The White House announced that children younger than five can receive a Covid vaccine potentially starting on June 21, “Not all parents are eager.” No surprise there, after the recent findings of the ineffectiveness of the Johnson and Johnson vaccine. “Only 29 percent of 5- to 11-year olds are fully vaccinated against Covid-19, even though that age group has been eligible since November.” Read more below!
Read more below.
NEW YORK TIMES: Youngest Children Could Get Covid Shots in Late June, White House Says
Sheryl Gay Stolberg; June 2, 2022
WASHINGTON — A top federal health official, anticipating that regulators will soon authorize coronavirus vaccines for children younger than 5, said Thursday that the first doses could be administered as early as June 21, and that states, pharmacies and community health centers can begin ordering them from the Biden administration on Friday.
Dr. Ashish Jha, President Biden’s coronavirus response coordinator, shared the timeline during a White House briefing. He cautioned that the preparations are contingent on Food and Drug Administration authorization of doses for children 6 months through 4 years old, and a recommendation from the Centers for Disease Control and Prevention. No doses will be shipped until the F.D.A. and the C.D.C. sign off.
“I want to be very clear that I am not here to prejudge the outcome of the process,” Dr. Jha said. “But the administration is hard at work planning all sorts of scenarios based on whatever the outcome is.”
He said the administration has been working closely with local health departments, pediatricians and family doctors, and has asked states to distribute the initial tranche of doses to sites like children’s hospitals, which serve the most vulnerable young patients, and sites in neighborhoods hardest hit by the pandemic.
The nation’s 18 million children under 5 are the last group of Americans for whom Covid vaccines are not available, and the frustration among many parents has been palpable. Now, for the first time, they have a specific date, albeit a tentative one.
But not all parents are eager. Only 29 percent of 5- to 11-year olds are fully vaccinated against Covid-19, even though that age group has been eligible since November. A recent survey by the Kaiser Family Foundation reported that just 18 percent of parents with children under 5 said they would get them vaccinated right away; 38 percent put themselves in the “wait and see” category and 27 percent said they would “definitely not” get their children vaccinated.
Dr. Jha said that while it will take some time for the vaccines to become broadly available, the White House expects that “within weeks” of an authorization, “every parent who wants their child to get vaccinated will be able to get an appointment.”
To pediatricians and parents waiting for the shots, the announcement was welcome, though not entirely unexpected.
“It’s almost summer, people want to go on vacation, they want to feel like their kids are safe,” said Dr. Yvonne Maldonado, a Stanford University professor who chairs the American Academy of Pediatrics’ committee on infectious diseases. She said that when she talks to parents, “the first question they ask me is: ‘When?’ ”
Pressure has also been mounting on Capitol Hill, where lawmakers have demanded to know why there has been such a long wait.
Parents “are frustrated, they are confused, and I am, too,” Senator Patty Murray, Democrat of Washington, who chairs the Senate health committee, said at an F.D.A. oversight hearing in April.
Late last month, the F.D.A. laid out its own tentative timetable for considering applications from Moderna and Pfizer-BioNTech to authorize doses of their Covid-19 vaccines for young children; a decision on authorization could come soon after an outside panel of experts advising the F.D.A. meets to discuss it on June 15.
If the F.D.A. grants emergency authorization to one or both vaccines, a C.D.C. expert panel will convene soon after to make recommendations about how they should be used. If the process is complete by Friday, June 17, Dr. Jha said, doses could ship over the three-day weekend that includes the Juneteenth federal holiday, and be available on Tuesday, the 21st.
In making the announcement, Dr. Jha was treading a delicate path. Last summer Mr. Biden created an uproar when he announced that booster shots would be available to many Americans in mid-September pending F.D.A. authorization — only to meet resistance from the agency’s leaders, who said they needed more time to review the data.
But Dr. Jha said it was important for the White House to plan, and to be transparent about it.
Dr. Maldonado, a nonvoting member of the C.D.C. expert advisory panel that makes vaccine recommendations, drew a contrast between the messaging on pediatric doses and on booster doses. Because the F.D.A. has been so vocal in laying out its plans, she said, Thursday’s announcement by Dr. Jha did not catch doctors and patients off guard.
“This is of a surprise, absolutely,” she said, “but it’s still exciting to hear that we are almost ready to start vaccination for little kids.”
This particular regulatory path has been a torturous one for the two vaccine makers. The Biden administration initially hoped to offer shots to those under 5 as early as February.
But that timeline was pushed back, in part because the two-dose regimen Pfizer had been studying proved insufficient against the highly contagious Omicron variant. The company began focusing on a three-dose regimen: two doses given three weeks apart, and a third at least two months later.
Last week, Pfizer and BioNTech said preliminary findings from a clinical trial of children younger than 5 had shown that three doses of their coronavirus vaccine had been 80 percent effective in preventing symptomatic infection in a subset of the 1,678 trial participants, who were 6 months through 4 years old. Pfizer said Wednesday that it had completed its application for emergency authorization.
Moderna’s request has been pending since April, when it asked the F.D.A. to authorize its coronavirus vaccine for children under 6. Moderna’s vaccine would be given in two doses, four weeks apart. The Moderna dosage is one-quarter of the dosage given to adults; Pfizer’s is one-tenth of the dose strength for adults.
Moderna has also applied for emergency authorization of its vaccine for children 6 to 17; the F.D.A.’s advisory committee will meet to discuss that application on June 14.
Photo: Doug Mills/The New York Times