A pre-clinical study confirmed the investigational Johnson & Johnson serum elicits an immune response against the SARS-CoV-2 virus. In other words, it vaccinates the recipient against contracting COVID-19 disease. The J&J vaccine is now entering Phase 3 trials, where after the company hopes FDA will approve it for public use.
Two Facts About the Johnson & Johnson Serum
J&J uses the randomized, double-blind, placebo-controlled method in its trials. This means subjects, study staff, and investigators do not know who gets the vaccine, and who the dummy placebo. The trials, using multiple schedules, and dose levels then evaluate the safety of the investigational serum, immune responses, and side effects.
Phase 1 and 2 trials tested the investigational Johnson & Johnson serum on participants in US, Belgium, Japan, Netherlands, Spain and Germany. Those volunteers were in good health, and aged 18 to 55, and 65+. The J&J team allocated them to serum and placebo groups randomly. It tried its best to lower the bar in terms of transport and childcare. This was because it wanted to ensure a diverse group of volunteers.
Two Interesting Aspects About the J&J Serum
Johnson & Johnson hopes to produce 1 billion doses of their vaccine. This would then be sufficient to immunize 1 billion people, because their serum only requires a single dose. The U.S. has ordered 100 million of these, however this is pending FDA emergency use authorization.
Those volumes of Johnson & Johnson serum will require additional manufacturing capacity. Phase 1 and 2 are successfully complete, and with Phase 3 beginning J&J is therefore putting up-scaling measures in place.
The company has secured additional production capacity in the United States and Italy. But it could be one jump ahead of the other candidates already. That’s because it says it can use its existing distribution channels to reach the entire world, without special transport.
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