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Vaccine Trials

Questions and Answers about the COVID-19 Vaccine Trials

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Vaccine Trials
Q1:

Why are multiple different COVID-19 vaccines being developed?

A:

We need multiple different vaccines using different approaches to ensure everyone is protected safely and effectively from SARS-CoV-2.  Vaccines that have received Emergency Use Authorization from the FDA are also still being studied for safety and efficacy over time to gather necessary long-term data. Fully enrolled and completed clinical trials with long-term data are needed for the multiple vaccines in clinical development.

Q2:

How long will these trials last?

A:

Each trial lasts two years. Interim analyses will be conducted at scheduled time-points during the first year of the trial to evaluate safety of the vaccine and how well it protects people from getting sick from SARS-CoV-2 (efficacy).

Q3:

What happens if we don’t reach the volunteer goals at a location?

A:

Each trial has an overall target enrollment of 30,000 participants. The military sites have a goal to enroll 1,000 study volunteers in each market area (for a total target of 3,000 volunteers).  There will be more than 80 sites across the country participating in the trial and the trial will have “competitive enrollment.”  This means that sites participating in the trial will continue to enroll study volunteers until the total study enrollment target of 30,000 is met, and will stop as soon as that target enrollment for the study is met. 

Q4:

Will military members be directed to “volunteer” for the trials?

A:

Absolutely not. Any adult MHS beneficiary (active duty, retired, or family member) interested in participating in the study will be informed about the study and would need to provide voluntary written informed consent in order to be screened and considered for participation.

  • Active duty members who are considered vulnerable from an ethical and regulatory standpoint (including new recruits and trainees) are excluded from the study and won’t be able to participate.
  • Active duty military members who don’t fall into those categories may be able to participate in the study. 
  • Service members should consult with the study coordinator if they expect a permanent change of duty station or deployment within 12 months of beginning participation.  

Q5:

Will the general public be allowed to participate in a trial taking place at a DoD location?

A:

No. At this time, the DoD sites are only planning to enroll MHS beneficiaries (active duty, retirees, adult family members) and DoD civilians.

Q6:

Are Service Members allowed to participate in these trials?

A:

Yes. Part of the DoD contribution the federal response providing study sites at military treatment facilities (MTFs) and clinical research centers for the conduct of Phase 3 clinical trials of vaccines. Accordingly, Service Members may wish to volunteer as study participants in these trials. To preserve the integrity of the vaccine trials, Service Members should consult with the study coordinator if they expect a permanent change of duty station or deployment within 12 months of beginning participation. To determine vaccine efficacy and long term safety profile, follow-up data will be a critical portion of the study.

Q7:

Is there any concern about the risks to operational readiness if service members are participating in the trials?

A:

No. The expected risk to fitness for duty related to the vaccine trials is considered low. 

DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101

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