Pfizer to Seek FDA Authorisation for Injection for Babies
12 months ago no mRNA injection had ever been deemed fit for humans. Now your 6-month old should have some
Editor’s note: A travesty. The risk to children being so low, how would you even set up a meaningful trial? You would have to have a trial with hundreds of thousands — perhaps millions — of children participating to prove a hypothetical statistically-significant benefit. Pfizers’ trial has thousands. This is beyond voodoo. Last year no single mRNA vaccine had ever been deemed fit for humans, now millions of children who aren’t at the least bit at-risk are supposed to be injected with them, what for?
Pfizer‘s Covid vaccine could be rolled out to babies as young as six months in the US this winter, under plans being drawn up by the pharmaceutical giant.
In a move likely to cause international controversy, the company intends to apply for authorisation to immunise American infants within the next two months.
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.
For teenage children and young adults, there is about a less than one in 10,000 risk of heart inflammation known as myocarditis.
While the vast majority of people who get myocarditis are treated within days, it’s unclear what the long-term effects are.
The US has been vaccinating children aged 12 and above since the start of the summer and elementary-aged pupils are expected to be given the jabs in the fall.
Britain only this week signed off on those plans, with officials claiming the benefit was only ‘marginal’ because Covid poses such a low risk to children.
British children under 16 are only being offered one dose of Pfizer’s vaccine, until more data has been gathered on the safety of giving them two doses.
American children between the ages of five and 11 could be eligible for the Covid vaccine by the end of October, according to the former head of the FDA.
Scott Gottlieb, who headed the FDA under former President Donald Trump and now sits on the board of directors at Pfizer, says that the emergency use approval process for vaccinating young children could be done in a matter of weeks.
Gottlieb says the pharmaceutical giant is expected to file the paperwork with the federal government requesting authorization to vaccinate kids as early as September.
Source: The Daily Mail