Friday, October 29, 2021

FDA Adviser Explains Why He Abstained From Vote On Pfizer's COVID-19 Vaccine For Kids

FDA Adviser Explains Why He Abstained From Vote On Pfizer's COVID-19 Vaccine For Kids

Authored by Zachary Stieber via The Epoch Times,

The only Food and Drug Administration vaccine advisory panel member to abstain from a major vote this week that essentially authorized Pfizer’s COVID-19 vaccine for children as young as 5 said he did so because of limited safety and efficacy data.

All 17 others voted to advise the administration, or the FDA, to authorize the jab for children between the ages of 5 and 11. The agency already supported doing so and is expected to formalize the authorization soon. The Centers for Disease Control and Prevention would then decide which children should get the shot.

The vote was preceded by nearly eight hours of discussions and presentations, with multiple members expressing concern about the scant data on how the vaccine will affect the age group.

But Dr. Michael Kurilla, an expert on infectious diseases and pathology who directs a division inside the National Institutes of Health, was the only one who didn’t support the recommendation.

Kurilla told The Epoch Times in an email that he opposed the specific, binary wording of the question, which opens up the possibility that any child between 5 and 11 will be able to get the Pfizer vaccine. He was also concerned about the longest follow-up for the clinical trial involving the age group being only three months, data that shows children experience severe cases of COVID-19 much less often than adults, and how a large chunk of them have already had the disease, giving them some level of immunity.

If the authorization goes through as expected, at least some of the age group will be able to get two doses of 10 micrograms each, spaced three weeks apart.

The same dosage interval, with a dosage level three times as high, is currently in place for adults. But adults have seen waning effectiveness, especially against infection, prompting the recent authorization of booster doses.

Because the interval is the same, it can be predicted that the effectiveness will also wane in children, Kurilla said. The lower dosage level, meanwhile, brings into question whether the protection against severe disease and hospitalization will be as strong as in adults.

“Real-world evidence involving adults suggest the 3-week dosing interval is suboptimal in terms of durability and is likely to be similar in children, leading to waning immunity within 4–6 months,” Kurilla said.

“Because the Pfizer vaccine offers protection against serious disease even after antibody titers have waned, there is some other basis for immunity, but at the lower dose in children, there is no expectation that those same immune processes will behave similarly to the higher adult dose.”

Pfizer/BioNTech’s new pediatric COVID-19 vaccine vials are seen in this undated handout photo. (Pfizer via Reuters)

Low Hospitalization Rate

During the meeting, members heard that among children 5 to 11 in the United States, there have been over 1.9 million infections since the start of the pandemic, but just 0.4 percent, or 8,400 of those cases, have required hospital care. And just 94 of them ended up dying.

They also heard that an estimated 20 percent of the hospitalized children were admitted for a reason besides COVID-19 and that nearly seven out of 10 of the children had existing serious health conditions like heart disease, illustrating just how little risk COVID-19 poses to healthy children.

Further, the Centers for Disease Control and Prevention (CDC) estimates that 40 percent of children in the age group have already had COVID-19. Recovery from COVID-19 bestows some level of immunity, studies show, with multiple studies indicating the level is actually higher than vaccines provide.

“The benefit here is assumed to be prevention of severe disease, which is what we’re all hoping for,” Kurilla said during the meeting.

But among the recovered, he added later, “The question really becomes, does this vaccine offer any benefits to them at all?”

Kurilla signaled he would have voted “yes” if the FDA had proposed opening up access to the vaccine to a subset of the 5–11 group. He also explained why he abstained.

“My abstention was based on the specific question the FDA asked. A ‘no’ vote would have been misconstrued as my opinion about the vaccine,” he told The Epoch Times. “There are high-risk groups within the 5–11 age group that would benefit from the vaccine, suggesting a more tailored approach.”

In this image from video, Dr. Michael Kurilla (C) questions the CDC’s Dr. Fiona Havers (R) during an FDA advisory panel meeting on Oct. 26, 2021. (The Epoch Times via FDA)

Others Question Widespread Use

Additional panel members openly questioned whether all young children should get the vaccine.

“I’m torn. On one hand, we know that many mothers and fathers and parents are eager to administer this vaccine to children because they’re so frightened, perhaps overly so, … that they really are anticipating having access to this vaccine in children,” said Dr. Cody Meissner, the director of pediatric infectious disease at Tufts Medical Center.

On the other hand, I think we saw that approximately 68 percent of the children who are hospitalized with COVID-19 have underlying comorbidities. That means about 32 percent do not. And then if we were to take 40 percent of that group that may have immunity already, we’re getting down to a very small percent of otherwise healthy 6- to 11-year-old children who might derive some benefit,” he added.

But others said they saw the need for the vaccination. The protection it gives would prevent more hospitalizations and ensure schools remain open, some argued.

“We don’t want children to be dying of COVID, even if it is far fewer children than adults, and we don’t want them in the ICU,” said Dr. Amanda Cohn, a CDC official.

