Novavax Releases Efficacy Data

Novavax, a Maryland-based pharmaceutical company, released its Phase 3 clinical trial results for its COVID-19 vaccine on Monday, and they are good. The vaccine demonstrated 90% overall efficacy and 100% protection against moderate and severe disease. Here’s what you need to know:

• The U.S. study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate efficacy, safety, and immune response.
• The trial was placebo-controlled, observer-blinded, and randomized. Only 14 cases occurred among those that received the vaccine, and none were severe.
• Many of the variants that raised concern were circulating during this trial. In fact, the UK variant became the dominant strain in the United States during the trial.  
• Like Pfizer and Moderna, the Novavax vaccine is delivered in two doses. They are given a month apart.
• The technology used to make the Novavax vaccine is different than the others that have been given authorization so far. It uses purified spike protein and an adjuvant, which is a substance designed to enhance the immune response. The technology is not new. It has actually been used in a vaccine that prevent leukemia in cats! And adjuvants are used in many vaccines, including those for hepatitis A, hepatitis B, and diphtheria-tetanus.
• This vaccine is easy to store. It requires only basic refrigeration.
• The company is expected to seek Food and Drug Administration approval in September. Because many vaccines are now available in the United States, the company may be required to seek a full license, rather than the Emergency Use Authorization allowed for companies who made their vaccines available earlier.
• While all of the vaccines made available so far are safe and effective, the Novavax vaccine may be a good option for those who feel most comfortable with a more traditional type of vaccine. 
• Many other parts of the world still need vaccines. Novavax will apply for authorization in Britain, the European Union, India, and South Korea.

While each of the vaccines is a little different, what’s most important is that they all work exceptionally well to protect against COVID-19. I encourage those who have not yet received a vaccine to get one as soon as possible. Locally, SVMC’s Respiratory Evaluation Center/ExpressCare is offering vaccines to walk-ins 8 a.m. – 6 p.m. every day, even on weekends.

Marie George, MD, FIDSA, is Southwestern Vermont Medical Center’s infectious disease specialist.