President Rodrigo Duterte, “in principle,” has approved the recommendation of the Department of Health (DOH) to issue an executive order for COVID-19 vaccine emergency use in the country.
Palace spokesperson Harry Roque said the executive order would authorize Food and Drug Administration to issue emergency use authorization (EUA) for COVID-19 vaccines.
Health Secretary Francisco Duque told Duterte that the EO would shorten the processing time from six months to 21 days.
Duque said the EUA would allow the country to use medicines, vaccines, and other health technologies through reliance and recognition.
The EUA is a facilitated approval for public health emergencies like the COVID-19 pandemic.
The EUA could only be given if there is a medical health emergency, a serious or life-threatening disease, the product is proven effective to prevent, diagnose or treat the disease, there is a positive risk-benefit balance, and there is no adequate available alternative, Duque added.
Pfizer Inc. announced on Wednesday that it completed the late-stage trial of its COVID-19 and final results showed 95% efficacy.
The drugmaker added it had the required two-months of safety data and would apply for emergency US authorization in the following days.
COVID-19 vaccine update
Pfizer said the vaccine developed with German partner BioNTech SE showed consistent efficacy across age and ethnicity demographics. There were also no major side effects, making it deployable worldwide.
The COVID-19 vaccine reportedly showed 94% effectiveness for adults over 65 years, who are at particular risk from COVID-19.
Pfizer said there had been 170 infections in its trial of more than 43,000 volunteers. Of that number, 162 were observed in the placebo arm, and 8 were in the vaccine group.
Pfizer said it expects to make as many as 50 million vaccine doses this year, which could immunize 25 million people and produce up to 1.3 billion doses in 2021.
The final results were released just one week after Pfizer announced its initial results from the trial showing the vaccine was more than 90% effective. Moderna Inc. on Monday its vaccine was 94.5% effective based on the preliminary data.
Compared to Pfizer, Afeyan said that Moderna’s innovations enable it to “keep the vaccine under refrigeration conditions for up to 30 days,” enabling broad distribution.