WASHINGTON — The Pfizer and BioNTech firms have completed a submission to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.

In a statement issued on Monday, the two companies said that data support request for Emergency Use Authorization of a 30yg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.

The companies have rapidly scaled production and stand ready to deliver doses of Omicron BA.4/BA.5-adapted bivalent vaccines for September, and will begin shipping immediately pending authorization, it added.

Meanwhile, CDC Director Rochelle P. Walensky signed a decision memo that Novavax's COVID-19 vaccine be used as another primary series option for adolescents ages 12 through 17. This recommendation follows FDA's authorization to authorize the vaccine for this age group under emergency use.

Novavax's COVID-19 vaccine, which is available now, is an important tool in the pandemic and provides a more familiar type of COVID-19 vaccine technology for adolescents.

The US is preparing for a fall vaccination campaign using updated vaccines that target the dominant Omicron subvariants. Public health officials expect another wave of infection this fall and winter as immunity from the currently authorized shots wears off and people head indoors to escape the colder weather.

The updated vaccines would target the original strain of the virus that first emerged in Wuhan, China, in 2019 as well as Omicron, known as a bivalent vaccine. Scientists and public health officials hope the new shots will provide broader and more durable protection against infection and mild illness.

The currently authorized shots were developed to target the version of COVID-19 that first emerged in China. Though the original vaccines are still preventing severe disease, they are not providing substantial protection against infection and mild illness.

Dr. Ashish Jha, the White House COVID response coordinator, has said the new shots will become available to the public by early to mid-September. The US government has secured 105 million doses of Pfizer’s updated shots and 66 million doses of Moderna’s new vaccine.

The FDA is working closely with the vaccine manufacturers to ensure the updated COVID boosters are available in the fall after a review of the safety and effectiveness of the shots, according to agency spokesperson Abby Capobianco.

“The agency will work expeditiously to review this and any other submissions once received in order to make modified COVID-19 vaccines available for booster vaccination in this timeframe,” Capobianco said.

However, some infectious disease and public health experts are calling for the FDA and the vaccine companies to present more data on the new shots before they receive authorization. It’s unclear whether or not the FDA’s independent vaccine advisory committee will meet to review more data on the shots before the agency authorizes them. — Agencies