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The former head of the Food and Drug Administration has said he fears that Pfizer‘s decision to delay its FDA application to vaccinate children aged under five may confuse and alienate parents.

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

Gottlieb, who ran the FDA from 2017 to 2019, was speaking after the federal agency revealed on Friday that the application for the Pfizer-BioNTech vaccine to be used in children aged six months to four years old had been delayed.

He said that while it is ‘appropriate for the FDA to be very cautious when you’re dealing with a young child’, that going ‘back and forth’ can make people lose interest.

‘I do worry though, when you have a process that has seemed to deviate over the course of time, as this one has and also the boosters have, is that people lose interest,’ he said on Monday.

The former head of the Food and Drug Administration has said he fears that Pfizer's decision to delay its FDA application to vaccinate children aged under five may confuse and alienate parents

The former head of the Food and Drug Administration has said he fears that Pfizer's decision to delay its FDA application to vaccinate children aged under five may confuse and alienate parents

The former head of the Food and Drug Administration has said he fears that Pfizer’s decision to delay its FDA application to vaccinate children aged under five may confuse and alienate parents

Scott Gottlieb, who has also called on the CDC to relax its national indoor mask guidelines, appeared on CNBC's Squawk Box on Monday

Scott Gottlieb, who has also called on the CDC to relax its national indoor mask guidelines, appeared on CNBC's Squawk Box on Monday

Scott Gottlieb, who has also called on the CDC to relax its national indoor mask guidelines, appeared on CNBC’s Squawk Box on Monday

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‘If you look at the boosters, the way the federal government came out at first and said ‘No we don’t need boosters under any circumstances,’ and then within three months, it was effectively pleading with people to ‘Go out and get boosters,’ – it’s very hard to make that pivot.’

‘It’s very hard to ask consumers to make that kind of pivot. When you go back and forth on these things, people tend to get confused or lose interest and I fear that could happen in this case.’

Pfizer submitted the emergency use authorization application on February 1. It included data from the first two doses of the three-dose vaccine set to be used in younger children. A FDA advisory committee panel meeting to discuss the merits of the approval was scheduled for February 15.

Data for a third shot was supposed to come in later, and the New York City based company planned to apply for authorization for the third shot at another time.

The FDA said Friday it was notified by Pfizer that the company had new data regarding the shot that was worthy of being included in the decision making process.  

Pfizer has delayed its application for its COVID-19 vaccine to be used in children aged six months to 5 years old (file photo)

Pfizer has delayed its application for its COVID-19 vaccine to be used in children aged six months to 5 years old (file photo)

Pfizer has delayed its application for its COVID-19 vaccine to be used in children aged six months to 5 years old (file photo)

As a result, the February 15 meeting has been pushed back to an unknown date. 

Meanwhile, Gottlieb has also called on the CDC to change its national guidance on masks, which he believes is too broad.

He said that the CDC had attempted to set a ‘national standard’, but that didn’t match the diverse rates of infection across the US. 

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

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

States have begun to lift their mandates across the US, including the governors of Democratic blue states such as Connecticut, Delaware, New Jersey and Oregon. Others, like New York, have lifted their indoor mask mandates but have insisted on keeping them in schools for now. 

The CDC is working to review and potentially update its mask guidance but currently, it still recommends wearing masks in areas with ‘high’ or ‘substantial’ Covid-19 infection rates, about 99% of US counties. 

The US will be the only country in the world to vaccinate children as young as six months, if Pfizer goes ahead with its application and it is approved by the FDA.  

Unlike the two-dose shot used for people aged five and older, Pfizer’s shot for children aged six months to five years old is three shots.

The jab is significantly smaller as well, only three micrograms, compared to a ten microgram shot for children five to 12 and a 30 microgram shot for people 12 and up.

Pfizer initially only planned to have the two smaller doses for young children, though plans had to be changed in December after children aged three and four showed little antibody response to the first two, smaller, shots.

The FDA reportedly asked Pfizer to submit its application at the start of the month, citing a rise in pediatric Covid cases during the Omicron surge.

Trials for the third shot were not yet completed yet, though, so the first application only included the first two jabs – with a third to come later.

‘Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company provide us with initial data on two doses from its ongoing study,’ the agency wrote in a statement.

‘The goal was to understand if two doses would provide sufficient protection to move forward with authorizing the use of the vaccine in this age group.’ 

Not all experts agree the shot is necessary, though.

Dr Cody Meissner, the chief of pediatrics at Tufts Children’s Hospital in Boston and a member of the VRBPAC, doubted whether the vaccine is needed for group which already suffers such low risk of hospitalization or death from Covid.

‘I think we’re rethinking the way we looked at this question, because even though people are appropriately vaccinated they are still able to become infected and transmit the virus to susceptible people around them,’ Meissner told DailyMail.com on February 1.

‘So this is a little bit different than many other infectious diseases such as measles, or mumps, or rubella. If you’re protected from infection with the vaccine, then you’re not going to transmit it to other people.’

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

He noted that deaths among young children from Covid have remained very low. According to data from the Centers for Disease Control and Prevention, young children make up less than 0.1 percent of Covid deaths in America. 

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

A statement from the FDA said that new data from Pfizer’s emergency use authorization request, as well as the agency’s preliminary assessment, that ‘we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.’

Source: DailyMail

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