A CLOSER LOOK: the 1,2,3’s of getting a COVID-19 vaccine approved

A Closer Look

EUA meets in December to discuss Pfizer vaccine

In this photo illustration a bottle of Covid-19 coronavirus Vaccine is seen

ARKANSAS (KNWA/KFTA) — On Friday, November 20, Pfizer filed for an emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine, Arkansas Health Department Secretary Dr. Jose Romero announced.

The company said it is working with the U.S. government and state officials for vaccine distribution.

Most of Pfizer’s vaccines will be shipped from Kalamazoo, Michigan, and Pleasant Prairie, Wisconsin, directly to where the product will be used, according to a company statement. Points of distribution include hospitals, outpatient clinics, community vaccination locations, and pharmacies.

Dr. Romero said, “We’re going forward in such a way that [the vaccine] when it becomes available, will directly ship to institutions.”

Dr. Romero announced the distribution information on Wednesday, November 18, after meeting with the  Advisory Committee on Immunization Practices (ACIP), which he chairs.

Pfizer has developed an innovative reusable packaging and storage product, reducing the cost of recipients having to purchase freezers.

“We talked about the idea that we’d have to purchase freezers,” said state Senator Will Bond at the CARES Act Steering Committee Zoom meeting on Wednesday, November 18, which Dr. Romero attended. “I thought the department [Arkansas Department of Health] indicated the original amount was in the $30 million range, to $17 million … and now to $0?” questioned Bond.

Dr. Romero told Bond, “We don’t need the cold storage. We had a call with Operation Warp Speed (OWS) … The shipping containers themselves can be reused a number of times and use dry ice.”

OWS website: The goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

The Pfizer vaccine needs to be stored at -70 to -80 degrees, said Dr. Romero.

The company will use GPS-enabled thermal sensors. The product will be connected to a control tower that will track the location and temperature of each vaccine shipment across pre-set routes. Pfizer said the devices allow to “proactively prevent unwanted deviations and act before they happen,” per their statement.

Once the vaccine arrives at its destination there are three storage options.

  • The Pfizer thermal shipper can be used as temporary storage units by refilling with dry ice for up to 15 days.
  • The vaccine can be stored in a refrigerator for five days at 2-8° Celcius (36-46 Fahrenheit).
  • Ultra-low-temperature freezers and can extend the shelf life for up to six months.

The Emergency Use Authorizations, EUA, has an advisory meeting scheduled for the second week in December. This is where recommendations about the Pfizer vaccine will be discussed and recommendations made, such as the FDA approval. Also decided at this time will be who gets the vaccine first and where it will be distributed.

Dr. Romero said that the first doses would be for high risk groups and frontline workers.

Pfizer plans to have 50 million doses produced in 2020, and 1.3 billion by the end of 2021.

Each person is required to take two doses about 28 days apart, according to Dr. Romero.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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