FDA Head Promises Honest Science On Vaccine Approval
Stephen Hahn, the FDA commissioner, vows to resist pressure to release a COVID vaccine before it's ready. He suggests he would resign if he can't resist it.
FDA Commissioner Says He Would Consider Resignation If Asked To Release A Coronavirus Vaccine Too Early
The commissioner of the US Food and Drug Administration said "all options are on the table" when asked if he would resign if pressured to release a coronavirus vaccine before he feels it's ready. "I can tell you, our decision at FDA will not be made on any other criteria than the science and data associated with these clinical trials," Dr. Stephen Hahn told CBS. (Holcombe, 9/1)
COVID-19 Vaccine Will Be Made Available "On The Basis Of Science And Data," FDA Commissioner Says
The commissioner said, depending on that data, it's possible a vaccine could be available by Election Day under the Emergency Use Authorization program - before a Phase III trial is completely finished. Hahn acknowledged the pressure his agency faces to approve a vaccination. "There's been pressure throughout this pandemic and I think anybody who doesn't acknowledge that would be kidding themselves. There's been pressure to make sure that we get medical products as quickly as possible to the American people," Hahn said.(Lapook, 8/31)
In related developments —
The Wall Street Journal:
Covid-19 Vaccines: What’s Coming And When?
Some 170 Covid-19 vaccines are in development around the world, according to the World Health Organization, each one promising to protect people from the deadly coronavirus and allow them to go back to work and school. Now, a handful are starting or nearing the final stage of testing. Depending on the results, some companies say their vaccines could be greenlighted for use as soon as this year. (Rivas, Loftus and Cervantes, 8/31)
What Happens If China Gets The Covid-19 Vaccine First?
David Fidler has a nightmare scenario: In three months, China announces one of its Covid-19 vaccines has successfully completed Phase III trials. The World Health Organization is enthusiastic. Beijing doles out doses to countries in Latin America and Africa and those with claims to the South China Sea. The United States is nowhere to be found. “If China wins the race, exploits that advantage and we don’t have anything equivalent yet, what do we do?” he asks. “That to me is what concerns me the most.”
Past Vaccine Disasters Show Why Rushing A Coronavirus Vaccine Now Would Be 'Colossally Stupid'
Vaccine experts are warning the federal government against rushing out a coronavirus vaccine before testing has shown it's both safe and effective. Decades of history show why they're right. (Christensen, 9/1)
Large Trials For The Oxford COVID-19 Vaccine Begin In The U.S.
Phase 3 clinical trials for the much-anticipated Oxford COVID-19 vaccine are set to begin in the United States Tuesday, with participants in Madison, Wisconsin rolling up their sleeves for the injection. The University of Wisconsin is one of dozens of test sites in the U.S. for the vaccine candidate, made by AstraZeneca in partnership with the U.K.'s University of Oxford. Tuesday's trial will mark the start of the third phase 3 trial in the U.S. for a COVID-19 vaccine, following Moderna and Pfizer. (Edwards, 8/31)
AstraZeneca, Oxford Biomedica Expand COVID-19 Vaccine Supply Tie-Up
AstraZeneca has expanded its previous agreement with Oxford Biomedica to mass-produce the British drugmaker’s COVID-19 vaccine candidate, as it looks to scale-up supply ahead of a possible fast-track approval from the United States. Gene and cell therapy firm Oxford Biomedica said on Tuesday AstraZeneca would give it 15 million pounds ($20 million) upfront to reserve manufacturing capacity at its plant and that it could get an additional 35 million pounds plus other costs until the end of 2021 under the new 18-month deal. (9/1)