Pfizer to Seek Approval From US Administrator For Third COVID-19 Vaccine Dose

Pfizer is about to seek approval from the U.S. administrator for a third dose of the COVID-19 vaccine that it said will boost up immunity if it is taken within 12 months and maybe help fight the latest Delta coronavirus mutant.
The drugmaker Thursday announced “encouraging data” from its ongoing trial of the third coronavirus vaccine dose. According to preliminary data from the study, a third dose given six months after the second dose boosts antibody levels five to 10 times higher than just two doses.
Pfizer said it would share the trial data in August and then immediately seek regulatory authorization. It believes the third dose will prevent hospitalizations and deaths.

The development comes as U.S. regulators said Americans who have been fully vaccinated do not need a booster COVID-19 shot yet. “We are prepared for booster doses if and when the science demonstrates that they are needed,” the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) said in a joint statement late Thursday.

Research from several countries reveals the Pfizer shot and other widely used COVID-19 vaccines offer strong protection against the Delta variant, which is spreading rapidly across the world and now accounts for the majority of new infections in the U.S.
Two doses of most vaccines are crucial to developing high levels of virus-fighting antibodies against all variants of the coronavirus, not just the Delta variant — and most of the world still is grappling to get those initial protective doses as the pandemic continues to rage.

But antibodies naturally wane over time, so studies also are underway to tell if and when boosters might be needed.

The CDC last month said that”there is no data for recommendations of the other dose, if there are no certain cases, as such”.

Sara Oliver of the CDC told the agency’s Advisory Committee on Immunization Practices that officials will continue to monitor data to see if a booster shot is necessary for the future. But leading infectious disease expert Anthony Fauci had previously said that he expects booster shots to eventually be required.