By WK Editorial Staff
To assist stakeholders with the COVID-19 outbreak, Health Law Daily is compiling coverage and resources in this recurring tracker.
Vaccine. At a meeting on December 10, 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), a committee of independent experts advising the FDA made a recommendation to the agency — in a vote of 17 in favor, 4 against, and 1 abstaining — to grant an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine. V
RBPAC had been presented the following question: "Do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?"
The FDA subsequently approved the EUA that same day, and in coordination with the Centers for Disease Control and Prevention (CDC) and its vaccine distribution plans, began to vaccinate individuals designated as initial recipients earlier this week.
At-home test. The FDA issued an EUA to LabCorp for its Pixel COVID-19 Test Home Collection Kit for use with LabCorp’s COVID-19 RT-PCR Test. The Pixel COVID-19 Test Home Collection Kit is the first COVID-19 direct-to-consumer (non-prescription) test system, allowing a person to self-collect a nasal sample in their home and then send the sample to LabCorp for testing. It can be used by anyone aged 18 or over, and purchased online or in a store without a prescription.
It is intended to permit users to assess their COVID-19 infection status that could aid with determining if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional.
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