Janssen Biotech of Johnson & Johnson has submitted a request for emergency use authorization (EUA) from the US Food and Drug Administration (FDA).  Their COVID-19 vaccine candidate is unique in that it requires just a single dose, with normal refrigeration for up to 3 months or sub-zero freezing for up to two years.  It has demonstrated 66% effectiveness in eight countries on three continents (72% in the US), and 85% efficacy in completely protecting against COVID-19 related hospitalizations and death.

The FDA has announced they’ll be reviewing the data and will convene the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021.

IMA will continue to monitor regulator guidance and offer meaningful, practical, timely information.

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