FDA Approves Pfizer Candidate, Opens Door to Stronger Vaccine Mandates

by sam

Samuel Case, FISM News


On Monday the U.S. Food and Drug Administration gave full approval for the Pfizer / BioNTech COVID-19 vaccine candidate, becoming the first of the shots to receive full authorization from the drug regulator. That drug will now be rebranded as Comirnaty, according to the FDA.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said  FDA acting commissioner Janet Woodcock.

Pfizer CEO, Albert Bourla, shared a similar sentiment, saying in a statement, “Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed.” 

The Pfizer shot is by far the most widely administered vaccine with over 92 million having received the full 2 dose regimen, while the Moderna candidate trails behind at 64.7 million, according to CDC data. Currently 73% of American adults have received at least one jab. 

The full authorization may pave the way for hard vaccine mandates in certain institutions that were unable to do so without approval from the FDA, such as the Department of Defense. Defense Secretary Llloyd Austin said he would “seek the president’s approval to make the vaccines mandatory” either by mid-September or as soon as the FDA gives full authorization. 

Dr. Anthony Fauci told USA Today there would be a “flood” of mandates as soon as a shot is approved. “They can say: ‘If you want to come to this college or this university, you’ve got to get vaccinated. If you want to work in this plant, you have to get vaccinated. If you want to work in this enterprise, you’ve got to get vaccinated. If you want to work in this hospital, you’ve got to get vaccinated,'” Fauci said. 

The FDA’s full approval of the Pfizer candidate comes as the Biden administration seeks booster shots for those who are fully vaccinated. The Biden administration planned to begin administering the booster by mid or late September once given the green light by the drug regulator.