US: FDA gives full approval to Pfizer-BioNTech COVID 19 vaccine
Aug 23, 2021
Washington [US] August 23 : The US Food and Drug Administration (FDA) on Monday gave full approval to Pfizer's COVID-19 vaccine.
The agency made the decision, giving the Pfizer-BioNTech shot the full go-ahead for patients aged 16 years or older. The vaccine still holds an emergency use authorization for those aged 12-15 and for a third booster shot, FDA said in a statement.
"The FDA has officially approved the Pfizer COVID-19 vaccine. While all three COVID vaccines have met FDA's strict standards for emergency use, this FDA approval should give added confidence that this vaccine is safe and effective," US President Joe Biden said in a tweet.
Meanwhile, acting FDA Commissioner Janet Woodcock also said that "the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,"
The shot will now be known under the name Comirnaty.
The decision "will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives," Pfizer CEO Albert Bourla said in a statement.
This "milestone puts us one step closer to altering the course of this pandemic in the US," he added.
The Biden administration is also preparing to roll out an expansive booster-shot campaign next month, offering a third shot to patients who received the Pfizer or Moderna vaccines.
As the highly infectious Delta variant spreads, the US is experiencing a surge in Covid-19 cases. Many southern states are struggling for hospital capacity amid resistance from Republican leaders and the public to vaccinations and mask mandates.
The overwhelming majority of Covid hospitalizations and deaths in the US are among unvaccinated people.
