It’s been a dizzying week to be a parent of a kid under 5 who desperately wants them to be vaccinated against COVID.
On Monday night, the Washington Post reported that the FDA asked Pfizer to submit data on its COVID vaccine for kids for potential emergency-use authorization, which the company did on Tuesday. These developments were surprising because in December, the company announced it would need more time to evaluate a third shot in clinical trials after getting mixed results after two shots. On Wednesday, Surgeon General Vivek Murthy shed a little light on the change during a White House briefing, saying the crush of Omicron infections allowed for the collection of “additional clinical data that we did not have in December.” FDA advisers are scheduled to meet on February 15 to review the data, a necessary step on the road to emergency-use authorization for two shots while data comes in on a third.
Suddenly, the possible timeline for young children abruptly moved up from months away to weeks away. Though the trial results aren’t yet public, the updates are a refreshing change from the past few weeks, when parents — especially mothers, who overwhelmingly bear the burden of disrupted child care or keeping kids home entirely — relied on an informal information-and-advocacy network on social media.
Some of the most reliable information for anxious parents on what’s happening with the vaccine has come from a woman who calls herself Molly and sardonically described herself as “a housewife tweeting about gossip from other trial parents.” That’s underselling it a bit. In addition to having a kid in the youngest-kids trial, the mother of four tweeting under @MamaWeasleyy has a science background. (She asked to remain anonymous for her family’s privacy and to stay out of the firing line of the anti-vaxx.)
She didn’t plan on being what she jokingly termed the “Deuxmoi” of pediatric vaccines. “Back in the spring of 2021, Pfizer produced a little calendar that showed when they expected to have EUAs for every age group,” she told me. “I actually printed it out and taped it on the inside of the cabinet door in my kitchen.” That, she said, was the end of transparent updates about a timeline. (As I’ve previously written, my daughter is in such a trial, but that has given me no special insight.)
In the past few weeks, Molly has drawn on messages from fellow parents of trial participants to report on how the third shot is being handled and which sites are still enrolling, close-read Pfizer’s public submissions, and fact-checked news organizations that misreported Anthony Fauci’s comments on the under-5 vaccine by going to the tape. (She also turned down a parent who tried to bribe her in the DMs, apparently believing she could get them into a trial, she told me.)
As for the sudden sense of urgency from the federal government, she said, “If they’re listening to moms at this point, it’s great. I think it’s frustrating that they’ve waited essentially months before actually reacting to any pressure people have been putting on them. At this point, I’m mostly irritated.”
Three in ten parents of children under 5 say they’ll get their kids shots “right away” when eligible, according to new research from the Kaiser Family Foundation. Murthy counted himself among the eager in that briefing, saying he has a 4-year-old daughter. Over the past few weeks, first-person or reported accounts of the agony of waiting have been featured in Time and The Nation and on NPR, CNN, and Slate, to name a few. Two of the journalists who pressed the hardest on the timeline for the vaccine have identified themselves as such. “I ask you almost every week because my own kids can’t get vaccinated,” said CBS’s Face the Nation moderator Margaret Brennan last weekend to Scott Gottlieb, the Pfizer board member who used the moment to hint at the two-shots-first scenario. “There is a sense of urgency. We’ve certainly heard from many parents who would like to immunize their children,” said Janet Woodcock, acting FDA chief, on a recent Stat News podcast. Co-host and CNBC reporter Meg Tirrell, who has also pressed pharma CEOs on their timelines, responded, “I am one of them.”
Another is Fatima Khan, who told me she stopped working last summer, in part because of a desire to keep her young kids safe at home, as one in 15 mothers of children under 5 have done during the pandemic, according to a recent analysis from the Century Foundation. “A lot of parents don’t have that option,” she said. “This pandemic has forced parents into an impossible position.”
A few weeks ago, galvanized by the lack of a vaccine for her younger child, Khan found some like-minded moms through Facebook, including a frustrated pediatrician, and co-founded the advocacy group Protect Their Future. The group sent a letter to the FDA signed by 250 doctors that proposed multiple options for getting young kids vaccinated: letting pediatricians vaccinate children off-label or allowing companies to submit data for younger age groups even if older ones haven’t yet been approved. (That policy has hampered Moderna’s effort to submit younger-kids data to regulators.)
Khan, who had worked in political and corporate communications, says she realized that doctors demanding that officials move on a younger-kids vaccine could be a potent force. The FDA and Pfizer’s recent move to get the ball rolling on two shots wasn’t what Protect Their Future asked for, but Khan told me she welcomes the move anyway: “Some protection is always better than no protection, and a lot of kids don’t have the choice to hunker down at home.”
Having apparently gotten the attention of federal officials, the worry among advocates is now that they’ll be drowned out by skeptics, whose main concern is whether the appearance of a rush will backfire and reinforce hesitancy among parents. But the vaccine uptake for kids ages 5 to 11 is pathetic even without this procedural zigzagging; throughout the pandemic, public-health officials have done the worst when they’ve tried to second-guess or armchair-analyze the public. In fact, worry about backlash is partly how we got into this mess. Pfizer has said it chose the lowest possible dose for its trial — too low for some kids, by their own account — because it figured additional side effects would dissuade parents. In the time since Pfizer announced its delay, many more children under 5 got infected, and hospitalization in that age cohort rose sharply.
Let’s see the data. No safety concerns were identified in the trial, and if the results are good enough, as Molly put it to me, “They should give parents who believe in vaccines the option to protect their own children.”