FDA

Troubled Maryland plant told to toss part of the J&J vaccine ingredient it manufactured

BY: - June 14, 2021

WASHINGTON — Federal health regulators have instructed Maryland’s Emergent BioSolutions to scrap some batches of the Johnson & Johnson COVID-19 vaccine substance manufactured at the company’s troubled Baltimore plant, while clearing a small portion to be used in the U.S. or sent abroad. Two batches of the J&J vaccine substance made in Baltimore were deemed “suitable […]

Federal health regulators urge states to restart use of Johnson & Johnson vaccine

BY: - April 26, 2021

WASHINGTON — A federal advisory panel on Friday recommended that states return to using the COVID-19 vaccine from Johnson & Johnson, but also hand out updated fact sheets that will warn about the rare blood clots in women that paused the vaccine’s use. Top U.S. health officials swiftly acted on the recommendation by the panel, with the […]

Pause for Johnson & Johnson vaccine extended as federal health panel wrestles with next steps

BY: - April 15, 2021

WASHINGTON — Use of the Johnson & Johnson COVID-19 shot will remain paused for at least a week, after a federal vaccine advisory panel said Wednesday that it had too little data on a rare but serious blood-clotting condition reported in at least six women. That means states and federally run vaccine sites will be relying […]

Vilsack keys in on food insecurity and nutrition in USDA budget request

BY: - April 15, 2021

WASHINGTON — Agriculture Secretary Tom Vilsack on Wednesday laid out USDA’s goals to expand food insecurity and nutrition programs in the president’s budget request, as well as the agency’s focus on programs to address longtime racial discrimination. “Normally I would talk to you all about numbers in the budget,” Vilsack, the former governor of Iowa, […]

States start pausing J&J vaccine after recommendation from U.S. health officials

BY: - April 14, 2021

WASHINGTON — Top public health officials said Tuesday that they are recommending a pause in the use of a COVID-19 vaccine from Johnson & Johnson “out of an abundance of caution” following six cases of a rare and severe type of blood clot, and states and localities immediately began moving to suspend the vaccine’s use. Ohio […]

One-dose vaccine gets FDA green light after advisory panel OK

BY: - March 1, 2021

WASHINGTON — A Food and Drug Administration advisory panel on Friday gave its green light to a COVID-19 vaccine from Johnson & Johnson, signaling that states will soon see a third vaccine option in their weekly shipments — and the first that only requires one shot. Emergency-use authorization from the FDA Saturday swiftly followed the unanimous […]

Game-changing one-dose vaccine could be in states’ hands shortly

BY: - February 26, 2021

WASHINGTON — States struggling to provide enough COVID-19 vaccines are likely just a few days away from a pivotal development in the vaccination race: the availability of a shot that requires only one dose. The game-changing Johnson & Johnson vaccine would differ from the two current shots by Pfizer and Moderna in several critical ways. […]

Big uptick in vaccine supplies for states expected soon

BY: - February 24, 2021

WASHINGTON — Executives from five COVID-19 vaccine manufacturers told Congress Tuesday that they expect to significantly boost the number of shots delivered to states in the coming weeks. Pfizer will increase weekly shipments to more than 13 million doses by mid-March, an increase from the 4 to 5 million doses shipped weekly in early February, […]

FDA authorizes first COVID-19 vaccine, clearing the way for states’ rollout

BY: - December 15, 2020

WASHINGTON — The Food and Drug Administration on Friday authorized for emergency use the first COVID-19 vaccine in the U.S., a decision that serves as the starting gun for the vaccine logistics efforts that states have been preparing for months. The vaccine authorized for emergency use from Pfizer and German partner BioNTech began shipping across the […]

COMMENTARY

Big pharma’s safety pledge isn’t enough to build public confidence in COVID-19 vaccine – here’s what will

BY: - September 18, 2020

Americans are increasingly concerned that regulators and manufacturers will rush a vaccine to market without an adequate review. That prompted nine vaccine front-runners, including Pfizer and Merck, to promise to abide by clinical and ethical standards in an effort to increase the public’s confidence in any vaccine that ultimately comes to market. As a scholar […]

Librarians, national guard recruited for states’ new contact tracing armies

BY: - May 25, 2020

As states seek to loosen wide-ranging restrictions imposed to constrain the novel coronavirus, they’re also looking to deploy a huge new fleet of workers to keep cases under control. Enter the contact tracers. With interpersonal contact certain to increase as states lift COVID-19 restrictions, tracing the who infected people had contact with — and then […]

Reversing ‘reckless’ decision, FDA waives limits on coronavirus mask cleaners

BY: - March 30, 2020

Federal regulators removed daily quantity restrictions Sunday on an Ohio company’s new technology that it says allows health care providers to sterilize N95 respirators, masks in short supply as researchers forecast dramatic surges in hospital demand due to COVID-19. The Food and Drug Administration removed its previous restriction limiting Battelle Memorial Institute to decontaminating 10,000 […]