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The Ability to Use Medical Refrigerators Sets the J&J Vaccine Apart

  • by Kevin Driggers
  • Mar 15, 2021, 12:44 PM

On February 27, 2021, the FDA issued emergency use authorization (EUA) for Janssen's single-dose COVID-19 vaccine for patients age 18 and up. Janssen is a Johnson & Johnson pharmaceutical company.

In addition to requiring only one dose to be effective, the other key benefit of the J&J vaccine is that it remains stable in a medical refrigerator for months.

We've looked forward to this advancement for some months.

  • Back in December 2020, Operation Warp Speed (OWS) scientific director Dr. Moncef Slaoui said a single-shot COVID-19 vaccine was on its way and would likely be a "game-changer."

This is terrific news for patients and providers, especially in the remote and rural areas, and medical deserts of the US, where small clinics might not own the ultra-low temperature freezers needed to maintain the Moderna and Pfizer vaccines. And on a global scale, this advancement will eventually make remote COVID-19 clinics a reality for even the most difficult-to-reach populations.

Exploring the Logistics

As a single dose, the J&J vaccine is distinct from Pfizer and Moderna vaccines previously available, as both vaccines required patients to get a second dose within a few weeks.

  • Logistically, that meant providers needed to continually secure more vaccines on a specific schedule and to store them.

  • It also meant patients had to schedule their second dose carefully, which caused a lot of anxiety for them. 

Consider the challenges faced by the most extensive facilities, too. Imagine, for instance, the concern faced by Texas hospitals during February's brutal weather events. With an inventory of vaccines that must be kept at ultra-low temperatures, and a mostly immobile group of patients waiting on a second dose, Texas officials were scrambling to administer thousands of vaccines after a power loss before they expired due to power outages across the state.

About the Janssen Vaccine

The Food and Drug Administration (FDA) says the vaccine is "manufactured using a specific type of virus called adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive 'spike' protein of the SARS-CoV-2 virus."

  • Adenoviruses are considered to be relatively common.

  • Ad26 can cause symptoms similar to the common cold and conjunctivitis.

  • Janssen has modified Ad26 for the vaccine. It cannot replicate in the human body to cause illness.

  • After one receives this vaccine, the body can temporarily make the spike protein.

  • This protein doesn't cause disease but triggers the immune system to learn to react defensively and produce an immune response against COVID-19.

"With today's authorization, we are adding another vaccine in our medical toolbox to fight this virus," said Peter Marks, MD, PhD, and director of the FDA's Center for Biologics Evaluation and Research. He went on to say that Americans can be assured of the FDA's commitment to public health through rigorous and comprehensive evaluation of the data submitted for vaccine candidates.

How the FDA evaluated the J&J Vaccine

Safety Evaluation

Per the FDA, the available safety data to support the EUA includes an analysis of 43,783 participants enrolled in an ongoing randomized, placebo-controlled study conducted in South Africa, South America, Mexico, and the US.

  • 21,895 of the participants received the J&J vaccine.

  • 21,888 of them received a placebo.

  • Participants were monitored for about eight weeks.

The most commonly reported side effects were considered standard and like any other vaccination. These included:

  • Injection site pain

  • Fatigue

  • Headache

  • Nausea

  • And muscle aches 

The side effects were generally mild to moderate in severity, with a duration of one or two days. In other words, participants found themselves feeling much the same as they would after an influenza vaccine or "tetanus shot." Once the vaccination was found safe, it was time to understand its effectiveness.

Janssen Vaccine Effectiveness Data

The FDA's effectiveness data includes an analysis of 39,321 participants, also mostly from South Africa, South America, Mexico and the US. They did not have evidence of a COVID-19 infection before receiving the vaccine. 

Of them:

  • 19,630 participants received the vaccine

  • And 19,691 received a placebo.

The FDA found the vaccine to be 67% effective in preventing moderate to severe COVID-19 occurring the first two weeks after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 at least 28 days after vaccination. 

Between the effectiveness of a single dose and months-long stability in a simple medical refrigerator, the J&J vaccine truly is a game-changer. We all look forward to a time when Coronavirus vaccines are "one and done" and available in the most remote corners of the world. The fight against COVID-19 happening on a global battleground, not only a domestic one. 

The ABS Portfolio

At American Biotech Supply, our mission is to provide a full range of temperature-controlled equipment for our customers across the healthcare, clinical research, laboratory and pharmaceutical segments. In the race against COVID-19, we have expedited ultra-low freezers — and now refrigerators — to the hospitals and providers that need them.

We look forward to providing medical refrigerators to help you store the J&J vaccine.

Our portfolio includes everything from small capacity countertop refrigerators and freezers to cryogenic freezers for long-term sample preservation. Our medical refrigerator and freezer products are designed in various configurations, ranging from general purpose cold storage to medical and pharmaceutical storage with stringent temperature performance requirements. 

Hospitals, private practices, clinics and pharmacies must ensure that the proper cold storage equipment is in place. Whether frozen, refrigerated, and room temperature storage, American BioTech Supply can support all vaccine candidates' temperature ranges and provide solutions for any size requirements.

Our portfolio includes:

  • 4°C Refrigerators

  • -20°C to -40°C Low Temperature Freezers

  • -86°C Ultra Low Temperature Freezers

  • -196°C Cryogenic Freezers

  • And other specialty items like Controlled Auto Defrost Freezers

Check out our other blogs and contact us immediately if you have questions about our cold storage solutions. We can help you choose the right product for your practice, whether you plan on providing the Pfizer, Moderna or Janssen vaccine. 

 

Please contact us to discuss the best possible solutions for your refrigeration requirements and needs

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