Pfizer is seeking approval to vaccinate children in the US aged six months to five years as early as this winter
The big pharma giant has already been preparing to seek approval from US and European medicines agencies for its vaccine in 5-11 year-olds and is now seeking authorisation to use the jab on American babies as young as six months
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The Mail Online reports: In a move likely to cause international controversy, the company intends to apply for authorisation to immunise American infants within the next two months.
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The timeline will depend on the findings of in-house trials looking into whether the vaccines are safe and effective in youngsters aged six months to five years.
Frank D’Amelio, chief financial officer at Pfizer, told an industry conference yesterday that the firm plans to ‘go file’ by November, the Financial Times reports.
‘We would expect to have… data for children between the ages of six months and five years old that we would file with the FDA,’ D’Amelio said at the Morgan Stanley Global Healthcare Conference.’I’ll call it in the weeks shortly thereafter the filing of the data for the five- to 11-year-olds.’
Pfizer was already planning to seek approval from the Food and Drug Administration (FDA) for the jabs to be given in children aged five to 11 by October.
But the latest comments confirm the firm’s intention to work its way down much younger age groups. They will be given a lower dose than adults.
Pfizer’s jab, made alongside German partner BioNTech, is already approved for over-12s in Britain.
There is no publicly available safety data on babies given the Pfizer jab. Extremely rare events are normally only spotted when vaccines are rolled out on a national scale.
Pfizer and Moderna are due to release safety data on trials of children aged five to 11 in the coming weeks.
The Pfizer vaccine given to children is weaker than the version given to adults, with those aged between six months and five years injected with a 3 microgram vaccine.
Six to 11-year-olds are given 10 micrograms, while children over 12 and adults receive the full 30 micrograms.
Preliminary trials of the Pfizer vaccine in young children suggests it is safe, but there are ethical concerns as well as fears about the small risk of side complications.
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