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 11th.
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
I’m more concern about side effects of each vaccine than the price.
ReplyDelete