FDA reviewing COVID-19 vaccines’ EUA for booster shots

 (AFP)

“For now we have already submitted our letter of intent to the Food and Drug Administration. The DOH is applying for this EUA. We are just waiting for some more evidence to complete our documentation and submission. The FDA also has started their evaluation,” Health Undersecretary Maria Rosario Vergeire told ABS-CBN News Channel’s Rundown.

Health Undersecretary Maria Rosario Vergeire (INQUIRER file photo / EDWIN BACASMAS)

In a text message to INQUIRER.net, FDA Director General Eric Domingo said that the request of the DOH to the FDA was for a review of the vaccines’ EUAs “to include” an additional dose.

 

Meanwhile, Vergeire said that health experts have urged the government to wait for the recommendation of the World Health Organization (WHO) regarding booster doses.

“One of the conditions of our experts based on the HTAC (Health Technology Assessment Council) recommendation and the other experts’ recommendation is for us to wait for the completed SAGE (Strategic Advisory Group of Experts on Immunization) recommendation from the WHO. It is going to come out this November,” she said.

“Once the SAGE recommendations are out, the EUA and the evaluation of FDA can be completed also. So that will be about November maybe,” she added.

The DOH earlier approved the recommendation of HTAC to give booster shots and additional jabs against COVID-19 for priority groups.  

The HTAC recommended that healthcare workers be prioritized, followed by senior citizens and “eligible priority groups.”

Meanwhile, the council also suggested that a third dose be administered to immunocompromised individuals, but only after 28 days from completion of the initial COVID-19 vaccine series.

Vergeire earlier explained that booster shots are given to those whose immunity against COVID has waned over time, while third doses are provided to people who did not generate a sufficient immune response after their vaccination.

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