Covid-19 roundup: HHS may struggle to absorb Operation Warp Speed; Europe has no plans for a fourth vaccine dose
Operation Warp Speed, perhaps the greatest achievement of the former Trump administration, promptly delivered Covid-19 vaccine supplies nationwide when they became available, thanks to collaborations between HHS and the Department of Defense, while helping to fund and aid the manufacture of billions of doses.
But since the Biden administration took over a year ago, acting FDA commissioner Janet Woodcock transitioned out of her role as the therapeutics lead in Warp Speed, which has been converted into a new operation without the fancy name (now known as the “HHS-DOD COVID-19 Countermeasures Acceleration Group”), and as of the start of 2022, the Department of Defense is no longer helping HHS on the program.
According to a new report from the Government Accountability Office on Thursday, that transition away from DOD will be tough for the HHS, which might not be equipped to take on the Warp Speed skeleton without DOD resources and skilled personnel.
“It’s unclear whether HHS is ready to fully assume all responsibilities, especially those formerly led by DOD. HHS has assessed its workforce capabilities, but it hasn’t addressed the loss of DOD officials with specialized skills,” GAO said. “Moreover, HHS does not have a schedule that is consistent with best practices to help it manage remaining vaccine-related activities.”
The HHS did not concur with GAO’s recommendation on workforce needs, and GAO said it revised this recommendation based on updated information, but “maintains that it continues to be valid.”
Meanwhile, Texas Republican Rep. Michael Burgess introduced a bill recently that would integrate the process behind Warp Speed into the FDA. The bill also calls on FDA to “collect interim data that would allow for parallel assessments of the safety and effectiveness of multiple drugs and biological products and the parallel approval or licensure of multiple drugs and biological products, including through the conduct of concurrent clinical trials.” — Zachary Brennan
Europe has no plans for a fourth Covid-19 vaccine dose
As countries debate whether to administer a second booster vaccine to battle Omicron, the European Medicines Agency recently made clear that this is not the direction in which it’s planning to move.
The EMA announced earlier this week that a fourth dose is — at the moment — off the table for the general population, the agency said in a series of messages on Twitter.
— EU Medicines Agency (@EMA_News) January 18, 2022
The EMA did acquiesce slightly, saying that it would be reasonable for public health authorities to consider giving a fourth dose to those with severely weakened immune systems and who have already had three doses of a Covid-19 vaccine.
The agency went on to address vaccines designed to target the Omicron variant.
“Approval of Covid-19 vaccines with a different composition requires clinical data that show a superior immune response than the one generated by the boosters currently available,” the agency said.
Research on the effectiveness of a fourth dose against Omicron has been spotty. A study among healthcare workers in Israel found that while the fourth dose does increase an immune response, it’s likely not enough to prevent infection from Omicron, though it could boost protection against severe disease. — Paul Schloesser