Once Approved, Hurdles Remain for Vaccines and Recipients

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Within minutes of the Food and Drug Administration giving approval to a COVID vaccine, a complex operation will launch across the country to get the vials from vaccine plants into people’s arms.

Millions of doses of the Pfizer vaccine, which is first in line for possible approval, are ready to be turned over to UPS and FedEx, which hope to get them to destinations all across the nation within 24 hours.

UPS is handling logistics in the Eastern U.S., while FedEx is responsible for distribution in the West.

In Florida residents of long-term care facilities and frontline medical workers will be the first immunized.

“The doctors, the nurses, the technicians, the employees in general who work in the emergency department, who work in the COVID unit,” said Dr. Yvonne Johnson of Baptist Healthcare in Miami.

Pharmacists are also approved to administer them, as CVS and Walgreens have agreed to vaccinate at long-term care facilities.

But even when enough of this and other vaccines are produced to provide to others, not everyone will yet be recommended to receive it.

“Our label around the vaccines will not just say who should get it, but who should not receive the vaccine,” said FDA Commissioner Stephen Hahn.

For example, children under 16 and pregnant women are not yet part of the expected recommendations. 

“We can’t base things on empty guesses and there were no people in trials younger than 16 and there were no pregnant women in the trial,” said Dr. Aileen Marty, FIU epidemiologist. “So there is no way to know right now for certain what the efficacy or safety is in groups that were not part of the study.” 

Also a concern: people with severe allergies, such as those requiring them to carry EpiPens to get them out of shock if the6 come in contact with an allergen.

“We need to do further studies on that and determine who is likely to be getting an allergic reaction to it because not everybody will,” said Marty, adding under proper medical supervision the vaccine may be appropriate for some who do have allergies.

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