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 

As It Happens
LATEST UPDATE: April 22, 2021 - 5:15pm

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)

April 22, 2021 - 5:15pm

Fake doses of the Pfizer coronavirus vaccine are being sold in Mexico and Poland for as much as $2,500 a shot, the US drugmaker and an official confirm. 

At a clinic in Mexico some 80 people received bogus vaccines, which appeared to have been physically harmless though offered no protection against the potentially deadly disease ravaging the country, a report in the Wall Street Journal says.

Mexico's government spokesman on COVID-19 Hugo Lopez-Gatell said "no product was found that could affect" the health of those scammed, adding several people had been arrested. — AFP

April 22, 2021 - 9:29am

French-Austrian vaccine developer Valneva announces that it had launched a Phase 3 trial of its candidate vaccine against COVID-19 -- the last testing stage before seeking regulatory approval.

The study, which has been dubbed "Cov-Compare", will compare how participants' immune systems respond to Valneva's VLA2001 vaccine with how they respond to AstraZeneca's coronavirus shot. 

"Approximately 4,000 participants will receive two doses of either vaccine," says Valneva, adding that the study would be carried out at around 25 sites in the United Kingdom. — AFP

April 20, 2021 - 8:53pm

The EU will have enough COVID-19 vaccine doses to cover 70% of its adult population by mid-July due to higher production within the bloc, a senior official said Tuesday.

"Fifty-three factories are producing vaccines in the EU. Our continent is now the largest producer in the world after the United States," internal markets commissioner Thierry Breton told French daily Le Figaro in an interview.

"I am now certain of how many doses are currently in production and I know how many millions will be delivered each week," he said.

"This allows me to assure you that we well have by mid-July the number of doses necessary for vaccinating 70% of the European Union's adult population," he said, citing the threshold many health experts say is necessary to achieve "herd immunity". — AFP

April 20, 2021 - 12:50pm

The US Food and Drug Administration requests that production of the Johnson & Johnson coronavirus vaccine be halted at a factory that previously reportedly ruined about 15 million doses of the shot.

The pharmaceutical giant told AFP at the end of March it had identified a batch of doses at a plant in Baltimore run by Emergent BioSolutions "that did not meet quality standards," but did not confirm the specific number affected.

The New York Times later reported the batch consisted of about 15 million doses. — AFP

April 16, 2021 - 5:21pm

The European Union is very unlikely to renew its COVID-19 vaccine contracts with pharmaceutical company AstraZeneca, a French minister says.

Denmark this week banned the use of AstraZeneca jabs over blood clot concerns, just as the EU said it was expecting 50 million Pfizer vaccine doses earlier than expected.

No final EU decision had been taken, French Industry Minister Agnes Pannier-Runacher tells RMC radio, but "it is highly probable" that no further AstraZeneca doses would be ordered. — AFP

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