After the FDA announced U.S. regulatory approval for Omicron-adjusted booster vaccinations created by competing COVID-19 vaccine manufacturers Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA), the shares of Novavax (NASDAQ:NVAX) dropped to a new 52-week low on Wednesday.
The last company to enroll in the COVID-19 vaccination campaign in the United States was a Maryland-based biotech, whose regulators approved its protein-based vaccine for those 18 years of age and older in July.
However, when the pandemic’s impact diminished, the business’s vaccine sales suffered. In August, the company announced a significant Q2 sales miss and cut its 2022 revenue projection.
The monovalent booster injections created by Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX) and Moderna (NASDAQ:MRNA) will no longer be recommended as booster shots for those 12 years of age and older, the FDA announced today in announcing its decision.
The recently approved bivalent vaccinations are intended to protect against both the primary viral strain and the Omicron BA.4 and BA.5 subvariants. The monovalent boosters that had previously been cleared, however, only affected the original COVID-19 strain.
Recently, Novavax (NASDAQ:NVAX) reported that it had submitted applications to the FDA for approval to use the NVX-CoV2373 COVID-19 vaccine as a booster dose. The business anticipates submitting regulatory submissions in Q4 2022 in order to get FDA approval for an Omicron-containing vaccine.
Although the COVID-19 vaccine Nuvaxovid continues to score regulatory successes, the stock’s Monday performance would have you believe otherwise. Despite a very positive regulatory outcome for the firm and its jab, it declined by 2%, roughly mirroring the day’s decline of the S&P 500 index.
Recently, Nuvaxovid’s use in people between the ages of 12 and 17 was approved by the Food and Drug Administration (FDA), according to Novavax. The vaccine’s emergency use authorization (EUA), which was first granted by the American regulator in mid-July, is now extended to include that population.
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