Pfizer, BioNTech to Provide US, EU Bodies With Data on COVID-19 Vaccine Booster
03:28 GMT 09.07.2021 (Updated: 17:09 GMT 12.04.2023)
MOSCOW (Sputnik) – The companies of Pfizer and BioNTech will provide the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) with the information about the third dose of its coronavirus vaccine viewed as a booster of their drug.
"[We] plan to submit the data to the FDA, EMA and other regulatory authorities in the coming weeks," the companies said in a joint statement on late Thursday.
Pfizer and BioNTech pointed out that they had received "encouraging data" on the booster trial of the third dose of their vaccine.
"Initial data from the study demonstrate that a booster dose given 6 months after the second dose has a consistent tolerability profile while eliciting high neutralization titers against the wild type and the Beta variant, which are 5 to 10 times higher than after two primary doses," the statement reads.
The World Health Organization declared the COVID-19 outbreak a pandemic on March 11, 2020. To date, more than 185.48 million people have been infected with the coronavirus worldwide, with over 4 million fatalities, according to Johns Hopkins University.