J&J’s Vaccine Could Hit the Markets Soon Despite Cold Chain Woes

With Johnson & Johnson preparing itself for the FDA clearance of its single-dose vaccine, hopes are high on speeding the vaccination process. Here’s how the company plans to handle its vaccine rollout program.

Earlier this month, Johnson & Johnson (J&J) announcedOpens a new window that Janssen Biotech, Inc. had submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose COVID-19 vaccine candidate, Janssen. This EUA submission is based on topline efficacy and safety data observed in the phase 3 clinical trial. On clearance from the FDA, the company expects immediate shipment of the product.

“Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” said Paul Stoffels, M.D., vice chairman of the executive committee and chief scientific officer at Johnson & Johnson. “Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping.”

Last month, J&J had announcedOpens a new window that the level of protection provided by their single-shot Janssen COVID-19 vaccine against moderate to severe COVID-19 infection was 72% in the U.S., 66% in Latin America, and 57% in South Africa. The emerging evidence showed that the shot was particularly effective at stopping serious disease, with 100% of hospitalizations, and also prevented deaths.

Interested in learning more about our investigational single-dose #COVID19Opens a new window vaccine candidate? Watch here. pic.twitter.com/aobB4jRII8Opens a new window

— Johnson & Johnson (@JNJNews) January 30, 2021Opens a new window

J&J further confirmed that its manufacturing timeline will enable the company to meet its full-year supply commitments for 2021. Keeping track of this, the drugmaker is establishing a supply network across countries that involves multiple manufacturing sites in different facilities before the vaccine can be distributed globally.

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Could J&J’s Vaccine Accelerate the Vaccination Process? 

Johnson & Johnson’s COVID-19 vaccine could speed up the vaccination process as it only requires one dose. Besides, the vaccine only requires standard refrigeration, unlike other vaccines that need ultra-cold storage. Thus, people in remote and underserved areas will have a better chance of getting vaccinated.

UPMC infection prevention medical director Dr. Graham Snyder saidOpens a new window , “If the vaccine is easier to store, that changes the dynamic a lot because you can get the vaccine to those areas that may not have the medical infrastructure to store the vaccine and make it more readily available. That’s a wonderful, wonderful thing.”

The FDA advisory panel is expected to make a recommendation on Johnson & Johnson’s EUA application at the end of this month.

The Challenges of Cold Chain Management

Several pharmaceutical companies, including Pfizer, Johnson & Johnson, Sanofi, Moderna, BionNTech SE, and AstraZeneca, have COVID-19 vaccine candidates in the pipeline. All candidates, including J&J’s Janssen, will face challenges while dealing with the cold chain.

The cold chain will play a vital role in the fight against the pandemic. It is critical to focus on the quality of the supply chain to zero-in on the quality of healthcare and the safety of those treated. Temperature excursions during the storage, handling, or distribution of temperature-sensitive clinical trial materials and ultimately vaccines will significantly impact public health.  

According to Johnson & JohnsonOpens a new window , Janssen will fit in the standard vaccine distribution channels. If the vaccine is authorized, Janssen’s single-dose vaccine candidate is expected to remain stable for two years at a temperature of around -20°C (-4°F), with at least three months of which can be at temperatures in the range of 2 to 8°C (36°F to 46°F). Further, the company plans to ship the vaccine by accessing the same standard cold chain technologies used today.

Although the company highlighted the requirement of standard refrigeration for its vaccine candidate, maintaining operational consistency throughout the temperature-controlled logistics journey will be a major challenge, irrespective of the context. The logistics approach will be similar no matter where the vaccines are traveling and whether they are subject to extreme cold or extreme heat, or whether products need to be kept at 15 to 25°C, at 2 to 8°C, or even lower, as observed in J&J’s vaccine. 

Besides, Moderna and Pfizer vaccines reiterate the importance of cold chain management as their vaccines need to be stored at freezing temperaturesOpens a new window and rely on the cold chain to get anywhere.

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In conclusion

Pennsylvania is currently receiving around 175,000 doses of the COVID-19 vaccine from the federal government per week. Still, with Johnson & Johnson’s EUA closing in, there is hope that this number will shoot up drastically. However, the vaccine rollout program will face challenges while managing the cold chain and reaching out to remote locations or places where the mean daytime temperature is high, and electricity is unavailable. 

That being said, supply chain issues around the COVID-19 vaccine continue to surface as the vaccine’s ‘temperature-sensitive ecosystem’ is critical in ensuring a successful vaccine rollout program. 

Do you think the vaccination process will speed up if Johnson & Johnson’s vaccine gets clearance from the FDA? Comment below or let us know on LinkedInOpens a new window , TwitterOpens a new window , or FacebookOpens a new window . We’d love to hear from you!