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Happy Dance

Why we should be happy and doing a dance?  The Pfizer and Moderna vaccines were made with a completely new process and no one knew whether it would be successful.  Messenger RNA for a portion of the virus spike protein was created and after injection the mRNA entered muscle cells stimulating them to make antibodies.  Several months ago the FDA created stringent guidelines for the vaccine companies to follow.  The Phase 3 trials are randomized controlled trials and everyone except the Data and Monitoring Safety Board (DMSB) know which volunteers were vaccinated and which received placebo.  The number of volunteers who developed symptoms and needed to have a +Covid test were predetermined and 62 was established as the first time the DMSB (Scientists independent of the study) could look at the data.  By the time the DMSB received, analyzed the data, and met on Sunday, there were actually 94 symptomatic and Covid-19 +cases, more than 90% of them in the placebo group.  The only other parameter reported was safety - and only minor reactions to the injections were found.  Read Below

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The DMSB will next look at the data after there are 164 symptomatic and Covid-19 virus+ volunteers.  Then the trial will be unblinded and huge amounts of data will be studied.  A decision will then be made re: an application to the FDA for an Emergency Use Authorization.  Half of the volunteers need to be at least 2 months beyond their 2nd dose of vaccine.  And there must be at least 5 severe cases of Covid 19.  These are some of the requirements that the FDA established for all vaccine applications.

Some additional facts about this vaccine:

Pfizer and BioNTech, a German company, developed the vaccine.  The US did not contribute financially, (i.e it was not part of Operation Warp Speed). but the German Gov't did contribute millions.  The US has an agreement with Pfizer/BioNTech to purchase 100 million doses of the vaccine - that's it. If the efficacy and safety are as good after the 164th sick volunteer is counted, the placobo patients may be vaccinated, thereby ending the randomization.  Antibody production and T cell immunity still need to be assessed as part of the effectiveness assessment and the data from every 44,000 plus volunteer needs to reviewed  However the original vaccinated patients will be followed for a total of 24 months to assure there is no late vaccine side effect.  There will also a 4th Clinical trial - which is called "Post-Marketing" for everyone who subsequently received the vaccine.

Why should we do a happy dance?  It is exciting that the effectiveness is so high - proving the concept for an mRNA vaccine platform.  No one really knew whether this would work for either Moderna of Pfizer.  Secondly, the epidemiologists are predicting a Fall and Winter pandemic "from Hell" - i.e. the virus is already surging in the US, not rounding the corner.  High risk health care workers may be vaccinated before the end of 2020.  But everyone else will have to wait for manufacturing to ramp up.  Unfortunately this vaccine must be maintained frozen at -100 degrees F, and there must be national plan for distribution to accomplish that.

Comments

Now all of a sudden we hear that the Moderna vaccine does not need to be frozen at such a low temperature, just as the Pfizer vaccine is making news. I can’t help being skeptical.

You are a trustworthy source of information. A true public service. Thank you.

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