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What precautions do we need to take if we have providers who want to participate in a COVID-19 clinical trial?

It depends on the type of vaccine. Some live attenuated vaccines could potentially cause post-vaccination shedding of the virus to susceptible persons, requiring extra precautions to be taken; whereas inactivated viruses cannot replicate, because they are considered dead viruses and are unable to cause post-vaccination shedding of the virus. Other vaccines may not include the actual virus. Prior to having a provider personally participate in any clinical vaccine trial, we recommend that the practice review the manufacturers’ vaccine information and consent agreement related to the trial to determine if any precautions need to be taken post-vaccination.

In addition, the potential side effects to the vaccine mimic COVID-19 symptoms. Caution will need to be utilized to avoid missing a possible infection. A vaccine participant must follow practice policy and quarantine if they develop symptoms until COVID-19 is ruled out. Participants should not assume symptoms are side effects and not COVID-19.

We also recommend that practices maintain documentation of vaccine trial participation information, such as a copy of the vaccine trial consent, requirements, and precautions recommended to support that appropriate measures were taken by the practice and the participating individual. Any participating employees should alert practice mangers of any risk or concerns noted post-vaccination.

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All Curi recommendations are based on current CDC criteria at the time of publication. CDC guidance for SARS-CoV-2 infection may, or may not, be adopted by state and local health departments to respond to rapidly changing local circumstances. Providers should always check with their local health department to see if the CDC’s guidance on any given topic has been modified (particularly if more restrictive) from the CDC’s recommended guidelines. Follow this link https://www.cdc.gov/publichealthgateway/healthdirectories/index.html for contact information to your state/local health department. If local recommendations vary from those of the CDC, and you are unsure what recommendations to follow, then it is safer to follow the more restrictive guidelines/recommendations.