NASHVILLE, Tenn. (WKRN) – Pfizer announced Wednesday it plans to seek Emergency Use Authorization from the Food and Drug Administration “within days”. Infectious disease doctor David Aronoff with Vanderbilt explained the process has a few steps.
“The FDA will receive lots of data, from in this case Pfizer, to review exactly the safety and efficacy of the vaccine. They will also have to share the data with the Advisory Committee of the Immunization Practices. The ACIP is the expert group that generally gives advice to the Federal Government about who should be the key people to receive a vaccine,” said Aronoff.
Based on the information released, Dr. Aronoff said the Phase three trial findings support the announced 95-percent effectiveness.
“They did a very large trial with over 40,000 people in the trial. Half got active vaccine half got placebo. They reported 170 people got COVID-19 in their trial. 162 people who developed COVID-19 had received the placebo. The other eight who got COVID-19 had gotten the active vaccine,” Dr. Aronoff explained.
Unlike the Moderna vaccine trial, which reported a 94.5-percent preliminary effectiveness earlier this week, the Pfizer trial included a broader group of people.
“They really looked across a wide range of ages people as young at 16-years-old up to older than 65. They are reporting people in the older than 65 group also saw a benefit and didn’t see any safety signals,” said Aronoff.
Pfizer plans to have 50 million doses available by the end of the year with more than 12 million allocated for the US. Tennessee is among four states chosen by Pfizer for a pilot vaccine delivery program. The vaccine must be stored at ultra-cold temperatures of minus 94 degrees Fahrenheit, presenting a distribution challenge. The company said it will take what it learns in the pilot program and adapt it to other states across the country. The specific number of vaccines assigned to Tennessee is unclear at this time. But, Dr. Aronoff said, if the FDA grants an EUA, the vaccine is safe.
“Once the ACIP puts their seal of approval on that, I will be rolling up my sleeve and getting immunized as long as that vaccine is available for me to get,” Aronoff said.
The Commissioner of the Tennessee Department of Health, Dr. Lisa Piercey, addressed the vaccine roll out plan. If approved, she said the state is ready to distribute a limited supply of the vaccine to health care workers and first responders December 1.Wide-spread availability for the public likely won’t occur until Spring of 2021.
Stay with News 2 for continuing coverage of the COVID-19 Pandemic.
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(This reflects what the TDH is reporting each day at 2 p.m. CST )