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Israel: COVID vaccine for kids under 12 expected in winter, FDA official reportedly says

Emergency authorization for COVID-19 vaccines to be administered to children under 12 may come as early as the coming winter, a Food and Drug Administration official reportedly said Thursday.

The planned move comes as many families in the US and elsewhere remain hesitant regarding the shot since the vaccines currently in use are administered under emergency use authorization and have not been given full approval by the FDA, the official was cited as saying by the NBC network.

Currently, the Pfizer-BioNTech vaccine is being distributed under an emergency use authorization, which can be revoked when the COVID-19 crisis ends.

The company announced in May that it was seeking full FDA approval, which would allow the vaccine to remain on the market and be sold to customers directly.

The emergency use authorization only applies to those over 12 for now, as the company is seeking approval from the FDA to administer its COVID-19 vaccine to children aged 2-11.

 

In March, both Pfizer and competitor Moderna launched trials of their vaccines for children under 12.

The results, to then be reviewed by the FDA, are expected in the fall, according to NBC.

According to the FDA official, the agency is seeking at least four to six months of safety follow-up data for children under 12.

For adults, only two months were required to receive emergency approval.

For full FDA approval, at least six months of follow-up data is required, the report said.

Pfizer told the network that it expects results of trials for those aged 5-11 in September, for 2-5-year-olds shortly after, and results for kids aged 6 months to 2 years possibly in October or November.

Israeli Health officials have recommended vaccinating children under 12 suffering from preexisting conditions that may put them at risk if they contract COVID-19.

“Vaccination of children aged 5-11 years is not in the framework at this time, but there are special situations in which vaccination can be considered at these ages — this is when there is a high probability of serious illness and even mortality due to infection with the new coronavirus [variant],” the Health Ministry’s epidemiology department wrote last Tuesday, according to Channel 12 news.

In Israel, just over 30 percent of children aged 12 to 15 have been vaccinated, with an additional 9% who have recovered from the virus, according to Health Ministry data released Thursday.

The ministry also said 5,740,601 Israelis — 61.73% of the population — have received at least one vaccine dose, and 5,218,225 (56.11%) have been fully vaccinated.

Source: TOI