- Only two COVID-19 vaccines have a realistic chance of winning FDA emergency use authorization before the end of 2020.
- Supplies of vaccine doses and distribution capabilities will be very limited initially.
- With only priority groups receiving coronavirus vaccines at first, most Americans won't be vaccinated by year-end.
Americans are arguably more ready for 2020 to be over than any year in a very long time. It's no secret why: They're ready for the COVID-19 pandemic to be over.
Unfortunately, the pandemic is likely to carry on into next year. However, it's possible that the threat of COVID-19 could be reduced drastically before 2021 arrives, at least for some individuals.
Several companies are conducting late-stage testing of promising COVID-19 vaccines. It's possible that some Americans will be vaccinated before the end of 2020. What are your chances of getting a coronavirus vaccine by year-end?
Hurdle No. 1: Emergency use authorization
There are three major hurdles that must be jumped before you'll be able to receive a COVID-19 vaccine. The first -- and most critical -- is for at least one vaccine to win emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA).
Only two coronavirus vaccine candidates have a realistic shot at winning EUA before the end of the year. BNT162b2, the experimental vaccine developed by Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), probably has the best chance. If all goes well in late-stage testing, the two drugmakers think they'll be in a position to file for EUA for BNT162b2 by the third week of November.
Moderna's (NASDAQ:MRNA) mRNA-1273 is the other COVID-19 vaccine that potentially could win EUA before year-end. The biotech expects to have enough data to file for EUA for it by Nov. 25. This date assumes, though, that mRNA-1273 is found to be safe and effective in Moderna's late-stage clinical study.
How long will it take for the FDA to make a decision once each EUA has been requested? That's uncertain. The agency has indicated that it would have an advisory committee review submissions and make a recommendation about potential authorization. No meeting is on the calendar yet for the applicable advisory committee, but it seems likely the FDA could quickly pull the committee together for a virtual meeting.
The agency would then need to review the advisory committee's recommendation before making its EUA decision. The FDA could probably make all of this happen within a few weeks, which would potentially put EUA for BNT162b2 and/or mRNA-1273 in mid- to late December.
Hurdle No. 2: Distribution
The next problem is a race against the clock. It's one thing for a COVID-19 vaccine to win EUA, but actually distributing vaccine doses across the U.S. is another issue altogether.
Of course, there must be vaccine doses to distribute in the first place. Pfizer/BioNTech and Moderna have been cranking up production capacity for their respective COVID-19 vaccines. On Pfizer's Q3 conference call, CEO Albert Bourla said his company should be able to provide 30 million to 40 million doses of BNT162b2 by the end of this year. Moderna thinks it will have 20 million doses of mRNA-1273 available for U.S. distribution by year-end.
The U.S. government will be in charge of distributing the vaccines, at least initially. President Donald Trump has stated publicly that the military will be able to deliver 200,000 coronavirus vaccine doses per day.
Hurdle No. 3: Prioritization
Another hurdle affecting how quickly you'll be able to receive a COVID-19 vaccine is the prioritization being made by state and federal governments. High-risk healthcare workers and first responders are likely to be among the first to be vaccinated. Individuals with serious health risks would also be high on any list to receive a coronavirus vaccine.
Once there are enough COVID-19 vaccine doses available, prioritization won't be required. However, you can count on only the top-priority groups having even a chance of getting a vaccine before the end of the year.
You've probably figured out by now that your chances of getting a COVID-19 vaccine by the end of the year are pretty low. Even if BNT162b2 and mRNA-1273 win EUA quickly, both vaccines require the administration of two doses. This means that the combined 50 million to 60 million doses that Pfizer and Moderna anticipate will be available by year-end will fully vaccinate no more than 30 million Americans -- less than 10% of the population. Distribution bottlenecks could cause this number to be much lower.
Investors hoping to profit from coronavirus vaccines should have better odds of winning by the end of the year than the average American will have of receiving a vaccine by the same deadline. Pfizer's shares, for example, would almost certainly jump if it wins EUA for BNT162b2. However, the smaller biotech stocks -- BioNTech and Moderna -- would likely soar much higher than Pfizer would.
Over the longer term, though, everyone wins if safe and effective COVID-19 vaccines become widely available. But it's probably going to be well into 2021 before that can happen.