Since the beginning of the COVID-19 vaccine development process, Moderna has sought to be incredibly transparent with the trial population – from age groupings, to racial identifiers and risk groups. Today’s release of data about their vaccine candidate has not been any different.
Embedded in the FDA’s briefing document on the Moderna COVID-19 Vaccine, the company revealed that 22.3% of participants had one high risk condition, while 4% had at least two. Within the high-risk term, the briefing suggested that at least one person with cystic fibrosis was included in the trials:
These conditions included the following:
- Chronic lung disease (e.g., emphysema and chronic bronchitis, idiopathic pulmonary fibrosis and cystic fibrosis) or moderate to severe asthma
- Significant cardiac disease (e.g., heart failure, coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary hypertension)
- Severe obesity (body mass index ≥40 kg/m2)
- Diabetes (Type 1, Type 2 or gestational)
- Liver disease
- HIV infection
A quick glance at the same document from Pfizer-BioNTech’s hearing last week did not include the same information.
Unfortunately, nothing more can be said about the specific cystic fibrosis experience with the Moderna vaccine, but the data do break down quite nicely into different subgroups when efficacy is discussed.
Of the 1448 people identified to have chronic lung disease (which includes cystic fibrosis as part of the trial design), 707 or 4.7% received the vaccine while 741 4.9% received placebo. Worth sharing here is that 1448 people with chronic lung disease is more than 3.5 times the number of people in the pivotal phase III trial (VX-445+Tezacaftor+Ivacaftor) that led to Trikafta’s FDA approval. Yes, Trikafta was approved for use in CF with far few data points, though its unclear how the two trials compare in terms of follow up (also… it should go without saying that drawing further comparisons between clinical trials is not warranted).
Within the vaccinated vs placebo groups, 0/661 in chronic lung disease vaccine group had a COVID-19 infection while, 6/673 in the chronic lung disease placebo group did had a COVID-19 infection. The data were collected 14 days after the 2nd of two doses (vaccine or placebo) were administered. Vaccine efficacy was calculated to be 100% in the chronic lung disease group, though confidence intervals were not available. You can see the chart in my tweet below.
There is an inconsistency between the numbers (661 vs 707 vaccine and 673 vs 741 placebo) likely because the data cutoff occurred on November 7, 2020 for the interim analysis.
While I look forward to hearing how the FDA does evaluate these data in their meeting later this week, I am encouraged by the transparency around the chronic lung disease grouping. I am grateful Moderna included these subgroups.
Leading up to the critical emergency use authorization meeting, the FDA has already said that Moderna’s vaccine does meet its standard for efficacy and safety.
If I come across any more info about CF as it relates to this specific vaccine, I will be sure to update this article and share! I’d also encourage anyone with questions about these data to discuss them with their CF care team.