Dr. Fauci Says Johnson & Johnson COVID Vaccine Could Be Authorized 'Within a Week or So'
The COVID-19 vaccine candidate manufactured by Johnson & Johnson could be authorized for emergency use "within a week or so," Dr. Anthony Fauci, the Biden administration's chief medical adviser, said Wednesday.
Fauci, who also serves as director of the National Institute of Allergy and Infectious Diseases, told Savannah Guthrie on NBC News' Today program that the U.S. Food and Drug Administration (FDA) was currently reviewing data on the vaccine.
"We could see, literally within a week or so, that they wind up getting the emergency use authorization. I don't want to bet ahead of the FDA, but I would not be surprised, Savannah, if this happens within the next week or two," Fauci said.
Johnson & Johnson has yet to apply to the FDA for emergency use authorization (EUA) but Mathai Mammen, global head of research and development for Janssen—Johnson & Johnson's pharmaceutical division—told Fortune on Monday that the firm intended to submit their application by the end of the week.
Last Friday, Johnson & Johnson announced preliminary results from an ongoing, large-scale Phase III clinical trial, reporting that the vaccine was 66 percent effective overall in preventing moderate to severe COVID-19, 28 days after vaccination.
But this figure doesn't tell the whole story, as there were differences in efficacy results depending on the location. For example, the efficacy was 72 percent among trial volunteers in the U.S., but 66 percent in Latin America and 57 percent in South Africa—where a new more infectious variant has become dominant—at 28 days after vaccination.
In addition to the headline efficacy figure, the company said the vaccine was around 85 percent effective in preventing severe disease and demonstrated "complete protection against COVID-19-related hospitalization and death as of day 28" in all of the regions studied in the clinical trial.
Fauci called the preliminary results from Johnson & Johnson's Phase III trial "really encouraging" during a briefing with other federal health officials last Friday.
While the overall effectiveness of the Johnson & Johnson vaccine appears to be lower than that of the shots produced by Pfizer-BioNTech and Moderna, making direct comparisons between these two and the latest candidate is tricky because the trials tested for slightly different outcomes.
Unlike the Pfizer-BioNTech and Moderna vaccines, the Johnson & Johnson shot was also tested after the emergence of notable new variants detected in the U.K., South Africa and Brazil.
In response to the emergence of research indicating that the Oxford University-AstraZeneca vaccine may reduce transmission of the virus, Fauci told NBC: "I haven't seen the data yet. That's not yet been peer-reviewed. I certainly have every reason to believe the Brits, but I'd like to see the data myself."
"If that's true, it's good news. Yet again, another vaccine candidate in the mix. We heard yesterday about the Russian Sputnik candidate which had over 90 percent efficacy. J&J, Johnson & Johnson, from last week, also had some good results. So as we are going on getting into February, we're going to have multiple candidates in the mix, which is good news."
TOODLES
The COVID-19 vaccine candidate manufactured by Johnson & Johnson could be authorized for emergency use "within a week or so," Dr. Anthony Fauci, the Biden administration's chief medical adviser, said Wednesday.
Fauci, who also serves as director of the National Institute of Allergy and Infectious Diseases, told Savannah Guthrie on NBC News' Today program that the U.S. Food and Drug Administration (FDA) was currently reviewing data on the vaccine.
"We could see, literally within a week or so, that they wind up getting the emergency use authorization. I don't want to bet ahead of the FDA, but I would not be surprised, Savannah, if this happens within the next week or two," Fauci said.
Johnson & Johnson has yet to apply to the FDA for emergency use authorization (EUA) but Mathai Mammen, global head of research and development for Janssen—Johnson & Johnson's pharmaceutical division—told Fortune on Monday that the firm intended to submit their application by the end of the week.
Last Friday, Johnson & Johnson announced preliminary results from an ongoing, large-scale Phase III clinical trial, reporting that the vaccine was 66 percent effective overall in preventing moderate to severe COVID-19, 28 days after vaccination.
But this figure doesn't tell the whole story, as there were differences in efficacy results depending on the location. For example, the efficacy was 72 percent among trial volunteers in the U.S., but 66 percent in Latin America and 57 percent in South Africa—where a new more infectious variant has become dominant—at 28 days after vaccination.
In addition to the headline efficacy figure, the company said the vaccine was around 85 percent effective in preventing severe disease and demonstrated "complete protection against COVID-19-related hospitalization and death as of day 28" in all of the regions studied in the clinical trial.
Fauci called the preliminary results from Johnson & Johnson's Phase III trial "really encouraging" during a briefing with other federal health officials last Friday.
While the overall effectiveness of the Johnson & Johnson vaccine appears to be lower than that of the shots produced by Pfizer-BioNTech and Moderna, making direct comparisons between these two and the latest candidate is tricky because the trials tested for slightly different outcomes.
Unlike the Pfizer-BioNTech and Moderna vaccines, the Johnson & Johnson shot was also tested after the emergence of notable new variants detected in the U.K., South Africa and Brazil.
In response to the emergence of research indicating that the Oxford University-AstraZeneca vaccine may reduce transmission of the virus, Fauci told NBC: "I haven't seen the data yet. That's not yet been peer-reviewed. I certainly have every reason to believe the Brits, but I'd like to see the data myself."
"If that's true, it's good news. Yet again, another vaccine candidate in the mix. We heard yesterday about the Russian Sputnik candidate which had over 90 percent efficacy. J&J, Johnson & Johnson, from last week, also had some good results. So as we are going on getting into February, we're going to have multiple candidates in the mix, which is good news."
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