FDA Comments – Possible Emergency Authorization of the Moderna COVID-19 Vaccine

Docket No. FDA-2020-N-2242

Vaccines and Related Biological Products; Notice of Meeting; Establishment of a Public Docket; Request for Comments. Moderna COVID-19 Vaccine

To Whom It May Concern

The National Women’s Health Network (NWHN) is a nonprofit advocacy organization that works to improve the health of all women. We are supported by our members and choose not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns and needs of women consumers to policy and regulatory tables.

The National Women’s Health Network supports the development and availability of vaccines that protect people against COVID-19.  We believe that an emergency use authorization of a vaccine based on robust data demonstrating short-term safety and effectiveness is reasonable under the current circumstances.  Although not all questions can be answered with short-term data, in theory, a well-designed and conducted clinical trial could provide the public with enough information to make informed choices about whether or not to accept vaccination.

We are disappointed that the data from the Moderna vaccine trials do not provide the information all individuals need to make an informed decision.  Specifically, when a consumer asks “Was this vaccine tested in people like me?” the honest answer will have to be “It depends.”  If you’re white, yes.  If you’re a woman, yes.  If you’re over 65, yes.  If you’re Latinx, yes.  But, if you’re Indigenous, the answer is “no.”  And if you’re Black, the answer also has to be “no.”

There were not enough Black and Indigenous people included in the Moderna phase 3 trial.   Fewer than 10% of the people who received the vaccine were “Black or African American” – only 1,369 out of 13,934.  And only 107 people who received the vaccine identified as “American Indian or Alaska Native.”[1]

These figures are unjust, and are the product of avoidable study design limitations.   Clinical trial researchers have known for decades that African Americans, for example, will enroll in clinical trials at the same rate as whites, if they are asked to do so.  And yet, neither Moderna nor Pfizer and BioNTech appear to have conducted their phase 3 trials in a manner that resulted in Blacks and indigenous individuals participating in sufficient numbers.

It is true that the overall safety and efficacy data look good.  We can hope that there are no differences in safety or efficacy of the vaccine in racial and ethnic subgroups. But the fact of the matter is, we can’t tell one way or the other right now.

The NWHN urges the FDA to require that sponsors carefully follow up with everyone who volunteered for their vaccine trials. Further, we implore the FDA to strengthen the agency’s COVID-19 vaccine guidance to industry to ensure that the demographics of participants in future trials reflect the prevalence of the disease in racial and ethnic communities.

Sincerely,

Cynthia A. Pearson
Executive Director

 

[1] FDA Briefing Document. Moderna COVID-19 Vaccine.  Page 20.