Waiver sought for vaccines without Phase 4 trials

MANILA, Philippines — To speed up the government’s rollout of COVID-19 vaccines, two Senate leaders filed a bill waiving a regulatory guideline under the Universal Health Care (UHC) Act requiring the vaccines to have completed Phase 4 clinical trials.

Senate Bill No. 2029, filed by Senate President Vicente Sotto III and Sen. Pia Cayetano, would authorize the Health Technology Assessment Council (HTAC), a technical advisory panel of health experts, to recommend vaccines to be procured by the Department of Health using only preliminary data from Phase 3 trials.

At present, the Food and Drug Administration issues only emergency use authorization for COVID-19 vaccines on the basis of and upon review of the preliminary data submitted by the manufacturers.

The same practice is done in most other countries.

But under the UHC law, all pharmaceutical products must have undergone Phase 4 clinical trials, with systematic review and meta-analysis available, before the HTAC could issue any recommendations to procure them.

A positive HTAC recommendation is a requirement before any pharmaceutical product, including newly developed COVID-19 vaccines, can be procured.

“It will take another two to five years of further data gathering before reaching Phase 4,” Sotto and Cayetano said in an explanatory note to the bill, which they filed on Feb. 1.

To date, none of the COVID-19 vaccines being administered around the world have reached the final stage of the clinical trials.