Can JNJ's One-dose COVID-19 Vaccine Draw the Curtain?
Posted: Feb 23, 2021
Johnson & Johnson announced the Phase 3 ENSEMBLE clinical trial data of efficacy and safety, demonstrating that the investigational single-dose COVID-19 vaccine developed by Janssen met all primary and key secondary endpoints. The data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.
JNJ will apply for an Emergency Use Authorization (EUA) for its COVID-19 vaccine candidate to the FDA then. If approved, J&J will join Pfizer and Moderna as the third vaccine supplier in the United States.
The approval process after submitting the application will take several weeks. If all goes well, JNJ's vaccine can be administrated as early as March 2021.
Comparison of experimental data between JNJ's vaccine and others
South African Efficacy
US/UK Efficacy (D614G/B117)
JNJ's vaccine may change the status quo of vaccine distribution in the United States, and its position in the uncertain pharmaceutical industry will also be consolidated.
Vaccines become big business
Any vaccine that can effectively deal with the COVID-19 epidemic is a huge achievement.
From a historical point of view, the coronavirus is the biggest problem for mankind. Although the SARS outbreak at the beginning of this century and the MERS discovered in 2012 attracted the interest of pharmaceutical companies to develop coronavirus vaccines, neither of them formed a global pandemic. As a result, vaccine manufacturers switched their sights to other areas, taking advantage of advances in biotechnology to produce vaccines that are more effective or safer against known pathogens, or to develop vaccines against pathogens for which there was no vaccine before, such as the Ebola virus and human papilloma virus (HPV). They are also committed to the study of new viruses, such as the Zika virus.
With the outbreak of SARS-CoV-2, the landscape has changed.
Since the outbreak of the epidemic, SARS-CoV-2 caused more than 2.3 million deaths worldwide and caused serious sequelae to the confirmed patients, leaving them in a weakened state for several months or even longer. Although some therapies can be used to treat severely ill patients, the hope is still pinned to persist in worldwide quarantine until most people are vaccinated.
The expansion of the epidemic has prompted a huge influx of funds and attention into the field of vaccine development and has changed the pharmaceutical industry. Novavax and AstraZeneca have made the headlines of global pharmaceutical industry news because of their successful development of vaccine candidates.
As for Moderna and Pfizer's vaccines, lipid nanoparticles are used as delivery vehicles for mRNA to ensure that the mRNA is in a safe state until it conveys information to human cells. Lipid nanoparticles are composed of tiny particles of biological materials, similar to cell membranes.
After the mRNA enters the cell, the code it carries will generate the spike protein, the hallmark of the coronavirus. After vaccination, this S protein is produced in human cells, and then the immune system will recognize it and thereby produce antibodies. The mRNA won't survive for a long time, and its components will be broken down and recycled together with other cellular materials.
JNJ's vaccine is superior to the other COVID-19 vaccines on the market in the following aspects.
1. One shot works
Unlike Pfizer and Moderna's vaccines (two injections are required within the specified time), JNJ's vaccine only requires one injection to produce the neutralizing antibodies that can be produced by two doses of others. This is because it is an adenovirus vector vaccine based on Ad26, which is different from the mRNA vaccine developed by Pfizer and Moderna.
2. Easy to store and transport, low temperature requirements
The two vaccines that were urgently authorized by the FDA have strict restrictions during storage and transportation.
- Pfizer's vaccine must be stored and transported in a special freezer at -70°C±10°C.
- Moderna's vaccine can be stored for six months at -25°C and -15°C.
- JNJ's vaccine can be stored for two years at -20°C and three months under standard refrigeration conditions (home or medical refrigeration 2-8°C).
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