Letter to Dr. Stephen Hahn, Commissioner of the United States Food and Drug Administration - Shaheen & Hassan Call on FDA to Outline its Process for Ensuring a Future COVID-19 Vaccine is Safe for Older Adults
Letter
We write to you today to request information on how the Food and Drug Administration (FDA)
is ensuring that phase three clinical trials will provide adequate data and information on the
safety and effectiveness of COVID-19 drugs (including biologics) and vaccines in older adults.
The ongoing work by the biomedical industry and the federal government to develop safe and
effective drugs for the treatment or prevention of COVID-19, as well as vaccines, is critical to
combating the pandemic and protecting our most vulnerable citizens. As manufacturers seek
approval or authorization for drugs and vaccines from your agency, the public must have
confidence that the review process is comprehensive, evidence-based, and ensures safety for our
most vulnerable populations. Understanding that there are challenges associated with safely
enrolling certain high-risk populations in clinical trials related to COVID-19, we ask that FDA
provide a clear plan for how your agency will evaluate the safety and efficacy of investigational
COVID-19 drugs and vaccines in older adults.
COVID-19 has had a disproportionate impact on adults aged 65 years and older, accounting for
roughly 80 percent of COVID-19-related deaths. In documents released by the Centers for
Disease Control and Prevention (CDC), public health officials indicate that older adults residing
in nursing homes could be among the first groups recommended to receive a COVID-19 vaccine
once it is available to the public.1 A report by the National Academies of Sciences, Engineering,
and Medicine, requested by CDC and the National Institutes of Health, outlines a framework for
COVID-19 allocation that also prioritizes vaccine administration among older adults living in
congregate settings.
That is why it is critical that FDA provide clear, transparent information about the steps the
agency is taking to ensure that COVID-19 drugs and vaccines are safe and effective for use in
older adults. In June 2020, FDA released guidance on the development of COVID-19 vaccines,
1 https://www.nytimes.com/article/covid-vaccine-a-b.html
2
stating that late-phase clinical trials should include adequate representation of elderly
individuals.
2 As you know, adult representation in clinical trials is especially critical since older
adults experience age-related changes to immune systems that may impact their reaction to
immunizations. Yet, recent analysis suggests that ongoing COVID-19 clinical trials do not all
include significant age-based diversity.
3 For example, a recent study published in JAMA Internal
Medicine found that older adults are likely to be excluded from half of the clinical trials related
to COVID-19 drugs, and all COVID-19 vaccine clinical trials.
4 Although the developers of the
four COVID-19 vaccine candidates currently in U.S. phase three clinical trials have set goals for
the inclusion of older adults in these trials, actual participation rates are unclear. Some public
health experts have raised concerns about how this lack of adequate representation could affect
the ability for independent review boards to properly evaluate the safety and effectiveness of
COVID-19 vaccines in older adults, including the Vaccines and Related Biological Products
Advisory Committee (VRBPAC) and the Advisory Committee on Immunization Practices
(ACIP).5, 6 The disproportionate impact of COVID-19 on older adults further stresses the need to
ensure -- through inclusive clinical trial design, post-market surveillance, and other research
methods -- that COVID-19 drugs and vaccines are safe and effective for this particularly
vulnerable population.
To that end, we ask that your agency provide details on how FDA will ensure that COVID-19
drugs and vaccines are safe and effective for older adults. Please respond to the questions below
by October 29, 2020.
1. What percentage of ongoing phase three clinical trials for COVID-19 drugs include
adults over the age of 64?
a. In phase three clinical trials for COVID-19 drugs that include adults over the
age of 64, what percentage of participants are over the age of 64?
2. What percentage of ongoing phase three clinical trials for COVID-19 vaccines
include adults over the age of 64?
a. In phase three clinical trials for COVID-19 vaccines that include adults over
the age of 64, what percentage of participants are over the age of 64?
3. In clinical trials related to COVID-19, does FDA require detailed justification for the
exclusion of older adults from clinical trials?
4. What steps has your agency taken to ensure that COVID-19 related clinical trials
include older populations when it is medically safe to do so?
2 https://www.fda.gov/media/139638/download
3 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771091
4 https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771091 5 https://www.medscape.com/viewarticle/936937#vp_7 ; https://www.nytimes.com/2020/06/19/health/vaccinetrials-elderly.html; 6 https://www.forbes.com/sites/nextavenue/2020/10/01/missing-the-mark-covid-19-vaccine-trials-are-excludingolder-adults/#11c7e0721dbb
3
5. How does your agency intend to evaluate the safety and efficacy of COVID-19 drugs
or vaccines for older adults if clinical trials for those products did not include or only
included limited representation of adults over the age of 64?
6. Will the VRBPAC review data and issue recommendations focused on adults over
age 64 prior to any vaccine being authorized for emergency use in this population?
7. If the VRBPAC finds there is insufficient data to determine the safety and efficacy of
a vaccine candidate for adults over the age of 64, how will your agency work with
vaccine developers to generate this necessary information?
8. To what extent will data and information from COVID-19 vaccine clinical trials,
including age-based exclusions, the demographic breakdown of trial participants, and
data disaggregated by age, be available to the public if a vaccine is authorized for
emergency use?
Source