Friday, December 11, 2020

Weighing the risks and benefits of newly available Covid-19 vaccines

A Federal Food and Drug Administration (FDA) Advisory Panel has recommended an Emergency Use Authorization (EUA) for the Pfizer Covid-19 vaccine. Final approval by the FDA could come within days. [See “F.D.A. Advisory Panel Gives Green Light to Pfizer Vaccine” by Katie Thomas, Noah Welland, and Sharon LaFraniere, New York Times, 12/10/10]: 

“The initial shipment of 6.4 million doses will leave warehouses within 24 hours of being cleared by the F.D.A., according to federal officials. About half of those doses will be sent across the country, and the other half will be reserved for the initial recipients to receive their second dose about three weeks later. “

The Michigan Department of Health and Human Services (MDHHS) has a Website for “COVID-19 Vaccine Provider Guidance and Educational Resources” with the following statement:

“This webpage will house materials to support COVID-19 Vaccine Providers in successful implementation of the COVID-19 Vaccination Program. Be sure to ‘bookmark’ this page and check back frequently for updates!”

This document, “COVID-19 Vaccine Information for Providers,” gives details for how the vaccine program will be administered including billing codes and other requirements that may not be of general interest, but it does have some relevant information for people needing a vaccine.

According to the MDHHS vaccine provider document, 

“The EUA [Emergency Use Authorization] authority allows the U.S. Food and Drug Administration (FDA) to authorize either (a) the use of an unapproved medical product (e.g., drug, vaccine, or diagnostic device) or (b) the unapproved use of an approved medical product during an emergency based on certain criteria. The EUA will outline how the COVID-19 vaccine should be used and any conditions that must be met as requirements of authorized use. FDA will coordinate with CDC [Centers for Disease Control and Prevention] to confirm these ‘conditions of authorization.’ Additional information on EUAs, including guidance and frequently asked questions, is located on the FDA website.”

There is more information on the CDC Communications Website: 

“Looking for information on ensuring safety of COVID-19 vaccine, how CDC is making recommendations, FAQs and more? Visit CDC’s new website featuring information on COVID-19 vaccine..."


PRIORITY GROUPS for Vaccination from the MDHHS Website

The phases distributing the vaccine are outlined below, according to the CDC Playbook and most recent ACIP meeting (11/23/2020).

PHASE 1: Potentially limited supply of COVID-19 vaccine doses available - Concentrate efforts on reaching the initial populations of focus for COVID-19 vaccination. The interim subsets for phase 1 are as follows: 

Phase 1-A:

  • Healthcare personnel: Paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials…
  • Long-Term Care Facility Residents: Residents of skilled nursing facilities and/or assisted living facilities, homes for the aged, adult foster care, etc

Phase 1-B: 

Essential Workers: People who play a key role in keeping essential functions of society running and cannot socially distance in the workplace (e.g., Education Sector, Food & Agriculture, Utilities, Police, Firefighters, Corrections Officers, Transportation)…

Phase 1-C:

High-Risk Adults: Adults with high-risk medical conditions who possess risk factors for severe COVID-19 illness

Adults 65 years of age or older

PHASE 2: Large number of vaccine doses available: Focus on ensuring access to vaccine for all critical populations who were not vaccinated in Phase 1, as well as for the general population; expand provider network.

PHASE 3: Sufficient supply of vaccine doses for entire population (surplus of doses): Focus on ensuring equitable vaccination access across the entire population. Monitor vaccine uptake and coverage; reassess strategy to increase uptake in populations or communities with low coverage.

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There is also information in the MDHHS document referring to the Moderna vaccine that may be available soon. Keep in mind that different versions of a vaccine will be available and there may be different recommendations for who should take these vaccines and varying side effects.

We are looking at over 3,000 deaths per day nationally from Covid-19 and a persistent resistance by a significant minority of the population to even acknowledge that the virus exists. I have friends who have had the virus and have survived, but say it is one of the worst experiences they have had. They continue to have lingering effects. I also know others who are critically ill during this current surge of cases. My husband’s second cousin recently died of the disease. Most cases of Covid are asymptomatic or relatively mild. That, along with how contagious the disease is and the fact that it can be transmitted before an infected person even knows they have it, make it especially difficult to contain its spread.

A vaccine is crucial to achieving control over the virus, but there is no federal mandate for anyone to take it. Private businesses, schools, hospitals, etc., may eventually require vaccination for employment or participation, but it is highly unlikely that this will happen with vaccines approved under an emergency authorization. [See "Yes, some Americans may be required to get a COVID-19 vaccine but not by the federal government" by Grace Hauck, USA Today, 12/06/20]

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See also:

"Are there side effects to a COVID-19 vaccine? What are the 'ingredients'? The cost? Answers to your vaccine questions" by Adrianna Rodriguez and Grace Hauck, USA TODAY,12/02/20

"Side effects from the COVID-19 vaccine means 'your body responded the way it's supposed to,' experts say" by Adrianna Rodriguez, USA TODAY, 12/07/20

"Pfizer and Moderna use mRNA in their COVID-19 vaccines. This never-before-used technology could transform how science fights diseases." by Karen Weintraub,USA TODAY, 11/23/20

"Britain warns against Pfizer vaccine for people with history of ‘significant’ allergic reactions" by William Booth and Erin Cunningham, The Washington Post, 12/09/20

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