Pfizer and BioNTech will submit trial data to the European Medicines Agency in the coming weeks
Pfizer Inc and its German partner BioNTech SE have submitted preliminary data from an early-stage trial to US regulators seeking authorization of booster doses of their COVID-19 vaccine, drugmakers said on Monday.
They said the third dose showed significantly higher neutralizing antibodies against the initial SARS-CoV-2 virus than the two doses as well as the beta and highly infectious delta variants.
Pfizer says its vaccine’s efficacy decreases over time, citing a study showing 84% effectiveness from a peak of 96% four months after the second dose. Some countries, including Israel, have already gone ahead with the plan to give booster doses.
However, decisions by some wealthy countries to buy booster shots have sparked outrage from health workers and the World Health Organization, which has called for a moratorium on boosters until at least the end of September.
Pfizer and BioNTech had said that all patients in the trial received their third shot, BNT162B2, eight to nine months after their second dose.
Drugmakers will submit trial data to the European Medicines Agency and other regulatory authorities in the coming weeks. He said the results of the late-stage trial of the third dose are expected soon.
Last week, US regulators authorized a third dose of COVID-19 vaccines by Pfizer-BioNtech and Moderna Inc for people with compromised immune systems, who are likely to have weakened protection from the two-dose regimen.
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