A panel of independent experts is evaluating how the Food and Drug Administration is shepherding coronavirus vaccine development.
This type of meeting would normally only attract interest from Wall Street analysts and those closely involved with vaccine development. But today’s gathering is attracting widespread attention given the pandemic’s high stakes and lagging public trust in the vaccine development process.
The meeting, which will be live-streamed today, is widely viewed as reassurance that science, not the White House, is guiding the endeavor.
The unprecedented speed at which the vaccines are being developed has raised an ethical question.
Instead of waiting months or years to fully collect data on trial participants, developers are expected to apply to the FDA through an alternative pathway known as emergency use authorization. If an EUA is granted for a coronavirus vaccine, the vaccine could be given to certain high-risk populations to be spelled out by regulators.
The plan is to continue Phase 3 trials even while the vaccine is being distributed to select people, so researchers can get a fuller picture of how long the vaccine works and whether it causes side effects — and eventually apply for full authorization.
But continuing the trials requires maintaining a placebo group of patients. One question the panel is likely to consider today is whether to allow the placebo group to get the vaccine once it’s available.
If an EUA is approved, participants in that trial may want to know whether they received the vaccine – and if they didn’t, to get inoculated.
But vaccinating the placebo group could undermine the ability of researchers to make ongoing, longer-term comparisons that help determine the efficacy and safety of the vaccine.
There’s another challenge, too. There are currently 10 vaccine candidates in final-stage trials, according to The Washington Post’s tracker. If one gets emergency approval, patients in the other clinical trials may also want to know whether they received a placebo. If so, they also may be tempted to drop out of that trial so they could receive the approved vaccine.
“Issuance of EUA will likely slow down the trials,” said former FDA scientist Luciana Borio.
Vaccine manufacturers and other groups have raised concerns about this possibility.
The Biotechnology Innovation Organization wrote that it has an ethical obligation to inform trial participants that a vaccine may be available, saying “additional discussion is needed to determine how placebo-controlled trials can be maintained after an EUA is granted.”
“It is likely that any EUA issued for a covid-19 vaccine will have a broad impact on other covid-19 vaccines in development,” BIO wrote in comments submitted to the review panel.
Janssen Pharmaceuticals, which owns coronavirus vaccine developer Johnson & Johnson, submitted a letter outlining similar concerns.
“Once the first vaccines are licensed/authorized, this may lead willing volunteers to seek available vaccines over participating in ongoing trials,” the company wrote.
If the FDA approves use of the vaccine only for a narrow group of people, it could potentially minimize this risk. For example, if it