COVID-19 vaccines cleared for emergency use abroad still needs Philippines' approval

COVID-19 vaccines given emergency use authorization (EUA) in other countries would still need to secure approval from Philippine regulatory agencies before the government could buy them, the Department of Health (DOH) said Friday.

Health Undersecretary Rosario Vergeire made the announcement a day after Presidential spokesperson Harry Roque, Jr. said President Rodrigo Duterte will issue an executive order authorizing Food and Drug administration to grant EUA on COVID-19 vaccines.

“Kapag nabigyan ng EUA ang isang vaccine sa ibang bansa, kailangan pa rin ito dumaan sa ating proseso. Nariyan po ang Vaccine Experts Panel, Ethics Board, ang FDA [Food and Drug Administration] at ang Health Technology Assessment Team,” Vergeire said at an online briefing.

“Once na nabigyan na ito ng approval, then that is the time we can proceed sa procurement,” Vergeire added.

Other countries with mechanism for an EUA include:  United States, China, the 27-member European Union, Australia, Japan, among others.

Only COVID-19 vaccines developed by American firms Pfizer-BioNTech and Moderna have been proven at least 94% effective in preventing COVID-19 infection after human trials so far.

Moderna's vaccine can be stored under standard refrigerator temperatures of 2 to 8 degrees Celsius (36 to 48°F) for 30 days and it can be stored for up to 6 months at -20 degrees Celsius.

Pfizer-BioNTech's vaccine, meanwhile, requires an ultra cold storage of -70 to -80 degrees Celsius making its distribution a great challenge for countries with a tropical climate and limited storage resources such as the Philippines.

Vergeire said that while the DOH has initially estimated that the cost of buying COVID-19 vaccine from one manufacturer can cost P3 billion including its logistical requirements, the final amount is not cast in stone just yet since the vaccine to be procured is yet to be identified at this point.

“Wala pang final cost. Iyong estimate na P3 billion, P1.3 billion roon ay para sa cold storage [ng vaccines]. That was two weeks ago, zero we have to be mindful na araw araw, may lumalabas na ebidensiya [on what vaccines are effective] kaya nababago ang plano natin on what vaccines we will be procuring for the country,” Vergeire said. 

“Iyong mga bakuna kasi in advanced stages, meron silang pagkakaiba, kasama na ang presyo,” Vergeire added. 

The Philippines has recorded 413,430 COVID-19 cases so far. Of this number, 374,939 recovered while 7,998 died.

The number of active COVID-19 cases is 30,493. -MDM, GMA News