FDA reviewing at-home flu vaccines

by Lauren Sforza - 10/25/23 11:21 AM ET

FILE - A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. Expedited drug approvals slowed in 2022, as the FDA's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in the year, the agency’s drug center has granted 10 accelerated approvals — fewer than the tally in each of the last five years, when use of the program reached all-time highs. (AP Photo/Manuel Balce Ceneta, File) — A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. (AP Photo/Manuel Balce Ceneta)

The Food and Drug Administration (FDA) will review an at-home flu vaccine as uptake for the inoculations remains low this year.

AstraZeneca announced Tuesday that its needle-free nasal spray was accepted by the FDA for review. If approved, the company said it would be the first self-administered flu vaccine available in the United States, which AstraZeneca said could boost vaccination rates.

Iskra Reic, AstraZeneca’s executive vice president of vaccines and immune therapies, said the nasal spray “could revolutionize flu vaccination.” Reic said AstraZeneca’s self-administered vaccine would be delivered directly to homes, which he said would be an “innovative, more accessible option for individuals, families and communities.”

The company said its nasal spray is backed by a usability study that found that those older than 18 years could self-administer the vaccine or administer it to those between the ages of 2 and 49. It also said the spray has proven “comparable effectiveness and acceptable safety relative to other flu vaccines.”

It said it expected to have a response from the FDA during the first quarter of 2024. If approved then, the vaccine could be ready by the 2024-25 flu season.

Centers for Disease Control and Prevention (CDC) Director Mandy Cohen said last month that only 47 percent of U.S. adults received a flu vaccine during the 2022-23 respiratory season, which was down from 49 percent in 2021-22.

A survey from the National Foundation for Infectious Diseases also found last month that only about 20 percent of Americans are worried about themselves or someone in their family getting infected with the flu, COVID-19 or respiratory syncytial virus.

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