Many Americans have tossed their facemasks aside. They're seeing friends and family. They're eating out once again. Life has returned to normal, at least for the most part.

Unfortunately, it's a much different story in other parts of the world. The key difference is the availability of vaccines. In the U.S., 88 COVID-19 vaccine doses have been administered for every 100 people. In India, the number is only 15 doses per 100 people. 

The U.S. government secured major supply deals with leading vaccine makers, notably Moderna (MRNA 3.06%) and Pfizer (PFE 0.11%). These companies made billions of dollars, but the U.S. has seemingly turned the corner in the fight against COVID-19 thanks to their vaccines.

However, things could be about to change. An ominous warning from Moderna could shake up the COVID-19 vaccine market.

Person looking a a computer image of coronavirus with a city street in the background.

Image source: Getty Images.

New COVID-19 waves are coming

Last week, Moderna held its fourth annual Science Day. In this virtual event for investors, the company laid out its research and development plans. But the biotech's top scientists also sounded an alarm reminiscent of Paul Revere's famous call that the British were coming. In this case, though, Moderna's warning was that new COVID-19 waves are coming.

Moderna chief scientific officer Melissa Moore stated, "As the virus spreads, it is rapidly mutating." She added, "Some of these new viral strains appear to be even more transmissible than the original strain."

The good news is that vaccines from Moderna and Pfizer, in particular, have been highly effective so far. The bad news is, in Moore's words, "We already know that some of these new strains are less susceptible to neutralization by our current vaccine."

Moderna's researchers have found lower neutralizing antibody levels against several key coronavirus variants to be of concern, which suggests a risk of reduced duration of protection against infection. Because some of these variants are more transmissible, Moderna thinks that "new epidemic waves are undoubtedly on the way."

Vaccine market implications

What does all of this mean for Americans and for the COVID-19 vaccine market? The bottom line is that booster shots and new vaccines targeting the variants will likely be needed.

Dr. Anthony Fauci, chief medical advisor to President Biden and longtime head of the National Institute of Allergy and Infectious Diseases, thinks that we won't know for sure if booster doses are needed until the fall. Moderna's research appears to indicate that it's not a question of if but when booster shots will be required.

The emergence of potent new variants could alter the dynamics in the COVID-19 vaccine market. Companies that have focused all of their efforts on developing vaccines targeting the original coronavirus strain could be left behind if they don't quickly pivot to developing variant-specific vaccines.

There are two primary challenges at play for vaccine makers. First, the rapid coronavirus mutations mean that drugmakers must have a technological approach that lends itself to quickly developing variant-specific vaccine candidates. Second, companies will need the financial resources not only to develop these new vaccines but also to conduct clinical studies.

Most likely to succeed

Smaller biotechs that don't have large cash stockpiles or supply deals already in place for their COVID-19 vaccines could be at a serious disadvantage in the fast-moving market. Larger pharmaceutical companies that have experienced setbacks with their vaccine rollouts could also find it difficult to keep up.

Arguably the most likely to succeed in the variant-focused COVID-19 vaccine market are the drugmakers that have already been the most successful: Moderna and Pfizer (along with its partner BioNTech (BNTX 2.23%)). Why? Perhaps most important, their messenger RNA technology allows these companies to rapidly develop variant-specific vaccines. Moderna and Pfizer are already in testing with their respective variant-specific candidates.

But has the rise of the coronavirus variants already been priced into these stocks? You might think that's the case for Moderna and BioNTech. The biotech stocks have soared nearly 80% and more than 150% year to date, respectively. Pfizer's shares, though, are up only 5% this year.

However, all three of these stocks trade at low forward-earnings multiples. If the coronavirus continues to mutate and force the need for new variant-specific vaccines to keep the pandemic at bay, Moderna, Pfizer, and BioNTech could have plenty of room to run.