'Despite the wide availability of authorized or approved vaccines, the SARS-CoV-2 pandemic is not well controlled in the U.S. Novavax has said the shot, NVX-CoV2373, will play a role in driving vaccination among those who have been hesitant to get immunized and it has started an educational effort on vaccine choices. One patient in the trial reported myocarditis after receiving placebo. we believe there is insufficient evidence to establish a causal relationship,' the company said in a statement. 'Based on our interpretation of all the clinical data supporting NVX-CoV2373. Novavax, in response to the safety concerns flagged by the FDA, said natural background events of myocarditis can be expected in any sufficiently large database. The agency said it had requested Novavax to flag myocarditis and another kind of heart inflammation called pericarditis as an 'important identified risk' in its materials. Shares of the company fell nearly 14% after the FDA's analysis of data from the company's trial. 'These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID-19 vaccines,' FDA staff wrote in briefing documents released on Friday. įollow Yahoo Finance on Twitter, Facebook, Instagram, Flipboard, SmartNews, LinkedIn, YouTube. about what the total global COVID marketplace looks like into the future,' Trizzino said.įollow Anjalee on Twitter the latest financial and business news from Yahoo Finance. 'I think the investment community, as far as Novavax is concerned, wants to see what the rest of the year looks like. Trizzino said the difference is that now people are more complacent about the virus, and another surge - like the one experts are anxious about striking this winter - could trigger more vaccinations.

Pfizer's CEO had been similarly frustrated by the investment community's reaction to its vaccine even after record sales. Novavax isn't the first COVID vaccine company to see a split between regulatory news and stock movement. 'I think that the doubts are in overall kind of market size -What does the investment community think about the what the COVID market will be going forward? Will it continue to shrink aggressively? Will people get vaccinated? There's a variety of opinions about what the global Covid market will be,' he said. That's something Trizzino said the company is acutely aware of. It has been down from the highs of 2021, as firms like JPMorgan have expressed doubt about the company's future. Different rulesīy comparison, mRNA second boosters were required to be bivalent shots with against the BA.4/BA.5 Omicron subvariants, which were the dominant strains in the summer.ĭespite the news, the company's stock remained under pressure Wednesday. 'There's still significant opportunity there for those people that want to get another vaccine,' he said. That's where Novavax sees market opportunity, according to Trizzino.

Older adults are doing better, with about 40% of adults over the age of 50 and 46% of adults over 65 having received their second doses, according to the CDC. While mRNA doses have been available for second boosters since September, uptake has been slow.Īs of last week, about 5% of the eligible population has received an additional booster. He said he doesn't have a timeline for when that second boost data will be available, however.Ībout 20% of the adult population has yet to receive any vaccine for COVID and at least 50% have not received a booster, Trizzino said. but they wanted to see additional data,' Trizzino said of the FDA. Now, logically, you would think that if you're good enough to be the first heterologous boost then you should be good enough to do a second heterologous boost. 'The data that we submitted was exclusively for the first boost dose. Novavax chief commercial officer John Trizzino told Yahoo Finance that the company is already working on clinical trial data that it hopes will amend the emergency use authorization (EUA) to include the option for use as a second booster.

Nova vax fda