FDA approves emergency use of Johnson & Johnson's COVID-19 vaccine, which may be administered to persons 18 years of age and older.
Pamela Cruz. Peninsula 360 Press [P360P].
The U.S. Food and Drug Administration ?FDAOn Saturday, Janssen's COVID-19 vaccine, manufactured by Johnson & Johnson Pharmaceuticals, was approved on an emergency basis and may be administered to persons 18 years of age and older.
This vaccine is the first single-dose immunization vaccine to be licensed by the U.S. government to counter the SARS-CoV-2 epidemic.
The statement issued by the FDA indicates that Janssen's vaccine meets the legal criteria for its application in the country.
"The totality of available data provides clear evidence that Janssen's COVID-19 vaccine can be effective in preventing the disease," the agency reported.
FDA Acting Commissioner Janet Woodcock noted that the licensure of this vaccine expands the availability of vaccines, "the best method of medical prevention for COVID-19, to help us in the fight against this pandemic, which has claimed more than half a million lives in the United States."
The trial for the Janssen vaccine involved 44,000 people, and found the vaccine to be 66 percent effective in preventing moderate to severe COVID-19 four weeks after inoculation, and 100 percent effective in preventing hospitalization and death due to the virus.
The document also details that there are very few serious side effects from the vaccine, and shows preliminary evidence that immunization reduced asymptomatic infections. However, more data are awaited from the vaccine, as according to the FDA there is no data on how long the vaccine protection lasts.
It should be noted that the distribution and storage of this vaccine is much more effective and safer when using a normal refrigeration system, unlike the immunizations made by Pfizer/BioNTech and Moderna, which must be transported and stored in special conditions at temperatures below 70 degrees Celsius.
The U.S. government, which has purchased 100 million doses of Johnson & Johnson vaccine, plans to distribute about 4 million doses this week.
This would be in addition to the approximately 16 million doses of Pfizer/BioNTech and Moderna vaccines that are expected to be distributed throughout the United States.
For his part, President Joseph Biden stated that "this is exciting news for all Americans, and it furthers developments in our efforts to end the crisis. But I want to be clear: this fight is far from over. While we celebrate this news today, he called on all Americans to continue to wash their hands, to keep their social distance, and to keep wearing masks.
"There is a light at the end of the tunnel, but we cannot let our guard down now or assume that victory is inevitable. We must remain vigilant, act quickly and aggressively and look out for each other, that's how we will reach that light together," he said in his statement.
Johnson & Johnson's vaccine joins Pfizer/BioNtech and Moderna's biologics, both of which have two applications.
