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DOST: FDA approval, ethics board review needed to start clinical trials on mixed COVID-19 vaccines

Metro Manila (CNN Philippines, May 21) – Before testing if mixing COVID-19 vaccine brands for the first and second doses will be effective for Filipinos, the planned clinical trials should get the nod of two government agencies.

Science and Technology Undersecretary Rowena Guevara said they need to secure the approval of the Philippine Food and Drug Administration and a review by the Philippine Health Research Ethics Board to start the clinical trials.

“Those are the limiting factors. That will take about 1-2 months before we start (clinical trials),” Guevara told CNN Philippines’ Newsroom Ngayon on Friday.

Guevara explained the expected outcome of the planned clinical trials for mixing COVID-19 vaccine brands will help balance the country’s vaccine supply amid delays in deliveries. She cited the recent surge of infections in India, which affected the delivery of India-made Novavax vaccines to the Philippines.

The DOST Undersecretary said during the clinical trials, they need to solve whether mixing two different COVID-19 vaccine brands for the first and second doses will be effective. In addition, the study is expected to tackle the need for booster shots once two distinct vaccine brands have been administered.

“Ang interesting dito kasi hindi pa natin nasubukan sa ethnicity ng Filipino itong ganitong bagay. It will reveal several things in the study, yung immunogenicity tsaka syempre ‘yung pinakaimporte ‘yung safety,” Guevara added.

[Translation: What’s interesting here is we haven’t tested this to the ethnicity of a Filipino. It will reveal several things in the study, like the immunogenicity and the most important factor of all, which is safety.]

Guevara also emphasized the importance of clinical trials since COVID-19 vaccines are created differently, in terms of technology platform used. At present, the four COVID-19 vaccine types being used are inactivated vaccine, viral vector vaccine, mRNA or messenger ribonucleic acid vaccine, and subunit vaccine.

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The Science and Technology Department is also currently assessing whether the vaccines’ reported efficacy rates match with those who received their vaccine dose.

The Department of Health is not yet recommending the use of different COVID-19 vaccines for the first and second doses until there is solid evidence to support that option.

So far, only the United Kingdom is holding a clinical trial on mixing two different COVID-19 vaccine brands.

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