Pfizer Vaccine For Children Under 5 Years Old Delayed Because It's Not Effective

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JAKARTA - US health regulators postponed a review of Pfizer's COVID-19 vaccine for children under 5 years old because its two-dose regimen was ineffective against the Omicron variant, the Wall Street Journal (WSJ) reported.

Last week the US Food and Drug Administration (FDA) said it needed more data on the vaccine, so it decided to postpone using the vaccine in children aged 6 months - 4 years, for at least two months.

Reported by Antara, Saturday, February 19, preliminary figures in the data showed the vaccine was effective against the Delta variant during testing, while Delta was the dominant variant. But a number of vaccinated children developed COVID-19 once Omicron appeared, the report said, citing people familiar with the FDA's decision.

But since overall COVID-19 cases have died down, the small number of Omicron jerseys makes the vaccine appear less potent in initial statistical analyses, the report said.

The FDA did not respond to Reuters for comment.

Pfizer and BioNTech have submitted data on the first two doses of a planned three-dose regimen earlier this February at the request of the FDA. Pfizer does not disclose data on efficacy.

The proposal came as a surprise, as in December 2021 both companies said initial trial results of the low-dose two-dose vaccine were not what was envisioned and that clinical trials had shifted to testing a three-dose version.