U.S. media reported that data from the U.S. pharmaceutical company Pfizer (Pfizer) and the German biotech company (BioNTech) jointly developed the Fubitai vaccine to protect children under the age of 5 from being infected with the new coronary pneumonia variant strain Omicron (Omicron). Rong), there are signs of low protection.
News broke a week ago that U.S. health regulators had delayed a decision for at least two months before deciding whether to grant emergency use authorization to children between 6 months and 5 years of age to be vaccinated against the novel coronavirus pneumonia (COVID-19) vaccine produced by Pfizer-BioNTech .
The U.S. Food and Drug Administration (FDA) said on the 11th that the reason for the delay is that the authorities will not review the data of the first two doses, but the data of the three doses.
The US "Wall Street Journal" said on the 18th that early data from the trial showed that the vaccine was effective against the mutant virus strain Delta (Delta); Delta was the mainstream virus strain at the time.
However, after Omicron appeared, some young children who had been vaccinated were still infected with Covid-19.
New crown pneumonia epidemic in the United States: The picture shows a girl in Chicago, the United States being vaccinated against the new crown on November 12, 2021.
(Getty)
The newspaper quoted people familiar with the matter as saying that the small number of Omicron cases in the trials so far made the vaccine appear less effective in early statistical analyses, given that so few study subjects had been infected during the trial, whether they had been vaccinated or not.
Forbitx Vaccine｜Whether to allow children under 5 years old to be vaccinated in the United States to delay the decision of Forbitx vaccine by at least 2 months｜Pfizer applies to FDA to vaccinate children from 6 months to under 5 years old for the new crown vaccine Forbitx vaccine｜The world's first vaccine New crown vaccine for children under 5 years old or available at the end of February
In the event that more cases of Omicron appear in the future, the data may show that the vaccine is more protective against Omicron, if more cases of "unvaccinated infection" are recorded in the trial, the sources said.
Therefore, both the FDA and Pfizer agreed to wait for more cases before making a decision, and the extra time would allow the FDA to assess the efficacy of two or three doses.
