Gov. Edwards, others applaud FDA’s approval of Pfizer’s COVID-19 vaccine
The approval could trigger more vaccination mandates
NEW ORLEANS (WVUE) - It is no longer an emergency use authorization for Pfizer’s COVID-19 vaccine. The FDA on Monday gave full approval of the vaccine for individuals 16 years of age and older.
Dr. Lucio Miele of LSU Health Precision Medicine reacted to the approval.
“It’s excellent news, it was expected,” he said. “It brings a significant measure of certainty for anyone who might still have been wondering about the safety and efficacy of this vaccine.”
Miele is also head of Genetics at LSU Health and he previously worked at the FDA approving biologics which includes vaccines.
He discussed the difference between vaccine approval and emergency use authorization.
“So, an emergency use authorization is built for use in the event of a health emergency such as the pandemic. It’s based on the best available evidence, it can be rescinded. In this case, the evidence was more than enough particularly from the safety standpoint,” said Miele.
To grant full approval, Miele said the FDA wanted even more data.
“The agency wanted to see six months of follow-up data on the participants of the original clinical trial and also wanted to do something which consisted in studying the real-world data from tens of millions who have received the Pfizer-BioNTech vaccine,” said Miele.
He said the additional time involved in getting approval answered some important questions.
“One of the things, for example, that wasn’t known was how long would protection last,” said Miele. “Now we have data showing that certainly for six months protection will last and that information goes into the package insert of the approved vaccine. Without six months follow-up we wouldn’t know that.”
Governor John Bel Edwards issued a statement following the FDA’s approval of the vaccine.
“Today’s FDA approval of the Pfizer vaccine, now marketed as Comirnaty, is yet another historic moment in our journey out of this COVID-19 pandemic. This full FDA approval of the first COVID vaccine follows months of clinical trials and millions upon millions of real-world doses safely administered across the globe. This vaccine is well researched, very safe and highly effective at preventing serious COVID illness, hospitalization and death,” Gov. Edwards said. “It is my fervent hope that any Louisianan who was waiting for the FDA approval of the vaccine will take action to immediately receive their shot. Already, more than 2.2 million Louisianans have taken at least one dose of the vaccines that are available statewide. We are optimistic that our numbers will grow as we fight together to end this COVID pandemic once and for all. Today would be a great day to get your COVID vaccine.”
“After an exhaustive review process we are very happy to see the Pfizer vaccine receive full licensure from the FDA. More than 200 million Americans, including 2.2 million people in Louisiana, already have received at least one dose of a COVID-19 vaccine,” said Dr. Joseph Kanter, State Health Officer. “The COVID-19 pandemic and our most recent surge have been devastating. To date, we have lost more than 11,900 Louisianans to this virus. Many more people going sleeves up for this life-saving vaccine will protect us against future COVID-19 surges and help us put an end to this pandemic.”
U.S. Sen. Bill Cassidy, a physician, hopes the approval of the Pfizer vaccine will lead to more vaccinations.
“As a doc who saw people die who were not vaccinated from other diseases and now see people die who I know, who I love who are dying because they weren’t vaccinated, I hope people will,” said Cassidy.
But some people may still question if approval was too fast or involved shortcuts.
Miele is confident that is not the case.
“There were no shortcuts. Either for the Emergency Use Authorization and for the approval,” he said.
Ochsner Health, the largest hospital system in Louisiana, said it will discuss with the media on Tuesday how the approval will impact its employee vaccination policies.
Further, a written statement by Dr. Sandra Kemmerly, an infectious disease specialist and co-leader of Ochsner Health’s COVID-10 Response Team said:
“Today’s announcement from the FDA underscores the safety and efficacy of the Pfizer vaccine and confirms what we have been saying, which is that getting vaccinated is the best way to keep yourself, your family and our community safe from COVID-19.
The Pfizer vaccine has been administered to tens of millions of people and proven to be safe and effective against serious disease and death, with few documented serious side effects. We heard from several community members who were waiting on full FDA approval to get vaccinated and are hopeful that all eligible community members get their vaccines as soon as possible. Today, Ochsner Health is caring for 967 COVID-19 patients in our hospitals across the state, and nearly 88% are unvaccinated.
The Pfizer COVID-19 vaccine has full FDA approval for individuals 16 years and older. Pfizer is also available to ages 12-15 under Emergency Use Authorization (EUA). People wishing to get vaccinated can visit one of the more than 1,400 vaccination clinics in the state.
Ochsner is proud to offer vaccination opportunities across the region in clinics, shopping centers, community sites and even at Saints games. To find a vaccine location near you, please visit https://www.ochsner.org/appointment-availability.”
Meanwhile, a spokeswoman for LCMC Health which operates several hospitals in the New Orleans area said, “We continue to consider a vaccine policy now that it is approved.” Also, LCMC Health continues to administer vaccines.
Miele also encourages people to get vaccinated. He said with large portions of the population unvaccinated there will be more variants of the virus.
“The virus keeps mutating, it’s not going to stop mutating. We have Alpha, now we have Delta, we’re seeing other variants of interest coming up,” he said.
He also reminds the public that getting COVID-19 infection can have long-lasting effects.
“The latest data indicates that at least one in four of all of the people who develop COVID is going to have long-haul damage and long-haul symptoms. That is independent of age and independent of severity of disease,” said Miele.
See a spelling or grammar error in our story? Click Here to report it. Please include the headline.
Copyright 2021 WVUE. All rights reserved.