How the FDA and CDC Are Failing Us on BA.5, the Worst Covid Variant Yet

·6 min read
Parts of Manhattan Back at 20% COVID Positivity - Credit: John Smith/VIEWpress/Corbis/Getty Images
Parts of Manhattan Back at 20% COVID Positivity - Credit: John Smith/VIEWpress/Corbis/Getty Images

The latest subvariant of the novel-coronavirus is spreading fast. And the federal government is struggling to keep up.

There’s a lot the Food and Drug Administration and Centers for Disease Control and Prevention can do to slow the BA.5 subvariant and prevent deaths.

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But both the FDA and CDC have dragged their heels. The FDA still hasn’t taken arguably the most important steps — approving both second boosters for Americans under age 50 and new booster formulations for subvariants such as BA.5. The CDC meanwhile isn’t clearly communicating to the public just how serious BA.5 is.

The delays are hard to explain, experts say. “We have known for a while that this variant was coming and that it seemed to be more transmissible,” says Cindy Prins, a University of Florida epidemiologist.

BA.5, an offshoot of the basic Omicron variant of SARS-CoV-2, first turned up in viral samples in South Africa back in February. Three months later it was dominant in Israel and across Europe, displacing earlier forms of the pathogen while also driving an increase in global daily Covid cases from around 477,000 a day in early June to 940,000 a day this week. 

In late June, BA.5 became dominant in the United States, too. For months before BA.5, daily new U.S. Covid cases had hovered around 100,000. This week cases jumped a third to 130,000 a day. Daily Covid deaths in the U.S. also increased a third, to 400.

BA.5’s dominance is baked into its RNA. Where the mutations that produced many earlier variants and subvariants largely affected the spike protein — the part of the pathogen that helps it to grab onto our cells — BA.5 has mutations all over its structure. 

BA.5’s broad mutations make the subvariant less recognizable to our antibodies, whether they’re from vaccines, boosters, past infection, or a mix of all three. BA.5 is skilled at sneaking past our immune systems, contributing to rising rates of reinfections and breakthrough cases in fully-vaccinated people.

Still, practically no U.S. experts expect a fresh round of mask mandates or new restrictions on business or travel. Public-health measures such as these have become politically toxic in the U.S. “It’s a tough atmosphere right now,” Prins concedes. 

But that doesn’t mean we’re powerless against BA.5 — or that the federal government doesn’t have a role to play.

One of the most helpful things the CDC can do is promptly communicate where the risk is greatest and where people should consider voluntarily masking up and limiting their exposure to crowds. 

It’s not doing a great job, Prins says. “I do think that the messaging about BA.5 has been slower than what I would have expected.”

One of the CDC’s main tools for communicating Covid risk is an interactive map it maintains that displays COVID data on a county level. “The CDC’s community-specific model for assessing current transmission levels is an excellent compromise to keep the public vigilant that we are still amidst a pandemic, while adapting the recommendations to the local level,” says Anthony Alberg, a University of South Carolina epidemiologist.

But the map in its default setting displays somewhat old data. Joaquín Beltrán, a Congressional candidate in California, called the map “intentionally misleading.” The CDC didn’t immediately respond to requests for comment. 

The CDC’s Covid map includes a default “community levels” setting that appears to show a quarter of America’s 3,223 counties with low Covid rates and 40 percent with medium rates, leaving just 35 percent of counties in the high category. 

That might seem to imply that most of the country is weathering BA.5 without a big increase in cases. But that’s not true. Click on the map’s “community transmission” setting and the problem is apparent: 92 percent of countries are in the “high” transmission category. 

The devil is in the definitions. The CDC defines the “community levels” on its default map as “new admissions” to hospitals in a given county. In other words, the “levels” map is all about Covid hospitalizations: how many people have been admitted to hospitals for serious infections. 

The “transmission” map is more comprehensive and immediate. It depicts all reported Covid cases in a county — even ones that haven’t landed someone in the hospital yet. It even counts cases that might be pretty serious, but where the infected person chose to recuperate at home. 

Hospitalizations are what epidemiologists call a “lagging indicator.” Hospitals start filling up days or weeks after a local surge in infections. If you’re watching hospitals for signs a Covid wave, you’re way behind the curve. But that’s the data the CDC shows you first. 

The FDA is struggling to keep up, too. Vaccines, boosters and past infection still offer meaningful, if somewhat reduced, protection against BA.5. The best protection comes from two prime doses of the messenger-RNA vaccines from Pfizer or Moderna plus two boosters. 

The problem is that regulators have only approved Americans 50 years old or older, or younger adults with certain immune disorders, for a second booster. “They need to allow all adults to get a second booster,” said Ali Mokdad, a professor of health metrics sciences at the University of Washington Institute for Health.

But the FDA won’t say whether, or when, it might authorize second boosters for younger people. “I have nothing to share at this time,” an FDA spokesperson said when asked about boosters for under-50s.

Pfizer and Moderna meanwhile have developed new boosters that they’ve tailored specifically for Omicron subvariants including BA.5. An FDA advisory panel endorsed these subvariant-specific boosters on June 30. The FDA announced it might finally approve them for emergency use for some Americans starting this fall. But the BA.5 surge is here now.

The FDA needs to move faster on various boosters, says Eric Bortz, a University of Alaska-Anchorage virologist and public-health expert. “It’s not hard to make [a booster] and shouldn’t need a long approval process.”

The agency already has methods for speedily approving new vaccine formulations. After all, it signs off on fresh flu vaccines every year without a top-to-bottom review process, Mokdad pointed out. 

Regulators could apply the same fast-track process to Covid boosters. “The FDA should be able to rapidly assess the efficacy and safety of a new formulation,” Bortz said. But it’s stuck doing things the slow way.

The bureaucratic sloth is a bad omen as the Covid pandemic grinds into its 32nd month. It’s looking increasingly likely that the virus will be with us, well, forever — surging from time to time as more-transmissible new variants and subvariants evolve. 

To help manage the virus, the feds must keep pace with its evolution. But they’re already falling behind.

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