Operation Warp Speed: Utah lawmakers need to look at vaccine reforms now

Written by Derek Monson

May 1, 2020

A strong and sustainable economic recovery from the novel coronavirus pandemic will require a safe and effective treatment, and more importantly, a vaccine.

In pursuit of the latter, the federal Department of Health and Human Services, under orders from President Donald Trump, has undertaken a collaborative “Manhattan Project-style effort” between federal regulatory agencies, university and industry vaccine researchers, and private-sector drug manufacturers, spurred on by public health policy thought leaders. The goal of this initiative – labeled Operation Warp Speed – is to deliver 300 million doses of a safe and effective COVID-19 vaccine by January 2021.

Presuming the imminent arrival of a safe and effective vaccine in 2021, we should anticipate rapid delivery. This begins with an immediate update of state vaccine policies and regulations to encourage the quickest and broadest possible public access to the vaccine – especially given how fast the novel coronavirus spreads. For that reason, we should lower regulatory barriers to pharmacies offering federally approved vaccines for pandemic diseases to the public.

Specifically, Utah lawmakers should allow pharmacies to administer pandemic vaccines approved by the federal Food and Drug Administration (FDA) without an agreement with or prescription from a licensed prescriber.

Regulation of vaccine development and production is done at the national level. But states regulate how vaccines are offered to the public. Utah’s Vaccine Administration Protocol allows pharmacists, pharmacy interns or pharmacy technicians to administer 13 vaccines to eligible patients of all ages, according to guidelines from the CDC (U.S. Centers for Disease Control) and Prevention’s Advisory Committee on Immunization Practices. Vaccines not on that approved list “may also be administered by a licensed Utah pharmacist pursuant to a prescription from a licensed prescriber.”

Many pharmacies follow this regulation through an agreement with a hospital or doctors’ office that can prescribe medication, known as a collaborative pharmacy practice agreement. In various situations requiring immunizations, such as international travel that requires a specific combination of vaccinations, such an arrangement makes medical sense. The case of a pandemic disease, on the other hand, is different.

Once a COVID-19 vaccine is determined to be safe and effective by the FDA, doctor’s offices will be overwhelmed. Time spent checking and/or revising collaborative pharmacy practice agreements is time wasted when it comes to public access to the vaccine. A model from the Johns Hopkins School of Public Health found that allowing pharmacies to offer flu vaccines during a severe epidemic “averted up to 23.7 million symptomatic cases, prevented up to 210,228 deaths and saved $2.8 billion in direct medical costs, $97.1 billion in productivity losses and $99.8 billion in overall costs.” In other words, delaying access to FDA-approved vaccines for COVID-19 at pharmacies could mean more symptomatic cases of the disease – and more deaths.

The unique and urgent circumstances of a pandemic require unique vaccination policies that deliver safe and effective vaccines to the public as fast and as broadly as possible. In order to encourage a strong and sustainable economic and public health recovery from the current pandemic, Utah policymakers should ensure that pharmacies are approved to offer FDA-approved vaccines for pandemic diseases without the need for a prescription from or an agreement with a licensed prescriber.

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