COVID-19 vaccine phase 3 trials to begin in November â DOH
This handout picture taken on August 6, 2020 and provided by the Russian Direct Investment Fund shows the vaccine against the coronavirus disease, developed by the Gamaleya Research Institute of Epidemiology and Microbiology.
Handout/Russian Direct Investment Fund/AFP
COVID-19 vaccine phase 3 trials to begin in November — DOH
(Philstar.com) - October 11, 2020 - 9:47am

MANILA, Philippines — The third phase of the country's coronavirus vaccine trials will begin in November, health officials said Saturday evening. 

In a statement, the Department of Health said that the phase, during which patients will actually be treated with a vaccine to test its safety, would first begin with an application review by a vaccine expert panel and ethics review committees in the Philippines before the clinical trials led by the Department of Science and Technology.  

"After thorough review of the clinical trial applications, these will be submitted to the FDA for final pass. The vaccine trials may begin upon the FDA’s regulatory review and approval of the conduct of the clinical trials," the statement read.  

Three developers have already submitted applications to conduct phase 3 trials as of this publishing, including Russia's Gamaleya Research Institute, China's Sinovac and Jannsen Pharmaceuticals Companies of Johnson & Johnson from the United States of America        

For the trials, the foreign affairs department is set to coordinate bilateral partnerships related to the vaccine trials "for the possibility of manufacturing the vaccines locally in partnership with the pharmaceutical companies," while the DOH, the vice chair of the sub-TWG, will oversee the hospitals joining the clinical trials and will manage the operations and logistics of the clinical trials.

The Food and Drug Administration "will monitor the entities approved to conduct clinical trials. It will also approve vaccines that will be released and sold to the public," the statement added. 

"The DOST chairs the sub-TWG on COVID-19 vaccine development which includes other government agencies such as the Department of Health (DOH), the Department of Foreign Affairs (DFA), and the Department of Trade and Industry (DTI). Other members of the sub-TWG include the Food and Drug Administration (FDA) and the Research for Tropical Medicine, both of which are under the DOH; and, the National Development Company (NDC) under the DTI," it also said. 

RELATED: Tolentino shuns DOST role in clinical trials for COVID-19 vaccine, says matter is 'purely' for DOH

On Friday, October 9, Sen. Francis Tolentino questioned the role of the DOST on the sub-TWG, pointing out that such a venture would need the expertise of medical doctors and practitioners.

As of the department's latest case bulletin, the national caseload stands at 336,926, with 54,594 of which still classified as active cases.  

Worldwide, over 37.4 million coronavirus cases have been recorded, leading to over 1.07 million deaths, according to latest data from the World Health Organization.  

President Rodrigo Duterte has routinely emphasized in his public addresses that securing a vaccine is the only solution to the Philippines' coronavirus situation moving forward. 

“The responsibilities of each agency under the Sub-TWG on Vaccine Development are clear. I am confident that all agencies involved in vaccine development will work tirelessly in carrying out each individual responsibility...We also recognize the exigency of these vaccine trials given our ongoing situation,” Health Secretary Francisco Duque said.

Franco Luna 

CORONAVIRUS COVID-19 COVID-19 VACCINE DEPARTMENT OF HEALTH DOH NOVEL CORONAVIRUS
As It Happens
LATEST UPDATE: October 27, 2020 - 9:45am

Pharma giants Sanofi and GSK said on July 29, 2020, that they have agreed to supply Britain with up to 60 million doses of a potential COVID-19 vaccine. The agreement covers a vaccine candidate developed by France's Sanofi in partnership with the UK's GSK and is subject to a "final contract."

This thread collects some of the major developments in the search for a vaccine to ease the new coronavirus pandemic. (Main photo by AFP/Joel Saget)

October 27, 2020 - 9:45am

Brazil is a top testing ground for vaccines against COVID-19, but its plans for vaccinating its own population have been plunged into chaos by a political war waged by President Jair Bolsonaro.

Hit hard by the new coronavirus, Brazil has been tapped to help test several of the leading vaccine candidates, giving it a potential edge in the race to secure access to an eventual shot.

That could be a welcome silver lining for the country of 212 million people, which has the second-highest COVID-19 death toll in the world, at more than 157,000.

But one promising test vaccine, developed by Chinese pharmaceutical firm Sinovac Biotech, has triggered the ire of the far-right president, who last week canceled his health minister's plan to buy 46 million doses. 

The vaccine's most visible proponent in Brazil is the governor of the large and wealthy state of Sao Paulo, Joao Doria, who also happens to be one of Bolsonaro's top opponents. — AFP

October 21, 2020 - 12:38pm

Brazil's health minister says the country would add the Chinese-made CoronaVac vaccine against COVID-19 to its national immunization program, despite a political and diplomatic row over whether to use it.

Health Minister Eduardo Pazuello says the federal government had reached a deal with Sao Paulo state, which is helping test and produce the vaccine, to buy 46 million doses to be administered starting in January.

"This vaccine will be Brazil's vaccine," in addition to another developed by Oxford University and pharmaceutical firm AstraZeneca, Pazuello says in a video meeting of the South American country's 27 governors. — AFP

October 7, 2020 - 3:41pm

The US Food and Drug Administration made public its guidance for issuing emergency approval for a COVID-19 vaccine on Tuesday, making it clear it wants to see follow-up two months after trial volunteers have their second dose.

It is therefore unlikely for President Donald Trump's administration to have a vaccine on the market before the November 3 election, something the president frequently says is on the cards.

"Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine's benefit-risk profile," the document said. — AFP

October 7, 2020 - 7:33am

The US Food and Drug Administration made public its guidance for issuing emergency approval for a COVID-19 vaccine on Tuesday, making it clear it wants to see follow-up two months after trial volunteers have their second dose.

It is therefore unlikely for US President Donald Trump's administration to have a vaccine on the market before the November 3 election, something the president frequently says is on the cards.

"Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine's benefit-risk profile," the document said.

The two companies that are furthest along in their vaccine trials, Moderna and Pfizer, both began their final stages at the end of July, and both require two separate injections 28 days apart. — AFP

September 30, 2020 - 8:10am

The World Bank says it has asked its board of directors to approve $12 billion to help poor countries purchase and distribute eventual vaccines against COVID-19.

The bank has already implemented emergency response programs in 111 countries and the extra money, if approved, would be aimed at low- and middle-income countries.

"An effective and safe COVID-19 vaccine is the most promising path forward for the world to reopen safely," a World Bank spokesman says. — AFP

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