The United States has struck a deal with a pharmaceutical company to buy 100 million doses of a potential COVID-19 vaccine candidate.  Under the agreement, the US government will pay $1.95 billion to the drug company Pfizer. But only if the vaccine proves to be effective. 

That’s a lot of money, nearly $2 billion dollars.  But here’s the good news, if this experimental vaccine is purchased, it won’t cost a dime for Americans to get vaccinated for COVID-19.  Now, we know that 100 million doses won’t cover the entire population of the United States.  So the agreement allows our government to buy an additional 500 million doses.  But as was mentioned, this all hinges on how successful the vaccine is. It not only has to prove that it’s effective, but it has to be approved or granted emergency use authorization by the FDA, the Food and Drug Administration.

So where are we at with this vaccine?  Is it showing promise?

Technically, there are 4 potential vaccine candidates under what’s called the “BNT162 mRNA-based vaccine program”.  Now Pfizer has partnered with a biotech company in Germany called BioNTech. And each of their vaccine candidates are in clinical studies.  But one in particular, called BNT162b1 is showing very encouraging results.  Early data shows it can produce neutralizing antibodies at low dose levels.  And the phase 1/2 study found that this vaccine was able to produce a T cell response.  If you remember when I talked about T cells on Monday, I called them “immune Jedi’s”.  Because just like Jedi’s in Star Wars, T cells can find, attack and destroy.  And that’s exactly what we want them to do in a vaccine, attack body cells that have been infected by the coronavirus.

Has a phase 3 trial begun yet?

A phase 3 trial has not yet started. But Pfizer and BioNTech have said that they’re on track to begin what they’re calling a Phase 2b/3 safety and efficacy trial later this month.  But first, they still need to decide which of the four vaccine candidates to move forward with, and at what dose.  It’s likely to be one of the companies two investigational vaccine candidates that recently received Fast Track designation from the U.S. Food and Drug Administration: BNT162b1 that I just talked about and BNT162b2.  The companies are just waiting on more data from their Phase 1/2 clinical trials.

Last question Doc, when do the companies think that the vaccine might be ready?

They hope to get a regulatory review this coming October.  If all goes well, their plan includes manufacturing up to 100 million doses by the end of this year.  With the goal of producing over 1.3 billion doses by the end of 2021.