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Yesterday, officials from the Centers for Disease Control and Prevention recommended that everyone above the age of six months should get a dose of the new, updated COVID-19 vaccine that the FDA just green-lighted. To learn more about the vaccine, and for guidance on how to approach COVID as cases rise, I called Katherine J. Wu, an Atlantic staff writer who covers science.

First, here are three new stories from The Atlantic:

Stress drinking has a gender divide. The conservative censorship campaign reaches its natural conclusion. Kevin McCarthy is a hostage.

For Everyone

Lora Kelley: Why is the CDC recommending that everyone get a COVID vaccine this fall?

Katherine J. Wu: Experts at yesterday’s CDC advisory panel were really making it clear that everyone stands to benefit in some way from this vaccine. COVID is very much still a real threat. People are still dying, and people are still being debilitated by long COVID. Even if risk is not equal across everyone in the population, this is a really important public-health intervention.

It’s also important to keep in mind the historical and cultural context here. Last year, uptake for the fall COVID vaccine was abysmal; less than 20 percent of people got it even though it was also widely recommended. And certainly, with uptake that low, the goal will be to raise uptake this year.

Lora: How does this shot differ from previous COVID shots and boosters?

Katherine: I would argue that this is not a booster. This is another move toward routinizing COVID-19 vaccines to be like the annual flu vaccine, a shot that is given to much of the population every fall in advance of respiratory-virus season. With the flu vaccine, there’s an expectation that the composition of the vaccine is going to change with some regularity: The main variants or strains the vaccines are targeting may change.

This COVID shot is different from last year’s: It no longer contains any ingredients targeting the original coronavirus variants that were in the very first vaccines that we got in 2020 and 2021. It targets just the XBB subvariants of Omicron.

Lora: In your article today, you wrote about an expert who believes vaccine recommendations should prioritize only vulnerable groups. What is motivating some experts not to offer full-throated endorsements of everyone getting a vaccine this fall?

Katherine: To be clear, there is really widespread consensus that everyone needs at least a couple doses of the vaccine. There’s no doubt in experts’ minds that going from zero vaccines to two or three is essential. The gains are going to be massive for everyone.

The disagreement here is not necessarily about the facts—it’s more about how they should be framed. There’s widespread consensus that certain groups are at higher risk than others, including people who are older, immunocompromised, pregnant, living with chronic health conditions, and living in congregate settings, to name a few. The question then is: Should we target the recommendations only to these groups, to really make sure that they are the ones going out to get this vaccine with no hesitation?

There is worry among some experts that the universal recommendation does not adequately focus vaccination efforts on the people who most need it. And some experts feel that young, healthy people, who are at a lower risk of bad COVID outcomes, may be set with the vaccines that they’ve already got.

Lora: How would you recommend that people who aren’t in those high-risk categories approach vaccines this fall?

Katherine: I am all for enthusiastically recommending this vaccine to everyone. Some people are at higher risk, so I would even more strongly encourage those people to go get it.

When we think about any vaccine, especially COVID-19 vaccines, we think most about preventing severe disease. But there are secondary benefits of these vaccines too: For at least a time, you will have a lower risk of getting infected and spreading the virus. And if you do get sick, your symptoms may be shorter if you’ve been recently vaccinated. There may even be a lower risk of developing long COVID down the road, which is an important thing to keep in mind because we know that it can come out of even mild infections. Also, there’s really not a concern at this point of the vaccine running out.

Lora: When should people get this vaccine?

Katherine: There are a few things to keep in mind on timing: If you are lower risk, there is relatively less rush to get the shot. That said, COVID cases have been rising for weeks now. So I certainly wouldn’t tell anyone to not get a shot anytime soon.

The one exception is if you’ve recently been infected. If you have had COVID recently: First, I’m sorry. Second, there are a lot of immunologists who would argue it’s not a terrible idea to wait maybe two or three months after your infection before getting a shot, because you probably have some lingering immunity left behind from that infection. (Huge caveat here: This is not an endorsement of infection, but just a matter of fact.) You don’t want to hamper the ability of your body to form a good immune response to the vaccine if you get it too close to infection.

You totally can get the COVID shot at the same time as the flu shot. It’s convenient, and you only have to deal with possible side effects once.

Lora: What precautions can people take this fall, beyond just getting vaccinated?

Katherine: I am definitely getting a vaccine this fall. But a vaccine is not a silver bullet. It’s going to work best against severe disease, but the protections against infection and transmission are more porous and more temporary. So when I go into crowded settings, when I travel on planes, when I see people in my life who are more vulnerable than I am, I am going to be testing and masking.

