June 7, 2022
Thank you for the opportunity to speak today on behalf of the National Center for Health Research. My name is Sophia Phillips, and I am a fellow at the center. We analyze scientific data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.
Today, the panelists are asked to evaluate if the benefits of the Novavax COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older.
While this vaccine demonstrates similar levels of efficacy as compared to vaccines approved for COVID-19, the data suggests additional safety risks. As was stated in the FDA materials, there was an elevated risk of myocarditis and pericarditis demonstrated in Study 301. Further, this risk could be higher in the Novavax vaccine compared with mRNA COVID-19 vaccines. There were six cases identified pre-authorization of Novavax, while no cases were identified before the authorization of mRNA COVID-19 vaccines. Although these serious complications were also identified for mRNA vaccines, that was only when much larger numbers of people were vaccinated, not the original mRNA study participants. Data from passive surveillance in other countries where the Novavax vaccine is authorized also indicate a higher than expected rate of myocarditis and pericarditis associated with the vaccine. As a result, the FDA requested that the sponsor change “myocarditis and pericarditis” to an important identified risk on the Pharmacovigilance plan.
The design of study 301, which is the basis for today’s discussion, initially resembled that of the other three COVID-19 vaccines granted an EUA; they were similarly Phase 3, randomized, placebo-controlled trials with a similar number of vaccinated participants. However, the study design transitioned to a blinded crossover due to the availability of EUA vaccines for certain populations. Efficacy of the drug compared to placebo could only be determined in the pre-crossover period after dose two for approximately two months before the opposite treatment was given to each participant. Therefore, it is not possible to assess sustained efficacy over a longer period of time. It remains unclear how long protection lasts, and while the FDA remains hopeful that Novavax will provide some meaningful protection against Omicron, that is also uncertain, since the vaccine was primarily studied on the Alpha variant.
Additionally, very few of study participants were immunocompromised, pregnant or lactating, or at risk of severe COVID because of cardiovascular, chronic renal, and chronic liver disease. That made it impossible to meaningfully evaluate the vaccine’s efficacy for those populations.
Few cases of PCR-confirmed COVID-19 were analyzed for participants ≥65 years of age, limiting the value of the efficacy data for that age subgroup. For those that were studied, there was a 12.5% dip in Vaccine Efficacy for individuals 65 or older, which is also typical for the mRNA COVID-19 vaccines.
What would be the value of this vaccine, compared to the three COVID vaccines that have already been approved? If it is less safe than the other three vaccines, it does not provide additional benefit to make up for that. Even if it is not proven to be less safe than the other COVID vaccines, it lacks long-term, placebo-controlled efficacy data and there is very little safety or efficacy data for the most at-risk patients. When we already have vaccines on the market that are FDA approved, and based on much better data, why would the FDA authorize this vaccine? Wouldn’t it just add to the controversy surrounding COVID vaccines?
Thank you.