The US Food and Drug Administration (FDA) on Saturday, February 27, approved the coronavirus vaccine from Johnson & Johnson’s Janssen, the third such vaccine in the United States alongside Moderna and Pfizer / BioNTech. This is stated in the regulator’s message posted on its website.
It is noted that the product from Johnson & Johnson is the first monovalent vaccine approved in the country.
The FDA has determined that the Janssen COVID-19 vaccine meets the criteria for an emergency authorization, the document says.
US President Joe Biden, whose speech was published on the White House website, welcomed the approval of the Johnson & Johnson vaccine, noting that “this battle is not over yet,” so US citizens need to remain vigilant.
“I appeal to all Americans to continue washing your hands, maintaining social distancing, and wearing masks. As I have said many times, the situation may worsen with the spread of new variants (of the virus – Ed.), And current improvements may be reversed, ”he said.
According to the American leader, “there is a light at the end of the tunnel,” but we must act “quickly and aggressively, look after each other,” and only in this way, Biden concluded, “we will reach this light together”.
Johnson & Johnson announced on January 29 that its single-component vaccine was 66.1% effective in FDA studies. The drug developer estimated the efficacy at 64% in the third phase of the trial – with an efficacy of 72% in the United States and 57% in South Africa, where new mutations of the virus were identified.
On February 4, Johnson & Johnson sent a request to the FDA to approve the use of its coronavirus vaccine in emergency situations.
The company also announced that they are ready to start supplying the vaccine immediately after receiving the appropriate permission.
In October 2020, it became known that Johnson & Johnson had stopped testing its coronavirus vaccine due to an unknown disease in one of the participants. However, later it was reported that trials of the COVID-19 vaccine of this company would resume.