Story at a glance

  • As the delta variant forces renewed lockdown measures, Pfizer submitted Phase 1 data for a booster vaccination.
  • Results indicate comparable immune levels to the initial two shot series.
  • The booster would go to immunocompromised people first.

As the delta variant circulates throughout the U.S., drug and COVID-19 vaccine manufacturer Pfizer announced the submission of required data to regulators in a bid to get clearance on using an additional dose of its vaccine as a booster shot.

The company submitted Phase 1 data to the U.S. Food and Drug Administration (FDA) as it seeks a license to administer a third dose, according to an announcement on Monday. It also submitted the same findings to the European Medicines Agency (EMA).

This follows the FDA’s approval of booster vaccines in immunocompromised individuals last week. 

“Vaccination is our most effective means of preventing COVID-19 infection – especially severe disease and hospitalization – and its profound impact on protecting lives is indisputable. Still, with the continuing threat of the Delta variant and possible emergence of other variants in the future, we must remain vigilant against this highly contagious virus,” said Chairman and Chief Executive Officer Albert Bourla in a press release


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He noted that current data suggests a third dose of the Pfizer shot cultivates antibody levels that “significantly exceed” those seen following the standard two-dose administration of the vaccine. 

In conjunction with its development partner BioNTech, Pfizer will continue with Phase 2 and Phase 3 testing and submit that data when the results are available. 

The Phase 1 data looks at patients who have received a 30 microgram dose of the booster shot between eight and nine months following the first series of vaccinations.

If approved, the booster will be eligible for patients aged 16 years and above.

Booster shots have entered mainstream dialogue following the rampant growth of the delta variant. White House COVID-19 Advisor Anthony Fauci commented last week that eventually everyone will likely need booster shots. 

This is mainly due to the waning immunity offered by the original two doses. 

“We’re already starting to see indications of some diminution” in the durability of the vaccines, Fauci told reporters


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Published on Aug 16, 2021