Pfizer and BioNTech one step closer to planned Covid-19 booster campaign this fall Finish They asked the FDA to urgently authorize a version of their messenger RNA injectable for the popular omicron sub-variant circulating in the United States. The booster injection will ship immediately after authorization, the company said on Monday.
The booster shot is a bivalent vaccine designed with two main parts: one protects the original SARS-CoV-2 virus, and the other addresses the now-dominant BA.4 and BA.5 micron variants. But in seeking authorization for this booster shot, Pfizer and BioNTech are moving forward without the same level of data supporting the authorization of the original vaccine.
The only enhanced clinical data Pfizer and BioNTech have are the vaccine versions against the original strain and the BA.1 omicron subvariant.In a Phase 2/3 study testing a 30-microgram dose, the two companies report In June, the vaccine produced a better immune response to the BA.1 variant than a version of the vaccine designed for the original strain. Based in part on these results, the FDA advisory committee subsequently voted to recommend the omicron component as part of the new booster.
After committee vote, FDA Publishing Guidelines All Covid-19 vaccine manufacturers are advised to modify their boosters to deal with the BA.4 and BA.5 sub-variants that have become the dominant strain in the United States. At the time, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the clinical data for BA.1 were sufficient to seek authorization for booster injections for the BA.4 and BA.5 subvariables.
Pfizer and BioNTech only have preclinical data to test their boosters against the BA.4 and BA.5 sub-variants. In these results, the companies reported that the vaccine produced strong neutralizing antibody responses against the four omicron subvariants as well as the original strain. A clinical trial testing the updated vaccine in people 12 years of age and older is expected to begin by the end of August.
For those who have completed a primary vaccine series with any approved or authorized Covid-19 vaccine, the recommended dosing schedule is a single booster shot. The companies are also requesting authorization for a second booster dose in people 50 years of age and older and in people 12 and older with compromised immune systems.
“After rapidly scaling up production, if authorized, we will immediately begin distributing the bivalent Omicron BA.4/BA.5 boosters to help protect individuals and families in preparation for a potential fall and winter surge,” Pfizer said. Chairman and CEO Albert Bourla said in a prepared statement.
The federal government has reached $3.2 billion deal with Pfizer in June to buy 105 million booster doses. The government also has the option to purchase up to 195 million additional doses.Last month, the government signed Signed a $1.74 billion bivalent booster purchase agreement with Moderna. The agreement covers the government’s purchase of 66 million doses of the vaccine, with an option to purchase up to 234 million more doses.
Pfizer and BioNTech are also seeking authorization for their booster shots in Europe. They said on Monday they expected to complete their conditional marketing authorization application to the European Medicines Agency in the next few days.
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