Which Covid-19 vaccine would you choose? Covid vaccines, let's look under the hood :)

 FOLLOW THE MONEY and other controversies about the Covid vaccine.

Behind the scenes in the Covid vaccine business!

When you read about vaccines and corona virus remember everything can be spun. When people don’t like the spin, its labeled one way and when it suits their purposes it is labeled differently. It is d particularly difficult as a lay person to cut through the spin to the facts.

But do you have questions about the new vaccines that are coming? Here are some to consider:

Where will the vaccine be made? Where is it made now? Where was the vaccine tested and on whom? Why does the FDA have a definite date for approval (December 10) when supposedly the data is still being evaluated? Is approval automatic? Is that why Pfizer is already flying in millions of vaccine on dry ice from Brussels? Who paid for what? Why did one company claim they did not get government funding? Who is confirming that the ‘not for profit’ vaccine really is the case? What is the cost of each vaccine, which costs the most which costs the least? Based on the information we have so far which is the best vaccine for my community? Why are people spinning information (you know the answer to that :). And on and on……………

I know it seems a little overwhelming and I will not attempt to answer all of them. If I did, this email would become so long no one would read it. I would however like to spark some curiosity, enough that you research some of the answers to your own satisfaction, well in advance of having a needle stuck in your arm.

There are many Covid-19 vaccines under development, over 30 have moved to clinical trial and are being tested on humans. Research and development of new vaccines can take on average 10 years under normal circumstances, although some have been developed faster as seen with some previous outbreaks such as SARS and Ebola. There is good reason why it takes so long to develop a new vaccine, basically they have to be safe and effective. It is clear that right now we cannot wait for business as usual and all eyes are on the scientists and their amazing contributions. Of course it makes sense to throw everything at them to build on their capacity to get a successful vaccine. And then once they get it to make sure those who need it get it as quickly as possible.

Although normal vaccine development takes years, lucky for us, researchers aren't starting from scratch to develop a COVID-19 vaccine. Past research on SARS and MERS vaccines identified potential approaches and so they were able to build on this research fairly quickly.

So let’s look at a few of the controversies surrounding the earliest corona vaccines. There are three so far: Pfizer/BioNtech (PF), Moderna and Oxford University/AstraZeneca (AZ).

Money

A friend of mine told me last night, she would take the Pfizer vaccine “because Pfizer didn’t take government funds ” to make the vaccine. Hmmm, yes and no! Pfizer got a $1.95 billion deal with the government’s Operation Warp Speed (the multiagency effort to rush a vaccine to market) to deliver 100 million doses of the vaccine. The arrangement is an advance-purchase agreement, meaning that the company won’t get paid until they deliver the vaccines. Pfizer did not accept federal funding to help develop or manufacture the vaccine, unlike the other two front-runners Moderna and AstraZeneca.

“Although it’s true that Pfizer and BioNTech had been working on a vaccine all year before the companies struck their deal with the U.S. government in July, a $1.95 billion deal is nevertheless a significant incentive to keep going. In fact, international health organizations have long used such market guarantees to encourage for-profit manufacturers to supply vaccines to the developing world”.

The other thing is that if you do not take money to ‘create’ the vaccine, in the free market you can set the price of your vaccine wherever you want it. Pfizer is talking about selling their vaccine starting at $20 per dose. Multiply that by however many millions you want and the distribution will be through the warp speed deal.

Oxford/AstraZeneca (AZ) said they would not make any profit from their vaccine until the pandemic is controlled. Sounds good, but Doctors Without Borders (MSF) are demanding that in writing, and that there be an oversight body to make sure this really happens. They want the vaccine to be free in the developing world as well as the US.

"MSF welcomes AstraZeneca's commitment to sell the vaccine at a 'no-profit' price during the pandemic, but the reality is that it's an empty promise unless we're able to substantiate these important claims with data," said Roz Scourse of medical group MSF, also known as Doctors Without Borders.

The money is also an issue with Moderna:

 Moderna now says it will charge $32 to $37 per dose for smaller volume sales agreements, the highest price yet announced for a potential vaccine. Public Citizen and Knowledge Ecology International (KEI) wrote to the federal government Friday, noting that Moderna has been ignoring public disclosure provisions in its vaccine development funding contract. Public Citizen also found the U.S. government may co-own the vaccine candidate with Moderna. 

