Vaccine Development Builds on COVID-19 Breakthroughs

The remarkable success of using mRNA technology to combat the severity and spread of COVID-19 is transforming the world of vaccine discovery and testing, stimulating a new generation of vital preventives for global diseases.

Despite the anticipated drop in pandemic vaccination in the coming months, industry’s ability to deliver nearly 700 million anti-COVID shots in the US and internationally is generating multiple initiatives to further compress the timeframe for vaccine development and production. New vaccines to combat cancer and to better prevent a range of infectious diseases are being tested as are more efficient seasonal influenza shots that more closely match prevalent viral strains.

These developments are fostering new partnerships among vaccine makers and more clinical trials to develop mRNA therapeutics and preventives for a range of serious conditions, including melanoma, Zika virus, malaria, and shingles. New shots to prevent pneumococcal disease are in development from Pfizer and several firms, while GSK announced plans to boost vaccine R&D, building on strong sales of its Shingrix shingles vaccine last year. Moderna recently made waves with data indicating 84% effectiveness for a new preventive for respiratory syncytial virus (RSV) as well as progress in developing a vaccine to help combat melanoma. Takeda is gearing up to launch a new dengue fever vaccine that provides several years of protection in anticipation of FDA approval later this year.

Despite plans to end the COVID public health emergency, additional preventives for that virus continue to emerge. Novavax gained FDA approval of its protein-based COVID vaccine only in July 2022 and recently announced the sale of 1.5 million vaccine doses to the federal government to cover the transition from government-supported shots to a commercial market. Daiichi Sankyo is building an mRNA vaccine production plant in Japan to provide its COVID vaccine candidate.

But a vaccine to prevent HIV appears as elusive as ever, as Johnson & Johnson’s Janssen unit recently reported failure to show effectiveness in clinical trials, adding to the list of disappointing efforts to block continued spread of this lethal disease.

Annual shots for COVID?

These developments speak to the need to review research and regulatory approaches for testing, assessing, and marketing potential vaccines. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) agreed on the value of a common bivalent anti-COVID shot for all patients that targets both the original strain and the Omicron subvariants. However, the expert panel was less certain about recommending annual vaccination against COVID due to uncertainty about the continued effectiveness of the current shots and about what time during the year would be best for a national COVID vaccination campaign.

Pfizer, Moderna, and Novavax reported to VRBPAC on efforts underway to produce reformulated bivalent vaccines and supported the plan for a common formulation for all manufacturers to simplify vaccination recommendations and reduce patient questions about the effectiveness and safety of vaccines from different manufacturers. The three firms also said that they are already studying combination shots for flu and COVID and emphasized the need for specifics from FDA on the process for updating vaccine strains and the timing, process, and methodology for producing a data package for new licensure.

While the expert panel and officials from FDA and other health agencies acknowledged the value of utilizing mRNA platforms to produce anti-COVID vaccines so quickly and effectively at the start of the pandemic, some panel members called for further analysis of how well the new formulations provide long-term protection and avoid safety issues and emphasized the need to assess whether more traditional vaccine production methods may have broader benefits moving forward. They urged additional research on the possible need for different vaccination schedules for both young children and older adults with health impairments.

In concluding the advisory committee meeting, Peter Marks, director of the Center for Biologics Evaluation and Research, reiterated the importance of a “data-driven approach” to achieve a vaccine regimen that is as simple as possible. But he also noted the value of monitoring vaccine safety and assessing product effectiveness in shifting to a next generation of COVID vaccines able to provide “greater depth of protection.”

Jill Wechsler is Pharm Exec’s correspondent in Washington and can be reached at jwechsler7@gmail.com.