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Johnson & Johnson has submitted its vaccine for FDA review

Following successful testing, it has requested emergency use authorization

Photo (c) sinology - Getty Images
Johnson & Johnson has requested emergency use authorization (EUA) for its coronavirus (COVID-19) vaccine after completing a successful clinical trial.

The U.S. Food and Drug Administration (FDA) said it will review the trial data later this month. Assuming an EUA is granted, Johnson & Johnson could begin distributing its single-dose vaccine almost immediately.

In the portion of the trial conducted in the U.S., the vaccine was 72 percent effective at preventing COVID-19, less than the efficacy rate of vaccines produced by Pfizer and Moderna. However, when subjects did get the virus the vaccine was 85 percent effective in preventing severe cases.

In the study, the definition of severe COVID-19 disease included laboratory-confirmed SARS-CoV-2 and one or more of the following: signs consistent with severe systemic illness, admission to an intensive care unit, respiratory failure, shock, organ failure or death, among other factors. 

‘A promising moment’

“These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment,” said Dr. Paul Stoffels, Johnson & Johnson’s chief scientific officer. “A one-shot vaccine is considered by the World Health Organization (WHO) to be the best option in pandemic settings, enhancing access, distribution, and compliance.”

The Johnson & Johnson vaccine may also present fewer logistical challenges than its counterparts. The developers say it can be transported and stored with simple refrigeration and does not require extreme temperatures. Doctors are also pleased that the vaccine appears to provide protection against severe cases of the virus.

“Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19,” Stoffels said. “It also offers the hope of helping ease the huge burden placed on healthcare systems and communities.”

Generally consistent protection

The company said the trial showed the vaccine provides protection generally consistent across race, age groups, including adults over 60 years of age, and across all variants and regions studied, including South Africa where nearly all cases of COVID-19 were due to infection with a SARS-CoV-2 variant].

Johnson & Johnson has been producing the vaccine during the time it was being tested in clinical trials. The company said it has millions of doses ready to ship once the FDA flashes the green light.

An FDA advisory committee has scheduled a meeting for Feb. 26 to review the data.

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