Biologics

Senators Want Answers on Vaccine Option

Some 20 U.S. Senate Democrats are asking the leaders of Operation Warp Speed to respond to questions about reports that the federal government declined to exercise its option to purchase additional doses of the Pfizer Covid-19 vaccine earlier this year. “We are concerned the failure to secure an adequate supply of vaccines will needlessly prolong the Covid-19 pandemic in this country, causing further loss of life and economic devastation,” the senators wrote in a 12/14 letter. “We fear this is yet another instance in which the Trump administration’s failure to develop a comprehensive national vaccines plan in a timely manner could jeopardize efforts to get people vaccinated and ultimately end this pandemic.”

The letter says that Pfizer told the government that demand for the vaccine would likely outpace supply, and the government still declined to exercise its option to purchase additional supplies.

It says the administration must be more transparent about its preparations, as well as how much funding is available and is needed to purchase, distribute, and administer sufficient vaccine to end the pandemic. The senators ask for answers to these questions:

the government’s current projection of how many vaccine doses are necessary to vaccinate the entire population;
how much vaccine the U.S. government has contracted for and paid for, with specific questions about delivery times and details on the decision not to purchase additional doses from Pfizer; and
how much vaccine the U.S. government has a contract option to purchase and with which manufacturers, including specific information on funding available and needed.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome