The Food and Drug Administration (FDA) will release its decision regarding Pfizer’s emergency use authorization (EUA) on ita coronavirus disease 2019 (Covid-19) vaccine before the end of January 2021, FDA Director General Eric Domingo said. 

Usually, evaluating new vaccines would take up to three to six months. However, due to Covid-19 pandemic and President Rodrigo Duterte’s Executive Order, the FDA is allowed to issue an EUA to speed up the approval process without compromising safety. 

“Mabilis ito (timeline of deciding if Pfizer is safe and effective), considering the evaluation of other regulatory bodies that we know are mature such as US, UK…ang maganda sa Pfizer pati sa Switzerland and other parts of Europe, meron na silang [emergency use] authorization,” Domingo said.

“If we find that the product will be stable when it is brought here…since we are working now, I think before the end of January we will be able to complete it (evaluation),” Domingo added.

Pfizer submitted its EUA application to the office of the FDA last December 24. The said vaccine has been proven 95% effective after human trials, compared to the controversial China-made Sinovac, which posted only 50% efficacy in human trials conducted in Brazil. 

The Pfizer vaccine requires a -70 to -90 degrees Celsius storage, or an ultra cold freezer, which the government does not have so far. 

Even though Pfizer was proven effective in the United States, United Kingdom, Canada, Singapore, among others, Domingo, however, said that approving the said vaccine is not simple. 

“It cannot be faster than two to three weeks. I have to give my experts time to look at it. Lalo na itong Pfizer ay hindi ginawa sa Pilipinas, wala silang clinical trials rito. We have to see disaggregated data on their studies and their subjects who were at least Asians. These are the things not previously presented in the US and Europe,” Domingo added.

“The EUA is not a one-page certification. It involves a lot of documents stating the conditions on how the emergency authorization will be used,” Domingo said.

The FDA said that only Pfizer has submitted an application for EUA to the Philippines. 

Meanwhile, Presidential spokesperson Harry Roque Jr. guaranteed to the public that the mass vaccination program of the government is still a go starting the first quarter of 2021. RJ Espartinez