Children Age 5-11 On Track To Receive Covid Vaccine Approval By Halloween

As with booster shots, Pfizer is being very aggressive about pressing for additional vaccination opportunities - despite or perhaps because - its vaccine does not appear to provide as effective longer term protection as Moderna's.

But the good news is that if Pfizer is getting approval for vaccinating children, other vaccines will soon get it as well. JL 

Martin Pengelly reports in The Guardian:

If the US regulatory process proceeds as it has for older age groups, authorisation for use would be expected by the end of October. Earlier this month, FDA chief, Dr Peter Marks, said that once Pfizer turned over results, his agency would evaluate the data “hopefully in a matter of weeks”. After a second dose, (in trial tests) children aged five to 11 experienced similar or fewer temporary side-effects – such as sore arms, fever or aches – that teens experience. Data for  children two to five years of age and children six months to two years of age  are expected as soon as the fourth quarter of this year.

In news sure to be greeted by parents across the US, Pfizer and BioNTech said on Monday children aged five to 11 are on track to receive the two companies’ Covid-19 vaccination by Halloween.

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Albert Bourla, chairman and chief executive officer of Pfizer, hailed “the first results from a pivotal trial of a Covid-19 vaccine in this age group”.

If the US regulatory process proceeds as it has for older age groups, authorisation for use would be expected by the end of October. Earlier this month, FDA chief, Dr Peter Marks, told the Associated Press that once Pfizer turned over results, his agency would evaluate the data “hopefully in a matter of weeks”.

Pfizer and BioNTech said European and British authorities would also be asked for emergency authorisation.

In a statement, Bourla said: “We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children.

“Since July, paediatric cases of Covid-19 have risen by about 240% in the US – underscoring the public health need for vaccination.”

Dr Kristin Oliver, a paediatrician and vaccine expert at Mount Sinai hospital in New York, told the New York Times: “There’s going to be a huge number of parents who are going to heave a big sigh of relief when they hear this. We’ve been waiting for these kids to be protected.”

Pfizer and BioNtech’s trial included 2,268 participants, the companies said. Two shots of a 10-microgram dose, one-third of an adult shot, produced antibody levels comparable to those in 16-to-25-year-olds given the adult dose.

Dr Bill Gruber, a Pfizer senior vice-president and paediatrician, told the Associated Press that after a second dose, children aged five to 11 experienced similar or fewer temporary side-effects – such as sore arms, fever or aches – that teens experience.

“I think we really hit the sweet spot,” he said, adding: “I feel a great sense of urgency. There’s pent-up demand for parents to be able to have their children returned to a normal life.”

In New Jersey, Dr Nisha Gandhi enrolled her 10-year-old daughter, Maya Huber, in the Pfizer study at Rutgers University. Once she knows she is protected from Covid, Maya told the AP, her first goal will be “a huge sleepover with all my friends”.

Maya said it was exciting to be part of the study even though she was “super scared” about getting jabbed. But “after you get it, at least you feel like happy that you did it and relieved that it didn’t hurt”, she said.

Pfizer and BioNTech also said data for “the other two age cohorts from the trial – children two to five years of age and children six months to two years of age – are expected as soon as the fourth quarter of this year”.