FDA assures no shortcuts in approval of COVID-19 vaccine
MANILA, Philippines — The Food and Drug Administration (FDA) will not approve a COVID-19 vaccine unless it has completed all the required local procedures to ensure its safety and efficacy.
FDA Director General Eric Domingo made the assurance on Friday, August 14, 2020, as a COVID-19 from Russia is set to be tested in the Philippines.
“Hindi tayo magreregister ng vaccine for COVID-19 unless compelete yung phase 3 trial at makita na talagang convincing naman yung kanyang safety and efficacy,” he said in an interview on ABS-CBN’s TeleRadyo on Friday.
(We will not register a vaccine for COVID-19 unless it has completed the Phase 3 trial and we are convinced with its safety and efficacy.)
The Philippines is set to conduct the Phase 3 of clinical trials of Russia’s COVID-19 vaccine from October 2020 to March 2021, Malacañang earlier said.
During Phase 3 of the clinical trials, thousands of volunteers will have to be vaccinated to test its safety and efficacy. These trials will be funded by the Russian government and will be conducted simultaneously in Manila and Moscow.
Russian President Vladimir Putin earlier announced that Moscow has approved and registered a vaccine for COVID-19, which has now infected more than 20 million people worldwide.
Meanwhile, the head of the Russian Direct Investment Fund, which finances the vaccine project, said the Russian vaccine may be available in the Philippines by Novermber.
In an earlier interview, Domingo said a COVID-19 vaccine could be available by yearend as there are vaccines being developed by other countries that are currently undergoing phase 3 trials.
Domingo explained that under phase 1 trials, only around 20 to 100 healthy participants not exposed to the disease are adminsitered the vaccines. Under phase 2, “a few hundred to a few thousands” of patients who are possibly exposed to the disease take part in the trials.
The number of participants would then increase to 3,000 to 30,000 under phase 3, the last phase in the clinical development of a vaccine before FDA approval.
Domingo said this phase will take two to three months to monitor side effects of the vaccine.
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