Section 7Sec./Art. 7

Authority to Make Recommendations Based on Preliminary Data from Phase III Clinical Trails. -Notwithstanding any law to the contrary, the Health Technology Assessment Council (HTAC) shall have the authority to make recommendations to the DOH on COVID-19 vaccines based on preliminary data from Phase III clinical trials and World Health Organization recommendations, in the absence of completed Phase III and Phase IV clinical trials:Provided,That the COVID-19 vaccine manufacturer has been issued an EUA by the FDA:Provided further,That the authority granted to the HTAC herein shall only be valid for as long as the EUA issued by the FDA is in effect, such that in the event of revocation or cancellation thereof by the FDA Director General, the HTA process shall be terminated regardless of stage, and if it has been completed, the results shall be set aside.