Will A Vaccine Be Safe? FDA Under Pressure Over Approval Process
And as the development of several experimental vaccines is fast tracked, thorny questions are raised about efficacy, testing, costs, ingredient availability and quality.
Stat:
FDA Chief Pressured To Stick To Science For Covid-19 Vaccine Approvals
As pressure mounts to develop a successful Covid-19 vaccine, Food and Drug Administration Commissioner Stephen Hahn insisted any agency approval would “adhere to standards” that ensure safety and effectiveness. But Hahn left the door open to a so-called emergency use authorization, raising concerns the FDA might still face political pressure to approve a vaccine before the November elections. (Silverman, 8/6)
ABC News:
Dems Want Expert Panel To OK Coronavirus Vaccine Before Mass Use
House Democrats are calling on the Food and Drug Administration to empower an independent panel of experts to review and sign off before a coronavirus vaccine is distributed to the general public, a move aimed at quelling some health experts' fears the Trump administration might ram through a vaccine candidate ahead of the November election. A new legislative proposal obtained by ABC News would require the FDA to seek input from the Vaccines and Related Biological Products Advisory Committee in a public hearing before giving an emergency authorization for the widespread use of any COVID-19 vaccine. (Siegel, Bruggeman and Rubin, 8/6)
CNN:
Fauci 'Satisfied' With Enrollment For The First Week Of Covid-19 Vaccine Trial
Dr. Anthony Fauci said he's "satisfied" with the enrollment in the first week of the first US Phase 3 clinical trial of a Covid-19 vaccine. CNN has obtained part of a Friday, July 31 email from Moderna, the company running the trial, that states 1,290 people were randomly assigned to get either the vaccine or a dummy shot as of that date. The trial began on Monday, July 27. (Cohen and Vigue, 8/7)
NPR:
Vaccine Prices For COVID-19 Begin To Emerge
How much will vaccines against the coronavirus cost? Even though none has finished clinical testing, some clues about pricing are starting to emerge. Cambridge, Mass.-based Moderna, one of the leading horses in the vaccine race, has already made deals at between $32 and $37 per dose of its experimental coronavirus vaccine in agreements with some foreign countries, rattling consumer advocates, who fear an unfair deal for U.S. taxpayers. (Lupkin, 8/6)
Kaiser Health News:
Test Sites Quickly Attract Thousands For COVID-19 Vaccine Study
Dr. Eric Coe jumped at the chance to help test a COVID-19 vaccine. At his urging, so did his girlfriend, his son and his daughter-in-law. All received shots last week at a clinical research site in central Florida. “My main purpose in doing this was so I could spend more time with my family and grandchildren,” Coe said, noting that he’s seen them only outside and from a distance since March. (Galewitz and Aleccia, 8/7)
NPR:
A Key Ingredient For Making A COVID-19 Vaccine Work
There are many approaches to making a vaccine against COVID-19. Some use genetic material from the coronavirus, some use synthetic proteins that mimic viral proteins and some use disabled versions of the virus itself. But before any of these approaches can generate the antibodies to the coronavirus that scientists say are essential to protecting people from getting sick, the immune system has to be primed to make those antibodies. Palca, 8/6)
Stat:
The Story Of A Scientist’s Mea Culpa On Covid-19 Vaccines
The development of Covid-19 vaccines is progressing at an unprecedented speed. Vaccines that were mere blueprints in January when the coronavirus began spreading globally already have advanced into massive Phase 3 clinical trials. The U.S. government wants hundreds of millions of doses of Covid-19 vaccine or multiple vaccines ready to distribute by January. Many experts have raised concerns about this highly compressed development schedule. (Feuerstein, Robbins, Garden, 8/7)
In vaccine news from other nations —
AP:
The Latest: Switzerland Signs Vaccine Deal With Moderna
The Swiss federal government has struck a deal with Moderna to supply Switzerland with 4.5 million doses of COVID-19 vaccine if the U.S. biotech firm successfully develops one. The Federal Office of Public Health says the agreement aims “to guarantee Switzerland early access to the vaccine of Moderna” and is one of the first such deals by any government with the company. (8/7)
AP:
Russia's Race For Virus Vaccine Raises Concerns In The West
Russia boasts that it’s about to become the first country to approve a COVID-19 vaccine, with mass vaccinations planned as early as October using shots that are yet to complete clinical trials -- and scientists worldwide are sounding the alarm that the headlong rush could backfire. Moscow sees a Sputnik-like propaganda victory, recalling the Soviet Union’s launch of the world’s first satellite in 1957. But the experimental COVID-19 shots began first-in-human testing on a few dozen people less than two months ago, and there’s no published scientific evidence yet backing Russia’s late entry to the global vaccine race, much less explaining why it should be considered a front-runner. (Litvinova, 8/7)
