COVID-19 vaccine endorsed for emergency use
FDA approval anticipated
Last updated 12/29/2020 at 2:33pm
The FDA is expected to approve a vaccine for COVID-19, a medical innovation with the potential to end the pandemic sometime in 2021.
The committee meeting that advised approval was planned in an open meeting and livestreamed for public view.
"The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA's process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible," said FDA Commissioner Stephen M. Hahn, M.D. in a statement posted before the meeting.
The FDA spent the past several months reviewing data, and the date of when the public would know results was deemed unpredictable prior to Dec. 10, Hahn said in a statement posted on the FDA website. In a rapid response after a day of discussion, the committee gave the nod to the new science and endorsed data.
The hope expressed officially prior to Dec. 10 was to make a vaccine available. Various news reports this week said both Canada and the United Kingdom were already using the vaccine.
Locally, Snohomish County health officials in the Joint Information Commission meeting earlier the same week said a plan is in place for distribution. First responders, health care workers and those with high risk for severe disease are anticipated as first in line for the mRNA vaccine.
The mRNA vaccine is considered new science but has shown promising data in clinical trials.
The FDA committee, made up of outside scientific and public health experts from around the country, was tasked with offering a clear understanding of the scientific data and information put before the FDA. The committee considered what vaccine research always does: safety and effectiveness. The group evaluated data from clinical trials to make a decision about whether to authorize, Hahn said in the statement and ended up recommending for authorization. News reports from other outlets today say the FDA is expected to approve it, within days.
Background materials are available to the public, the FDA statement said. Additional experts with specific expertise were an option for individual meeting, the FDA stated.
Meeting information is available here: https://bit.ly/2VJwbqH. Check back for a follow-up story, in the Beacon.