Saturday, September 26, 2020

Here’s How the Pandemic Finally Ends (Part 2, Politico)


“The vaccine arrives: ‘I expect a little bit of chaos’

“While many experts see value in strategies like vastly expanding testing, most agree that finding a working vaccine will be the biggest step on the road to normalcy. The optimistic prediction that a vaccine will be ready for distribution by Election Day—put forth not only by Trump but also Pfizer CEO Albert Bourla—is looking increasingly unlikely. The two leaders in the U.S. race for the Covid-19 vaccine, Moderna and Pfizer, are still enrolling participants in their Phase III trials. In these trials, some participants receive a vaccine and the rest get a placebo, and then administrators wait to see who gets sick. U.S. presidents and CEOs can’t control the speed at which that happens. ‘It depends upon the frequency of [Covid exposure in] the neighborhood, how loose a person is’ with masks and social distance, says Emanuel. Remember: The trial participants are still being told, like all Americans, to take precautions against infection.

“An October vaccine authorization would require either a lot of participants to be exposed to Covid-19 in a short time, or a vaccine so effective that its power becomes apparent soon into the trial. But many experts doubt that the first-generation vaccines will be hyper-effective. Plus, releasing a vaccine early carries the danger of missing a rare side effect, and drug companies in the world’s glaring spotlight will be reluctant to take that risk.

“Nonetheless, given the urgency across the world, it’s probable that one or several approvals will happen at the end of the year or early next year. ‘Best-case scenario, we get a few vaccines that work by December,’ says Landon. It could take longer. Larry Corey, who is in charge of coordinating the clinical trials of U.S. government-funded vaccines, has guessed the first U.S. Phase III results won’t be available until February.

“Getting a vaccine out to the American people, of course, is a different problem—and a colossal one. Pharma companies and the U.S. government must produce, distribute and administer around 660 million doses of vaccine over the next year or so, because the vaccines furthest along in trials require two doses per person. Krammer says he expects ‘a little bit of chaos.’

According to the U.S. government, hundreds of thousands of doses have already been made. But recent guidance from the Centers for Disease Control and Prevention indicates that only a few million doses of two leading vaccines—believed to be the Moderna and Pfizer candidates—will be available at first, to be given to essential workers and society’s most vulnerable.

“Many experts, including the director of the CDC, predict that vaccines could be widely available as early as late spring or summer. But Emanuel believes that they’re underestimating just how difficult it will be to manufacture and distribute the doses at scale. In a report published by the Center for American Progress this summer, he and co-author Topher Spiro pointed out large gaps in the country’s vaccine setup, including potential shortages of production capacity, syringes and packaging.

“And then there’s the problem of actual shot-in-arm delivery. Pfizer’s vaccine, for example, needs to be stored at minus 70 degrees Celsius. ‘No doctor’s office has negative 70,’ says Emanuel. ‘You can’t do ‘the usual’—you know, this sort of hodgepodge we have of CVSes, Walmarts, … Walgreens, doctor’s offices, schools.’ CDC guidance suggests states prepare to distribute doses at hospitals and mobile clinics.

“Making sure that most Americans receive two doses of the same vaccine four weeks apart smoothly and efficiently will be a massive government operation—one that Emanuel thinks the country can pull off no earlier than November 2021—and that’s if you have ‘good management skills, good logistics,’ he says. ‘If there is some element of optimism and not just realism, it’s in that. There is no evidence this administration has the capacity to manage that.’

“After vaccination: ‘We have to wait to prove that it’s working.’

“It’s 2021, and you’ve just gotten your two doses. What happens next will largely depend on two factors: How effective the vaccine is and how many people get it. The goal is for the vaccine to be effective and widespread enough for the U.S. population to reach the herd immunity threshold—the point at which, theoretically, Americans can safely take off their masks and attend large sporting events. A rough, back-of-the-envelope estimate for Covid-19 (derived from calculating the point at which each infected person, on average, infects less than one other person) is that society will reach herd immunity when around 60 percent to 70 percent of the population is immune.

“Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, walked through the math: Roughly, ‘the formula would state that about two-thirds of the population would need to be vaccinated if [the vaccine] was 75 percent effective against shedding’ (i.e., transmitting) the virus. If the vaccine is less effective than that, a greater percentage of the population needs to get vaccinated to close in on herd immunity. And vice versa.

“Experts aren’t optimistic that these first-generation vaccines are going to be highly effective at preventing transmission. ‘The likelihood that we are hitting a home run in the first at bat is just very low,’ says Michael Kinch, director of the Centers for Research Innovation in Biotechnology and Drug Discovery at Washington University in St. Louis.

“Nor has the FDA set the bar very high: The agency indicated that any approved vaccine must prevent Covid-19 or decrease severity in at least 50 percent of those vaccinated, but that means more than 50 percent of the population could continue to transmit the disease.

