Panel urges US regulators to approve single-dose Covid-19 vaccine

Washington, Feb 26 (efe-epa).- A panel of independent experts voted unanimously Friday to urge the Food and Drug Administration (FDA) to authorize the use of Johnson & Johnson’s single-dose Covid-19 vaccine in the United States, where the death toll from the virus has is approaching 510,000.

While the recommendation from the Vaccines and Related Biological Products Advisory Committee is non-binding, the FDA generally heeds the panel’s views.

In the case of both of the vaccines currently being administered in the US, the Pfizer/BioNTech and Moderna medications, the FDA issued an emergency use authorization the day after the endorsement from the advisory committee.

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.

Besides leading the world in coronavirus deaths, the US also has the largest number of confirmed cases – 28.5 million – and several members of the advisory committee pointed to the urgency of making more vaccines available.

Adding the Johnson & Johnson vaccine to the system will help “meet the needs of the moment,” according to Dr. Archana Chatterjee, an infectious disease expert at Chicago Medical School.

“We need to get this vaccine out now,” Dr. Jay Portnoy, a professor at the University of Missouri Kansas City School of Medicine, said. “We’re in a hurry.”

The Johnson & Johnson medication falls short of the 90 percent efficacy achieved by the Pfizer/BioNTech and Moderna vaccines, 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 jmr/dr

Related Articles

Back to top button