With the onset of the COVID-19 pandemic came a race to develop a robust, effective, and safe vaccine; and a number of players entered the race led by mRNA-based vaccine products developed by BioNTech, which partnered with Pfizer and Moderna here in the United States. The two have been neck in neck in the race for supremacy. Pfizer did manage to finish the Emergency Use Authorization (EUA) race first (December, 2020), narrowly beating Moderna but by only a week. Both vaccines require two doses and presently, about 49 million Americans have been vaccinated with Pfizer’s BNT162b2 (Comirnaty) while about 40 million have been fully vaccinated with Moderna’s mRNA-1273. Given the pathogen is mutating with numerous variants, both companies are now developing booster shots and Pfizer’s CEO even acknowledged that a third dose is likely after 12 months, according to new reports. Both companies are now evaluating the use of the vaccines on children in randomized, controlled trials. While Pfizer, of course, is a much bigger company with far greater reach, more capital and resources, it’s possible that Moderna may outflank and pass their primary COVID-19 vaccine competitor assuming side effects remain minimal. But how would they do this?
TrialSite has reported that the BNT162b2 (Comirnaty) requires significantly colder temperatures for longer storage cycles. According to Pfizer, the vaccine must be stored in an ultra-cold freezer at temperatures between -80°C and -60°C (-112°F to -76°F) and can remain stored in this environment for up to 6 months. Pfizer has accumulated product data that supports some flexibility with shorter storage durations which were given the OK by the FDA.
Positioned for Winning the Race?
Some would argue Moderna’s investigational vaccine (again not formally approved with FDA yet) was designed to pass Pfizer from the beginning. For starters, it’s easier to transport and keep in storage—it can be kept in standard refrigerator temperatures, that is 35.6 degrees Fahrenheit to 46.4 degrees Fahrenheit for up to a month. Moreover, the product can be maintained in storage for up to seven months in a normal freezer. Pfizer’s product, again, requires more high maintenance.
Moderna Making Moves
Moderna recently announced a series of investments to increase global COVID-19 global supply, including a forecasted doubling of supply. They are now tinkering with lower-dose products in addition to the booster and child research. They are forecasting that they will boost supply in 2021 to between 800 million to 1 billion doses. Again, the Massachusetts-based biotech announced data supporting at least 3-month refrigeration (2-8°C) as stable formulation.
Safety & Move to Formal Approval
While the press doesn’t mention this much, TrialSite will. The public at some point will demand that the vaccine products be moved from EUA to formal registered status, implying some available liability. The safety record of the respective products will matter. These products have barely been tested for over a year and so TrialSite will continue to monitor the CDC’s adverse event database as well as scour the market for signals. We suggest just a couple high profile safety events could materially impact this market.
What’s the Competitive Outlook?
In the USA, the main competitors are Pfizer’s BNT162b2 (Comirnaty) and Moderna’s mRNA-1273. The U.S. CDC voted to resume vaccinations with the single dose Johnson & Johnson vaccine. While this has a lower efficacy rate, it’s only one dose and if safety incidents remain insignificant and, of course, the largest of pharmaceutical companies will secure some market share. Its not clear what’s in the future for the AstraZeneca vaccine in America while others are making their way through Phase 3 trials such as Novavax.
Worldwide, AstraZeneca’s vaccine is more competitive (cheaper, easier to transport) although they’ve struggled with safety issues (blood clotting) leading to delays in vaccination programs in some countries in Europe, Africa, etc. Denmark has elected to not use this vaccine moving forward. Meanwhile, Russia’s Sputnik V becomes utilized in ever more countries as do one of a handful of competing Chinese vaccines, although one particular maker is struggling with a potential challenge in Brazil.
Both Pfizer and Moderna seek to produce about 3 billion doses each next year, which, given each requires two doses, means 3 billion complete inoculations between the two of them. The world has about 7.8 billion people.