Senator Hassan Leads Colleagues in Asking FDA to Outline its Process for Ensuring a Future COVID-19 Vaccine is Safe for Older Adults

WASHINGTON – U.S. Senator Maggie Hassan (D-NH) is leading her colleagues in requesting that the Food and Drug Administration (FDA) outline its process for ensuring that a future COVID-19 vaccine is safe for older adults.

“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,” the Senators wrote. “Understanding that there are challenges associated with safely enrolling certain high-risk populations in clinical trials related to COVID-19, I 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.”

In their letter to FDA Commissioner Dr. Stephen Hahn, the Senators ask the FDA to provide clear, transparent information about the steps that the agency is taking to ensure that COVID-19 drugs and vaccines are safe and effective for use in older adults. Along with Senator Hassan, the letter is also signed by Senators Jeanne Shaheen (D-NH), Elizabeth Warren (D-MA), Bob Casey (D-PA), Tina Smith (D-MN), Bernie Sanders (I-VT), and Gary Peters (D-MI).

Senator Hassan is pushing to ensure that the COVID-19 vaccine process is free from political interference and that a potential COVID-19 vaccine is safe and effective. During a recent hearing, the Senator secured commitments from FDA Commissioner Hahn and Dr. Robert Redfield, Director of the Centers for Disease Control and Prevention (CDC), that their agencies would conduct key oversight measures during the COVID-19 vaccine review process to help ensure that any potential COVID-19 vaccine is safe and effective and that the American public have confidence in the vaccine. The Senator also introduced a bipartisan bill that would codify these safeguards into law and ensure that these processes are followed.

To read the Senators’ letter, click here or see below.

Dear Commissioner Hahn:

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, 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?
   1. 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?
   1. 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?
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?

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