Washington, Feb 27 (efe-epa).- The US Food and Drug Administration (FDA) announced Saturday that it has given final approval for the use of Johnson & Johnson’s single-dose Covid-19 vaccine.
“The FDA, through our open and transparent scientific review process, has now authorized three Covid-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Acting FDA Commissioner Janet Woodcock said on the agency’s website.
Officials said that people could begin receiving the J&J vaccine in the next few days.
No country has been hit harder by the coronavirus than the United States, where the disease has claimed 511,000 lives and the number of confirmed cases stands at 28.5 million.
Though the median number of new infections in the US has declined from around 300,000 a day at the start of the year to fewer than 70,000, authorities are urging Americans to remain vigilant, especially in regard to new and potentially more dangerous variants of the virus.
“Now is not the time to relax restrictions,” Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, said Friday. “Cases, hospital admissions and deaths all remain very high.”
The independent experts on the FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously Friday to recommend approval of the Johnson & Johnson vaccine.
Johnson & Johnson said late last month that its prospective Covid-19 vaccine had proven 66 percent effective in protecting against moderate to severe coronavirus and 85 percent effective in preventing cases requiring hospitalization.
Those findings emerged from a Phase 3 ENSEMBLE clinical trial including 43,783 participants in the US, South Africa and several Latin American countries.
The level of protection against moderate to severe Covid-19 infection varied by region: 72 percent in the US; 66 percent in Latin America; and 57 percent in South Africa, where a more dangerous variant of the virus has taken hold.
The Johnson & Johnson medication falls short of the 90 percent efficacy achieved by the Pfizer/BioNTech and Moderna vaccines that are already being administered in the US, but it also offers significant advantages.
While the Pfizer and Moderna medications are two-dose vaccines and the former must be maintained at a super-low temperature, posing a logistical challenge, J&J said that the single-dose Janssen vaccine is “compatible with standard vaccine distribution channels.”
Johnson & Johnson has committed to delivering roughly 20 million doses by the end of March. EFE afs/dr