“Without a highly effective vaccine, the country needs relatively high vaccination rates. And yet a whopping two-thirds of Americans say they won’t get the vaccine when it’s first available—and a quarter say they’ll never get it. Many scientists fear that so many people are going to refuse to get both doses of a vaccine out of distrust or fear or just plain forgetfulness that America won’t reach a high level of protection, much less herd immunity.

“‘Apparently, these shots with Covid … they give you some fevers, some chills, you feel a little flu-like,’ says Emanuel. ‘Well, how many Americans are coming back [to say], ‘Oh, I would like that again. I would like to feel like under the weather for a few days to get this vaccine.’ … What I worry about is we have a lot of people who are only partially immunized with one shot.’

“There’s also the problem of even distribution. Some places like Boston, with its robust medical industry, might see very high vaccination rates, while states like Idaho and Colorado, with the lowest measles vaccination rate in the country, might end up with a lot of unprotected residents—and more disease. This is also a risk in Black communities in particular, where the coronavirus has taken an outsized toll but where distrust of the U.S. medical establishment runs high after decades of horrific experiments like the Tuskegee Syphilis Study.

“‘If you’re immunizing effectively above that immunity threshold, then it means that you can go back to business as usual,’ says Cobey. ‘But that’s assuming … you’ve got the vaccine pretty evenly distributed in the population. And vaccines are almost never evenly distributed. Which is to say that you could easily have pockets like we’ve seen in Marin County and other places with measles [where] you can still get outbreaks.’

“This isn’t a reason to panic. Any vaccine is going to be a big help in containing the pandemic. ‘Even if you don’t get herd immunity … the closer you get to it, the slower the virus spreads,’ says Krammer, who expects many of the vaccines in development to work. ‘Fifty percent [effectiveness] is not that little.’ But it won’t enable people to attend the theater or cozy up in their favorite dive bar right away. ‘I’m not sure people get that,’ says Offit. ‘What worries me in this is that people would think, ‘Great. I’ve got the vaccine. I’m good. I can engage in high risk activity.’ And that would put us right back to where we were.’

“Adds former CDC director Tom Frieden: ‘I think even with a vaccine, for the indefinite future, handshakes are out and masks are in.’ The key to figuring out what’s possible with a vaccine, Landon says, is patience. ‘You have to treat the vaccine the same as a masking policy. You make a policy that everybody has to wear masks and then some percentage of people actually do.’ Similarly, ‘You give people a vaccine, and then some proportion of people will actually get the vaccine and some proportion of them will be protected.’ Next, you wait to see whether the Covid-19 disease and death counts go down, which will take about two months after people receive their doses—a few weeks for people to develop immunity and then four to six weeks for that protection to appear in the numbers.

“If rates are coming down, says Landon, ‘then you say, ‘OK, I think we can allow people to eat inside at restaurants.’ And then the rates stay low even though you invited people back to restaurants.’

“Eventually, if the country doesn’t open too quickly, ‘we could find ourselves in a situation that China is in, that Taiwan is in, where we might still have limited little outbreaks here and there, but the majority of us can get back to most of the things that we used to do. We can have, you know, some parties … some gatherings.’ She thinks we could get there by spring 2021 but that it will still take a couple of years to put the pandemic in the rear-view mirror.

“It’s all about how many people in a given situation are likely to have Covid. Landon has been helping companies walk through the numbers as they consider whether to reopen their offices. If, for example, the positivity rate in a given population is 2.5 percent, as is true in many communities today, and ‘you have a company that has 100 people in it, two or three of them would have [Covid-19] on the day that you come back to work,’ Landon explains. ‘And as soon as [companies] see that, they’re like, ‘Maybe we should keep working remotely if we can.’ But if you get it so that it’s only one in a thousand people who have Covid, having one hundred people together in a gathering place and putting masks on them means that no one’s going to get sick.’

“This process is going to take much longer internationally. A coalition of international organizations—GAVI, the Center for Epidemic Preparedness and the WHO—are aiming to purchase and deploy 2 billion vaccines to the world’s most vulnerable in 2021. But Oxfam recently warned that 61 percent of the global population will not have a vaccine until at least 2022. Rich countries are not making equitable access easy: According to Oxfam, wealthy countries representing 13 percent of the world’s population have already reserved over half the supply of leading vaccine candidates.

“Emanuel anticipates countries opening up international travel as they get and deploy vaccines, but that ‘it’s going to take a couple or three years to really get … a full return to pre-Covid normalcy’ in international travel…” (Politico).

Elizabeth Ralph is deputy editor at Politico Magazine.


No comments:

Post a Comment

Note: Only a member of this blog may post a comment.