Amid concerns over the US regulatory nod and the initial rollout of the company’s COVID-19 shot, Novavax (NASDAQ: NVAX) shares have fallen this year following a key FDA meeting on the use of the vaccine in the domestic market next month.
The federal agency announced Friday that a group of its vaccine experts would meet on June 7 to discuss the company’s request for approval of the protein-based vaccine for use by those 18 years of age.
A positive opinion would mark the addition of a differentiated tool to the COVID-19 immunization effort at a time when more than 10% of American adults remain unvaccinated more than a year after two mRNA-based vaccines and a vector-based vaccine were introduced to COVID tired public.
For Maryland-based Novavax (NVAX), it will be a validation of its Matrix-M adjuvanted vaccine platform whose candidates include a combined seasonal influenza vaccine linking the COVID-19 shot with a quadrivalent influenza vaccine.
While the company’s shares ended a three-day slide last Friday following the announcement of the FDA review, the Novavax (NVAX) stock continues to trade ~ 68% lower than the level at the beginning of the year.
Interestingly, Moderna (MRNA) and BioNTech (BNTX), which – like Novavax (NVAX) – boast of their COVID-19 shots as the only products in their portfolio, have only dropped ~ 46% YTD, as shown in this graph.
The underperformance is striking, as more than a dozen countries, including the EU and the World Health Organization (WHO), have already given the green light to the Novavax (NVAX) vaccine for adults.
More positive legal news could be on the way. Last month, the company asked EU regulators to extend the marketing authorization for its vaccine, branded as Nuvaxovid in the region, to young people.
However, the slow roll-out of the vaccine remains a problem as vaccine supply constraints ease and COVID-19 concerns ease in many countries. None of the analysts covering the stock have raised their quarterly earnings estimates for Novavax (NVAX) over the past three months.
Meanwhile, consensus suggests $ 4.5 billion in revenue for the company in 2022, about 64% higher than forecasts made by data analytics firm Airfinity for Novavax (NVAX) vaccine for this year. Still, the company is still a favorite on Wall Street with no sales ratings at the moment.