In the science shot heard ‘round the world, Pfizer and BioNTech announced Monday that their vaccine candidate (aka “BNT162b2”) appears to be more than 90% effective in preventing SARS-CoV-2 among those without evidence of prior infection. And since that news broke on the same day that the number of confirmed U.S. cases of COVID-19 crossed yet another grim threshold — 10 million infected — it couldn’t have come at a better time.

While there are still many potential challenges in rolling out this solution (starting with a required storage temp of -94⁰ Fahrenheit), this is still a big, big deal. Especially when you stop to consider that the companies report they can have up to 50 million doses (of the required two-dose schedule) ready by year’s end, and more than a billion ready for distribution throughout 2021. 

For those of us in the antibody discovery world who have “protein” on the mind from dawn ‘til dusk, it’s an especially interesting development: If approved, BNT162b2 would be the first mRNA-based vaccine approved for use in the U.S.  

Plenty of researchers see great promise in the potential of mRNA-based medicines and vaccines (to date, no mRNA-based vaccine has been brought to market). Figuring out how to turn our cells into mini drug assembly lines, though, isn’t trivial work. That’s why it’s a speciality research interest that’s still largely in its infancy: The first therapeutic that works by intercepting mRNA (Alnylam Pharmaceuticals’ Onpattro) was just approved in 2018. 

Here at Antibody Solutions, we’ve leveraged the benefits of modifying that code for the “software of life” for more than a decade with impressive results. Put simply, in close collaboration with our clients, we’ve found genetic immunization techniques to be an indispensable tool in designing strategies for specific targets, including multi-pass transmembrane proteins and heteromeric complex targets such as CD3.  

In addition, the effectiveness of the Pfizer-BioNTech vaccine suggests strongly that the spike protein on the virus is, in fact, an effective target. As Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, put it, “There was always a discussion: Is the spike protein the right target? Well, now we know it’s the right target. So, it’s not only immediate good news, it really is optimistic about what’s going to roll out in the next several months with the other vaccines.” 

As encouraging as the preliminary data on BNT162b2 are, however, there remain several questions about the vaccine that must be answered before we can speed ahead to solve this global crisis. Some examples:

• What types of symptoms did those in the non-effective group show? 
• Do we know if the vaccine blocked mainly mild cases, or is there evidence that it also may have prevented some severe infections?
• How will the vaccine be tolerated among larger and more diverse populations? 
• How will this affect the discovery efforts for therapeutic treatments to COVID-19? 
• And at what point would the vaccine be considered safe to test in pediatric patients (some physicians have already posed this question to the FDA, noting that the pattern of COVID-19 infection is different in children versus adults)? 
• While Pfizer is working to improve the stability of the cold chain requirements for BNT162b2 to at least 2 C to 8 C degrees (the standard refrigerator temperature), it currently needs to be shipped and stored at -70 C, thus limiting the ease of distribution; how quickly can this issue be addressed to facilitate immunization around the world if the vaccine is approved? 

Still, if we’ve come to the point where those are the most pressing issues, we’ve made incredible progress, indeed. We congratulate our scientific peers on the Pfizer and BioNTech team for their swift progress on a SARS-CoV-2 vaccine candidate, a clear testament to their tirelessness in tackling a pandemic like none other in the past century. 

Meanwhile, we hope this highly visible demonstration of mRNA’s potential value will spark additional research around it. If you’d like to explore together how it can be put to work in helping you develop innovative, efficacious vaccines and therapeutics, please just reach out to me.