Summary –
-On the day the public and members of the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee were going to get a look at Pfizer and BioNTech’s COVID-19 vaccine data for children under 5, the companies pulled the Emergency Use Authorization (EUA) submission.
Pfizer indicated it will wait for the full data on a three-dose series of the vaccine for that population, believing it “may provide a higher level of protection in this age group.” The data, which was going to be discussed by the advisory committee on February 15, will not be available until early April. The FDA has postponed the advisory committee meeting.
The vaccine has been fully approved for a two-dose regimen in adults and a third-dose booster in people 12 years and older. It has an existing EUA in children 5 and older.
Pfizer had reportedly been planning to wait anyway, until the FDA requested the companies initiate a rolling submission for the EUA, which they then submitted on February 2. The vaccine has been fully approved for a two-dose regimen in adults and a third-dose booster in people 12 years and older. It has an existing EUA in children 5 and older.
In late December 2021, Pfizer reported that two child-sized doses of the vaccine did not provide as robust an immune response in 2-to-5-year-olds as desired but did in children 6 months to 2 years of age. They indicated at the time that they would evaluate a third injection eight weeks after the second.
It’s not clear why the discrepancy, although children’s immune systems are not as mature as adults. The companies have declined to speculate.
This discrepancy had caused some health experts to urge the FDA to delay authorization until the results from a third booster dose are complete. According to NBC Health/Yahoo! News, two people familiar with the FDA’s plans indicated experts had been pushing back against the authorization over concerns Pfizer and BioNTech’s data wasn’t sufficient, but those concerns were “falling on deaf ears” within the FDA.
John Moore, professor of microbiology and immunology at Weill Cornell Medical College, thinks that Pfizer and BioNTech need to decide which dose is appropriate. “They have to make the best guess about what dosage to use in young children and they got it wrong, they underdosed,” he said.
Pfizer, in its statement, said, “The trial in children 6 months through 4 years of age is ongoing and data on the first two 3 microgram doses in this age group are being shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children in this age, especially due to the recent Omicron surge.”
Pfizer also said the independent Data Monitoring Committee for the trial supports continuing according to the protocol and so far suggests the vaccine is well tolerated and supports a potential three-dose regimen. “The extension allows the FDA to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion,” Pfizer stated.
There are about 19 million children in the U.S. under 5 years of age.
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