Pfizer Inc and its German partner BioNTech SE have submitted the first data from an early-stage trial to US regulators to get approval for a booster dose of their COVID-19 vaccine, the drug makers said Monday.
They said the third dose showed significantly higher neutralizing antibodies against the original SARS-CoV-2 virus compared to the two doses, as well as against the beta and highly contagious Delta variants.
Pfizer has said the vaccine’s efficacy declines over time, citing a study that showed 84% effectiveness with a peak of 96% four months after a second dose. Some countries, including Israel, have already gone ahead with plans to give booster doses.
However, the decision of a few rich countries to buy booster shots has sparked the ire of health activists 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 study received the third injection, BNT162b2, eight to nine months after their second dose.
The drug manufacturers will submit the study data to the European Medicines Agency and other regulatory authorities in the coming weeks. They said results of a late-stage study 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 weaker protection against the two-dose regimens.
(Except for the headline, this story has not been edited by NewsMadura staff and has been published from a syndicated feed.)