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TAG’s Take on FDA’s New Vaccine Booster EUA

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TAG’s Take on FDA’s New Vaccine Booster EUA

On Wednesday the FDA amended its emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose at least six months after the second dose for certain groups considered to be at higher risk.

Those groups include those who are:

  • 65 years of age and older.
  • 18-64 years old at high risk of severe COVID-19.
  • 18-64 years old “whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”

It is the third group that has caused the most question and discussion, as Acting FDA Commissioner Janet Woodcock, M.D. explained that the update would “allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”

This third group tends to include workers who have contact with symptomatic patients, the general public where masking practices vary and where customers may be symptomatic, and groups who still cannot be fully vaccinated.  A third dose of the Pfizer vaccine will boost the level of circulating antibodies in a person’s immune system and can offer extra protection against symptomatic and severe infection as the Delta surge crests in the U.S.

Based on this announcement, we’re likely to see more specific guidance from the FDA and CDC in coming weeks, and TAG encourages individuals to consider their personal situation, including risk of exposure and underlying health conditions to determine if a booster dose is necessary.  Employers can also consider the layered risk mitigation measures they have in place when determining if their employees are at a greater risk of exposure and should consider a booster dose.

If you or your employees have questions on the booster – or vaccines or COVID-19 in general, please contact TAG. We would be happy to consult with you or provide a Townhall for your company.

50-State Risk Matrix, updated September 21, 2021

This week 27 states have a TPR > 10% and case rate >25 cases/100K. Idaho’s TPR is at 22%, with Tennesse at 19% and South Dakota at 18%. Other states like Mississippi and Oklahoma have a Test Positive Rate at 17%. On the other hand, states like 21 states have a TPR 25 cases/100K.

TAG’s Take on FDA’s New Vaccine Booster EUA

Case rates, though, have risen slightly across the majority of states. States with a case rate >100 cases/100K people include Alaska (101 cases/100K), Tennessee at 109 cases/100K, and West Virginia at 102 cases/100K. Similarly, Kentucky’s case rate is at 98 cases/100K and South Carolina’s case rate is also 98 cases/100K. While we had seen a drop (last week) in case rates – many states finally below 100 cases/100K, that seems to risen up again.

TAG’s Take on FDA’s New Vaccine Booster EUA

Yet as case rates are rising, Test Positive Rates and Rts have mixed rise/falls, too!

TAG’s Take on FDA’s New Vaccine Booster EUA

TAG’s Take on FDA’s New Vaccine Booster EUA

Additionally, while case rates have risen across the country (week-over-week), we do continue to see those states with higher rates of vaccination having lower case rates than those with lower rates of vaccination.

TAG’s Take on FDA’s New Vaccine Booster EUA

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