Translated by: MOS Translation Team – Sania

On February 11, Pfizer-BioNTech has abruptly postponed its ongoing application to the U.S. Food and Drug Administration for authorization of two doses of the CCP virus vaccine for children aged 6 months to 4 years, citing “insufficient data”.

Pfizer stated that it is awaiting test data from its third dose of the vaccine, which is expected to be released in early April. Pfizer said the third dose “may provide a higher level of protection for this age group.” However, the company’s data from last December showed that two doses of the vaccine did not produce the required immune response in a trial for children aged 2 to 4 years.

According to two people familiar with the FDA’s plan, numerous outside experts have submitted extensive documentation to the agency expressing their concerns that Pfizer’s data was not sufficient. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said that after reviewing Pfizer’s two-dose data, the regulator decided they needed to see the 3-dose trial data before considering authorization.

Many medical experts said Pfizer’s request for authorization for two doses of vaccine for infants and children is not in line with science and common sense, because the first two doses did not work, and there is no guarantee that adding a third dose will be sufficient.


Proofread and Edited by: Dai Maru
Posted By: Emily G

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