Data from a clinical trial show that Pfizer’s COVID-19 vaccine triggers a strong immune response in children between the ages of 5 and 11, the company and its German partner said on Sept. 20.
The shot also had a favorable safety profile in the age group in the phase 2/3 trial, according to a summary of the trial data released by Pfizer and BioNTech.
Approximately 2,268 children received two shots of 10-micrograms each, spaced 21 days apart. A month after receiving their second shot, the children had a SARS-CoV-2-neutralizing antibody geometric mean titer of 1,197.6, which was around the same level seen in participants between the ages of 16 and 25, who were used as a control group and given two doses of 30 micrograms each.
The companies also said that the younger group tolerated the vaccine well, with side effects “generally comparable” to those seen in the older group. Side effects seen after the vaccine include severe allergic reactions, heart inflammation, and fever.
A Pfizer spokeswoman told The Epoch Times via email that there were no cases of myocarditis, or heart inflammation, in the trial.
There was no control group of non-vaccinated children, it wasn’t clear how many COVID-19 cases occurred among the participants, and the specific data weren’t released. Pfizer declined to say when the data would be made available, apart from outlining plans to submit it for peer-reviewed publication soon. The companies also plan to share the results with the Food and Drug Administration and the European equivalent of the U.S. drug regulator. The companies are hoping to gain emergency use authorization for the shot for children aged 5 to 11.
“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,” Albert Bourla, Pfizer’s CEO, said in a statement.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” added Dr. Ugur Sahin, CEO and co-founder of BioNTech. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
The Biden administration said the announcement was good news.
“We were encouraged to see that but it needs to move its way through the official government process,” White House press secretary Jen Psaki told reporters in Washington.
But others questioned why so little information was released by Pfizer and its partner.
“Pfizer’s transparency is poor. Releasing some actual data would be nice,” Dr. David Boulware, a professor of medicine at the University of Minnesota Medical School and an infectious disease doctor, wrote on Twitter.
Experts said the information that was released showed that the study didn’t look at effectiveness, but did explore immunogenicity, or the triggering of an immune response.
“There is far more data to look at. Hopefully we’ll get those data to review within the next few weeks so we can make the best decision for America’s children,” Dr. Paul Offit, a member of the Food and Drug Administration’s (FDA) vaccine advisory panel, said on CSPAN.
The update comes as all three vaccines authorized or approved for use in the United States continue to wane in effectiveness, particularly against infection by the CCP (Chinese Communist Party) virus, also known as SARS-CoV-2, which causes COVID-19.
U.S. regulators last month approved Pfizer’s vaccine, but only for those 16 or older. The jab remains under emergency use authorization for children aged 12 to 15; no other shot is authorized for that age group.
Pfizer and BioNTech also are studying the effects of the vaccine in children as young as 6 months of age.
This is an excerpt from The Epoch Times.
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