It said it would seek emergency permission from the U.S. Food and Drug Administration for a booster dose in August after releasing more data on how well a third booster dose of the vaccine works.
“According to real-world data released by the Israeli Ministry of Health, vaccine efficacy for the prevention of both infection and symptomatic disease has decreased six months after vaccination, although the efficacy for the prevention of serious diseases remains high,” the company said in a statement. statement sent to CNN.
“In addition, the Delta variant during this period is becoming the dominant variant in Israel as well as in many other countries. These findings are in line with an ongoing analysis from the companies̵
“While protection against severe disease remained high for a full six months, a decrease in efficacy against symptomatic disease is expected over time and the continued emergence of variants. Based on the overall information they have so far, Pfizer and BioNTech believe that a third dose may be beneficial within 6 to 12 months after the second dose to maintain the highest levels of protection. “
Israel’s health ministry said in a statement earlier this week that it had seen the effect of Pfizer’s vaccine drop from more than 90% to approx. 64% as B.1.617.2 or the Delta variant spread.
The company said that booster doses of its vaccine, developed with BioNTech, produce levels of neutralizing antibodies that are five to ten times higher than what is produced after two doses.
“Companies expect to publish more final data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA, EMA and other regulators in the coming weeks,” Pfizer said in a statement.
And it says it’s also developing a new formulation for a booster dose that might more thoroughly protect people from new varieties.
“While Pfizer and BioNTech believe that a third dose of BNT162b2 has the potential to maintain the highest levels of protection efficacy against all currently known variants, including Delta, companies remain vigilant and develop an updated version of the Pfizer-BioNTech COVID-19 vaccine there. is targeted at the full tip protein of the Delta variant, “the company said. Current vaccines target only a piece of the spike protein – the part of the virus it uses to bind to cells.
“The first batch of mRNA for the trial has already been produced at BioNTech’s plant in Mainz, Germany. Companies expect clinical trials to begin in August, subject to regulatory approvals.”