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Coronavirus (COVID-19) Update: FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted
July 13, 2022
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.
“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. COVID-19 vaccines remain the best preventive measure against severe disease caused by COVID-19 and I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-emergency-use-novavax-covid-19-vaccine-adjuvanted
https://archive.ph/uw4rc
FDA user fee bill deadline falls apart? Thousands of pink slips for FDA could be coming as Burr seeks to start anew
The battle over what to include in this latest round of user fee legislation — the industry money that pays for all biopharma drug and biologic reviews at the FDA and has to be reauthorized every five years — is coming to a head as Congress looks to meet an August recess deadline before the FDA has to send out thousands of warnings to much-needed reviewers that they’ll be soon laid off.
https://endpts.com/fda-user-fee-bill-deadline-falls-apart-thousands-of-pink-slips-for-fda-could-be-coming-as-burr-seeks-to-start-anew/
https://archive.ph/PfORr
paywall
Could Rail Workers Now Strike Starting Monday As Concerns Of a Feed Shortage Continue In the West?
Continued issues shipping feed and other products via rail are growing more severe. Feed users already report being just days away from running out of feed, and as labor negotiations continue between the railroads and unions, a weekend deadline looms to keep the collective bargaining process on track.
President Joe Biden has until Sunday, July 17, to appoint a Presidential Emergency Board (PEB) to investigate and make recommendations for settlement. If the Sunday deadline isn't met, rail labor has already voted to go on strike. However, the Association of American Railroads told AgWeb on Wednesday that it's widely expected there will be an appointment of a PEB by the deadline.
https://www.agweb.com/news/policy/politics/could-rail-workers-now-strike-starting-monday-concerns-feed-shortage-continue
https://archive.ph/LVO5x