Pfizer and BioNTech submitted a request Monday for an emergency use authorization with the Food and Drug Administration for its Omicron-specific bivalent booster for kids between the ages of five and 11.

Currently, people over the age of 12 can receive an updated, Omicron-specific bivalent booster, per guidelines set by the Centers for Disease Control and Prevention. 

The two companies also stated that they have initiated a Phase 1/2/3 study for the efficacy of Omicron-specific boosters in children who are between six months and 11 years of age. A request for a vaccine marketing application will be submitted to the European Medicines Agency in the coming days, according to a joint press release.

The COVID-19 vaccine continues to be a reliable asset for both Pfizer and BioNTech, according to recent earnings reports.

Pfizer projected that Comirnaty would generate revenues of $32 billion by the end of the year, while BioNTech reiterated its outlook for 2022, including COVID-19 vaccine revenue between €13 billion to €17 billion.

The EUA submission also comes at a critical time for the fall COVID booster campaign.

Last week, President Biden declared the pandemic over, generating pushback from stakeholders in the healthcare industry. 

Some worried that his comments may hinder the public health effort to encourage the general public to receive their next round of booster shots. Recent data suggested that less than 5 million people have received an updated booster shot since they were authorized earlier this month. 

The Pfizer-BioNTech Omicron-specific booster may also be an easier option for patients and providers in some parts of the U.S. due to logistical issues. 

Around the country, some vaccinators have reported weeks-long delays in shipments of Moderna’s updated COVID-19 vaccine boosters due to a manufacturing facility concern highlighted by the FDA.

One month ago, Moderna sued Pfizer and BioNTech, alleging they copied its patented mRNA technology for their COVID-19 vaccine.

Additionally, Pfizer CEO Albert Bourla announced two days ago that he tested positive for COVID, noting that he had not received his updated booster shot yet since he was not three months removed from his most recent positive test.