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This is big because it seems they have announced the results hurriedly before the trial concluded. Copy pasting a blog entry from https://raviopendiary.blogspot.com/2020/11/corona-daily-271-... Corona Daily 271: Pfizer Vaccine – Celebrate with Caution In an earlier chapter on the vaccine race, I wrote: God forbid Pfizer wins the race. God answered my fears. Yesterday, Pfizer announced with aplomb a 90% effective vaccine. Editors changed headlines, stock markets vaulted, people made new Christmas plans, respectable newspapers foresaw the end of the pandemic. The Pfizer vaccine needs to be stored at -80 C (-112 F) all the time. The ultracold logistics rule out most of Asia and Africa. In the best case, it is accessible to 2.5 billion people in 25 countries, mainly North America and Europe.
Dr Fauci called the results extraordinary, at the same time admitting he hadn’t seen the data yet. May the vaccine truly have extraordinary success, and spell the end of the pandemic.
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When such joyous news is announced, it is in bad taste to criticize or express concerns. The critic will be termed a spoilsport, a pessimist, a conspiracy theorist, or antivaxx activist. I am none of these. I am, however, puzzled by the way Pfizer has gone about the process. I would like to voice these concerns so as to tone down the hype, if it is hype.
As I wrote earlier, in the trials, the company must reach pre-agreed numbers of Covid-19 cases, in the vaccine and the placebo groups. Since the beginning, Pfizer has been aggressively demanding more interim points, and fewer cases. Their minimum point for seeking authorization was 32. (32 patients among 30000 participants). Anybody who has studied statistics would know the number doesn’t look significant. In fact, scientists not working for Pfizer raised this concern. This was summer time, and the curve was going down. The Pfizer scientists were worried about the time it may take to reach a higher figure. But they amended protocol to look at the data at 62 cases. Not only the numbers, Pfizer’s plan allowed the mildest cases to be counted.
Most other trials including Johnson & Johnson and Oxford, even the Chinese vaccine trial currently, were paused because of adverse events. This is when a participant develops a condition that may have been caused by the vaccine. The trial remains paused until the condition is investigated. Pfizer enlarged its sample size to 44,000 but didn’t face a single adverse event, which must be attributed to its luck.
On 26 October, Albert Bourla, Pfizer’s CEO said they didn’t have 32 covid cases yet. The interim data, when available, is reviewed by an independent board. Pfizer was once again lucky, the cases surged dramatically. On Sunday, 8 November, the independent board came, reviewed the data of 94 cases, and let the company management know the conclusion without sharing data.
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The trial is not over. It will be over once Pfizer reaches 164 cases. The right thing was to wait till the end of the trials, and then publish the data in a medical journal for peers to review. Once it is peer-reviewed, the results can be published worldwide. Instead of that, Pfizer opted to release unpublished, unreviewed half-baked data as news.
Not only that, the news was released consciously early on Monday morning before the US stock markets open. Stock markets are like dogs who will drool and jump at the sight of a dummy bone. When the markets opened, Pfizer shares leaped by 15%, its partner BioNTech’s by 24%, and the major indexes reached new records. Such outright corruption was glossed over in the euphoria of the 90% effective vaccine.
FDA now has stricter standards after botching hydroxychloroquine and plasma episodes. Scott Gottlieb, the previous FDA commissioner, is now on Pfizer’s board. That may help in the approval process.
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Though times are exceptional, and any vaccine may be better than no vaccine, knowledge of Pfizer’s maneuvers dilutes the joy of their 90% effective news.
Ravi |
I wonder if anyone will even notice though as it would require putting energy into criticizing anything other than the election