AstraZeneca asks the FDA to let adults give themselves the annual flu vaccine

AstraZeneca (AZN) is asking the FDA to approve its nasal flu vaccine, FluMist, for use at home — a move that would make it the first ever self-administered vaccine.

The pharmaceutical giant announced Tuesday morning that its supplemental license application, which was accepted by the FDA, requests approval for use in ages 2-49 at home. The vaccine has been around for 20 years, but has only been used in pharmacy or clinical settings.

AstraZeneca expects the FDA will make a decision by the first quarter of 2024.

Adults 18 and older would be allowed to self-administer the single-use nasal syringe and, also, give the vaccine to those aged 2-17, if approved, according to the company.

Lisa Glasser, head of US medical affairs, vaccines, and immune therapies at AstraZeneca, told Yahoo Finance the move comes as a result of lessons learned from the COVID-19 pandemic. “We put in people’s hands nasal swabs to test for COVID, which people were very easily able to handle and continue to use,” Glasser said.

Nurses prepare influenza vaccine injections during a flu shot clinic at Dorchester House, a health care clinic, in Boston, Massachusetts January 12, 2013. Influenza has officially reached epidemic proportions in the United States, with 7.3 percent of deaths last week caused by pneumonia and the flu, the U.S. Centers for Disease Control and Prevention said on January 11.   REUTERS/Brian Snyder    (UNITED STATES - Tags: HEALTH SOCIETY)

Nurses prepare influenza vaccine injections during a flu shot clinic in Boston. (Brian Snyder/REUTERS) (Brian Snyder / Reuters)

The company said it is confident that people can also easily use the nasal syringe, which will be slightly different from nasal spray medications. It comes in a single syringe and will have specific instructions on how to use it.

Shipping the syringes to customers is another piece of the equation.

In order to send the vaccine to patients, AstraZeneca will have to ensure it stays at a certain temperature. But details about the packaging and shipment process are not yet available.

“I think what I could tell you right now is that people will be able to order FluMist through a website or an online pharmacy partner, it’ll be shipped to their home, it’ll be in a packaging that maintains the temperature controls required for the best vaccine,” Glasser said.

She said the company pursued this idea in light of low flu vaccine uptake during the annual season. Even with low efficacy — about 50% this year — the flu vaccines do help reduce the disease’s impact, Glasser said.

“No, flu vaccines are not perfect. And while there’s always potentially room for improvement in vaccines, a vaccine that’s given is better than no vaccine,” she added.

The latest move also opens the door for other diseases, like COVID-19. “There is actually an effort ongoing right now to produce a live attenuated SARS-CoV-2 vaccine that would be intra-nasally delivered,” Glasser said.

Since respiratory disease typically enter the body through the nose, getting a vaccine delivered at the point of entry is ideal, she said.

Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. Follow Anjalee on all social media platforms @AnjKhem.

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