J&J hoping for quick emergency authorization of single-shot COVID vaccine
Dr. Paul Stoffers updates 'America's Newsroom' on the process for getting its single-shot COVID vaccine out to Americans.
Johnson & Johnson executive Dr. Paul Stoffels addressed the efficacy of the coronavirus vaccine compared to others already available to the public, saying it had revealed "complete protection against death and hospitalization."
"We have done this study in the height of the pandemic with huge transmission in the presence of several different variants," the chief scientific officer told "America’s Newsroom," citing the variants in Brazil, South America and South Africa.
"What we learned is that the high percent efficacy against severe disease as well as complete protection against death and hospitalization was basically the key finding," he added.
Johnson & Johnson on Friday said its single-shot coronavirus vaccine was 72% effective in preventing moderate-to-severe COVID-19 in the U.S, but fell to 66% in a larger trial conducted worldwide. The results stem from a Phase 3 ENSEMBLE clinical trial, which involved 43,783 participants.
The shot was found to be 66% effective in preventing moderate-to-severe illness in Latin America, and 57% effective in South Africa at 28 days post-vaccination. When the company only looked at severe cases, protection rose to 85%.
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The coronavirus vaccine developed by Pfizer Inc. and partner BioNTech SE proved to be more than 90% effective in the first 94 subjects who were infected by the new coronavirus and developed at least one symptom, the companies announced in November.
Moderna said in November that its experimental vaccine was 94.5% effective in preventing COVID-19 based on interim data from a late-stage clinical trial.
Stoffels noted that "90% of the people in our study were people with the South African strain and it’s known that is highly resistant against already many therapies, but also current vaccines."
"That’s why the finding we have here is very relevant that we can still protect regardless of age, risk factor, ethnicity, geography and strain," he continued, noting that the Johnson & Johnson single-dose vaccine will play a "very important role in combating the pandemic in the world."
J & J’s vaccine differs from currently approved jabs in the U.S. in that it requires a single shot as opposed to two doses, and it can be stored in warmer temperatures that the others.
The company suggested the shot was safe and well-tolerated; 9% of trial participants developed a fever and there were no serious allergic reactions.
Stoffels told "America’s Newsroom" on Wednesday that the company plans to file for an emergency use authorization (EUA) in the U.S. this week and will be submitting the results of a clinical trial. The company said it will be ready to ship immediately after authorization.
"The FDA will take a few weeks in the course of February to review [the data] and hopefully we’ll get the emergency use authorization in early March, in that time frame," Stoffels said.
In August, Johnson & Johnson announced it will deliver 100 million doses of its coronavirus vaccine to the U.S. in a deal with the government valued at more than $1 billion.
On Wednesday, host Bill Hemmer asked Stoffels if the U.S. will "get 100 million Johnson & Johnson shots by the summertime?"
"Correct," he responded, noting that "100 million shots means 100 million people."
"That is going to make a huge difference in the U.S. for many, many people to get protected from the disease, but also for the country to get back to normal," Stoffels continued.
"So I think we will make a significant contribution in the next few months on getting the pandemic under control in the U.S."
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FOX News’ Alexandria Hein and Kayla Rivas and FOX Business’ Daniella Genovese contributed to this report.
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