Novavax Vaccine Could Generate $33 Billion in Revenue through 2027, Analyst Says

Novavax is aiming to seek Emergency Use Authorization for its COVID-19 vaccine NVX-CoV2373 later this spring. If the U.S. Food and Drug Administration gives it the green light, the Maryland-based company could see revenue of approximately $1.8 billion in sales by the end of the year.

Data and analytics company GlobalData pegged the potential revenue for Novavax based on a potential authorization from the U.S. Food and Drug Administration and other regulatory agencies across the globe. The revenue stream from the vaccine is expected to continue well past the close of business for 2021. GlobalData forecast Novavax’s vaccine will generate $33.3 billion from expected authorization this spring through 2027. A peak forecast of $7.2 billion is expected in 2027 alone, according to the report.

Novavax anticipates EUA in both the United States and the United Kingdom in the second quarter of this year, based mainly on the promising Phase III data generated in a U.K. study. While U.S. trials are ongoing, Novavax anticipates the FDA will allow it to use the U.K. trial data for EUA.

Data from that study, released in March, showed the vaccine demonstrated efficacy of 96.4% against mild, moderate, and severe disease caused by the original COVID-19 strain. Additionally, that study showed the efficacy of 86.3% against the B.1.1.7 variant primarily circulating in the U.K.

Keshalini Sabaratnam, a GlobalData Analyst, said efficacy demonstrated by Novavax’s vaccine candidate against the original strain of the virus is on par with the leading COVID-19 vaccines developed by Moderna and Pfizer, and BioNTech. Additionally, Sabaratnam noted the Novavax efficacy against the U.K. strain should boost sales in those countries due to the prevalence of that particular form of the COVID-19 virus.

Novavax has also been testing its vaccine candidate against a South African strain, which has become predominant in that country. The data is not as promising against that particular variant, with efficacy of only 55.4% in healthy adults. However, the overall efficacy of the vaccine declined to 48.6% when those with compromised immune systems due to HIV infection were factored into the equation.

Across both the Phase III U.K. study and the Phase IIb study in South Africa, NVX-CoV2373 demonstrated 100% protection against severe disease, including all hospitalization and death, the company said.

Earlier this month, the company initiated crossover arms in its ongoing U.K. and U.S. Phase III studies. This allows study participants who received a placebo to go ahead and get two doses of the vaccine, while those who received the vaccine will receive two doses of placebo. In the Phase IIb South African study, those who received a placebo will now become vaccinated, while those who were dosed twice with the Novavax vaccine will receive a booster injection. Participants across all three trials will remain blinded to their courses of treatment to preserve the ability to assess efficacy in each trial. All will be followed for up to two years to monitor the safety and durability of the vaccine, the company said.

Sabaratnam noted the Novavax vaccine is stable and does not need to be stored in extremely cold settings, which will allow for broader distribution.

“If NVX-CoV2373 receives approval, it will contribute toward boosting the vaccine roll-out across multiple geographies in H2 (second half of 2021), which will help bring the pandemic under control,” Sabaratnam said in a statement.

If the Novavax vaccine is authorized in the U.S., that would provide a fourth vaccine option in this country. Pfizer and BioNTech, and Moderna were the first to receive EUA for their mRNA vaccines, and earlier this year, the FDA authorized Johnson & Johnson’s single-dose vaccine, which had been placed on a temporary hold while health authorities conducted a safety review regarding blood clots. The hold has been lifted and the J&J vaccine is being administered again.

NVX‑CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax’s proprietary Matrix‑M adjuvant. Phase I data from a Phase I/II study showed that NVX‑CoV2373 produced antibodies in healthy patients, a sign the vaccine is working as intended. The vaccine was also well-tolerated in those patients, the company said. Novavax is already preparing for the potential of authorization by boosting its manufacturing capabilities.

The company has a standing deal with Emergent BioSolutions. Last month, the company struck a deal with GlaxoSmithKline to support the manufacturing of up to 60 million doses of the vaccine for use in the U.K. The government of the U.K. secured 60 million doses of the vaccine under an advance purchase agreement with Novavax. The company also has agreements in place for 40 million doses of its vaccine candidate to be used in South Korea.

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Alex Keown is a freelance journalist who writes about a variety of subjects including the pharma, biotech, and life science industries. Prior to freelancing, Alex has served as a staff writer and editor for several publications.