FDA waiting for Novavax EUA application

Published July 4, 2021, 2:52 PM

by Analou de Vera

(FILES) This file photo illustration picture shows vials with COVID-19 Vaccine stickers attached and syringes with the logo of US biotech company Novavax, on November 17, 2020. JUSTIN TALLIS / AFP

The Food and Drug Administration (FDA) said Sunday, July 4, it is waiting for American biotechnology company Novavax to apply for an emergency use authorization (EUA) for its coronavirus disease (COVID-19) vaccine.

FDA Director-General Rolando Enrique Domingo said that Novavax has already expressed its interest to apply for an EUA in the Philippines.

“Letter of intent palang. Wala pang formal application ([It already sent] a letter of intent. There is no formal application yet),” said Domingo in a text message.

In a radio interview on Sunday, the FDA chief said that Novavax is still waiting for the approval of its EUA application in the United Kingdom, India, and in the United States of America.

Domingo described the Novavax vaccine as “very promising.”

“Ang taas ng efficacy rate at mukhang maganda din siya sa Delta variant. Nag published na rin sila ng kanilang results last week at binabasa na rin ng mga experts natin (The efficacy rate is high and it also looks good against the Delta variant. It also published its (clinical trial) results last week and our experts are currently reading them),” he said.

The FDA already granted EUA for the COVID-19 vaccines made by Pfizer-BioNTech, AstraZeneca, Sinovac Biotech, Gamaleya Research Institute, Johnson & Johnson, Bharat Biotech, and Moderna.

Domingo, meanwhile, urged the public to get vaccinated. He reiterated that these vaccines can give protection against the different types of coronavirus variants.

“Meron tayong nakikitang trend na diminishing effect…. Pero nakikita natin na meron pa rin protective effect at nagpre-prevent pa rin ng severe COVID saka ng pagkamatay (We are seeing a trend of diminishing effect …. But we see that they still have a protective effect and still prevent severe COVID as well as death),” he said.