The United States continues to address the changing landscape of COVID-19 immunization, with notable progress by vaccine companies and regulatory agencies. This article explores the recent advances, challenges, and regulatory issues that frame the country’s vaccination strategy.
Moderna’s Dual COVID-19 and Flu Shot: An Evolution Towards Simplified Immunization
Moderna’s investigational combined mRNA vaccine, mRNA-1083, is designed to guard against COVID-19 and influenza in one dose. According to a study recently published in the Journal of the American Medical Association, this combination vaccine produced a more robust immune response in people 50 and older than current standalone vaccines. The research, which enrolled more than 8,015 participants, determined that the combination shot elicited higher levels of antibodies against COVID-19 and other flu strains. Side effects were mild, such as pain at the injection site, fatigue, and headaches. The U.S. Food and Drug Administration (FDA), however, has asked for more information on how well the vaccine works to prevent illness and hospitalization before it can be approved, pushing its expected release to 2026.
Novavax’s Pursuit of Full FDA Approval
Novavax is actively engaged in discussions with the FDA to convert its emergency use authorization into full approval for its protein-based COVID-19 vaccine, Nuvaxovid. The company remains optimistic about resolving formulation concerns and is working to provide the necessary data to meet regulatory requirements. Despite a missed April 1 approval target, Novavax’s CEO expressed confidence in the approval process, noting that the FDA’s request for a post-marketing commitment typically follows product approval.
The firm announced a dramatic financial turnaround during Q1 2025, with $519 million in net income and $667 million in revenue, far exceeding the expectations of analysts.
The boost was the result of $603 million in revenue related to the cancellation of advance purchase agreements in Canada and New Zealand. Moreover, Novavax updated its 2025 revenue projection to $975 million – $1.03 billion, supported by a $1.2 billion licensing deal with Sanofi for distribution rights in key markets.
FDA Advisory Panel to Discuss Updated Vaccine Recommendations
The FDA’s Vaccines and Related Biological Products Advisory Committee meets on May 22 to provide discussion and a recommendation for how to choose the 2025-2026 formula for the COVID-19 vaccine. Following the new commissioner, Martin Makary, this is an increase in influence, expressing a belief that natural immunity beats mandates. To date, the United States approves three COVID vaccines: Moderna’s and Pfizer-BioNTech’s mRNA-based vaccines and Novavax’s protein-based injection.
The upcoming advisory panel meeting is expected to address the composition of future COVID-19 vaccine formulations, taking into account emerging variants and current epidemiological data. The outcome of this meeting will play a crucial role in shaping the nation’s immunization strategy for the upcoming flu season.
Declining COVID-19 Cases Impact Vaccine Sales
Health experts have observed a smaller wave of COVID-19 cases in the U.S. this winter compared to previous years.
This has put added pressure on businesses such as Pfizer to seek growth through non-COVID treatments since COVID-related sales have fallen heavily from pandemic levels.
Even as expectations of sales worth $5.3 billion in 2024 for Paxlovid were forecast, a 25% decline is projected for 2025. COVID products are estimated to contribute to 16% of Pfizer’s revenue in 2024, falling to 13% in 2025.
The reduction in COVID-19 cases has resulted in reduced demand for COVID-19 vaccines and treatments, which has encouraged pharmaceutical companies to diversify their portfolios and concentrate on other therapeutic areas. This change highlights the necessity of ongoing innovation and adjustment in the pharmaceutical sector to respond to changing public health issues.
References:
- https://www.cidrap.umn.edu/covid-19/combo-flu-covid-vaccine-shows-good-immune-response-safety-older-adults
- https://jamanetwork.com/journals/jama/article-abstract/2833668
- https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-swings-profit-lower-expenses-related-covid-shots-2025-05-08/
- https://www.reuters.com/business/healthcare-pharmaceuticals/smaller-us-winter-covid-wave-adds-pressure-pfizer-turnaround-2025-02-03/