“Moderna is taking taxpayers for a ride – and the Trump administration is doing nothing about it. Taxpayers are paying for 100% of Moderna’s COVID-19 vaccine development. All of it. Yet taxpayers may wind up paying tens of billions more to Moderna to buy our vaccine back, if it proves safe and effective.The so-called Moderna vaccine belongs in significant part to the people of the U.S. We paid for it. Federal scientists led the way. It ought to be the people’s vaccine, not a new taxpayer burden”                                                                                      

Statement by Peter Maybarduk Director, Public citizens access to medicines.

Price

Remember: The prices for the vaccines are moving targets, dependent upon the amount ordered.

All three vaccines require 2 doses, 28 days apart.

Moderna is talking about selling the vaccine for $25 to $37 per dose. Compared to the $20 for Pfizer, and Astrazeneca will cost $3 a dose and can be made very quickly and in bulk.

Johnson and Johnson is working on a vaccine that only requires one shot and is predicted to cost $10 per dose.

The vaccines

The AZ vaccine is different from the other two. It is made (via chimpanzees) from an adenovirus like the common cold virus. So we know it is very safe because this is the technology that has been used for decades for other vaccines. Pfizer and Moderna use recombinant RNA technology which is very new.

The Pfizer vaccine has a major problem. It must be stored at -70 degrees. There are very few facilities including hospitals that have the capability of storing something at this temperature. If the cold chain is broken along the transport route the efficacy of the vaccine cannot be guaranteed. For example, in my office, our vaccine suppliers know that on Fridays I may be in the Laurel office and they cannot ship vaccines to me after Wednesday. This is for regular vaccines that are stored in a simple refrigerator. If Fedex drops off a shipment with my neighbors on a Friday, we come in on Monday and return it to the distributors who understand it is their fault, pay for return shipping and ship us out another batch. This is routine for regular vaccines, how much more a vaccine that is supposed to be kept 3 times colder than your freezer. It’s a problem, even on dry ice, I think the logistics will be difficult.

Distributing Pfizer's vaccine to larger population centers is problematic, not just because of its temperature, but because the smallest amount you can order is 975 doses (usually its 100 doses or fewer) which cuts down the size of the facilities that will order it.

Statement of Peter Maybarduk, Director, Public Citizen’s

The efficacy of the vaccines and approval

On November 16, a week after Pfizer’s announcement, Moderna issued a preliminary data readout out of its COVID-19 vaccine, suggesting an efficacy rate of 94.5%. Unlike the PF vaccine, however, the Moderna vaccine is stable at 36 to 46 degrees F, about the temperature of a standard home or medical refrigerator, for up to 30 days and can be stored for up to six months at -4 degrees F. It is expected to go to the FDA for consideration for an EUA within days.

On November 23, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The analysis was from the trials in the UK and Brazil and demonstrated efficacy of up to 90%. The vaccine was effective at preventing COVID-19, with no hospitalizations or severe cases in people receiving it. The AstraZeneca vaccine can be stored, transported and handled at normal refrigerated conditions for at least six months and administered within existing healthcare settings.

But the devil is in the details: 28 days after the first shot immunity was 62% and after the second shot it went up to 70% but…. Wait, before you jump for a different vaccine: if the person got only half a dose as the first dose then the efficacy increased to 90% with the second shot! Go figure. No one knows why this is the case. The thought is that the half dose ‘primes the pump’ so to speak and then the body responds really well to the second shot. I am really pleased that AZ was honest enough to share this detail as opposed to just stating the “efficacy is up to 90%”. More transparency is always good. Two advantages of the half dose approach: The body has an opportunity to acclimatize and the cheapest vaccine becomes even cheaper because it only needs 1.5 dose to get 90% immunity.

Pfizer was the first to announce their vaccine and they have already applied to the FDA for Emergency Use Approval (EUA).

Pfizer said their vaccine was 90% effective but when Moderna came out the following week with their 94.5% figure, Pfizer changed its press release to 95%.

The FDA approval decision will be announced on December 10 and Pfizer is poised to start delivering vaccines on the 11^th.

