Shares of Novavax Inc. NVAX, -20.03% tumbled 22.9% in trading on Friday after the Food and Drug Administration published a report that detailed the agency’s assessment of the clinical data for the company’s COVID-19 vaccine candidate. There were at least four instances of myocarditis, a type of heart inflammation, in the clinical-trial participants. “If causally associated, the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorization use of mRNA COVID-19 vaccines,” the FDA said. No cases of myocarditis were reported in clinical trials for either of the approved mRNA vaccines, which were developed by Moderna Inc. MRNA, -2.16% and BioNTech SE [sbntx] and Pfizer Inc. PFE, +0.99%. The first reports about myocarditis came after the mRNA vaccines had already been authorized. The FDA report was released in advance of next Tuesday’s meeting of the Vaccines and Related Biological Products Advisory Committee. The two-shot vaccine has a 90% efficacy rate against mild to severe symptomatic COVID-19. Novavax’s stock is down 70.0% this year, while the broader S&P 500 SPX, -1.63% has declined 12.3%.
JARED BLIKRE: Welcome back. And we want to head straight to the YFi Interactive, where we are looking at the pharmaceutical industry today. And Novavax one of the worst performers on Wall Street, and that is after an FDA warning on its COVID vaccines. And you can see, year to date, down 68%. Yahoo Finance’s Anjalee Khemlani is here with the details. Anj.
ANJALEE KHEMLANI: That’s right, Jared. Of course, that coming as a result of the FDA out with their data analysis from Novavax’s data that they submitted for the emergency use filing for that meeting coming up on June 7th. The advisory committee to the FDA is going to be weighing all this information and deciding whether or not to recommend Novavax’s vaccine. We saw in that report today from the FDA saying, quote, “Multiple events of myocarditis/pericarditis were reported in temporal relationship to the Novavax vaccine.” And that is cause for raising concern for a causal relationship.
So that is looking at something that we knew we heard of after those mRNA vaccines. Moderna and Pfizer both had similar relationships associated. And that’s something that really made Novavax a fan favorite among those looking to find a less likely of having a side effect type vaccine. We had spoken to CEO Stanley Erck earlier on, and he had specifically said that this was supposed to be a safer vaccine. Here’s what he had to say.
STANLEY ERCK: We don’t have tens of millions of doses out there yet. And so you don’t have the opportunity to see what rare or infrequent events there are. We haven’t seen any or much, and our label will reflect that. But we have a very standard protein-based vaccine that has so far proven safe.
ANJALEE KHEMLANI: So, as you can hear, saying that it’s so far safe. We’ll see more in the broader population. But there are concerns that we will see more cases of that. Novavax in a statement saying, quote, “Based on our interpretation of all the clinical data, it is insufficient evidence to establish a causal relationship.” But they will continue to monitor those events.
And of course, we have to also keep an eye on the calendar because the CDC now, as we talk about vaccines, the CDC has now finally given a date for those kids under five vaccines. We know that the FDA advisory meeting is on June 15. And then a couple of days later on the 17th and 18th is when we’re getting to see the advisory committee for the CDC. So stay tuned.
SEANA SMITH: Yes, certainly, many of us, particularly me with kids under five years old, are very interested to see the outcome of that. But Anjalee, you mentioned the CDC. They were also out with news today, but this time, they were talking about monkeypox. Cases in the US more than doubling over the last week. Still, though, just at 20. So how worried should we be? And what is the CDC telling us now about the outbreak?
ANJALEE KHEMLANI: They are still saying that there is no reason for alarm necessarily. We do know now that there are 21 cases reported in 11 states. They have noted that the strain that they’re looking at is mostly from the West African clade, which is not the most severe, though it does, obviously, have some painful symptoms for those who are infected. We’ve still got FDA-approved vaccines available, more than enough supply, as well as approved treatments.
They are saying, though, that while it is mostly identified in men right now and especially males who have sex with males, we are noting that anyone can get monkeypox, so that’s something that you have to keep an eye on. But there is a lot of focus on making sure that there’s more communication about what to look for within the community and make sure that anyone who’s a healthcare staffer can really ensure that they’re scanning more for this so that we don’t miss any of those cases.
Meanwhile, we know that there are testing companies really racing to meet the demand, even though there isn’t necessarily a stress on the testing system, like we saw with COVID. But there is some concern that we might need some more testing available. Back to you.