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Child-vaccine doses favored by FDA panel

Wheels in motion for shots soon for 5- to 11-year-olds by Compiled Democrat-Gazette Staff From Wire Reports | October 27, 2021 at 7:18 a.m.
FILE - This Thursday, Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. On Friday, Sept. 24, 2021, The Associated Press reported on stories circulating online incorrectly asserting that experts with the Food and Drug Administration revealed that the COVID-19 vaccines are killing at least two people for every person they save. But FDA experts did not say this, and strongly refuted this false claim in an email to The Associated Press. A speaker who is not affiliated with the FDA made these statements during the open public hearing portion of a Sept. 17 FDA vaccine advisory panel meeting. (AP Photo/Jacquelyn Martin, File)

WASHINGTON -- The U.S. moved a step closer to expanding covid-19 vaccinations for millions more children as government advisers Tuesday endorsed child-size doses of Pfizer's shots for 5- to 11-year-olds -- setting in motion a string of decisions that could lead to them getting shots as soon as late next week.

A Food and Drug Administration advisory panel voted unanimously, with one abstention, that the vaccine's benefits in preventing covid-19 in that age group outweigh any potential risks. That includes questions about a heart-related side effect that's been rare in teens and young adults who received much higher vaccine doses.

While children are far less likely than older people to get severe covid-19, ultimately many panelists decided it's important to give parents the choice to protect their youngsters -- especially those at high risk of illness or who live in places where other precautions, like masks in schools, aren't being used.

"This is an age group that deserves and should have the same opportunity to be vaccinated as every other age," said panel member Dr. Amanda Cohn of the Centers for Disease Control and Prevention.

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The FDA isn't bound by the panel's recommendation and is expected to make its own decision within days. If it concurs, there's still another step: Next week, the CDC will have to decide whether to recommend the shots and which youngsters should get them.

About 28 million children could become eligible, with only the youngest, those younger than 5, remaining unvaccinated.

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Full-strength shots made by Pfizer and its partner BioNTech already are recommended for everyone 12 and older, but pediatricians and many parents are clamoring for protection for younger children. The highly contagious delta variant has caused a rise in pediatric infections, and families are frustrated with school quarantines and having to say no to sleepovers and other rites of childhood to keep the virus at bay.

In the 5- to 11-year-old group, there have been more than 8,300 hospitalizations reported, about a third requiring intensive care, and nearly 100 deaths.

States are getting ready to roll out the shots -- just a third of the amount given to teens and adults -- that will come in orange-capped vials to avoid dosage mix-ups. More than 25,000 pediatricians and other primary care providers have signed up so far to offer vaccinations, which will also be available at pharmacies and other locations.

But for all that anticipation, there also are people who strongly oppose vaccinating younger children, and the FDA and its advisers were inundated with an email campaign seeking to block the Pfizer shot.

Dr. Jay Portnoy of Children's Mercy Hospital in Kansas City, Mo., said despite more than 4,000 emails urging him to vote against the vaccine, he was persuaded by the data showing that it works. Portnoy said he also was representing "parents I see every day in the clinic who are terrified of sending their children to school. ... They need a voice also."

Panelists stressed that they weren't supporting vaccine mandates for young children -- and the FDA doesn't make mandate decisions. FDA vaccine chief Dr. Peter Marks also said it would be highly unusual for other groups to mandate something that's cleared only for emergency use. Several advisers said they wished they could tailor the shots for the highest-risk youngsters, a decision that would fall to the CDC.

Dr. James Hildreth of Meharry Medical College said he ultimately voted in favor of the vaccinations "to make sure that the children who really need this vaccine -- primarily Black and brown children in our country -- get it."

Pfizer studied 2,268 elementary schoolchildren given two shots three weeks apart of either a placebo or the children's dosage. Vaccinated youngsters developed levels of virus-fighting antibodies just as strong as teens and young adults who got the full-strength shots.

More important, the vaccine proved nearly 91% effective at preventing symptomatic infection -- based on 16 cases of covid-19 among youths given dummy shots compared with just three who got vaccinated.

The child dosage also proved safe, with similar or fewer temporary side effects -- such as sore arms, fever or achiness -- that teens experience. At the FDA's request, Pfizer recently enrolled another 2,300 youngsters in the study, and preliminary safety data has raised no red flags.

But that study isn't large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. The panel spent hours discussing whether younger children, given smaller doses, might face that side effect too.

Statistical models developed by FDA scientists showed that in most scenarios, the vaccine would prevent far more hospitalizations in this age group than would potentially be caused by that rare problem.

The FDA's models suggested that the vaccine could prevent 200 to 250 hospitalizations for every 1 million youngsters vaccinated -- assuming that virus spread remained high, something that's hard to predict. FDA scientists also said younger children probably won't have as much risk of heart inflammation as teens, but if they did it might cause about 58 hospitalizations per million vaccinations.

Marks of the FDA noted at Tuesday's meeting that 1.9 million children ages 5-11 have been infected and more than 8,300 of them have been hospitalized, a third of whom needed intensive care. Nearly 100 have died, making covid-19 one of the top 10 causes of death in this age group.

Children in this age range are "far from being spared from the harm of covid-19," he said.

Dr. Fiona Havers, a specialist in viral diseases at the CDC, noted that children in this group make up 10.6% of all cases but only 8.7% of the population.