Here’s the problem I have with that: How did the FDA come up with a fixed date? Usually they let you know when they are satisfied after scrutiny, then they deliver an approval. Scrutiny usually includes going back to the applicant with questions and sometimes requests for additional testing. You normally cannot predict how long that should take. I almost feel like it is a ‘done deal’. A rubber stamp if you will. Elements of the FDA have been suspect for quite a while now. I think they should always maintain professional decorum irrespective of political pressure. Is anyone else with me here? (please let me know).

Meanwhile: United Airlines Holdings Inc. on Friday began operating charter flights from Belgium to position doses of Pfizer Inc.’s Covid-19 vaccine for quick distribution if the shots are approved by regulators, according to people familiar with the matter. If PZ is incurring all that expense (the planes had to carry more dry ice than aviation rules usually allows) they must be pretty confident they will have approval. I understand they want to be first in line since the early bird usually catches the worm.

So currently there are 3 vaccines on the table. Do we know everything about them? The short answer is No. I may have made it more confusing so here’s a summary:

Pfizer/BioNtech Covid vaccine is a recombinant vaccine, efficacy 95%, will cost $20, EUA already requested from FDA, must be kept at minus 70 degrees centigrade (-94 degrees farenheit).

Moderna has a recombinant vaccine, efficacy 94.5%, will cost $32 to $37 can be kept at normal refrigeration temperature. Funded by the federal government. Poised to request EUA.

Oxford/AstraZeneca has a vaccine based on Adenovirus (like a cold virus), efficacy up to 90%, will cost $3, can be kept at normal refrigeration temperatures. Will apply for EUA possibly January 2021

All these three require 2 shots one month apart. Lastly there is another vaccine in the pipeline:

Johnson and Johnson, vaccine based on Adenovirus also. EUA date March or April 2021, normal refrigeration. Costs $10, needs only one shot.

Hopefully this information helps you to understand the ins and outs of the vaccine issues. Meanwhile watch this space

Love

Dr. Tuakli

Thanksgiving and gratitude in spite of the horror

 When I first came to this country I used to say "I don't celebrate Thanksgiving, its not a tradition I grew up with" and other ignorant statements.

I didn't see how this holiday, which is supposedly based on the kindness of the native Americans, related to me. So for a while it had as much significance to me as the UK 'Bank Holidays' basically, just a day off.

But over the years I have come to understand and appreciate the uniqueness of this American holiday.

I used to say to my American friends "well, you know in England Christmas is the biggest holiday, that's when we all get together". But it isn't the same. The exchange of gifts and all the shopping and the glitter, take front and center stage at Christmas.

Thanksgiving is a day when family and friends gather and share food and love. Nothing more, nothing less.

It is interesting that the whole world has taken on the concept of 'Black (read money) Friday' but not the essence of the day before. The day, when Americans of all stripes go any distance to be with their families and all their family members show up warts, family tension and all. 

It used to amaze me when I would hear on the TV how, 3 times more people travel in the US for Thanksgiving than Christmas. But now I understand it and its significance, it is truly the best holiday and worthy of celebration. Even if this year it has to be done by zoom.

This morning a patient touched me deeply when she thanked me for my emails and my work. It made me realize that I too should say thank you. This kind of encouragement keeps me churning these out.

I truly appreciate and am honored by all the trust and support I have received over the past 30 years.

I am deeply grateful that I have a loving and supportive husband. He always allows me to do what I feel I need to, for my patients (it's his birthday today :).

I am grateful to be alive when many of my colleagues and nearly 1.5 million people have died from Covid. People who had no idea that they would not be here this Thanksgiving.The depth of this plague is mind boggling but it is up to us to defeat it, hopefully sooner than later.

Enjoy the festive season and let's hope 2021 is better for the whole world. I will certainly try to do my part.

Love 

Dr. Tuakli

 

Do not be blindsided by the news of a Covid vaccine!

 Don’t get blindsided by the news on the vaccine. Here is the inconvenient truth!

In the last 24 hours in Maryland 26 people died and there were 2152 new cases. Bringing the number of dead in our state to 4201 and total cases 171,823. There are 1144 people in the hospital with covid-19 here in Md as you read this, what a huge change from July.

