Pfizer, a major American pharmaceutical company, has postponed the procedure to extend the emergency use authorization of the new coronavirus vaccine to children aged 6 months and under 5 years old, and waits for data on the effect of the third vaccination to be gathered. Was announced.
On the 1st of this month, Pfizer began applying to the FDA = US Food and Drug Administration to extend the emergency use authorization for the new coronavirus vaccine to children under the age of 5, and the FDA will first review the two doses. I was planning to do it.
However, on the 11th, Pfizer announced that it would postpone this procedure and wait for data from clinical trials for the third vaccination to be collected.
According to the interim results of a clinical trial released by Pfizer in December last year, the immune response did not reach a sufficient level in adults aged 2 to under 5 years after one month after two vaccinations. Therefore, the effect of the third inoculation is being verified.
In the United States, the spread of the Omicron strain has increased the number of cases in which children of the age not yet vaccinated are infected and become more severe, and experts should hurry to inoculate children of this age. On the other hand, there were criticisms that the application procedure was hasty.
The FDA said in a press conference following Pfizer's announcement, "I think it makes sense to wait for more data before reviewing."