Novavax (NVAX 1.27%) recently announced that it's changing the protocol for its pivotal late-stage study of COVID-19 vaccine candidate NVX-CoV2373. In this Motley Fool Live video recorded on May 12, 2021, Motley Fool contributors Keith Speights and Brian Orelli talk about what investors need to know about this protocol change.
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Keith Speights: Now, there was some other news from Novavax earlier this week as well. The company announced a change to the protocol for its prevent 19 Phase III study of its COVID-19 vaccine. It doesn't seem like there's anything earth-shattering here for investors with this change, but what's your take on the impact?
Brian Orelli: The original protocol called for an interim analysis after 144 COVID-19 cases, that's in the placebo and the vaccine group combined. You'll wait until there's 144 cases in both and then you look and see, are there more cases in the placebo group than in the vaccine group?
They set up a crossover so everyone could get the vaccine but they remain blinded to generate additional safety data. People who got the placebo will now get the vaccine and people who got the vaccine will now get the placebo and then they'll be able to gather more safety data that way. The new protocol is going to look at events up until that cross-over event, and the data is expected in the second quarter of this year, so before the end of June. Not too long from now.
Speights: As a Novavax shareholder yourself, was there anything about this protocol change that raises the flag at all?
Orelli: No. I think [laughs] this is almost the only way they can do it. I guess I was expecting at some point, they will just announce they had 144 events and be done with it. But I guess now, they figured the difference in time and they're going to delay the Emergency Use Authorization application, so why not gather more data? This allows them to gather more data than the 144 events labs however many events they have up until the point where they do the crossover.
Speights: In connection with their news about delaying the authorization filings, this actually makes a whole lot of sense then.