Pfizer seeks FDA emergency use approval on booster jabs for kids 5-11 years old

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COVID booster jabs for the nation’s youngest citizens could soon be forthcoming after pharmaceutical giants Pfizer and BioNTech formally asked the Food and Drug Administration (FDA) to approve an emergency use authorization for the extra vaccine doses for children from 5 to 11 years old.

On Tuesday, the companies announced that an application has been filed with the agency which is tasked with ensuring the safety and efficacy of drugs, citing the results of clinical trial data that showed that the additional shot increased protection against the virus in children of the age group.

According to a press release put out by the companies, “Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12).”

“The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10-µg two-dose primary series, which was authorized under EUA for this age group in October 2021. Data from this study demonstrated a strong immune response in this age group following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine with no new safety signals,” the statement reads.

The clinical trial included 4,500 children in the U.S, Finland, Poland, and Spain and sought to “evaluate the safety, tolerability, and immunogenicity” of the vaccine.

Pfizer and BioNTech, its German partner also said that they would seek similar approval from other global regulatory agencies in the coming weeks.

According to the FDA’s website: “An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.”

“Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA,” the agency states.

In January, Pfizer CEO Albert Bourla was cool to the idea of frequent boosters, expressing his preference for a once-a-year COVID vaccine.

“What I’m hoping [is] that we will have a vaccine that you will have to do once a year. Once a year it is easier to convince people to do it. It is easier for people to remember. From a public health situation, it is an ideal solution,” Bourla said.

FDA approval is a likely slam dunk but it is unclear how much demand there will be for the latest round of booster shots.

According to a CNBC report on the request, “It’s unclear whether the FDA’s advisory committee will meet to discuss the data and make a recommendation. The FDA did not call meetings of the outside expert panel before authorizing third shots for kids ages 12 to 15 in January and fourth shots for people ages 50 and older last month.”

The FDA authorized the emergency use of initial vaccines for the 5-11 age group in October 2021.


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