Parents of America, Unite!
Tens of millions of children are awaiting the approval of a vaccine to protect them from COVID-19. Their impatient parents should know that they don’t just have to sit around and wait. Consider, for example, what happened during the AIDS epidemic, when the advocacy group ACT UP, but a scant year old at the time, figured out where the holdup in dealing with the AIDS crisis was: a featureless building in Maryland, home of the Food and Drug Administration. ACT UP’s realization was as relevant three decades ago as it is now.
President Joe Biden has offered little explanation as to why so many must wait. “We can’t take shortcuts with that scientific work,” he said last week. But after telling the public nothing of what the delay was, he assured the audience, the “nation’s top doctors are committed to keeping the public at large updated on the process.” And this past weekend, a little news did slip out: Pfizer expects to submit its data from its trials on 5-to-11-year-olds “in the coming weeks.” But that information is still not not detailed enough, and that timeline is still not soon enough. ACT UP had it right years ago: The FDA doesn’t know how to respond to a crisis, but citizens can pressure it to do what’s right.
Many parents of children under 12 are despairing. They have children who have special needs, or who have respiratory problems. They have no child care; they live in communities that don’t require masks or take other protective measures. School has started, leading to potentially more exposure. Not surprisingly, some parents of 10- and 11-year-olds are pirating the adult vaccines, passing their children off as older (something the CDC has sternly warned against).
What is going on? The foot-dragging on children’s shots appears to have taken hold in late June, before the Delta variant’s threat was clear. On June 10, one of the many FDA advisory committees, the Vaccines and Related Biological Products Advisory Committee, debated whether to grant emergency-use authorization (EUA) to vaccinate children. Most of those on the committee opposed to EUAs for children came from regulatory agencies such as the FDA and the National Institutes of Health, and most of the members stressing the emergency situation were academic doctors from outside, although the split was not perfectly clean.
The opponents cited reports of a few cases of a side effect—myocarditis, the inflammation of the heart muscle—in young men. Rare, transitory, and usually not fatal—and anyway what was the rush to vaccinate children? “I really am not seeing this as an emergency authorization in children. The EUA just seems like overkill in my opinion,” said Michael Kurilla, director of the division of clinical innovation at the NIH’s National Center for Advancing Translational Sciences. In mid-July, President Biden had used the word soon for the children’s shot, but one week later, on July 26, the FDA announced that it was requiring Moderna and Pfizer to double the size of their test groups, which would delay the rollout.
The agency soon heard from the doctors in the field. “Last week saw the largest week-over-week percentage increase in pediatric COVID-19 cases since the start of the pandemic,” Lee Savio Beers, the president of the American Academy of Pediatrics, wrote to FDA Acting Commissioner Janet Woodcock on August 5. The Delta variant has changed whatever the cost-benefit analysis had previously been.
A Birmingham, Alabama, pediatric infectious-disease specialist, David Kimberlin, appearing on the former Biden senior adviser Andy Slavitt’s podcast on August 30, revealed more. “Here’s the problem: The few additional subjects are not going to tell you anything at all about rare side effects,” he said. “We are not likely at all to learn anything from an additional thousand subjects enrolled in terms of any rare side effects which may or may not be there … You need an additional hundred thousand to see that, and that’s not a desirable sample size … I personally would not have introduced the additional subjects. The original design was adequate.”
The FDA has provided the public with nothing helpful as to what delayed the process in July. On September 2, Acting Commissioner Woodcock offered what can only be called “word salad” in a conversation with John Whyte of WebMD: “But it depends on trials getting done, that the results are favorable, that we feel comfortable, everyone feels comfortable, that the new safety questions do not arise … That trials have to be done,” she said. “There is some safety followup at some trials [that] are still inoculating children, so they’re in different phases and they need to be completed. And we really need that information before we start exposing children to these vaccines.” Woodcock’s assertion that trials “need to be completed” simply assumes that vaccination cannot proceed along a parallel track, with an approved vaccine based on the first round of completed trials and continued monitoring of the additional subjects added in July. All of this is to say that the FDA isn’t moving fast enough—or at the very least hasn’t sufficiently explained its plodding pace.
