Former FDA chief Scott Gottlieb warns against postponing COVID-19 vaccine application for children

Former FDA chief Scott Gottlieb warns against postponing COVID-19 vaccine application for children

The former head of the Food and Drug Administration said he feared Pfizer’s decision to delay filing an FDA application to vaccinate children under the age of five could confuse and alienate parents.

Scott Gottlieb, who also urged the CDC to relax its national indoor mask rules, appeared Monday on CNBC’s Squawk Box.

Gottlieb, who led the FDA from 2017 to 2019, came forward after the federal agency said Friday that a Pfizer-BioNTech vaccine application for children aged six months to four years has been shelved.

He said that while “it’s appropriate for the FDA to be very careful when you’re dealing with a young child,” this back and forth movement can make people lose interest.

“However, I’m worried when you have a process that seems to deviate over time, like this one, as well as boosters, people lose interest,” he said on Monday.

The former head of the Food and Drug Administration said he feared Pfizer's decision to delay filing an FDA application to vaccinate children under the age of five could confuse and alienate parents.

The former head of the Food and Drug Administration said he feared Pfizer’s decision to delay filing an FDA application to vaccinate children under the age of five could confuse and alienate parents.

Scott Gottlieb, who also urged the CDC to relax its national indoor mask rules, appeared Monday on CNBC's Squawk Box.

Scott Gottlieb, who also urged the CDC to relax its national indoor mask rules, appeared Monday on CNBC’s Squawk Box.

“If you look at boosters, the way the federal government first said, ‘No, we don’t need boosters under any circumstances,’ and then, for three months, it actually begged people, ‘Go and get boosters,’ is very it’s hard to make that turn.”

“It is very difficult to ask consumers to make such a turn. When you talk about these things over and over, people tend to get confused or lose interest, and I’m afraid that in this case it might happen.”

Pfizer applied for an emergency use authorization on February 1st. It included data on the first two doses of a three-dose vaccine kit for young children. An FDA advisory committee meeting to discuss the merits of the approval was scheduled for Feb. 15.

The data for the third shot was due later, and the New York company planned to apply for a third shot permit at another time.

The FDA said Friday that Pfizer has notified the company that the company has new vaccine data that merit inclusion in the decision-making process.

Pfizer postpones application for COVID-19 vaccine for children aged six months to 5 years (file photo)

Pfizer postpones application for COVID-19 vaccine for children aged six months to 5 years (file photo)

As a result, the February 15 meeting was rescheduled to an unknown date.

Meanwhile, Gottlieb also urged the CDC to change its national mask guideline, which he says is too broad.

He said the CDC was trying to set a “national standard” but it didn’t match the varying levels of infection in the US.

He urges the agency to allow communities to make their own mask recommendations based on local infection rates.

“That’s probably where they should have been all along,” he told Face the Nation. “I think they’re going to make this adaptation because there are clearly parts of the country where prevalence is low enough right now and moving in a positive direction that they can start to lift this mitigation.”

States have begun to revoke their mandates across the US, including the governors of Democratic blue states such as Connecticut, Delaware, New Jersey and Oregon. Others, such as New York City, have lifted their indoor mask mandates but are pushing for them to remain in schools for now.

The CDC is working to revise and possibly update its mask use guidance, but currently it still recommends wearing masks in areas with “high” or “significant” levels of Covid-19 infection, in about 99% of US counties.

The US will become the only country in the world to vaccinate babies at six months of age if Pfizer goes ahead with its application and it is approved by the FDA.

Unlike the two-dose vaccine used for people five years of age and older, the Pfizer vaccine for children six months to five years of age consists of three shots.

The shot is also significantly smaller, at just three micrograms, compared to a ten microgram injection for children 5 to 12 years old and a 30 microgram injection for people 12 and older.

Pfizer originally planned to make only two smaller doses for younger children, although plans had to be changed in December after children aged three and four showed poor antibody responses to the first two smaller doses.

Former FDA chief Scott Gottlieb warns against postponing COVID-19 vaccine application for children Former FDA chief Scott Gottlieb warns against postponing COVID-19 vaccine application for children Former FDA chief Scott Gottlieb warns against postponing COVID-19 vaccine application for children Former FDA chief Scott Gottlieb warns against postponing COVID-19 vaccine application for children

The FDA reportedly asked Pfizer to file an application earlier this month, citing an increase in Covid cases in children during the Omicron surge.

However, the trials for the third shot had not yet been completed, so the first entry only included the first two jabs, with the third coming later.

“Given the recent spike in omicrons and the marked increase in hospital admissions in the youngest children to their highest levels during the pandemic, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including asking the company to provide us with baseline data. about two doses from their current study,” the agency said in a statement.

“The goal was to see if two doses would provide enough protection to allow the vaccine to be used in this age group.”

However, not all experts agree that vaccination is necessary.

Dr. Cody Meisner, director of pediatrics at Tufts Children’s Hospital in Boston and a member of VRBPAC, questions whether a vaccine is needed for a group already suffering such a low risk of hospitalization or death from Covid.

“I think we’re rethinking how we’ve looked at this because, even if people are properly vaccinated, they can still get infected and pass the virus on to susceptible people around them,” Meisner told DailyMail.com on Feb. 1.

“So it’s a little different than a lot of other infectious diseases like measles, mumps or rubella. If you are protected from getting a vaccine, you won’t pass it on to other people.”

‘But it’s not the same with [this virus].’

He noted that the death rate among young children from Covid remains very low. Young children account for less than 0.1 percent of Covid deaths in America, according to the Centers for Disease Control and Prevention.

A new time for the Vaccine and Related Biological Products Advisory Committee (VRBPAC) meeting has not yet been scheduled.

The FDA said in a statement that new data from Pfizer’s request for an emergency use authorization, as well as the agency’s preliminary assessment: “We believe that additional information relating to the current evaluation of the third dose should be considered as part of our decision on the potential hazard “. authorization.

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