Moderna developing combo COVID-19 booster, flu shot

Moderna announced on Thursday that it is currently developing a vaccine that combines a COVID-19 booster as well as a seasonal flu shot. 

"Today we are announcing the first step in our novel respiratory vaccine program with the development of a single dose vaccine that combines a booster against COVID-19 and a booster against flu," Moderna CEO Stéphane Bancel said in a press release.

Bancel had told CNBC in April that he hopes to have a booster shot ready and available by the fall.

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"I want to make sure there are boost vaccines available in the fall so that we protect people as we go into the next fall and winter season in the U.S.," he said at the time while appearing on CNBC"s "Squawk Box."

Currently, Moderna is still awaiting full FDA approval for its vaccine. The Pfizer-BioNTech COVID-19 vaccine, now marketed as Comirnaty, was granted full FDA approval on last month.

On Aug. 25, Moderna passed a major milestone on its path to getting full approval from U.S. regulators when it completed the rolling submission process for its Biologics License Application. The BLA, which Moderna began on June 1, involves submitting nonclinical and clinical data to support the licensure of the COVID-19 vaccine.

Most of the 206 million Americans at least partially vaccinated against COVID-19 received the Pfizer shot, but about 80 million received the Moderna vaccine, according to CDC data.

Despite Moderna’s efforts to get full federal approval, a recent plan by the Biden administration to start delivery of booster shots by Sept. 20 for most Americans who received the COVID-19 vaccines are facing new complications that could delay the availability of third doses for those who received the Moderna vaccine, administration officials said last week

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Biden announced last month that his administration was planning for boosters to be available for all Americans who received the mRNA vaccines in an effort to provide more enduring protection against the coronavirus, pending approvals from the Centers for Disease Control and Prevention and the Food and Drug Administration.

Those agencies, though, are awaiting critical data before signing off on the third doses, with Moderna's vaccine increasingly seen as unlikely to make the Sept. 20 milestone.

According to one official, Moderna produced inadequate data for the FDA and CDC to approve the third dose of its vaccine and FDA has requested additional data that is likely to delay those boosters into October. Pfizer, which is further along in the review process, in part because of data collected from the vaccine's use in Israel, is still expected to be approved for a third dose for all by Sept. 20. A key FDA panel is to review Pfizer’s data on boosters on Sept. 17.

Meanwhile, the Biden administration's public pronouncement about booster availability, a break from the more deliberate and behind-the-scenes planning that defined its early vaccination campaign, sparked concerns from some that the White House was getting ahead of the science on boosters.

Even before Biden's announcement last month, his administration had been preparing for months for the possibility that boosters would be required, maintaining America's supply of doses and devising promotion plans with the same "intensity" that it brought to the initial vaccination campaign, Zients told reporters Thursday.

Biden on Aug. 18 touted boosters as a protection against the more transmissible delta variant of the virus, which is raging across the country and slowing the economic recovery from the pandemic, as well as potential variants to come.

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"Just remember, as a simple rule — rule: Eight months after your second shot, get a booster shot," he said then, adding that health experts were aiming to be ready to administer them by Sept. 20, pending approval by the regulatory agencies.

Dr. Anthony Fauci, the nation’s top infectious disease expert, has become an outspoke champion of the booster campaign, as the Biden administration looks to curtail the delta variant.

He told reporters on Thursday he believes it is likely that Americans will all need to get a third dose of the mRNA vaccines to be considered fully vaccinated against COVID-19.

"From my own experience as an immunologist, I would not at all be surprised that the adequate, full regimen for vaccination will likely be three doses," he said.

This story was reported from Los Angeles. FOX News and The Associated Press contributed.