The state of the vaccines

This is Pfizer's press release reporting on the full data of their phase 3 trial. Do know that this is not the scientific paper that will follow but it does talk about the endpoints and the results.

https://www.pfizer.com/news/press-r...ntech-conclude-phase-3-study-covid-19-vaccine

There was one severe case of Covid-19 in a vaccinated person, and 9 in non-vaccinated controls.

That is slightly worse than Moderna's result; with their product, nobody had severe cases. It's hard to conclude based on one case (maybe it was a person with very poor immunity who would have had severe disease even if he/she had received the Moderna product instead of the Pfizer one).

 

Without specifying numbers for individual vaccines, China announced late yesterday that their Emergency Use Program has reached one million recipients of their various coronavirus vaccines (this report mentions two from Sinopharm and one from SinoVac; previous reports had mentioned CanSino too).

According to this report, no person among the 1,000,000 recipients developed serious adverse events, and no person contracted Covid-19.

It is hard to trust the Chinese in these reports... but I'm mentioning it here since it was issued, in the spirit of completeness.

 

Pfizer has applied today for FDA Emergency Use Authorization of their Covid-19 vaccine BNT162b2. The FDA has scheduled the meeting of the external and independent Vaccines and Related Biological Products Advisory Committee for December 10, and a favorable advice from the Committee is possible at the end of the meeting. [You may be asking, why wait that long? Well, the committee members will have to scrutinize Pfizer's data in advance of the meeting].

After that, there are two more steps. The FDA itself will need to analyze the data and agree with the Advisory Committee, granting the EUA. Then, the CDC's Advisory Committee on Immunization Practices will have to meet (they plan to do so within 24 to 48 hours of the FDA authorization) to recommend the vaccine and decide if there are any subsets of the population that should be excluded from the vaccine (such as children below a certain age, given that just a few children - 100, ages 12 to 15 - were included in Pfizer's phase 3). Only after the CDC recommends the vaccine, Americans can get it.

Pfizer said they can start distribution immediately, 24 hours after the final approvals are in.

Is it possible that the first doses will be given in December? Certainly. But I'll count on it more strongly, in early January.

The Pfizer vaccine needs two doses, 21 days apart. Protection kicks in 28 days after the first dose.

Say, someone gets the first dose on Tuesday January 5th, and the second on January 26th. The person would be protected starting on February 2nd, that is, Groundhog Day...

Gee, if I do catch the first wave of vaccines (and chances are that I will - it was announced yesterday by the CEO of my hospital that we are included in the first wave and it will be given first to direct care workers which is my case and my wife's) and by February 2nd we're immune, I'll certainly immediately ask for vacations and engage in some travel, go see my children, go to restaurants... paradise. I can't wait.

 

I would be very happy for you and your wife if get the vaccine and the immunization first and can do your jobs with less fear and start to live free again.

One more thing. The Pfizer cool box a a GPS, which will transmit its temps constantly to some satellite outfit.
The temps will be consistently controlled.
In Germany they are preparing vaccination centers for the bioNtech/Pfizer vaccine, indoor sports arenas, conference centers and so on.
I think that will be the model for the US, which Pfizer will follow. Its the only way that makes sense, with this vaccine, for mass vaccinations.

A interesting side story, my neighbor works for a company which produces gigantic amounts of CO2 in the county. Its for oil production.
CO2 is short in supply for dry ice, for the production of dry ice, it is a side product from bio fuels.
Because the demand for biofuels is down, diesel for example, less CO2 for dry ice.
Demand for oil is down, overproduction on CO2 for oil wells.

There will quiet a few profiteers.

A nother interesting thing. The glass containers, -70 C. Needs a rather special glass, going from -70 to room temp without cracking.
The companies who have the recipe and can produce in the billions, they have a license to print money, too.
Even if other vaccines may have normal storage temps, the glass, or plastic containers have to be produced, besides the run of the mill production.
We are talking several billion extra, for several years.
I run a business, small, in the end its all about money, loans, investments, sales figures, wages, cost and so on.
If you do that for over 30 years, that's how your brain works.
The amounts of money this pandemic will generate for certain branches will be just beyond believe, never seen before.

Good for them

 

Thanks.
Yes, interesting post. I heard of the GPS thing with Pfizer's special dry ice container. Cool! (Pun intended).

Yes, given the logistics of the deep cold chain, we need large immunization centers to make good use of the shipped vaccines so that they don't spoil or go unused by passing the "good by" date. If I'm not mistaken, once Pfizer's special box is open, if you're not equipped with a deep cold freezer (they cost $22,000 each), then you can keep the temperature for chunks of five days, three times, with replenishing dry ice in pellets every five days. And once you gently swirl (don't shake!) the multi-dose vials and start vaccination people, they have to be used within 6 hours. So lots of planning needs to be given to this, so that the already initially scarce vaccines don't go unused or spoiled.