Over the past week, the country has been averaging 158,265 cases per day, an increase of 79 percent from the average two weeks earlier.

11.5 million cases and a quarter of a MILLION people dead nationwide.

These numbers sound like they come from a war zone in  a third world country but even then they would be shocking. If you can sit home and let these numbers sink in and still not be shocked then nothing will shake you.

If you do, in fact understand the gravity of this situation, are you sure you do not want to rethink your Thanksgiving plans? I suggest you do.

Even if you don’t catch covid-19, Thanksgiving is not the time you want to end up in the ER with hundreds of infected people who have it.

Plus the medical staff is now beyond the point of exhaustion. When you think YOU have 'covid fatigue' try putting yourself in the place of those who have been serving for these 9 months.

Now that the election is over and the news cycle is slowing down TV anchors are pouncing on the news put out by Moderna and Pfizer last week about having a vaccine that is over 90% effective.

 Last week Monday, Pfizer said their vaccine was 90% effective but then Moderna said this week theirs was 94.5% effective. So today Pfizer revised their figures and it suddenly became 95% effective. Maybe if we wait another week the number will be even higher.

But all jokes aside, we are in the midst of a pandemic like no other and the whole management of it has been a comedy of errors. The only thing you can rely on is your own social behavior. That is the only thing under your control.

The earliest you will see (or want to take) a vaccine is March and a lot can happen between then and now.

Taking solace in the idea that there is a vaccine on the horizon is, in my opinion, a fool’s paradise. You are not guaranteed to still be here when it is finally available to you!

Somehow people are getting a false sense of security because “there is a vaccine” even though it is not available.

Please reread the email I wrote on how vaccine trials are conducted and what kinds of vaccines there are. Do you realize that a vaccine may be 95% effective today and show no efficacy 2 months later?

I know I am a party pooper and that is by design. The parties must wait, as inconvenient as it sounds.

There is, however, a glimmer of hope. The home test that I wrote about 5 months ago has just been approved. This means that home testing and possibly weekly testing at home with testing of contacts may soon be possible. As I wrote in April, testing is in some ways more critical than the vaccine at getting the pandemic under control.

The last piece of good news is that we will have a new corona virus task force with dedicated individuals determined to save lives and create a workable solution.

I don’t suggest traveling for the holidays or having out of town visitors but if you are determined to be ‘special’ please look at the Hot Spot maps on line. They are truly illuminating.

Please be safe, be well. Be a good citizen.

Pray for the essential workers who are already extended beyond their limits.

New face products for winter dryness.

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We still have L-hydra for all over the body for people with very dry skin.

Remember to minimize the use of hot water on your face in the winter.

Yesterday we celebrated change, now we need to get back to work. 240,000 deaths in the US. 10 million cases.

 The United States could soon report more than 200,000 coronavirus cases per day as infections continue to surge across the country, according to CNN.

The US reported 100,000 new cases 7 days in a row last week, and that total will likely continue to increase.

"We are watching cases increase substantially in this country — far beyond, I think, what most people ever thought could happen," Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told CNN.

Osterholm and his team have created accurate forecasts for COVID-19 cases throughout the pandemic. He was named to President-elect Joe Biden's Transition COVID-19 Advisory Board on Monday.

"It will not surprise me if, in the next weeks, we see over 200,000 new cases a day," he said.

On Monday, the national 7-day average of new cases was nearly 120,000, which is triple the average from mid-September.

The number of hospitalizations in the United States are up as well, according to The COVID Tracking Project. On Monday, 59,275 people were in hospitals for COVID-19, marking the country's highest total since July and slightly lower than the April 15 peak of 59,940.

Deaths are on the rise, too, CNN reported. Last week, more than 1000 COVID-19 deaths were reported for 5 days in a row, which hasn't happened since August.

"We're going to see, by far, the darkest days of this pandemic between now and next spring when the vaccine becomes available," Osterholm told CBS This Morning on Tuesday.

"We have a perfect storm coming together," he said. "We have pandemic fatigue...we have pandemic anger...we just are not taking this virus seriously."

WebMD Health News © 2020 

Cite this: Carolyn Crist. US Could Hit 200,000 Daily COVID-19 Cases Soon - Medscape - Nov 10, 2020.

