The US Food and Drug Administration (FDA) authorised Johnson & Johnson's Covid-19 vaccine Saturday. It is the first single dose Covid-19 vaccine available in the US.
US President Joe Biden welcomed the FDA's announcement that it issued an emergency use authorization for a third safe and effective vaccine to help defeat the Covid-19 pandemic the Janssen Covid-19 (Johnson & Johnson) vaccine.
"This is exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis," Biden said in a statement.
"Though we celebrate today's news, I urge all Americans keep washing your hands, stay socially distanced, and keep wearing masks," he said.
"As I have said many times, things are still likely to get worse again as new variants spread, and the current improvement could reverse," the US President added.
The FDA has determined that the Janssen Covid-19 Vaccine has met the statutory criteria for issuance of an emergency use authorisation. The totality of the available data provides clear evidence that the Janssen Covid-19 Vaccine may be effective in preventing Covid-19.
The data also show that the vaccine's known and potential benefits outweigh its known and potential risks, supporting the company's request for the vaccine's use in people 18 years of age and older.
After a thorough analysis of the data, the FDA's scientists and physicians have determined that the vaccine meets the FDA's expectations for safety and effectiveness appropriate for the authorisation of a vaccine for emergency use.
The single-dose vaccine does not need to be frozen when it is shipped and distributed. The vaccine is what's known as "fridge stable," meaning it can be shipped and stored at the temperature of a regular refrigerator. Both those characteristics will make this vaccine much easier to deploy.
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