Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

Update on the Moderna Vaccine Candidate

Today Moderna issued another press release to update the information available on their vaccine candidate. The results are consistent with the previously released results and will be followed by a much more detailed release of information at an FDA advisory panel meeting, expected to be on December 17, 2020.

The new cases are more than double the 95 cases from the November 16 press release. The total is now 196 symptomatic cases – 185 in the placebo group and 11 in the mRNA-1273 group – efficacy of 94.1%. There were 30 severe cases, including 1 death, in the placebo group and no severe cases in the mRNA-1273 group.

We do not know how many asymptomatic cases are in either group, so this route of transmission by vaccinated people is still a possibility.

Another part of the press release raises different questions.

Efficacy was consistent across age, race and ethnicity, and gender demographics. The 196 COVID-19 cases included 33 older adults (ages 65+) and 42 participants identifying as being from diverse communities (including 29 Hispanic or LatinX, 6 Black or African Americans, 4 Asian Americans and 3 multiracial participants).

But . . .

The study includes more than 11,000 participants from communities of color, representing 37% of the study population, which is similar to the diversity of the U.S. at large.

The minority rate in the study is stated to match the 37% minority rate of America, but the symptomatic infection rate among American minorities in the study is 42 out of 196 (21.4%), but according to a meta-analysis of over 18 million patients in the Lancet, the symptomatic infection rate among minorities is significantly higher than 37%:

Patients from ethnic minority groups are disproportionately affected by Coronavirus disease (COVID-19). We performed a systematic review and meta-analysis to explore the relationship between ethnicity and clinical outcomes in COVID-19.

How is this study of randomized volunteers, who are allegedly representative of the American population, producing symptomatic infection rates that are much less than half of what is expected among minorities?

The November 18 Pfizer/BioNTech vaccine candidate press release only states:

Efficacy was consistent across age, gender, race and ethnicity demographics.

I did not find any details of the actual numbers in the press release, nor in any of the links. The Moderna press release has a similar statement, even though the numbers provided disagree with that statement: “Efficacy was consistent across age, race and ethnicity, and gender demographics.” Is the Pfizer/BioNTech statement more trustworthy, because it does not provide any numbers? No, but this is something that needs to be addressed for all of the vaccine candidates.

What are the Pfizer/BioNTech numbers for minorities? The FDA meeting for Pfizer/BioNTech is scheduled for December 10, so we should learn a lot more from that open to the public by video FDA meeting.

Why does the Moderna press release list such disproportionate numbers, but not mention that they are disproportionate? There is no reason to expect that a placebo would provide this kind of disproportionate protection.