December will be a crucial month for both Moderna (NASDAQ:MRNA) and Pfizer (NYSE:PFE). These leaders in the coronavirus vaccine race have reached the final hurdle. Earlier this week, Moderna requested Emergency Use Authorization (EUA) for its coronavirus vaccine candidate. Pfizer and its partner BioNTech (NASDAQ:BNTX) made their request about ten days earlier.
In the meantime, nine other programs remain in phase 3 studies. So even if Moderna and Pfizer cross the finish line with EUAs in their hands, that doesn't mean the race is over. The U.S. Food and Drug Administration (FDA) may grant EUAs to other players in the coming months if their results are solid. Before that, a lot may happen, however. Let's take a look at what's next for the Moderna and Pfizer vaccine candidates.
A matter of days
Pfizer is the furthest ahead from a timeline perspective. But we're talking a matter of days. The FDA called a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the investigational vaccine. VRBPAC will meet on Dec. 17 to discuss Moderna's candidate. These meetings are an opportunity for the panel of experts to weigh in on the potential product. The FDA opens the meetings to the public, livestreaming them on the agency's social media channels.
The companies will present trial data to VRBPAC and answer any questions about the trials and the vaccine candidate. VRBPAC then will advise the FDA on whether the regulator should give the potential products a nod. But the FDA isn't obligated to follow. The agency's decision may come at any point after VRBPAC has provided an opinion.
So, if the FDA acts quickly in both cases, we could expect an EUA for Pfizer and Moderna this month -- and only a few days apart.
Let's assume the FDA authorizes both potential vaccines. Pfizer and Moderna have said they're ready to begin distribution. Pfizer may provide as many as 50 million doses globally by the end of the year. In the U.S., Pfizer will ship frozen product from distribution centers in Michigan and Wisconsin to vaccination sites. The company expects to deliver product to points of use within a day or two.
Moderna may produce as many as 20 million doses in the U.S. by year's end. The biotech is working with the Centers for Disease Control and Prevention, Operation Warp Speed, and vaccine distributor McKesson (NYSE:MCK).
A full quarter of revenue
This means that both Moderna and Pfizer may generate a full quarter of coronavirus vaccine revenue by the end of March. Meanwhile, the FDA and regulatory bodies in other countries will continue to review the companies' data for full product approval. An EUA offers the companies the opportunity to sell a product prior to full review, considering the urgent need for it. But the FDA could eventually revoke an EUA or decide not to grant the vaccine full approval. So, gaining approval will be a crucial step for both players.
Now, how do these upcoming milestones translate into share-price catalysts?
For Pfizer, I would expect a possible EUA and then an eventual approval to trigger gains. But vaccine sales figures aren't likely to offer much share movement. This big pharma has a full portfolio of commercialized products; investors will focus on total revenue rather than on sales of one product.
Moderna's shares have more to gain. A possible EUA and an eventual approval are sure to boost the stock. That's because Moderna doesn't yet have products on the market. Success in the coronavirus vaccine program could be its ticket to near-term revenue. And speaking of revenue, investors will keep an eye on the first quarter of vaccine sales. Those results also will offer the stock direction.
While it may look like the coronavirus vaccine excitement is almost over, it actually isn't. Full product approvals, revenue, and potential for market share gains (or losses) mean we'll all be talking about -- and maybe investing in -- vaccine makers for the foreseeable future.