Pfizer Will More than Double Its Vaccine Output: Vaccine Updates

[appalachiablue]

Daily Kos, Feb. 20, 2021.

One month into the Biden Administration and we are almost half way to getting the 100 million vaccinations the President promised for his first 100 days. Vaccinations have slowed considerable in the last week due to extreme winter weather, but 42.8 million Americans have received at least one dose, 13% of the US population (16.5% of those old enough to be eligible). Since the weather probably had little effect on production of the vaccine, we can look forward to making up for lost time in the coming weeks.

Meanwhile, there is mostly good news with Pfizer and Moderna expecting to increase their production and Johnson and Johnson expecting to get approval for its vaccine after a meeting of advisors to the FDA on February 26.

www.msn.com/...Pfizer's chief executive, Albert Bourla, announced that he expects to more than double the approximately 5 million doses per week that the company provides to the US government. Per Reuters, he made the comments when the president visited one of its biggest manufacturing facilities.

Pfizer is also looking at changing the requirements that its vaccine be kept at ultracold temperatures. This would facilitate its transportation and storage and reduce the likelihood of wastage.

www.yahoo.com/...The companies have submitted new temperature data to the U.S. Food and Drug Administration to support an update to the current label that would allow vaccine vials to be stored at -25 to -15 degrees Celsius (-13°F to 5°F) for a total of two weeks.

The current label requires the vaccine to be stored in an ultra-cold freezer at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), meaning it has to be shipped in specially designed containers.

And there is continuing strong evidence that even one shot of the vaccines work well against Covid-19 virus and the British variant. The evidence with the South African strain is less promising...

More,
https://www.dailykos.com/stories/2021/2/20/2017224/-Pfizer-Will-More-than-Double-Its-Vaccine-Output

[Pobeka]

1. This one dose thing is a whole lotta BS.

Let me tell you why:

The Pfizer trials *never* had a one dose test.
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They, and a number of virologists on an external panel determined based on experience with similar vaccines, and expertise about human immunological responses, that the best approach was a two dose regimen, spread about 21 days apart. The goal of the trials were to give the vaccine the best chance to build an immunological response. Because of the dire nature of the pandemic they had to go for the single best option.

So of the about 40,000 subjects in the trial, half got a placebo, and half got the two dose regimen.

Pfizer kept detailed records on every subject over time, so there is a period of 3 weeks where individuals are on a single dose.

If you examine the occurrence of COVID19 disease in the *single week before the second dose*, it does make it look like the single dose is nearly as effective as the two doses.

Problem is, the data to show a single dose is as effective as two doses even a month after the first dose *does not exist* -- because no such regimen was tested.

A couple of folks in Canada (Skowronski and De Serres), simply looked at that little one week interval, and noticed that the single dose was possibly doing quite well in the third week, with a huge caveat that know one knows if or how much the immune response for the single dose will fall after the third week. They got short letter (not even an official paper) published in the New England Journal of Medicine.

The "news" media saw this letter -- and started this huge story, not once mentioning the time interval of the 1 dose observation is only one week, or the caveat about anticipated drop in immune response of a single dose anticipated by the consensus of a number of experts in the field of virology and immune response.

Now, in Canada, I have already heard talk radio accusing Pfizer of wanting to doses just to increase profits, and they think there is "proof" one dose works.

It's going to create a ton of false hope, and ultimately confusion. It will create *immense*, unwarranted public pressure to move to one dose.

If news outlets all had actual science folks researching the science news, and who were willing to spend *just a few hours* researching this, the story would be quite different.
(on edit -- yahoo new actually printed the caveat I mentioned, good for them!, I have heard the story on CBS, NPR with no mention of the caveat)

p.s. I don't have actual links, but if you search for these documents you'll find the pertinent info:

1. The Pfizer protocol -- C4591001_Clinical_Protocol_Nov2020.pdf
2. The original Pfizer results submitted to the FDA - VRBPAC-12.10.20-Meeting-Briefing-Document-FDA.pdf
3. The Pfizer results submitted to the NEJM - nejmoa2034577.pdf
3. The Skowronski De Serres letter to the NEJM - nejmc2036242.pdf