(CNN) — Pfizer and BioNTech submitted their application to the US Food and Drug Administration (FDA) for emergency use authorization of their covid-19 bivalent vaccine for use in people 12 years of age or older. more, according to the companies in a statement on Monday.
This updated formulation will combine the original vaccine with one targeting the BA.4 and BA.5 sublineages of omicron, and will be administered in a 30-microgram dose.
The companies say they are following “FDA guidance” and are including clinical data from their bivalent BA.1 vaccine and preclinical and manufacturing data from the bivalent BA.4/5 vaccine for the submission.
“The FDA will use the totality of available evidence to authorize the fall bivalent boosters,” FDA spokeswoman Abigail Capobianco said in a statement emailed to CNN last week.
“There are data on many millions of individuals who have received the prototype component as a booster. For the BA.4/5 component, a combination of non-clinical data from mice, data from earlier variant vaccines ( including beta, delta and omicron BA.1), along with our extensive knowledge of the safety and efficacy of mRNA platforms.”
Preclinical data showed that the new bivalent BA.4/5 vaccine “generated a strong neutralizing antibody response against the BA.1, BA.2, and BA.4/BA.5 omicron variants, as well as against the original type wild,” according to the companies. A clinical study is expected to begin this month.
The companies previously announced data from a phase 2/3 trial showing that their bivalent BA.1 booster resulted in a substantially greater immune response against the omicron variant and also appeared to be safe and well tolerated.
When will covid vaccine boosters be available in the US?Dr. Ashish Jha, White House covid-19 response coordinator, recently said the updated boosters should be available to the public in early to mid-September, but it’s ultimately up to the FDA when when. green light for the vaccine.
Pfizer and BioNTech say they have “rapidly scaled up production and are ready to supply doses of omicron-adapted bivalent BA.4/BA.5 vaccines by September, and will begin shipping immediately pending authorization.”
“The agility of the mRNA platform, coupled with Pfizer-BioNTech’s extensive clinical experience with the COVID-19 vaccine, has enabled us to develop, test and manufacture high-quality, up-to-date vaccines that are tailored to circulating strains with a unprecedented speed,” Albert Bourla, Pfizer’s chairman and chief executive officer, said in the statement.