We’ve already seen that cases have been rising even at the tail end of summer, which is atypical for most respiratory viruses. That’s another reminder that COVID has not yet settled into a super predictable pattern. I don’t want to hide in my house forever. I want to be able to enjoy the company of others. But I see vaccines, testing, and masking as tools that enable me to interact more safely in those settings.

Related:

This fall’s COVID vaccines are for everyone. How bad could BA.2.86 get?

Evening Read

Didier Viodé

I Never Called Her Momma

By Jenisha Watts

Ms. Brown didn’t tell me where we were going. I knew we would be visiting someone important, a literary figure, because we took a gypsy cab instead of the subway. It would probably be someone I should have known, but didn’t.

A brownstone in Harlem. It was immaculate—paintings of women in headscarves; a cherry-colored oriental rug; a dark, gleaming dining-room table. Ms. Brown led me toward a woman on the couch. She knew that I would recognize her, and I did, despite the plastic tube snaking from her nostrils to an oxygen tank. Maya Angelou’s back was straight. Her rose-pink eyeshadow sparkled.

My mind called up random bits of information from I Know Why the Caged Bird Sings. Canned pineapples—she loved them. Bailey—her brother’s name. What she felt when she heard someone read Dickens aloud for the first time—the voice that “slid in and curved down through and over the words.” And that, like me, she had called her grandmother Momma.

Read our October cover story.

More From The Atlantic

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Today’s News

Danelo Cavalcante, a convicted murderer who escaped from Chester County Prison, has been captured after an extended manhunt. Ukraine launched a missile offensive on Crimea in one of its most significant attacks on Russia’s Black Sea Fleet. Tech leaders, including Sam Altman, Elon Musk, and Mark Zuckerberg, gathered in Washington for a bipartisan AI forum with lawmakers.

Dispatches

The Weekly Planet: You can transform your relationship to shopping with just a few basic sewing skills, Ann Friedman writes.

Explore all of our newsletters here.

Culture Break

Bob Berg / Getty

Read. “Rainbow Queen Encyclopedia,” a new poem by Sam Sax:

“my ex wanted a pet pig, so we imagined it. / even gave the thing a name, rubbed its invisible head / before bed—”

Listen. Smash Mouth’s 1999 album, Astro Lounge, is accessible yet weird—and the reason our staff writer Spencer Kornhaber became a music critic.

Play our daily crossword.

Katherine Hu contributed to this newsletter.

When you buy a book using a link in this newsletter, we receive a commission. Thank you for supporting The Atlantic.

You wake up with a stuffy nose, so you head to the pharmacy, where a plethora of options awaits in the cold-and-flu aisle. Ah, how lucky you are to live in 21st-century America. There’s Sudafed PE, which promises “maximum-strength sinus pressure and nasal congestion relief.” Sounds great. Or why not grab DayQuil in case other symptoms show up, or Tylenol Cold + Flu Severe should whatever it is get really bad? Could you have allergies instead? Good thing you can get Benadryl Allergy Plus Congestion, too.

Unfortunately for you and me and everyone else in this country, the decongestant in all of these pills and syrups is entirely ineffective. The brand names might be different, but the active ingredient aimed at congestion is the same: phenylephrine. Roughly two decades ago, oral phenylephrine began proliferating on pharmacy shelves despite mounting—and now damning—evidence that the drug simply does not work.

“It has been an open secret among pharmacists,” says Randy Hatton, a pharmacy professor at the University of Florida, who filed a citizen petition in 2007 and again in 2015 asking the FDA to reevaluate phenylephrine. This week, an advisory panel to the FDA voted 16–0 that the drug is ineffective orally, which could pave the way for the agency to finally pull the drug.

If so, the impact would be huge. Phenylephrine is combined with fever reducers, cough suppressants, or antihistamines in many popular multidrug products such as the aforementioned DayQuil. Americans collectively shell out $1.763 billion a year for cold and allergy meds with phenylephrine, according to the FDA, which also calls the number a likely underestimate. That’s a lot of money for a decongestant that, again, does not work.

Over-the-counter oral decongestants weren’t always this bad. But in the early 2000s, states began restricting access to pseudoephedrine—a different drug that actually is effective against congestion—because it could be used to make meth; the Combat Methamphetamine Epidemic Act, signed in 2006, took the restrictions national. You can still buy real-deal Sudafed containing pseudoephedrine, but you have to show an ID and sign a logbook. Meanwhile, manufacturers filled over-the-counter shelves with phenylephrine replacements such as Sudafed PE. The PE is for phenylephrine, but you would be forgiven for not noticing the different name.