This article should cause you to sit up and take notice. The number of cases are rising throughout the country again, including Maryland.

Current hospitalized cases in Maryland 761, in total we have had 156,709 cases. Our positivity rate is back up to 5.24% total death count 4084.

One of my biggest worries is that this is happening BEFORE Thanksgiving and the onset of the flu season. In a few weeks it could be way worse. Please do not allow “Covid fatigue” to let your guard down. It is not in your best interest and all it takes is being careless.

Maybe things will start to improve now but only if everyone plays their part. We haven’t even begun to turn the corner yet but maybe we can in January now that all the crazy rallies are over.

2 positive things: A new presidential task force (which includes people from my alma mater, yay!) and the imminent release of a vaccine.

Pfizer released their report yesterday that their new recombinant vaccine is 90% effective. Unfortunately there hasn’t been the usual time for ‘peer review’ because they said they would not have been able to keep it secret for the usual month it takes for that process. None-the-less the numbers still have to be examined and then cleared by the FDA. I worry that the media attention will pressurize the FDA to allow emergency clearance which will lead to distrust on the part of the public.

Anyway, as I have said many times, this is not when you need to be focusing on the vaccine. Focus on your life style choices which is something you have control over.

So “Happy Thanksgiving!” is in words only. I really don’t mean it literally.

If it makes you feel better, they plan on using the vaccine on us (medical workers) first. Whoopee!

A closer look at Joe Biden Jr's medical record

 For the record, let's take a closer look at Joe Biden Jr’s health status.

80 is the new 60 if you take care of yourself and Joe Biden is 77.

A review of the former vice president’s health record shows:

He has had his gall bladder removed along with several skin cancers.

He has seasonal allergies and acid reflux.

The biggest medical issue is that he has had atrial fibrillation which is controlled and he is on blood thinners.

He maintains a perfect weight 178 pounds for his 5 feet 11 inch height and exercises 5 days a week. His blood pressure is 128/84.

He takes his medicine and believes in science.

He is fit enough to be president.

I bring  this up because I believe he is not in denial like some others and as such he is probably healthier than they are. When you acknowledge your health issues and take care of them the sky is the limit.

With good anti-aging maintenance Mr. Biden will be fine. He has my vote!

We should all spend more time on our health and less time listening to misinformation. 

Why you may want to rethink your flu shot this year and the Anxiety epidemic

 The health community is on the look out for a “Twindemic” and reports are beginning to surface about patients who have tested positive for both the flu and Covid. There were reports last week as far apart as California and Tennessee. Obviously it is just a matter of time before Maryland reports as well, especially after Thanksgiving.

If we are lucky it will be a light flu season because the same measures that prevent Covid also prevent the flu. But if we are not it could be disastrous.

The most glaring difference between prevention of the two conditions is that there is a vaccine for the flu which is as specific as possible for this season’s flu.Sadly, we don't have one for Covid.

The commonest reason people tell me they won’t take the flu shot is because “I’ve never had the flu.” You’ve never had Covid either!

I would like to suggest that those who haven’t had their flu shot for this season yet, rethink that decision.

Symptoms of the flu can be like early symptoms of COVID-19, so people with these symptoms may require a COVID-19 test and then will have to stay home from work and isolate from the family until they get their results.

When you have influenza, which is a respiratory illness, in addition to COVID, which also impacts the respiratory tract, it only makes sense that you are going to have a serious respiratory component with shortness of breath and the potential for respiratory failure is very high.

Vaccination not only reduces the risk of catching the flu, it also reduces the chance that you will be hospitalized. In other words, the flu vaccine will provide some protection and reduce your chances of needing a ventilator if you do get sick with Covid.

A word to the wise, rethink the flu shot and get it as soon as possible.

There is another epidemic going on that is not much talked about and that is Anxiety. The whole nation is gripped by anxiety and many are embarrassed to admit it. Please if you feel it is affecting your quality of life, reach out and seek help. I am here to help you.

For those of you who like the outdoors remember to get out there now, winter is coming. There are still lots of places you can go and still have social distancing.

I was in Rehoboth today, the beach is amazingly clean and there was almost no one out there. https://youtu.be/gWNJP5e6Wkg

Get creative, there are so many outside places you can go before it gets too cold.