delivered to the professionals who will administer it.

It is reported that Pfizers product may require ultra-cold storage at minus 94 degrees Fahrenheit. This type of specialized storage is not available in your typical doctors office; it is found in universities and research centers. If the vaccine thats first out of the gate does require this kind of storage, the logistics of distribution will be daunting. Even if the military is mobilized to distribute the vaccine, the hurdles will be formidable. Suppose a second vaccine is approved rapidly. In that case, the complexity will multiply, since the vaccines are not interchangeable: You must have the same vaccine for both shots.

And how many people will need to be vaccinated? An optimistic model says 43 percent will need to have potent antibodies to achieve herd immunity, and the administration claims it will do it in one year. That is 142 million people. But if the vaccine is only 50 percent effective, it could take many more people to reach immunity. Currently, we cant get that many people to wear a mask. And an NBC News poll showed that more than half of Americans are still wary of a Covid-19 vaccine.

Nonetheless, if the federal government steps up to the job, pharmaceutical companies and the military fill the supply chain and vaccine supply is unlimited and available at every hospital with an ultra-cold freezer, each of the approximately 7,000 hospitals in the U.S. will need to vaccinate 20,000 people, two times. That will be 40,000 visits or nearly 800 per week, on top of continuing to provide their routine care.

If this overwhelming task can be accomplished, then there will only be three things left to worry about: potential rare but serious side effects that were not discovered during testing, the possibility of vaccine-enhanced infections or respiratory disease and the ever-present risk of mutation that could cause us to need to do the whole thing over again.

Dr. Kenneth Gorelick

Kenneth Gorelick, M.D., is a board-certified internal medicine and pulmonary disease specialist and a member of the Committee to Protect Medicare. He has more than 35 years of experience in the development of drugs, biologics, and medical devices in the health care sector. A former vice president of global clinical research and development at Dupont Merck Research Laboratories, Inc, he currently runs biopharmaceutical consulting company Zymo Consulting Group.

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Trump's Covid-19 vaccine timeline is missing key context about logistics of herd immunity - NBCNews.com

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Excerpt from:

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

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

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

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

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

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

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

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

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

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

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

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

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

But wide distribution?

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

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

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

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

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

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

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

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

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

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

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

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

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