Jeannette Lee, a biostatistics professor at the University of Arkansas for Medical Sciences, said she was impressed by the data presented by Pfizer, which relied on an approach called immunobridging. In this case, Pfizer’s trial showed the vaccine triggered antibodies in children. The antibodies were compared to those elicited in older groups, and that was used as proof the vaccine will protect the kids against COVID-19.

Kurilla, though, voiced disapproval with the approach, telling colleagues “it’s being based on an immunogenicity marker that we know wanes.”

He said he hoped for more flexibility in the authorization, including a single dose for some children and no doses for others, based on factors like prior infection.

“There are high-risk individuals and I think they do need to be attended to, that we do need to provide a vaccine for them. But for many others, one dose—or no dose, even, if they’ve had prior COVID infection. I think they may not need anything more,” he said.

A 14-year-old girl gets a Pfizer COVID-19 vaccine in Hartford, Conn., on May 13, 2021. (Joseph Prezioso/AFP via Getty Images)

Side Effects

Cases of heart inflammation after receipt of the Pfizer and Moderna vaccines are highest in youth, especially boys in their teens. Based on reports submitted to the federally run Vaccine Adverse Event Reporting System (VAERS), the cases are higher than expected in males aged 12 to 49 after the second Pfizer dose and females 12 to 24 after the second Pfizer dose.

Over half of the children with confirmed myocarditis or pericarditis studied in the Vaccine Safety Datalink surveillance system required hospital care, though no post-vaccination deaths due to the conditions have been confirmed, according to federal authorities.

Pfizer said none of the 5- to 11-year-olds in its trials experienced post-vaccination heart inflammation. Using a third of the amount of that given to older people is, in part, an attempt to curb side effects, though how that will ultimately turn out is unknown.

FDA scientists said they determined the vaccine would prevent more COVID-19 cases, hospitalizations, and deaths among the age group than vaccine-linked heart inflammation cases, hospitalizations, and deaths. They assumed a vaccine efficacy of 70 percent against COVID-19 cases and an efficacy of 80 percent against hospitalizations linked to the disease. Among young males, “the benefits appear to outweigh the risks,” Hong Yang, an FDA scientist, told members. Among young females, “the benefits clearly outweigh the risks,” she added.

“What will the actual myocarditis rate be in these younger kids?” Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital, wondered. That group “may be less susceptible to myocarditis, but right now that’s a speculation,” he added. “We don’t know that for sure.”

Members of the public also expressed concern, arguing the safety data wasn’t sufficient to authorize the vaccine for children so young.

But other members pointed to the trial data, the fact fewer reports have come in for 12- to 15-year-olds than 16- and 17-year-olds, and how, generally, fewer younger children experience heart inflammation versus older ones.

“I am not as concerned about myocarditis in this age group as I am in the older kids,” Dr. Melinda Wharton, another CDC official, said.

Surveillance systems like VAERS will help detect if inflammation becomes an issue in the younger children, members said.

“If the surveillance systems do start seeing severe outcomes and deaths from vaccination, I’m quite confident that those surveillance systems will tell us that we need to pause like we did with the J&J vaccine to really have a good idea of what the effects are vaccinating this age group,” said Dr. Patrick Moore, professor at the University of Pittsburgh Cancer Institute.

In this image from video, Dr. Eric Rubin (L) explains why he will vote to advise the FDA to authorize Pfizer’s COVID-19 vaccine for young children during an FDA advisory panel meeting on Oct. 26, 2021. (The Epoch Times via FDA)

The ‘Yes’ Votes

Ultimately, most members said the benefits and predicted benefits of the vaccine in the 5- to 11-year-olds outweighed the risks and potential risks.

“I think this vaccine will likely be effective in reducing pediatric COVID in this age group and may also help reduce transmission. On the safety end, I’m encouraged by the lower dose, … finding a dose that’s immunogenic and had not too much in terms of reactogenicity,” said Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital.

Dr. Eric Rubin, an adjunct professor at the Harvard TH Chan School of Public Health, said he wanted to give parents the choice to vaccinate their kids, imagining he had a child who was a transplant recipient, though he joined others in saying there are probably some younger children who shouldn’t get the vaccine.

“The question of how broadly to use it, though, I think is a substantial one. And I know it’s not our question, but I—and I know we’re kind of punting that to [the CDC’s advisory panel]—but I do think that it’s a relatively close call,” he said.

Soon after, in a comment that was widely distributed online, he added: “We’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes. That’s how we found out about rare complications of other vaccines, like the rotavirus vaccine.”

Rubin told The Epoch Times in an email, responding to critics: “The clinical trial of the Pfizer-BioNTech COVID-19 vaccine in children showed no adverse events. All data to date indicate that it is safe. It will prevent the hospitalization of children with severe disease, as it does with adults. The vaccine works, and saves lives.”

Tyler Durden Fri, 10/29/2021 - 08:47