Novavax tempers its revenue expectations as it unveils PhIII data for bivalent booster
As Novavax reports third quarter results, the vaccine maker is tempering its expectations once again on Covid-19 sales.
The company reported that it netted $725 million in Q3 and administered around 94 million doses so far, but it has lowered its financial guidance for the year further to an even $2 billion from an expected $2.3 billion just last quarter. The company also lowered its guidance from an estimated $5 billion during its Q2 results.
This is certainly not what investors want to hear, as the company’s stock price $NVAX finds itself trading below $20 a share and down 86% since the start of the year.
Novavax’s vaccine rollout earlier this year had been compounded by months of delays due to filings and manufacturing concerns, but even as the company got the coveted EUA from US regulators and the shot serves as an alternative to the more common mRNA vaccines, it still came with some limitations. The EUA noted that increased risks of myocarditis and pericarditis, along with fainting and other adverse effects, may occur with the shot.
Despite falling demand for booster shots, Novavax is forging ahead against choppy winds with its booster candidate to counter the Omicron variant.
The topline results from its Phase III trial showed that Novavax’s BA.1 vaccine candidate had met the primary “strain-change endpoint,” displaying a “neutralizing” response. However, the data also showed no benefit for the Novavax bivalent vaccine candidate compared to the BA.1 vaccine candidate or “prototype vaccine” in the overall population.
The reported antibody responses countering BA.1 showed “similar responses across the three vaccine groups.” For the BA.5 strain, responses also showed there was “no benefit” for the BA.1 or bivalent candidates when compared to the prototype vaccine.
On the results, Gregory Glenn, the president of Research and Development at Novavax said:
Today’s results show that use of our prototype vaccine as a booster induces cross-reactive responses to a broad range of variants with the potential to protect against future strains. This is a hallmark of our vaccine technology and shows the suitability of our current prototype vaccine as a booster even as the COVID-19 landscape continues to evolve. Our vaccine, which provides a broad immune response even in the face of evolving variants, presents a potential strategy to protect against COVID-19 now and into the future.
The most common symptom of the candidate was pain or tenderness, with fatigue also being reported.
The initial vaccine showed that it was 80% effective at preventing symptomatic disease in patients 12 to 17 years old, but the vaccine had been faced with manufacturing delays as well as playing catch up with the Omicron variant.