Yes, it's really big business. And cool, I'm for capitalism, and I'm for these businesses running a profit. Honest good work is to be rewarded.

Yes, a company like our Corning will make a killing with their high quality vaccine glass vials. They are part of the Warp Speed, to come up with vials. They are a great company (I know them well and have visited them; among other things, they invented Pyrex, and they made the faceplates for the Apollo spacesuits for the moon landing).

Yes, shortage of dry ice will be a problem. Certain municipalities are being encouraged to invest in dry ice makers.

Anyway, I'm excited for the Pfizer/BioNTech vaccine, but I'll feel relieved once another vaccine that doesn't require -70C gets to the market. Moderna is coming. Only -20C.

Another possible winner is the Johnson and Johnson. Two advantages: refrigerator temps, no need for freezers. One dose, no need to come back for a second dose. But they are behind in their phase 3. They expect to only be able to get through everything, around April.

 

Now there's a shortage of CO2?
2020 just gets weirder and weirder.

 

Cutting edge technology has always fascinated me and Covid just threw one more twist to it. Being a business owner, I also look at the money side and it just blows your mind away, what certain branches will make.
This will be the largest money making event since WW2, for years to come.

 

Yes, because as of now dry ice production depends on the CO2 released by bio fuels production, which supplements diesel and gas fuels.
Fuel demands are down, les production, less CO2, when it is probably needed the most.
2020 can not get wilder, don't hold your breath, it ain't over jet

 

Yes you all know, Oxford/AstraZeneca has released their results and they have the weird fact that the smaller dose regimen yielded the best result. Half-dose followed by full dose, 90% efficacy. Two full doses, 62.something efficacy. Anyway. It shouldn't matter, the company will simply recommend the half-dose + full dose as the way to go. So we have 3 vaccines that achieved 90% efficacy or better. For those dismayed that Oxford/AstraZeneca has lower efficacy than Pfizer/BioNTech and Moderna, do realize that nobody that received it needed hospitalization or had a severe case, even those who did get infected. So it doesn't protect against the infection as well as the two others but it does protect against serious disease. And it is cheaper ($2.5) and doesn't require freezers; just refrigerator temperatures. So yes, it is another great tool.

The Brazilians have notified their DSMB that they have enough infections now to analyze CoronaVac's phase 3 trial, so soon we'll have the results for a fourth vaccine. If it comes back a bit lowish than the two mRNA vaccines that achieved 94.5% and 95%, it will suggest what we're suspecting already: that the mRNA platform is simply better. This is exciting as it opens the doors to many future vaccines, e.g. for cancer. Also, mRNA vaccines are easier to adjust in case of viral mutation. This is a great scientific breakthrough that is really worth highlighting. We didn't have mRNA vaccines for human use before, now we do, and they are great. Huge leap ahead in the matter of vaccines.

 

More efficacy data released for the Sputinik V today, by the maker. No peer-reviewed publication yet. I'm definitely not sure if I can trust the Russians (probably can't) but for what it's worth, here is what they are saying:
After one dose, efficacy sits at 91.4%. After the second dose, it improves to 95%.
It is curious that they went for the same number of the Moderna and Pfizer vaccines. It's like the news that vaccines were getting 94.5% to 95% efficacy prompted this Russian announcement that theirs too achieves 95%.
Anyway, hopefully it is not just politics and propaganda.
The Russian shot is projected to cost $10 per shot (a person needs two, 21 days apart, so, $20).

 

Moderna will apply for Emergency Use Authorization by November 30th. The FDA Advisory committee, meeting on December 10 to consider Pfizer's, will meet on December 17 to consider Moderna's.

 

Light at the end of tunnel, very good news.
There is no date set by EMA, but the expectation is middle of December.

 

Great. Thanks for the European update. I don't follow things as closely across the pond, so it's good to have you here to add the European side.

 

Ema is doing what they call revolving approval. BioNtech submitted its first paperwork 4 or 5 weeks ago, with the results of 1 and 2 and preliminary results of 3, when ever they got new results from 3 they admitted them. That is greatly speeding up the process, not only the science review but also the bureaucratic process.
In Germany they are going full steam ahead with their vaccination preparation.
Indoor arenas, conference center etc. are getting set up as vaccination centers, including the deep freeze storage infrastructure, distribution and what so ever.
Because of Christmas and New Year they expect, a time period were Germany normally closes down, big time vacation time, Christmas is a 3 day holiday, than just 3-4 day till New Year, 1 of Jan Holliday, They expect to start with large scale vaccinations in January. Naturally the first responder and Hospital will start immediately, 1 day after approval. They will have the vaccine from bioNtech already at the hospitals by than.

But lets not get to over exited, it takes 4 weeks to reach immunization and till production is on the top of its game a few month.

 

Oh, forgot a question
Will the first shot have already a influence on the disease, make it less harsh, serious.
Second shot, 1 week till immunization is complete, what happens if you catch the virus in that time period.

