FDA Says No Need for Vaccines to be Approved by WHO

COVID-19 Vaccine Thailand 2021

The Food and Drug Administration (FDA) has said that each country has the right to register COVID-19 vaccines that will be used by their people without relying on a vaccine list approved by World Health Organisation (WHO).

Secretary-General of the FDA Paisarn Dunkum said COVID-19 vaccines approved according to the WHO Emergency Use Listing Procedure (EUL) are for use under the Covax initiative. The procedure can also be used as a reference when considering COVID-19 vaccine registration in countries with an incomplete vaccine regulatory system, he said.

The doctor insisted it did not mean that vaccines outside WHO’s list were substandard, saying vaccines from Pfizer, Moderna, AstraZeneca, and Johnson & Johnson had all been registered in countries such as the UK, the US, and some European countries before they were approved by WHO EUL.

Thailand had a vaccine regulatory system approved by WHO’s Prequalification Programme and was a member of the Pharmaceutical Inspection Co-operation Scheme, the doctor said. The country was therefore able to register COVID-19 vaccines by itself, he said, adding Thailand had registered AstraZeneca’s COVID-19 vaccine before it was approved by WHO EUL.

CoronaVac, Sinovac’s COVID-19 vaccine, has been approved by over 45 countries worldwide. It passes WHO’s efficacy threshold with over 50% efficacy against infection, 100% efficacy against preventing fatalities, and 77.9% efficacy to prevent hospitalisation from severe symptoms.

In Chile, CoronaVac is 67% effective in preventing symptomatic infections, 85% in preventing hospitalisation, 89% in preventing the infected from entering ICUs, and 80% in preventing death, according to WHO.

COVID-19 vaccines approved by the FDA were safe and effective against COVID-19, he said.

The administration has approved three COVID-19 vaccines including AstraZeneca, Sinovac, and Johnson & Johnson vaccines. Moderna’s vaccine is under review, according to the FDA chief.