By Yong-Bee Lim
The National Academies of Sciences, Engineering, and Medicine (NASEM) released a report titled Biodefense in the Age of Synthetic Biology in 2018. Beyond focusing on pathogens and biochemicals, this report discussed how nefarious actors may use technical advances in delivering genetic information like messenger RNA (mRNA) to generate a new class of biological weapons: weapons that modify human cell protein expression. In the case of weaponizing mRNA, the report concluded that there are significant challenges “to determining the right targets or edits, packaging the genetic cargo into viral vectors, and delivering it to appropriate host cells.”
mRNA has received a significant amount of attention in a different context over the past few weeks. In what felt like a break in the dark clouds of COVID-19 morbidity and mortality numbers, the world learned of two promising vaccine candidates in November 2020. The first was Pfizer’s and BioNTech’s joint-effort vaccine candidate BNT162b2 – an mRNA-based vaccine that appears to produce benefits in 9 out of 10 recipients. The second was Moderna’s vaccine candidate mRNA-1273 – another mRNA-based vaccine that appears to be even more effective than BNT162b2. As of this weekend, Pfizer’s vaccine is starting to get to frontline workers and others in the United States after the FDA granted Emergency Use Authorization on Friday, and the Moderna vaccine’s authorization appears imminent.
To date, no commercial vaccines have used mRNA as a vaccine platform. However, researchers and pharmaceutical companies have been interested in mRNA technologies for the past 30 years. mRNA manufacturing is a cell-free system that is easily scalable to production volume needs. mRNA production facilities also do not have the same limitations that conventional vaccine manufacturing facilities experience – these facilities should be capable of manufacturing many types of mRNA constructs with minimal changes in the formulation and production process. Finally, mRNA constructs elicit strong immune reactions – a desirable trait for a vaccine.
The fact that both vaccine candidates are mRNA-based speaks to the remarkable advances in biotechnology and the life sciences since even 2018. Moderna’s mRNA-based vaccine candidate is particularly interesting given both its high effectiveness and a current lack of any significant safety concerns. These characteristics suggest that this product has overcome several significant technical barriers: Moderna has produced a stable mRNA product that contains the proper edits to elicit a robust immune response, safely encapsulates the mRNA in a lipid nanoparticle capsule, and delivers the mRNA successfully into cells.
Unfortunately, the barriers that Moderna has overcome appear to be the same barriers that the 2018 NASEM report stated were in the way of mRNA bioweapons. Fortunately, capability alone does not automatically mean that an adversary can adapt and use this type of technology as a biological weapon. At a minimum, adversaries must also have the intent to research and produce this type of bioweapon, as well as have access to the necessary expertise, equipment, and materials.
What this mRNA case highlights is how quickly technological advances are happening. Risk assessments from even two years ago may require updating. What national security experts need to realize is that life moves pretty fast – if we do not stop and adapt to the swiftly-changing circumstances around us, we could miss critical opportunities to avert the emergence and use of novel bioweapons.