Expert Interview: Protein-Based Vaccines for COVID-19

The COVID-19 public health emergency may have ended, but vaccine manufacturers are still hard at work updating immunizations against the SARS-CoV-2 virus. In an interview with Drug Topics, Seth Toback, MD, senior vice president, medical affairs at Novavax, discussed the development of the company’s protein-based COVID-19 vaccine and shared some counseling pearls that pharmacists can use when discussing vaccination with their patients.

Can you briefly explain the mechanism of action of the Novavax COVID-19 vaccine?

The Novavax COVID‑19 Vaccine, Adjuvanted, is a protein subunit vaccine produced using established technology that has also been used in some seasonal influenza, human papillomavirus, and hepatitis B vaccines. The vaccine presents a harmless piece of the spike protein part of the SARS-CoV-2 virus to the immune system, which triggers an immune response.

Seth Toback, MD

The vaccine also includes an adjuvant, called Matrix-M, which enhances the immune response to the spike protein. Matrix-M is proprietary to Novavax and comes from saponins, naturally occurring compounds in the bark of the Quillaja saponaria (soapbark) tree, which is commonly found in Chile.

After learning how to respond to the spike protein, the immune system is able to respond quickly if/when exposed to the actual virus spike protein, and therefore can help protect against COVID-19.

Overall, protein-based vaccines deliver the protein ready-made, directly to your immune system.

What is the history of protein-based vaccines? Are there any benefits to these types of vaccines?

Protein-based vaccines, such as the hepatitis B vaccine introduced in the 1980s, have a long history of use. As mentioned previously, they contain harmless pieces of the pathogen—such as proteins or protein fragments—rather than the whole organism. They do not contain any live virus.

Protein-based vaccines have a long track record of safety and efficacy, and have been used for years with well-documented safety profiles. Additionally, protein-based vaccines can be stored and transported at standard refrigerator temperatures, which can simplify logistics and distribution. This could represent a convenience to pharmacists from a workflow perspective.

The FDA, the CDC, and the CDC Advisory Committee on Immunization Practices (ACIP) all signed off on changes to the recommended COVID-19 vaccination schedule. Is the Novavax vaccine an appropriate option for patients who have received previous mRNA immunizations?

On October 3, 2023, Novavax received emergency use authorization (EUA) for the 2023-2024 formulation of its COVID-19 vaccine for individuals aged 12 years and older in the United States.¹ This authorization from the FDA, along with the ACIP recommendation from the September 12, meeting,² makes Novavax’s vaccine the only protein-based, non-mRNA COVID-19 vaccine option available in the United States.

Eligible patients can receive the vaccine, regardless of what COVID-19 vaccine type they received in the past. For individuals previously vaccinated with any COVID-19 vaccine, a single dose of the Novavax COVID-19 vaccine can be administered at least 2 months after receipt of their last COVID-19 vaccine.

We know there is still some hesitancy around COVID-19 vaccines in general. Given that hesitancy, what are some takeaways and counseling pearls around the Novavax COVID-19 vaccine that you can share with pharmacists?

Pharmacists play a critical role in addressing COVID-19 vaccine hesitancy and providing accurate, timely information to patients. The pandemic certainly underscored the value of the knowledge and accessibility that pharmacists offer to their communities and public health overall. They have been and will continue to be a trusted resource for their patients.

With so many immunizations occurring at pharmacies, pharmacists are in an optimal position to engage in a dialogue with patients about vaccines, understand any hesitancies they may have, and correct any misinformation. By offering a safe, nonjudgmental environment, pharmacists can ask open-ended questions to seek to understand underlying concerns. As a result, patients can feel heard and respected, and pharmacists can provide tailored counseling in a compassionate manner.

When speaking with appropriate patients about the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula), there is some information patients may want to know:

• The Novavax COVID-19 vaccine uses traditional, protein-based technology. Many people may have already received a protein-based vaccine, as it uses similar technology to what is used in some vaccines for influenza and hepatitis B.
• When it comes to getting the COVID-19 vaccine, there are choices. Individuals aged 12 years and older can receive the Novavax COVID-19 vaccine even if they previously received an mRNA COVID-19 vaccine
• General adverse effects include injection site reactions, fatigue or feeling unwell, muscle pain, headache, joint pain, and nausea. For a complete list, please refer to the Vaccine Provider Fact Sheet

Lastly, it may be helpful to remind patients that per CDC guidance, the Novavax COVID-19 vaccine can be coadministered with the flu and RSV vaccines to eligible patients.

Pharmacists can refer to the Vaccine Provider Fact Sheet at https://novavax.widen.net/s/9tkdmzh9z6/us-eua-fact-sheet-hcp and visit https://us-hcp.novavaxcovidvaccine.com for more information. They can also refer patients to the Vaccine Recipient Fact Sheet at https://novavax.widen.net/s/9mtxjf6rjv/us-eua-fact-sheet-recipients and https://us.novavaxcovidvaccine.com for more information.

Are there any other key points you’d like to touch on that we haven’t covered?

Overall, Novavax is excited to offer patients a choice in their COVID-19 vaccination type, a COVID-19 vaccine that is based on a well-established vaccine technology. The Novavax team also recognizes with gratitude the enormous role pharmacists play in providing immunization services and helping educate their communities.

References

1. FDA authorizes updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variants. News release. FDA. October 3, 2023. Accessed October 27, 2023. https://www.fda.gov/news-events/press-announcements/fda-authorizes-updated-novavax-covid-19-vaccine-formulated-better-protect-against-currently

2. Regan JJ, Moulia DL, Link-Gelles R, et al. Use of updated COVID-19 vaccines 2023-2024 formula for persons aged ≥6 months: Recommendations from the Advisory Committee on Immunization Practices – United States, September 2023. MMWR Morb Mortal Wkly Rep. 2023;72(42):1140-1146. doi:10.15585/mmwr.mm7242e1