MANILA – Malacañang on Tuesday said the coronavirus disease 2019 (Covid-19) vaccine offered by Russia will undergo thorough review by the Food and Drug Administration (FDA) before being administered to the public.
Presidential Spokesperson Harry Roque made this assurance after President Rodrigo Duterte on Monday night accepted the offer of Russia to supply the Philippines with its Covid-19 vaccines once mass production starts.
Duterte also offered to be the first person to be injected with the Russian vaccine, saying he believes the vaccine would be “good for humanity.”
“Kinakailangan din nating sundin ang batas na umiiral sa Pilipinas dahil nga po walang gamot na hindi pupuwedeng ibigay sa publiko na hindi dumadaan sa FDA. Ang FDA naman po, hindi mag-i-issue ng permit to utilize ang isang gamot kung wala po yung clinical trial so dadaan din po ‘yan sa proseso natin ‘yan (We should still follow existing laws in the Philippines because we can’t distribute medicine without it being assessed by the FDA. The FDA cannot issue a permit to utilize medicine if there are no clinical trials so it will all go through a process),” Roque said in a virtual Palace briefing.
While the Russian vaccine could be given for purpose of “compassionate use”, Roque said mass distribution would have to undergo clinical trials.
Compassionate use or expanded access, according to the US FDA, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
“Unless the FDA declares an emergency, compassionate use, dun po pupuwede pero for mass distribution, tingin ko po dapat sundin pa rin ang batas (it might be possible but for mass distribution, I think we will have to follow the law) and that calls for clinical trials po,” Roque said.
Following Duterte’s willingness to be the first to be injected by the Russian vaccine, Roque explained that the President is more than willing to sacrifice his life to ensure that the vaccine is safe.
“Well, ‘yan po siguro ay saloobin na ng Presidente…Kung kinakailangan na isugal nga niya ang buhay niya para masigurado na itong vaccine na ito ay makakasalba ng buhay dito Pilipinas, gagawin po niya ‘yun (Well, that’s his sentiment. If there is a need to risk his life to ensure that the vaccine will save lives in the Philippines, he will do it),” he said.
International concerns have been raised after Russia announced its plan to launch a nationwide vaccination campaign in October with a vaccine that has yet to complete clinical trials.
Independent foreign policy
Although Russia is the first to offer a vaccine, Roque said this did not mean that they are closing our doors to vaccine from other nations.
Besides Russia, the Philippines is also looking at the United States, United Kingdom and China to supply us with vaccines once available.
Roque explained that Duterte simply expressed gladness over Russia’s offer because it showed that his independent foreign policy of “friend to all, enemy to none” is effective.
“Kung ang sinusunod natin dati na ang kaibigan lang natin ay Estados Unidos, siyempre hindi naman mag-o-offer ang China at Russia (If we followed the former policy where our only friend was the United States, of course China and Russia would not have made the offer),” he said.
He said Duterte wanted to show the public that it “helps” and “pays” to maintain close ties with all nations.
“Ngayon na merong ganitong pandemiya, pinapakita niya sa taong-bayan na it helps and it pays na kaibigan tayo ng lahat dahil lahat ng kaibigan natin nagbigay na po ng assurance na makakakuha tayo ng vaccine pag sila po ay nag-develop (Now that there is a pandemic like this, he is showing the people that it helps and pays that we are friends to all because our friends have given the assurance that we will receive vaccines once they are developed),” he said.
In a statement, the Office of the Presidential Protocol and Office of Presidential Assistant of Foreign Affairs (OPAFA) expressed readiness to work with Russia on clinical trials, vaccine supply, and production, and other areas to address the Covid-19 pandemic.
“The Philippines appreciates Russia’s offer of cooperation to jointly combat the Covid-19 pandemic,” the OPAFA said.
The OPAFA assured that all cooperation initiatives will be consistent with protocols for testing and health standards like similar bilateral and multilateral arrangements.
“International cooperation is key to effectively combat this global pandemic,” the OPAFA said, vowing to continue working with partners across the globe to ensure access to a safe vaccine.