Pfizer says its coronavirus vaccine safely bolsters antibodies in younger children
- The results from a large-scale trial in kids ages five to 11 could pave the way for the inoculation of grade-school pupils
- Pressure to immunise children is on the rise in the US as a new school year begins amid a Delta-fuelled Covid-19 surge
In a trial with 2,268 participants, two shots of a 10 microgram dose – one-third the adult shot – produced antibody levels comparable to those seen in a trial of 16-to-25-year-olds who got the adult dose, the companies said, with similar side effects.
Pfizer and BioNTech plan to begin a submission as early as this month for an emergency-use authorisation from the US Food and Drug Administration, a Pfizer spokesman said. The companies also plan to share the data with regulators in Europe.
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A clearance would mark an important new phase of the immunisation campaign in the US, where the Pfizer vaccine already has full approval for people 16 and up and is authorised on an emergency basis for ages 12 to 15. And a paediatric clearance could arrive as millions of older Americans are receiving additional doses to bolster their initial shots.
The FDA is expected to decide whether to allow a booster shot for the Pfizer-BioNTech vaccine within days. On Friday, an advisory panel unanimously backed a third dose for people 65 and over, as well as those at high risk of severe complications, after voting against Pfizer’s request to authorise boosters for everyone 16 and older.
While the FDA often follows its advisers, it is not obliged to, and could still opt to support boosters for a bigger group. Only certain immunocomprised people are now officially permitted to get a third dose on an emergency basis.
Initial data from other arms of the Pfizer-BioNTech paediatric trial, testing the vaccine in children under five, could come in the fourth quarter, the companies said.
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The data on kids from five to 11 was from an initial tranche of patients in the trial. At the request of US regulators, Pfizer and BioNTech have submitted a plan to add 2,250 more children between the ages of five and 11 to their paediatric studies, a Pfizer spokesman said in an email.
In an interview with Bloomberg News this summer, top FDA vaccine official Peter Marks said he asked drug makers to expand their paediatric trials three or four times in size “to try to have a larger safety data set” to increase confidence in the shots.
Safety is a crucial metric for young children, as they get infected frequently and help spread the virus, but are at lower risk of developing severe complications than older adults.
In rare cases, the messenger RNA vaccines have been linked to heart inflammation and heart-lining inflammation, and the risk appears to be highest in younger males.
The companies did not give specific side effect numbers in the release.
Pfizer and BioNTech also did not say whether children who got the vaccine had lower rates of Covid-19 illness compared with those who got a placebo, data that the trial planned to collect as a secondary goal.
A spokesman for Pfizer said the trial is still ongoing and some data is still blinded. In the statement, the companies said they planned to submit the full data from the trial for publication in a scientific journal.
