FDA approves first self-administered flu vaccine spray

The U.S. Food and Drug Administration announced Friday that it has expanded its approval of FluMist nasal spray, making it the first “self-administered” nasal spray. Influenza vaccine However, any delay in the change would mean vaccines wouldn't be delivered to homes until next year. Flu season At the earliest.

“Today's approval of the first influenza vaccine that can be self- or caregiver-administered provides a new option that makes receiving a safe and effective seasonal influenza vaccine more convenient, flexible and accessible,” said Peter Marks, PhD, director of the FDA's Center for Biologics Evaluation and Research. statement.

The FluMist vaccine, made by AstraZeneca, was approved for administration by health care workers, like other flu shots, in 2003. Now, vaccine makers have approval to sell FluMist for adults to use on themselves at home or to give to children.

The FDA said patients will still need to get a prescription for the vaccine from their health care provider.

AstraZeneca say The company plans to sell FluMist directly to patients through an online pharmacy, where adults can fill out a screening questionnaire to get a prescription and order it for delivery to their home.

Also, Some limitations Types of people for whom FluMist is recommended: Because it uses a live, attenuated virus, some patients, such as pregnant women and those with severe immunocompromises, should not receive this vaccine.

FluMist has fallen out of use among pharmacies and doctors recently, partly due to recommendations from the Centers for Disease Control and Prevention. 2016 They are opposed to the use of the spray because it is “poorly or relatively low effective” compared to other vaccines.

AstraZeneca has since redesigned the vaccine's antigens and regained the CDC's recommendation. From 2018.

The CDC has since said that because of its limited use in the U.S., there isn't enough data to make new official effectiveness estimates comparing FluMist with other flu vaccines.

But AstraZeneca data It showed the vaccine was “comparably” effective compared with vaccines more widely used in Europe.

AstraZeneca initially told investors The company submitted data last year showing that adults could follow instructions to administer the vaccine spray themselves, and had hoped the FDA would expand its approval in time for this year's flu season.

AstraZeneca did not comment on why the FDA's approval decision came later than the company had previously stated expectations.

“We are working diligently to offer this 'first-of-its-kind' innovative, convenient, self-administered flu vaccine to consumers and look forward to launching FluMist Home as soon as possible for next flu season,” a company spokesperson said in a statement.

A spokesman said AstraZeneca needed time to work with its partners to “ensure a seamless customer experience” in rolling out FluMist for home use.

Alexander Ting

Alexander Ting is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers the Biden administration's public health agencies, including the federal government's response to infectious disease outbreaks like COVID-19.

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