How does a frustrated public move a fearful bureaucracy, if not to action, then at least to real answers? Thanks to ACT UP, that is not a rhetorical question. By 1988, people with AIDS—in America, mostly gay men—were desperate. (The playwright Larry Kramer had opened the founding meeting of ACT UP a year earlier by asking everyone on one side of the audience to stand. “At the rate we are going, you could be dead in less than five years,” he said.) The only treatment the FDA had approved in those years was AZT, a drug with little efficacy and terrible side effects. The connected and vigilant gay community knew that treatments such as ganciclovir, for the collateral symptom of viral blindness, were surfacing. But the FDA would not approve the drug, because it had no human placebo or animal studies. Enroll in a placebo double-blind study, the FDA advised the patients who were actually going blind. Not surprisingly, many people with AIDS began smuggling potential treatments, including importing unapproved drugs from abroad. On October 11, 1988, ACT UP sent 1,000 demonstrators to “seize control of the FDA.” For a year before the demonstration, ACT UP had been lobbying health agencies, pharmaceutical companies, and Congress for parallel trials, which would have granted people access to the drugs as early as phase one trials concluded. Within a year of “seizing control,” the FDA and the NIH adopted the new procedure, starting with dideoxyinosine, the next new potential AIDS treatment. And that was just the first change. Anthony Fauci has said repeatedly that there are two eras in American medicine: before Larry Kramer and after Larry Kramer.
When ACT UP’s members were done, they wrote a playbook for future actions. First, gather the crowd. The AIDS activists had 20 years’ experience of organizing marches after Stonewall, in 1969, but parents everywhere in 2021 have social media to gather the crowd. The advisory committee everyone names as the bottleneck has a meeting scheduled for Friday, September 17. Although it’s an online meeting because of COVID, there is a site for public comment. At least the director, Peter Marks, is likely to be in his office in Maryland, but even if he’s not, the street theater is what counts.
Second, prepare the media for a spectacle, and give them a spectacle. ACT UP timed its actions for prime conventional-media coverage: End before 3 p.m. and don’t act up on Friday. It put together press kits with detailed explanations and material on the issue and distributed them to the media. It scattered people designated to speak with members of the media throughout the October 11 demonstration, armed with the materials, and instructed them on how to follow up with any media contacts they made. Most of all, it had “clear, concise, [and] dramatic visuals.”
What outlet would be able to resist a picture of 1,000 parents each carrying a picture of their 5-to-11-year-old child?
Thousands of demonstrators worked because, as ACT UP discovered, even a bureaucracy like the FDA can be swayed by public pressure. In the years after 1988, the agency changed its procedures at every level, such as initiating parallel tracking of medicines in trials, allowing expanded access for whole patient populations, and adding consumer representatives to relevant committees. Congress even changed the statute that governs the agency to reflect the new order.
But all that has not been enough for COVID. In the early months of the pandemic, the CDC’s COVID test failed, and the FDA stopped everyone else from making a replacement. The advisory committee so central to the issue has one vacancy, and it appears it is that of the consumer representative. (My repeated requests to the FDA press office about the status of the vacancy have produced no response.)
Why have the parents of unvaccinated children, seeing their schools start to close down or the virus spread, not acted up? Part of the explanation lies in the nature of the risk. A disease like AIDS, fatal if not treated, in the ’80s threatened vulnerable populations even more immediately than COVID does today. Additionally, the ACT UP community was led early on mostly by white men who had not lost their sense of entitlement gleaned from the days before they came out as gay. Parents, however, is often a euphemism for mothers, who are generally women and not blessed with the expectation of empowerment more common among men.
Finally, drug regulators, led by the revered Anthony Fauci, cloak themselves in the mantle of science: “waiting for the science, following the science.” Unlike the anti-vaxxers, people who want vaccines see themselves rightly on the side of science. But ACT UP also faced this dilemma. It occasionally allied with right-wing and libertarian movements that were seeking FDA approval for fanciful treatments like apricot pits for cancer, but the ACT UP leaders focused on the drug issue did not want to position themselves against science. They knew that science was ultimately where their salvation lay.
Parents, too, can both protest and embrace science. ACT UP showed the world that the FDA isn’t the only arbiter of “the science” and that its dilatory procedures cannot be defended simply by invoking the word science. Schools all over America are open. Pediatricians are begging for action. If the FDA wants the parents of American children to wait for its bureaucracy, maybe as long as three more months, it must offer a better reason. And if it can’t, then give us the vaccines already.