Pfizer/BioNTech Announce New SARS-CoV-2 Injection

This was originally sent in January 25, 2022. Time flies, and people dies, eh?! :O(

[Note from Hedley: I’m busy putting the finishing touches to my next book for Wiley, of Hoboken, NJ. The title will be ‘Transforming the Pharmaceutical Supply Chain.’ To make up some time, I have been and will continue to recycle posts from the paid archives. This one is a belter!]

Pfizer/BioNTech Announcement

An article in Fierce Biotech, January 25 2022, titled Pfizer, BioNTech launch trial for potential omicron-busting vaccine, announced that Pfizer and BioNTech are launching a new clinical trial to test a potential omicron-busting COVID-19 vaccine.

The press release, Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age is shown here.

Important Safety Information

Included in the press release is some very helpful information:

Individuals should NOT get the vaccine if they:

• had a severe allergic reaction after a previous dose of this vaccine

• had a severe allergic reaction to any ingredient of this vaccine

Individuals should tell the vaccination provider about all of their medical conditions, including if they:

• have any allergies

• have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart) (Note from Hedley: they knew about it even then).

• have a fever

• have a bleeding disorder or are on a blood thinner

• are immunocompromised or are on a medicine that affects the immune system

• are pregnant, plan to become pregnant, or are breastfeeding

• have received another COVID-19 vaccine

• have ever fainted in association with an injection

The entire document is well worth a read.

What jumped out at me instantly is the warning that you should not get the jab if you have “had a severe allergic reaction to any ingredient of this vaccine”

How would anyone know what all the ingredients are?

It’s the Supply Chain that worries me, though

Not being medically qualified, I must leave it to others to comment on the trial itself.

The thing I am qualified to speak about though, is supply chain matters.

This will be a completely new product, with an active ingredient (drug substance) that will have to be made from scratch. Then it has to be shipped to another company to do the fill/finish operation, where the drug substance is filled into vials, bungs inserted and seals applied.

Then to another company to be frozen down to -70°C in trays of 195 units per tray, and packed into a bulk container filled with dry ice to keep it at that temperature.

Extensive safety testing must be carried out on the Product once it is completed.

Is there a magic wand we don’t know about?

The only explanation I can think of to explain this monumental ambition, is that the companies have a magic wand we don’t know about, as the press release goes on to say:

The companies have previously announced that they expect to produce four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022, and this capacity is not expected to change if an adapted vaccine is required.