“Thet switch from pseudoephedrine to phenylephrine was a big mistake,” says Ronald Eccles, who ran the Common Cold Unit at Cardiff University until his retirement. Eccles was critical of the switch back in 2006. The evidence, he wrote at the time, was already pointing to phenylephrine as a lousy oral drug.

Problems started showing up quickly. Hatton, who was then a co-director of the University of Florida Drug Information Center, started getting a flurry of questions about phenylephrine: Does it work? What’s the right dose? Because my patients are complaining that it’s not doing anything. He decided to investigate, and he went deep. Hatton filed a Freedom of Information Act request for the data behind FDA’s initial evaluation of the drug in 1976. He soon found himself searching through a banker’s box of records, looking for studies whose raw data he and a postdoctoral resident typed up by hand to reanalyze. The 14 studies the FDA had considered at the time had mixed results. Five of the positive ones were all conducted at the same research center, whose results looked better than everyone else’s. Hutton’s team thought that was suspicious. If you excluded those studies, the drug no longer looked effective at its usual dose.

All told, the case for phenylephrine was not great, but the case against was no slam dunk either. When Hatton and colleagues at the University of Florida, including Leslie Hendeles, filed a citizen petition, they asked the agency to increase the maximum dose to something that could be more effective. They did not ask to pull the drug entirely.

There was more damning evidence to come, though. The petition led to a first FDA advisory committee meeting, in 2007, where scientists from a pharmaceutical company named Schering-Plough, which later became Merck, presented brand-new data. The company had begun studying the drug, Hatton and Hendeles recalled, because it was interested in replacing the pseudoepinephrine in its allergy drug Claritin-D. But these industry scientists did not come to defend phenylephrine. Instead, they dismantled the very foundation of the drug’s supposed efficacy.

They showed that almost no phenylephrine reaches the nasal passages, where it theoretically could reduce congestion and swelling by causing blood vessels to constrict. When taken orally, most of it gets destroyed in the gut; only 1 percent is active in the bloodstream. This seemed to be borne out by what people experienced when they took the drug—which was nothing. The scientists presented two more studies that found phenylephrine to be no better than placebo in people congested because of pollen allergies.

These studies, the FDA later wrote, were “remarkable,” changing the way the agency thought about how oral phenylephrine works in the body. But experts still weren’t ready to write the drug off entirely. The 2007 meeting ended with the advisory committee asking for data from higher doses.

The story for phenylephrine only got worse from there. In hopes of making an effective product, Merck went to study higher doses in two randomized clinical trials published in 2015 and 2016. “We went double, triple, quadruple—showed no benefit,” Eli Meltzer, an allergist who helped conduct the trials for Merck, said at the FDA-advisory-panel meeting this week. In other words, not only is phenylephrine ineffective at the labeled dosage of 10 milligrams every four hours, it is not even effective at four times that dose. These data prompted Hatton and Hendeles to file a second citizen petition and helped prompt this week’s advisory meeting. This time, the panel didn’t need any more data. “We’re kind of beating a dead horse … This is a done deal as far as I’m concerned. It doesn’t work,” one committee member, Paul Pisarik, said at the meeting. The advisory’s 16–0 vote is not binding, though, so it’s still up to the FDA to decide what to do about phenylephrine.

In any case, phenylephrine is not the only cold-and-flu drug with questionable effectiveness in its approved form. The common cough drugs guaifenesin and dextromethorphan have both come under fire. But we lack the robust clinical-trial data to draw a definitive conclusion on those one way or the other. “What really helped our case is the fact that Merck funded those studies,” Hatton says. And that Merck let its scientists publish them. Failed studies from drug companies usually don’t see the light of day because they present few incentives for publication. Changing the consensus on phenylephrine took an extraordinary set of circumstances.

It also required two dogged guys who have now been at this work for nearly two decades. “We’re just a couple of older professors from the University of Florida trying to do what’s best for society,” Hatton told me. When I asked whether they would be tackling other cold medications, he demurred: “I don’t know if either one of us has another 20 years in us.” He would instead like to see public funding for trials like Merck’s to reevaluate other over-the-counter drugs.

There are other effective decongestants on pharmacy shelves. Even though phenylephrine does not work in pill form, “phenylephrine is very effective if you spray it into the nose,” Hendeles says. Neo-Synephrine is one such phenylephrine spray. Other nasal sprays containing other decongestants, such as Afrin, are also effective. But the only other common oral decongestant is pseudoephedrine, which requires that extra step of asking the pharmacist.
Restricting pseudoephedrine has not  curbed the meth epidemic, either. Meth-related overdoses are skyrocketing, after Mexican drug rings perfected a newer, cheap way to make methamphetamine without using pseudoephedrine at all. This actually effective drug still remains behind the counter, while ineffective ones fill the shelves.