Moving into the seventh month of the pandemic, are Americans watching a horror movie — or a Lifetime holiday special?
For Dr. Bob Wachter, the chair of UCSF’s Department of Medicine, the answer is, “yes.” “It feels like we’re viewing this in a split-screen,” he said during Thursday afternoon’s UCSF Grand Rounds session.
On one screen, he said, the horror show is “of epic proportions.” Case counts, hospitalizations and deaths are “skyrocketing” around the country as we move into colder months. San Francisco case counts are up “three-fold,” he said, and “hospitalizations and deaths are sure to follow.”
On the “rom-com” screen, a vaccine is so close we can almost feel the needles in our arms: The vaccine could begin reaching people in late December. “In fact, the news on vaccines is actually quite remarkable,” Wachter said, “almost beyond the dreams that we might have had a few months ago.”
Vaccines were the primary topic of the conversation on Thursday. Wachter invited Dr. Paul Offit, a University of Pennsylvania pediatrician who specializes in vaccine development — and a doctor who will evaluate whether the vaccine candidates are ready for use — to break down the good news about two vaccines that their producers report are extremely effective.
Those two producers are the pharmaceutical giant Pfizer and upstart Moderna — both of whom recently announced that their vaccines, following independent trials on tens of thousands of people, are more than 90 percent effective.
“It’s a remarkable technological achievement,” Offit said. For this, he noted, an administration that could not “tell the difference between a white cell and prison cell” should be “praised” for its Project Warp Speed, a $24 billion project that “created two vaccines that appear to be highly effective, safe, and work well in people who are older,” all in less than a year.
Offit drew a timeline for when Americans might expect a vaccine.
The Food and Drug Administration’s Vaccine Advisory Committee, a panel on which he will sit and evaluate whether the vaccine is ready for the public, will meet for three days, beginning on December 8. The panel will look closely at the vaccine trial data produced by Pfizer and Moderna. If all looks good, the committee will pass it to the Center for Disease Control’s Advisory Committee on Immunization Practices, which would take “24 to 48 hours” to make a determination of its own, Offit said.
“And then, in theory, as early … as the third week of December, you could start to see these vaccines rolling off the assembly line into the arms of the American public,” he said.
Though he “understood why people are hesitant,” Offit assured Wachter that the speed at which the vaccines were being developed and approved was safe.
The FDA was “back on the rails,” he said, following several dubious emergency authorizations of therapeutic drugs earlier in the year. Those included decisions on hydroxychloroquine and convalescent plasma, and the perceived deference to the Trump administration and its political desire to bring a vaccine to market before the election.
“It’s back on the rails because Commissioner (Stephen) Hahn finally stood up for the FDA,” Offit said. He explained that, in October, Hahn required vaccine developers to provide at least two months of safety data before their vaccines could be approved. Hahn said this despite “pushback” from the Trump administration, Offit said.
“That was the moment — the breaking moment — when he stood up for his agency, because, believe me, you want to trust the FDA,” Offit said.
And he said the FDA should be trusted, and states who are forming their own vaccine advisory committees — California is one of them — should pull back. “You can’t really have that kind of splintering; it’s too chaotic,” he said. “I do think you can trust the FDA and trust the CDC, no matter how much this administration has disparaged them in the past.”
Wachter then asked about distribution. “We’re trying to distribute vaccines to 330 million Americans and billions of people around the world,” he said. “What could go wrong?”
Offit used Pennsylvania as an example of how things may go right. Its Secretary of Health, Dr. Rachel Levine, has already identified specialized “vaccination centers” — retail pharmacies set up to store the vaccine doses in freezing cold temperatures. Offit said Levine has a clear idea of how it will work. She only needs to know how many vaccine doses are coming the state’s way, and when and where the government is shipping it. States may also need financial help to set things up.
Offit said states will have different strategies but clear guidance from the federal government will help. “When the Biden-Harris administration takes over on January 20, there may be clear direction from the federal government about how this is going to play out,” he said. “Obviously, right now, we have no federal leadership in this.”
Dr. Annie Luetkemeyer, a professor of infectious disease at UCSF, was up next and talked about the equally import topic of therapeutics. Although having a vaccine will help prevent Covid-19 from developing in people, therapeutics are still necessary to treat people who have developed Covid-19 and require hospitalization.
Luetkemeyer talked about “monoclonal antibodies” — which are laboratory-produced antibodies meant to target the “spikes” of the coronavirus to block further infection. There are currently trials studying the antibodies’ effects on patients at various stages of the disease — inpatient, outpatient, and prevention.
The downside is that two of the monoclonal treatments that are the furthest along have been either temporarily halted or partially halted, due either to safety concerns or a lack of efficacy, she said. But the upside is other versions of the drugs, which are not as far along in studies, seem promising.
While Luetkemeyer has thrown all of her efforts this year into developing treatments for Covid-19, she said, “we’re not going to be able to treat our way out of this disease.”
“It doesn’t mean that therapeutics aren’t important. We need them to save people’s lives,” she said. For there to be a real game-changer, “we need to prevent this disease from happening — so that’s where a highly effective vaccine will be critical.”
She reiterated her prediction from earlier in the year that, with a good vaccine, life will return back to normal this upcoming June. “That may still be true,” she said.
“I just booked a vacation for September,” Wachter replied. “And I may not be alone in doing that.”
Grand Rounds will not convene on Thanksgiving.