Moderna (NASDAQ:MRNA) beat Novavax (NASDAQ:NVAX) to market with a coronavirus vaccine. The U.S. Meals and Drug Administration (FDA) licensed Moderna’s candidate in December. Novavax expects to report U.S. section 3 trial knowledge within the coming weeks and full an Emergency Use Authorization (EUA) request this quarter.
However Novavax has a specific power that makes it stand out within the sea of coronavirus vaccine builders. The corporate has an investigational flu vaccine that’s solely a step away from commercialization. And Novavax ultimately goals to mix this candidate — NanoFlu — with its coronavirus vaccine candidate. Final week, although, Moderna’s CEO Stephane Bancel mentioned one thing which will jeopardize Novavax’s likelihood to shine.
The flu vaccine enterprise
Moderna final fall introduced plans to enter the flu vaccine enterprise. Then, early this 12 months, the biotech firm mentioned it will take a look at varied mixture flu vaccines. They’d doubtlessly embrace respiratory viruses such because the coronavirus, respiratory syncytial virus, and human metapneumovirus.
Now, Moderna’s intentions to pursue a mixed flu/coronavirus vaccine — and shortly — appear clear after a dialog Bancel had with CNBC.
“What we’re attempting to do at Moderna truly is to get a flu vaccine within the clinic this 12 months after which mix our flu vaccine to our Covid vaccine so that you solely must get one enhance at your native CVS retailer… yearly that might shield you to the variant of concern in opposition to Covid and the seasonal flu pressure,” Bancel advised CNBC.
Moderna plans to begin section 1 trials of flu vaccine candidates this 12 months.
Now, the questions are: How shortly can Moderna deliver a mixed product to market? And will it get there earlier than Novavax?
Up to now, Moderna’s timelines have been significantly quick because of the pressing want for a coronavirus vaccine. It introduced its vaccine to market in about 9 months. It began growth of a booster shot to focus on strains of concern in January. And it plans to launch the booster this fall, Bancel mentioned within the CNBC interview.
As soon as well being authorities declare the pandemic over, nonetheless, regulators could also be much less prone to provide EUAs. And timelines might lengthen. Meaning a mixed flu/coronavirus shot could also be just a few years away.
The following step
Novavax’s NanoFlu final 12 months met all main endpoints in a pivotal trial. The following step is a regulatory request. And, as I discussed earlier, Novavax’s coronavirus candidate additionally is almost prepared for a regulatory request if the upcoming trial report is constructive.
However the firm nonetheless should take a look at a mixed coronavirus/flu candidate in scientific trials. And it isn’t clear when which will occur. Novavax in October mentioned it was exploring the potential for a mixed vaccine. The corporate reiterated this plan in its earnings report final month.
Here is Novavax’s benefit: The corporate’s investigational flu and coronavirus vaccines are near commercialization. Moderna is just at the beginning of its flu vaccine journey.
However here is the Moderna benefit: Moderna’s mRNA expertise permits it to provide a vaccine candidate shortly. Researchers do not must undergo the normal time-consuming steps of rising virus and purifying viral proteins. As soon as researchers have a virus’ genetic code, they will produce a vaccine candidate inside just a few days. So, Moderna might quickly produce mixed flu/coronavirus vaccine candidates.
What does all of this imply for Novavax?
Moderna’s plan to work on a mixed vaccine might imply unhealthy information for Novavax — if Novavax lags too far behind. If Moderna enters the market first and stays the one one with a mixed vaccine for some time, it might set up itself as a pacesetter. And that might make it harder for Novavax to carve out market share later. So, it is vital for Novavax to maneuver ahead with a mixed flu/coronavirus vaccine candidate — and enter the market first or no less than shut behind Moderna.
In fact, it is nonetheless too early to foretell which firm might commercialize a mixed vaccine first. And here is some excellent news for each Moderna and Novavax. As we have seen with present coronavirus vaccinations, there’s room for a couple of participant available in the market. So even a late entry might result in income progress for each of those biotech corporations.
This text represents the opinion of the author, who might disagree with the “official” suggestion place of a Motley Idiot premium advisory service. We’re motley! Questioning an investing thesis — even one in all our personal — helps us all suppose critically about investing and make choices that assist us grow to be smarter, happier, and richer.