{"id":264862,"date":"2020-08-11T07:30:00","date_gmt":"2020-08-11T11:30:00","guid":{"rendered":"https:\/\/canadianinquirer.net\/v1\/?p=264862"},"modified":"2020-08-11T07:30:00","modified_gmt":"2020-08-11T11:30:00","slug":"malacanang-says-russian-covid-19-vaccine-will-need-fda-approval","status":"publish","type":"post","link":"https:\/\/canadianinquirer.net\/v1\/2020\/08\/11\/malacanang-says-russian-covid-19-vaccine-will-need-fda-approval\/","title":{"rendered":"Malaca\u00f1ang says Russian Covid-19 vaccine will need FDA approval"},"content":{"rendered":"
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Duterte also offered to be the first person to be injected with the Russian vaccine, saying he believes the vaccine would be \u201cgood for humanity.\u201d (Pixabay photo)<\/figcaption><\/figure>\n

MANILA<\/strong>\u00a0\u2013 Malaca\u00f1ang 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.<\/p>\n

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.<\/p>\n

Duterte also offered to be the first person to be injected with the Russian vaccine, saying he believes the vaccine would be \u201cgood for humanity.\u201d<\/p>\n

\u201cKinakailangan din nating sundin ang batas na umiiral sa Pilipinas dahil nga po walang gamot na hindi pupuwedeng ibigay sa publiko na hindi dumadaan sa<\/em>\u00a0FDA.\u00a0Ang<\/em>\u00a0FDA\u00a0naman po, hindi mag-i<\/em>-issue\u00a0ng<\/em>\u00a0permit to utilize\u00a0ang isang gamot kung wala po yun<\/em>g clinical trial so\u00a0dadaan din po \u2018yan sa proseso natin \u2018yan<\/em>\u00a0(We should still follow existing laws in the Philippines because we can\u2019t 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),\u201d Roque said in a virtual Palace briefing.<\/p>\n

While the Russian vaccine could be given for purpose of \u201ccompassionate use\u201d, Roque said mass distribution would have to undergo clinical trials.<\/p>\n

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.<\/p>\n

\u201cUnless 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,\u201d Roque said.<\/p>\n

Following Duterte\u2019s 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.<\/p>\n

\u201cWell,\u00a0\u2018yan po siguro ay saloobin na ng Presidente\u2026Kung kinakailangan na isugal nga niya ang buhay niya para masigurado na itong<\/em>\u00a0vaccine\u00a0na ito ay makakasalba ng buhay dito Pilipinas, gagawin po niya \u2018yun<\/em>\u00a0(Well, that\u2019s 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),\u201d he said.<\/p>\n

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.<\/p>\n

Independent foreign policy<\/strong><\/p>\n

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.<\/p>\n

Besides Russia, the Philippines is also looking at the United States, United Kingdom and China to supply us with vaccines once available.<\/p>\n

Roque explained that Duterte simply expressed gladness over Russia\u2019s offer because it showed that his independent foreign policy of \u201cfriend to all, enemy to none\u201d is effective.<\/p>\n

\u201cKung ang sinusunod natin dati na ang kaibigan lang natin a<\/em>y Estados Unidos,\u00a0siyempre hindi naman mag-o<\/em>-offer\u00a0ang<\/em>\u00a0China\u00a0at<\/em>\u00a0Russia (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),\u201d he said.<\/p>\n

He said Duterte wanted to show the public that it \u201chelps\u201d and \u201cpays\u201d to maintain close ties with all nations.<\/p>\n

\u201cNgayon na merong ganitong pandemiya, pinapakita niya sa taong-bayan na<\/em>\u00a0it helps and it pays\u00a0na kaibigan tayo ng lahat dahil lahat ng kaibigan natin nagbigay na po ng<\/em>\u00a0assurance\u00a0na makakakuha tayo ng<\/em>\u00a0vaccine\u00a0pag sila po ay nag<\/em>-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),\u201d he said.<\/p>\n

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.<\/p>\n

\u201cThe Philippines appreciates Russia\u2019s offer of cooperation to jointly combat the Covid-19 pandemic,\u201d the OPAFA said.<\/p>\n

The OPAFA assured that all cooperation initiatives will be consistent with protocols for testing and health standards like similar bilateral and multilateral arrangements.<\/p>\n

\u201cInternational cooperation is key to effectively combat this global pandemic,\u201d the OPAFA said, vowing to continue working with partners across the globe to ensure access to a safe vaccine.<\/p>\n","protected":false},"excerpt":{"rendered":"

MANILA\u00a0\u2013 Malaca\u00f1ang on Tuesday said the coronavirus disease 2019 (Covid-19) vaccine offered by Russia will undergo thorough review by the …<\/p>\n","protected":false},"author":33,"featured_media":262725,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1145,16,95],"tags":[],"class_list":["post-264862","post","type-post","status-publish","format-standard","has-post-thumbnail","category-headline","category-news","category-news-ph","mauthors-azer-parrocha","mauthors-philippine-news-agency"],"_links":{"self":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/264862","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/users\/33"}],"replies":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/comments?post=264862"}],"version-history":[{"count":1,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/264862\/revisions"}],"predecessor-version":[{"id":264864,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/posts\/264862\/revisions\/264864"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/media\/262725"}],"wp:attachment":[{"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/media?parent=264862"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/categories?post=264862"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/canadianinquirer.net\/v1\/wp-json\/wp\/v2\/tags?post=264862"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}