The company carried out a study of 44,000 patients in South Africa, the United States, and several other countries, according to the agency, adding that there were seven COVID-19 deaths among patients receiving a placebo—and none who got the vaccine.
“There were no specific safety concerns identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection,” the analysis said.
The J&J vaccine against the moderate to severe CCP (Chinese Communist Party) virus cases was 66.9 percent at least 14 days after the single-dose vaccination and 66.1 percent at least 28 days after the shot was administered, according to the FDA, as reported by CNN and other news outlets.
The vaccine was 72 percent effective in the U.S. alone, said J&J. It, however, said the vaccine was only 57 percent effective against the virus in South Africa, where a new and more contagious variant has emerged in recent months, reported the Wall Street Journal. The Moderna and Pfizer/BioNTech vaccines have 94.1 percent and 95 percent efficacy, respectively, according to studies.
The FDA also said it reviewed data for the vaccine, saying it is “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.”
J&J previously said it would deliver about 20 million doses for usage in the United States by March.
The rival Pfizer and Moderna vaccines being used in the United States and numerous other countries must be kept frozen, while the J&J shot can last three months in the refrigerator, making it easier to handle. Those two vaccines require two shots to provide a full benefit, officials said.
AstraZeneca’s vaccine, widely used in Europe, Britain, and Israel, is made similarly and also requires refrigeration but takes two doses.
If the FDA clears the J&J shot for U.S. use, it won’t boost vaccine supplies significantly right away. Only a few million doses are expected to be ready for shipping in the first week.
But J&J told Congress this week that it expected to provide 20 million doses by the end of March and 100 million by summer. European regulators and the World Health Organization also are considering J&J’s vaccine. Worldwide, the company aims to be producing around a billion doses by the end of the year.
The Associated Press contributed to this report.
From The Epoch Times