COVID-19

India’s Bharat Biotech applies for emergency use approval of COVID-19 vaccine in PH

Bonz Magsambol
India’s Bharat Biotech applies for emergency use approval of COVID-19 vaccine in PH

Bharat Biotech

Bharat has also applied for the conduct of clinical trials in the Philippines

The Department of Science and Technology (DOST) said on Friday, January 22, that India’s Bharat Biotech has applied for emergency use authorization (EUA) of its coronavirus vaccine in the Philippines.

In a virtual press briefing on Friday morning, DOST Undersecretary Rowena Guevara said that they received the company’s application on January 21.

She also said that the DOST has also recently signed a confidentiality data agreement with Bharat on the conduct of phase 3 clinical trials of its vaccine in the country.

“We are waiting for Bharat’s submission of the complete requirements for clinical trials which will be evaluated by the vaccine expert panel, and ethics board before it will given to FDA for final review and approval,” Guevara said.

To date, there are 3 vaccine developers allowed to conduct phase 3 clinical trials in the country:  Janssen Pharmaceutica, Clover Biopharmaceuticals, and Sinovac Biotech.

Clinical trials are a type of research that evaluates potential medical interventions that affect human health. During trials, medicines, treatments, procedures, and devices may be tested to study or verify their clinical or pharmacological effects before they are approved for public use.

Guevara said that there are no definite dates yet on the conduct of clinical trials in the country.

As for EUAs, 4 other companies have applied. Pfizer was the first to secure emergency approval. 

An EUA will speed up the processing time for the approval of COVID-19 vaccines that will enter the country, from 6 months to 21 days. – Rappler.com

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Bonz Magsambol

Bonz Magsambol is a multimedia reporter for Rappler, covering health, education, and social welfare. He first joined Rappler as a social media producer in 2016.