Plenty of debate with new vaccine
President Donald Trump says we are on track to start delivering and distributing a COVID-19 vaccine sometime in October.
U.S. Centers for Disease Control and Prevention Director Dr. Robert Redfield says the vaccine won’t be widely available until the second or third quarter of next year. Who’s right? Scientists side with Redfield. But the dispute comes
at a time of growing worry about whether political pressure from the White House could influence regulators — and erode public confidence in vaccines. To help you navigate the political thicket and understand what’s really happening, here’s a guide to vaccine approval, the likely timeline and the potential consequences, based on the perspectives of key researchers and regulators.
Vaccine trials aren’t pegged to the calendar. They’re over only when there are enough statistical “endpoints” — data that proves unvaccinated people got sicker than vaccinated people — to make a deci
sion. That takes time.
“I think that it will be hard to be able to have it by November, this early in the game.”
Immunologist Dr. Kari Nadeau, Stanford University’s Medicine Grand Rounds, Sept. 9 But there should be meaningful vaccine data by the end of the year: It’s possible to guess — based on the size of the study and infection rates in the community — when a trial will have enough “end points” to show whether a vaccine works. At least one company, Pfizer, said they’re expecting some meaningful data by the end of October.
“My projection is that it would likely be November or December; we don’t know, we’re just going to have to wait to see — the trials are on.”
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in an interview with WTOP, Sep. 17. Even that time frame would be the fastest vaccine development ever, and here’s why:
• New gene-based technologies are faster than traditional techniques.
• The different phases of clinical trials are now overlapped.
• Manufacturing facilities are already producing the vaccine candidates. Stanford Immunologist Dr. Kari Nadeau A group of independent experts, not the White House, is reviewing vaccine data: This board, called the Data Safety and Monitoring Board (DSMB), reviews the latest reports — including safety data and infections — from every vaccine trial at scheduled meetings. They report to the National Institutes of Health but they’re not government employees; they’re academic experts. They make recommendations,
not rulings.
They work in secret. They are, in principle, independent. We only hear from them if one of these two things happen: a safety problem or proof of indisputable effectiveness. Right now, the board has access only to the safety data.
Effectiveness data is expected to be evaluated at meetings in either midOctober or December. Traditionally, the next step is for the vaccine manufacturer to seek a license from the FDA: An FDA committee — called the Vaccines and Related Biological Products Advisory Committee comprising 15 authorities selected by the FDA commissioner — reviews the safety and effectiveness data at a public meeting. Then it votes on whether the vaccine should receive approval. VRBPAC’s next meeting is scheduled for October 22, about two weeks before the election, but it seems unlikely the needed data will be available by then.