Johnson & Johnson Requests Emergency Use Approval from FDA for Single-Dose COVID-19 Vaccine
On Thursday, Johnson & Johnson filed paperwork with the FDA for emergency use approval of their single-dose Coronavirus vaccine.
According to USA Today, the move comes after they finished up studies showing a 72 percent efficacy in a U.S. trial but a 66 percent efficacy in Central and Latin America.
Experts have said the lower efficacy rate comes at this particular time period for Coronavirus, saying that, if the trials had taken place at the same time, it may have been just as effective as the Moderna and Pfizer vaccines.
According to a press release by Johnson & Johnson, Janssen Biotech Inc., one of its companies, requested an emergency use authorization from the FDA for its vaccine. They state the emergency use authorization is based on a phase 3 ensemble where they called the vaccine “85 percent effective overall in preventing severe disease and demonstrated complete protection against COVID-19 related hospitalization and death as of day 28.” However, it was “72 percent effective in the US and 66 percent effective overall at preventing moderate to severe COVID-19, 28 Days after Vaccination.”
According to Paul Stoffels, M.D., who is the Vice-Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, “These topline results with a single-shot COVID-19 vaccine candidate represent a promising moment. The potential to significantly reduce the burden of severe disease, by providing an effective and well-tolerated vaccine with just one immunization, is a critical component of the global public health response.”
One key element of the Johnson & Johnson vaccine is that it appears to have fewer side effects as compared to the Moderna and Pfizer vaccines. Unlike the Pfizer vaccine, which has a fever rate of almost 15 percent, Johnson & Johnson’s vaccine only triggered a fever rate of 9 percent. But this is likely due to a disparity between the elderly who took the vaccine and received a much lower fever rate and young people who took the vaccine who received a fever rate of 20 percent.
However, unlike the Pfizer vaccine, which had some side effects in 84 percent of study participants, the Johnson & Johnson vaccine reportedly saw few side effects with its vaccine.
Photo courtesy: Pexels/Cottonbro
John Paluska has been a contributor for Christian Headlines since 2016 and is the founder of The Daily Fodder, a news outlet he relaunched in 2019 as a response to the constant distribution of fake news.
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