 

Yes, plans here are proceeding similarly. Healthcare and first responders first, then vulnerable patients and other essential jobs, than other adults, then teenagers/young adults. They say the first doses for healthcare personnel may be available one day after approval, that is, on December 11th or 12th. I'm still worried about the deed cold chain, but we'll see.

 

The data I saw talks about full immunity developing 4 weeks after the FIRST shot, not the second one. The second one is a booster. It's hard to very precisely respond to your question... I guess it varies according to a person's robust immune system or not. Because 4 weeks is an average; some people might develop antibodies a bit sooner, others a bit later.
Now, if you catch the disease between weeks 3 and 4, chances are that your disease will be milder, indeed.

 

There is a neat feature to the cooling containers, they get monitored by GPS, real time, when ever the temp gets critical a alarm gets of.

I am very cautious about when I can get a shot, I am a Senior and a essential worker. The production goal for Pfizer and bioNtech is 50 million by the end of the year, they hope 100 millions, which than get split up between the countries which have contracts, according to the contract numbers. Right now it looks like the US gets 10-20 million doses in 2020.
It will be interesting how they classify essential worker and than how you identify yourself as such.

The EU will be interesting, how will they distribute the shot through out their 27 member countries, naturally a good question for the US.
How many go to CO, or Germany, or Florida or France, hot spots first, or by population.

I have not read anything about that, US or EU.

 

I don't expect a lot of clarity and efficient distribution plan in the US because the incompetent Trump administration is still in charge.

 

Vaccine side effects: Yes, they are well-described in the Phase 1 and 2 trials that have been published, and will be too when the phase 3 trials make it into Lancet.

Yes, we need to warn everybody of them, otherwise people won't come back for the second dose of the vaccine. Yes, headaches, fatigue, flu-like symptoms, fever, nausea, muscle aches and joint pain have all been described, extensively, with these mRNA vaccines.

BUT and do trust me on this: they are benign and go away with no consequences. The mRNA washes out of the body in hours. These vaccines are proving to be quite harmless and quite effective. A couple of lousy days is a very minor price to pay versus contracting this EXTREMELY dangerous virus.

But yes, I'm afraid of the field day the conspiracy theorists and anti-vaxxers will have, when people start complaining of the side effects. This in itself can defeat the opportunity for herd immunity, and the medical community has already started to advise patients that the side effects are expected, normal, and should not be panic-inducing. I hope that patients and the public will believe us. The way misinformation is rampant, I'm not optimistic. It's an uphill battle. But the virus is bad enough now, COMPLETELY out of control, with hospitals close to filling up to capacity (which then will result in a VERY SHARP increase in death toll, which will probably happen before the vaccines roll in (due to Mother Of All Superspreaders a.k.a. Thanksgiving travel), that maybe this will scare enough people into taking the vaccine. I hope so, because we need to vaccinate 70% of the adult population to stop this thing.

 

What is going on with AstraZeneca? They are being blamed for NOT disclosing in the press release that the half-dose regimen was started in error. And also, the scientific community is unhappy with the fact that only 2,741 participants took the half-dose regimen and all of them were younger than 55, so this 90% efficacy is not as reliable. The company did not disclose any of this in their press-release, which was seen as lack of transparency.

Pfizer and Moderna, by contrast, did disclose their full set of Phase 3 data and were seen as much more transparent.

Shares of AstraZeneca fell 6% after the international scientific community expressed doubts about their data.

This is likely to delay approval of the Oxford/AstraZeneca vaccine, although even not considering the half-dose regimen, the full dose, with more participants, still achieved 62% efficacy which is more than the 50% needed for approval. But what may delay it, is that now the company seems uncertain about what dose regimen to pick, and they are talking about testing more people with the half-dose regimen, which of course will take a lot longer to finish up.

I think Oxford/AstraZeneca will definitely lose the race to Moderna/NIH and Pfizer/BioNTech.

 

Sounds sloppy to me.

 

They are starting a new test line with the half dose and full dose, that will delay approval for quiet some time.

 

Yes, it will.

 

Moderna filed with the EMA on Monday and bioNtech today, Thursday, for emergency approval.
It is expect that by December 28 both will be approved and vaccination could start in Hospitals December 29th.
The German Health Minister Spahr said upon approval, they would start vaccinating, even during the New Years Holidays and week end.
BioNtech has been stock piling for weeks and has its new factory in Marburg/Hessen/Germany about ready to get in full production.
The Governor of the most popules State in Germany Nordrein Westfahlen, NRW, is getting sports arenas ready, for mass vaccination.
He had a big show at one of them today.

I have not seen or heard about anything like that in my county. I watch Tuesday, which is my office day the county commissioner meeting online.
They are not talking about it or prepare for it. This is a massive effort for our local health providers. In 10 days we may have a vaccine approved, which needs some very special handling and nobody, maybe the Hospital, is doing anything. Not even talking about it.

It is very frustrating to watch that.