This is the final part of our four-part Battling Covid series, in which we speak with local Jewish researchers battling the pandemic.
When will we see a Covid-19 vaccine? Vaccinologist Dr. Nicola Klein is not about to estimate the date.
“The best you’re going to get is just a pure guess,” said Klein, director of Kaiser Permanente Vaccine Study Center and senior research scientist at the KP Northern California Division of Research.
But when a vaccine does come, it’s Klein and several others who will be double-checking, on behalf of California residents, that it’s safe. Klein, who has spent around 20 years studying vaccine safety, was one of 11 scientists named to the state’s Covid-19 Scientific Safety Review Workgroup by Gov. Gavin Newsom. The workgroup was set up in late October to oversee an independent review of any vaccine approved by the FDA in upcoming months.
“The purpose of the workgroup is to review all the data that is available, and the safety information about any new Covid-19 vaccines after they are authorized for use by the FDA,” Klein said. “The point is to evaluate the safety data to make sure the vaccines, according to data, are safe and appropriate for use in our population.”
Klein said setting up a separate committee to review the data for a vaccine approved by the FDA doesn’t mean that California doesn’t trust the federal agency’s OK. She said it’s quite common for outside groups of experts to be called in to advise government agencies “on how to use [a] vaccine in the whole population — who should be getting it? Should it be given to every infant? Should it be given to certain adults, certain age populations, or what have you, depending on the vaccine? So there is a longstanding tradition that there [is] another outside group of experts.”
In this case, the state of California has called Klein and other researchers — in fields from biostatistics to public health to infectious diseases — to review clinical data from any vaccines the FDA authorizes.
“Dr. Klein’s expertise, along with that of 10 other top health experts, will assist California reviewing any vaccine that receives federal approval and verify its safety, before California makes a Covid-19 vaccine available to those most at risk,” said Suanne Buggy, spokesperson for the California Department of Public Health.
Klein was selected for her work at Kaiser’s Vaccine Study Center, which Klein said works closely with the CDC on vaccine safety monitoring. The VSC works with vaccine trials but also specializes in following vaccines after they’re approved and given to the general public.
“We also do studies on how well the vaccines work in real life,” she said. “So ‘efficacy’ is when you look at how well a vaccine works in a clinical trial, like you’re hearing now about placebo-controlled efficacy trials. But what happens when vaccines are given to millions of people in the population? Those sorts of studies are called ‘effectiveness studies.’ You look to see how well, in a population, these vaccines work in real life.”
While the workgroup will definitely look at any vaccine that is authorized by the FDA, Klein said they’d start looking at any data as soon as it was made available to them even before it’s authorized. It’s one part of the way the vaccine research infrastructure is trying to move as fast as possible.
“Most vaccines take between eight and 10 years, for example, from start to finish — to be developed, to be all the way through all the clinical trials and through review and licensing at the FDA,” she said.
No one wants to wait that long for a Covid vaccine. But Klein said that speed doesn’t mean rushing through any safety considerations, and that the U.S. has a robust infrastructure for making sure new vaccines are safe.
“The timeline has been shortened because of the global emergency and the global pandemic, of course,” she said. “[But] all the steps we’ve been doing for clinical trials and all the steps happening look very much like all the normal routine processes, only everything’s been condensed into shorter time frames.”
The California workgroup is one part of this process. While there are six vaccines in Phase 3 trials in the U.S., no one yet knows how many will make it to emergency use authorization. But at that point, the workgroup will play a crucial role in whether and how it will be available to the public. As to when that’ll be, though, Klein couldn’t say.
“Maybe mid next year?” she said. “It’s hard to say when it’s going to be available for everybody. I think it’ll be the best-case scenario if, through 2021 we’ll have a reasonable amount of vaccine. But I think, like I said, that’s just a pure guess.”