Listen Up

Wednesday, December 9, 2020

Not enough Pfizer vaccine doses? Blame the feds, not the company: reports | FiercePharma




Just as thousands of Brits were lining up to get Pfizer’s mRNA COVID-19 vaccine yesterday, a troubling question emerged in the U.S.: Did the United States government fail to lock in enough doses of the vaccine to ensure a broad and quick rollout here?

The short answer appears to be yes.   The long answer is no.  Health Train Express theorizes that this was no accident.  The Feds were hedging their bet on both Pfizer and Moderna. Even with a successful clinical trial, there are many variables that can go wrong.  Many months ago when the bidding process began there was uncertainty if either pharmaceutical company would deliver a successful vaccine or whether the FDA. would grant a EUA to one, or both companies. 



Not being able to read the actual contracts I am stepping out here with my thoughts.  The entire vaccine development process is complex and adding to it is the cryopreservation for the Pfizer candidate vaccine adds logistics.  The first question is will it store?  Other factors are what would happen if a cryo storage warehouse failed?  There would need to be multiple storage warehouses (ie backup) to prevent this from occurring.
 
Federal contracts are complex and have opt-out, waivers, and cost overruns as part of the contract. If it is anything like military contracts they are developed to mitigate losses by the government taxpayers and prevent insolvency on the part of the manufacturer.  In the past, we have all read about the pitfalls in developing experimental aircraft, and military weapons.

Is it really important that 100 million doses be delivered at the outset? What is the difference between 50 and 100 million doses?  That is an unknown metric. Another variable is we do not know if permanent immunity will occur or for how long.  Since the clinical trial was abbreviated to insure a safe vaccine, it was a relatively short clinical trial. The next 12 to 24 months will determine how and if immunity results.

The pandemic is far from over and another cycle will begin in 2021,  If the federal government had ordered 100 million doses and it turned out the immunity was poor, or short-lived a considerable amount of your taxpayer dollars would go down a biological waste dump.    

In addition to contracts with Pfizer/BioNet the U.S.A has contracts with Moderna.  Vaccines will be available from both sources.  

Ultimately there will be enough vaccines to go around the globe. 










Not enough Pfizer vaccine doses? Blame the feds, not the company: reports | FiercePharma

No comments: