By NewsDesk @bactiman63
The Food and Drug Administration (FDA) Thursday issued an Emergency Use Authorization (EUA) to AstraZeneca’s COVID-19 vaccine, three weeks after its application.
“It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known potential risks. The interim data from the ongoing Phase 3 trial shows that the vaccine has an efficacy of 70 percent after the first dose,” FDA Director General, Dr. Eric Domingo said in an online press briefing.
In the EUA, FDA said that the vaccine regimen consists of 2 equally standard doses of 0.5 ml each given 4-12 weeks apart. Domingo also explained that a person, who get a least dose of the vaccine will get 70 percent chance of preventing possible COVID-19 infection, as well as almost 100 percent preventing severe symptoms in case they are reinfected.
“The longer interval between the 2 doses was deemed responsible for the higher immunogenicity in the group that was given the lower 1st dose,” Domingo explained following the standard regimen of 2 full doses given 4 to 12 weeks apart in the country.
Domingo noted that the adverse events reported are transient and are mostly mild to moderate similar to common vaccine reactions and no specific safety concerns were identified.
The country has signed a deal with the company for 17 million doses of its vaccine and the first tranche of deliveries is expected to arrive in May.
Two weeks ago, Pfizer-BioNTech’s Covid-19 vaccine received its EUA from the FDA.