Let's Talk COVID-19 Vaccines


December 11, 2020

As the pandemic continues and COVID-19 cases rise across our nation, it can be challenging to sort through all the news. Promising scientific advances in the continuing battle to control this virus include both prevention and treatment opportunities.

Today we’re talking about the latest vaccine news and what it means for payers and plan sponsors with Renee Rayburg, RPh, VP of Specialty Clinical Consulting, and Tara Higgins, PharmD, Pharmacy Benefit Consultant.

 

What do I need to know about the vaccine?

 Renee: The US Food and Drug Administration (FDA) advisory committee met yesterday, December 10, with Pfizer and voted 17-4 in favor of the Pfizer vaccine to recommend for approval. The vote was on a single question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer/BioNTech COVID-19 vaccine outweigh its risk for use individuals 16 years of age and older.”

Now the FDA officials must grant final approval.

 

Tara: While we’re currently focused on the Pfizer vaccine, two vaccine candidates have filed for emergency use authorization (EUA) from the FDA: Pfizer and Moderna.

 

 

How do these vaccines work?

 Renee: Both vaccines use a new technology involving messenger RNA (mRNA), which uses a synthetic copy of the SARS-CoV-2 virus’ genetic material, thereby tricking the body into thinking it has the virus and thus triggering the production of antibodies to the virus.  In comparison, other vaccines use weakened or inactivated versions of the pathogen, which causes the disease to stimulate the immune system to develop antibodies.

  • mRNA technology has been researched for many years. However, to date, no mRNA vaccines are licensed in the US.
  • mRNA vaccines are not live vaccines, nor do they use an infectious component, thus presenting no risk of causing disease in vaccinated patients.
  • mRNA from the vaccine never enters the cell’s nucleus. Therefore, it does not interact or affect a person’s DNA.

 

 

When will the vaccine be available in the US?

 Renee: This is essentially two questions. First, when will it be approved? Second, when will it be readily accessible?

COVID-19 vaccines will likely be available in the US before the end of 2020. The FDA expects to approve the emergency use authorization for the Pfizer vaccine, which could happen in a few days.

Additional treatments have become available to treat a broad spectrum of patients infected with the virus, including those at high risk of complications and/or hospitalization resulting from COVID-19 to hospitalized patients at the highest risk of complications, such as those who are oxygen and/or ventilator dependent.

Research continues for both treatments and vaccines with an additional 12 vaccine candidates in Phase 3 clinical trials, according to the World Health Organization (WHO).

 

Tara: For the second part of the availability question, we need to address how it will get into the hands (or arms, as it were) of Americans. The Pfizer vaccine has already started shipping in the US, and we expect availability within 24 hours of FDA approval.

Pfizer’s goal is to immunize 20 million in the US by the end of December and another 30 million each month after.

The methodology of distribution will look different from state-to-state. Based on the Centers for Disease Control and Prevention (CDC) guidance, state departments of health have created individual plans that include which population segments have access first.

In Rhode Island, for example, there are task forces planning vaccine clinics for first responders. Components of the setup include:

  • Staffing the clinic
  • Rotating first responders receiving the vaccine at a centralized location
  • Screening and monitoring those who receive the vaccine

Other logistics include:

  1. How is the vaccine transported to the clinic?
  2. How is the vaccine stored during the hours of the clinic?
  3. How are any extra doses handled since supplies will be tightly monitored due to limited supplies to start?

 

 

What challenges do you expect?

 Renee: Both vaccines require storage under extremely cold temperatures (-94° F for Pfizer vaccine; -4°F for Moderna vaccine). It will be paramount for pharmacies and hospitals receiving vaccines to have the necessary equipment for proper storage:

 

Tara: In addition to the sub-zero storage, another challenge is that both these vaccines are not “one and done.” They will both require two doses.

 

 

 

Are the vaccines safe?

 Renee: The FDA set precise requirements before manufacturers of vaccines can submit for emergency use authorization, including:

        • Two full months of safety data on 50 percent of clinical trial participants after final vaccine doses
        • Greater than 50 percent efficacy

Both companies are claiming “no serious safety concerns” have been found to date. Mild side effects are expected and are typical to those associated with flu shots: some reported injection site soreness, low-grade fever, and headache.

The vaccine intends to trigger an immune response, so some of these side effects experienced may be a good indication the vaccine is doing its job.

 

Tara: As I mentioned earlier, two doses are required, so it will be imperative for health care providers to communicate and educate patients ahead of time with suggestions for over the counter (OTC) medications that may help with any side effects experienced.

 

 

Who will receive the vaccine first?

 Renee: The CDC Immunization Advisory committee voted on recommendations for prioritizing those who should receive the vaccine first in the US. They made their recommendations in a phased approach based on these ethical principles:

  • Maximize benefits and minimize harm
  • Promote justice
  • Mitigate health inequalities

 

They expect to have enough vaccine for 20 million by the end of 2020. They have recommended the following:

  • Phase 1a
    • Health care workers
      • There are an estimated 21 million frontline workers in the US
    • Residents of long-term care facilities
      • There are an estimated 3 million nursing home residents in the US
      • The CDC reports that nursing home residents make up 6 percent of the cases, but 40 percent of the deaths from COVID-19
  • Phase 1b
    • Essential workers (e., education sector, food and agriculture, utilities, police, firefighters, corrections officer, transportation)
  • Phase 1c
    • Adults with high-risk medical conditions
    • Adults over 65 years of age

 

What will it cost?

Tara: An estimated 60 percent of US retail pharmacies have agreed to participate in the federal program to administer the vaccines, which will be at no cost to patients once they receive approval from the FDA.

 

 Renee: Also, the US Department of Health and Human Services (HHS) has issued guidance that allows state-licensed pharmacists and state-authorized pharmacy interns acting under the supervision of a pharmacist to administer the vaccines.

The federal government invested close to 9 billion to help fund the development and production of the vaccines. The government purchased the initial doses, but the costs for the vaccines and costs to payers are unclear beyond those doses. Some have estimated costs per dose of the vaccines may range in price from $3 to $37. Either way, there will not be out of pocket costs for patients who receive the vaccine.

 

 

PSG will continue to monitor the developments in COVID-19 vaccination and treatment.

Are you interested in learning more from these two pharmacy experts? Check out Renee Rayburg’s insights in our latest State of Specialty Spend and Trend Report and Tara Higgins’ powerful interview on managing diabetes.

 

Reference Information

  1. https://www.cdc.gov/vaccines/covid-19/hcp/mrna-vaccine-basics.html
  2. https://www.healthline.com/health-news/how-much-will-it-cost-to-get-a-covid-19-vaccine#How-much-each-dose-will-cost
  3. https://www.medscape.com/viewarticle/942475?src=mkm_covid_update_201210_MSCPEDIT&uac=79367BV&impID=2729604&faf=1