CHECKS HIT, MISS

In some U.S. cities, a person out for a night on the town might have to wait while someone at the door of the restaurant or theater closely inspects the person's vaccination card and checks it against a photo ID. Or the person might be waved through just by flashing a card.

How rigorously vaccination requirements are being enforced varies from place to place, even within a state or city.

Proof of vaccination is required in some cities to get into restaurants and bars, attend a concert or play, catch a movie or go to a ballgame.

Ticket agents dutifully ascertain the vaccination status of everyone passing through the turnstile at professional sports venues in some cities, and restaurant hosts do the same in many places. In other locations, vaccination checks are cursory at best. Sometimes it's practically on the honor system.

"There are some businesses that say they check for vaccination proof, but they are not even checking," said Jay Matsler of Palm Springs, Calif., who was visiting San Francisco's Fisherman's Wharf with his partner during a cruise stop.

"We actually tell them, 'I'm sorry, you're not enforcing this. We're not going to give you our business,'" Matsler said. He said they were recently in Prague and Paris and had to show their vaccination cards and IDs at every indoor space they visited.

Some places around the U.S. are afraid of losing business if they insist on proof. Some say they don't have enough staffing to conduct such checks amid a nationwide labor shortage. Some object on principle. And some don't want to risk ugly confrontations.

During the first month of enforcement in New York, inspectors issued warnings to 6,000 businesses for not checking patrons' vaccination status, and 15 were fined $1,000 as repeat offenders.

The indoor dining area at a burger joint in San Francisco was shut down by health authorities this month for not demanding proof of vaccination.

Public health authorities see the requirements as vital in slowing covid-19 at a time when 1,500 or more Americans are dying each day. Such rules face deep opposition in conservative states, however.

At the Highway Inn restaurant in Honolulu on Monday, the hostess asked diners for proof of vaccination or negative covid-19 tests before seating them indoors. The information on their cards must match their IDs, and they must give contact information that the restaurant keeps on record for two weeks in case of an outbreak.

Russell Ryan, the restaurant's co-owner, said business declined when the shot requirement for restaurants took effect in mid-September. A few unvaccinated people "stormed off in a huff," he said, but most have complied, and business has returned as more people have gotten vaccinated.

"Generally, it has been less confrontational than we feared," Ryan said. "We thought that we'd get some zealots who want to make a stand for whatever reason."

In many places, precisely how to enforce the vaccination rule is left up to businesses.

At a movie theater on a recent night in San Francisco, teenagers at the concession stand glanced at patrons' cellphone photos of their vaccination cards before handing them their popcorn, candy and drinks.

At the city's Opera House, however, an usher closely examines the proof of vaccination and compares it with a picture ID. Anyone who fails to show proof is asked to leave.

San Francisco health inspectors checking on the food permits of restaurants also routinely look to see whether businesses are complying with the rules, but the city relies largely on complaints of violations phoned in to its 311 line.

Since the city's mandate took effect Aug. 20, only one restaurant has been penalized: The In-N-Out at Fisherman's Wharf was closed for the day Oct. 14 after its managers refused to ask for proof of vaccination despite several warnings from the city. It now offers only takeout.

A spokesman said the company refuses to be "the vaccination police for any government."

LOUISIANA MANDATE

In Louisiana, Gov. John Bel Edwards said Tuesday that he's largely ending the indoor mask mandate since the state has emerged from its latest spike and is seeing lower rates of infection.

"I stand here today optimistic, relieved that the worst of the fourth surge is very clearly behind us now," Edwards said.

But while the Democratic governor is lifting the mask requirement for grocery stores, restaurants, bars, retailers, colleges and other sites, he's keeping a complicated set of face-covering rules in place for K-12 schools.

School districts that maintain tight quarantine regulations for students who come into close contact with someone who tests positive won't be required to have mask mandates. But those districts that don't require all exposed students to be sent home will have to keep students and staff members masked under the regulations taking effect today.

The Edwards administration said stricter requirements should remain in place at schools because children have greater exposure risks, with those younger than 12 unable to get vaccinated yet and sitting in crowded classrooms for hours.

MICHIGAN MASKS

In Michigan, the Republican-controlled Senate on Tuesday approved bills attempting to block broad requirements for students to wear masks or to be vaccinated.

The four-proposal package passed in party-line votes of 19-15. Republicans said decisions on children's health should be left to parents.

But Democrats contended that the policies went against science, put kids in danger and promoted conspiracy theories. Democratic Gov. Gretchen Whitmer is expected to veto the bills if they reach her desk.

Sen. Erika Geiss, D-Taylor, said there was no vaccine mandate for students and the legislation is a "waste of time."

"It is very clear that the school districts, the schools that have not put in place or where their health departments have not put in place the simple, effective procedure of having masks are the ones that are still continuing to put their student body and the families of their student body at risk for what is still a highly contagious, potentially deadly disease," Geiss said in a floor speech.

But Sen. Lana Theis, R-Brighton, said the bills would make sure all students have access to their constitutionally protected education. Forced vaccines and masks are driving people apart, she said.

Information for this article was contributed by Lauran Neergaard, Matthew Perrone, Caleb Jones, Olga R. Rodriguez, Lindsay Whitehurst, Melinda Deslatte and Kevin McGill of The Associated Press; by Sharon LaFraniere and Noah Weiland of The New York Times; and by Craig Mauger of The Detroit News (TNS).

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