Moderna vaccine gets emergency use approval

THE Covid-19 vaccine developed by American pharmaceutical firm Moderna has been granted emergency use authorisation (EUA), the Food and Drug Administration (FDA) said.

FDA director general Eric Domingo said the agency took 10 days to approve the EUA application, which was submitted on April 26.

“After a rigorous and thorough review by regulatory and our medical experts using the currently available published and unpublished data, the FDA is granting emergency use authorisation for the COVID-19 vaccine Moderna,” Domingo said in a Kapihan sa Manila Bay forum yesterday.

“All conditions for an EUA are present and the benefit of using the vaccine outweighs the known and potential risks.”

The EUA would only be valid within the duration of the declared public health emergency or upon the issuance of a certificate of product registration, he said.

Interim data from ongoing third phase trials of the vaccine showed that it had an overall efficacy rate of over 94%, he added.

Its efficacy rate was also consistently above 80% among all age groups above 18 and special groups such as health workers, people with comorbidities and the elderly.

The vaccine is administered in two doses, Domingo said, with the second dose given four weeks after the first shot.

The EUA cleared the vaccine for individuals aged 18 and above, he added.