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He said he would seek emergency use authorization from the United States Food and Drug Administration for a booster dose in August after it released more data on the effectiveness of a third booster dose of vaccine.
“As real-world data released by the Israeli Ministry of Health shows, the vaccine’s effectiveness in preventing both infection and symptomatic disease decreased six months after vaccination, although the effectiveness in preventing serious illness remains high, ”the company said in a statement to CNN.
“Additionally, during this period, the Delta variant is emerging as the dominant variant in Israel as well as in many other countries. These results are consistent with an ongoing analysis of the Phase 3 study of the companies.” , he added.
“While protection against serious illness has remained high for the full six months, a decline in efficacy against symptomatic illnesses over time and the continued emergence of variants are expected. Based on all of the data available to date, Pfizer and BioNTech believe that a third dose may be of benefit within 6 to 12 months of 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 efficacy of Pfizer’s vaccine drop from more than 90% to around 64% as variant B.1.617.2 or Delta worsened. propagated.
The company said booster doses of its vaccine, developed with BioNTech, produce levels of neutralizing antibodies five to ten times higher than those produced after two doses.
“The companies expect to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA, EMA and other regulatory authorities in the coming weeks,” Pfizer said in a statement.
And he says he’s also developing a new formulation for a booster dose that might better protect people from the newer variants.
“While Pfizer and BioNTech believe that a third dose of BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently known variants, including Delta, the companies remain vigilant and are developing an updated version of the Pfizer-BioNTech COVID-19 vaccine that targets the complete spike protein of the Delta variant, “the company said. Current vaccines only target part of the spike protein, the part of the virus that it uses to attach to cells.
“The first batch of mRNA for the assay has already been manufactured at BioNTech’s facilities in Mainz, Germany. The companies expect clinical studies to begin in August, subject to regulatory approvals.
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