Pfizer Seeking Full FDA Approval Of COVID-19 Vaccine
SALT LAKE CITY, Utah – Pfizer became the first drug-maker to ask the Food and Drug Administration for full approval of its COVID-19 vaccine.
That important step on Friday would make it easier for Utahns to get the shot from their own physician and might reduce vaccine hesitancy.
“This is really a signal that we have a great vaccine, that there’s enough confidence around it to license it as any other vaccine,” said Dr. Tamara Sheffield, Intermountain Healthcare’s medical director of Community Health and Prevention.
Sheffield said it won’t happen as quickly as emergency use authorization.
The FDA first granted the Pfizer vaccine an EUA in December, which allowed the federal government to distribute the vaccine in the midst of a public health emergency.
“They want to get full approval, like any other vaccine, that it would be considered to be safe and effective, and we’ve had enough experience with it,” said Sheffield.
It usually takes 12 months, but Sheffield expected they will work more rapidly under the circumstances of the pandemic.
“It’s a rigorous process, evidence-based process, and the nice thing is we now have time and experience with this vaccine, so that may move things ahead because it’s already been out in the market and we’ve been able to see its impact,” she said.
When it gets full licensure, the application process for physicians won’t be as difficult. Sheffield said they will be able to order it and provide it just as they would with any other fully approved vaccine.
“Anyone who’s been watching carefully and weighing out their personal risks and benefits I think should be very comforted by the millions of individuals and hundreds of millions who have received this vaccine in the United States,” Dr. Sheffield said.
She advised everyone to get their shot and continue to take precautions, especially indoors, or in a crowd.
“We can’t get too comfortable too soon,” said Sheffield. “We need to be very vigilant about getting the whole population vaccinated because that’s how we eradicate it.”
Sheffield cautioned that we are not out of the woods yet.
She urged Utans to continue social distancing and masking while the state builds herd immunity with the vaccines.
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How do I prevent it?
The CDC has some simple recommendations, most of which are the same for preventing other respiratory illnesses or the flu:
- Avoid close contact with people who may be sick
- Avoid touching your face
- Stay home when you are sick
- Cover your cough or sneeze with a tissue and then throw the tissue in the trash
- Wash your hands often with soap and water for at least 20 seconds, especially after going to the bathroom, before eating, and after blowing your nose, coughing or sneezing. Always wash your hands with soap and water if your hands are visibly dirty.
- If soap and water are not readily available, use an alcohol-based hand sanitizer with at least 60% alcohol.
The CDC recommends wearing cloth face coverings in public settings where other social distancing measures are difficult to maintain (e.g., grocery stores and pharmacies), especially in areas of significant community-based transmission.
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