COVID-19 vaccine phase 3 trials to begin in November — DOH
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
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)
As negotiations towards a new pandemic treaty pick up pace, observers warn of watered-down efforts to ensure equitable access to the medical products needed to battle future Covid-like threats.
Shaken by the pandemic, the World Health Organization's 194 member states are negotiating an international accord aimed at ensuring countries are better equipped to deal with the next catastrophe, or even prevent it altogether.
The process is still in the early stages, with the aim of reaching an agreement by May 2024.
But critics warn that revisions being made to the preliminary negotiating text are weakening the language -- notably in a key area aimed at preventing the rampant inequity seen in access to vaccines and other medical products during the Covid pandemic.
"I think it is a real step backwards," Suerie Moon, co-director of the Global Health Centre at the Geneva Graduate Institute, told AFP. — AFP
Africa's first mRNA vaccine hub is ceremonially launched on Thursday to acclaim from the UN's global health chief, who hailed it as a historic shift to help poor countries gain access to life-saving jabs.
The facility was set up in the South African city of Cape Town in 2021 on the back of the success of revolutionary anti-Covid vaccines introduced by Pfizer/BioNTech and Moderna.
"This precious project... will bring a paradigm shift in addressing the serious problem we faced, the equity problem, during the pandemic, so (that) it's not repeated again," World Health Organization (WHO) head Tedros Adhanom Ghebreyesus tells a media briefing to mark the inauguration. — AFP
China has approved its first locally developed messenger RNA (mRNA) vaccine against Covid-19, its manufacturer said Wednesday, months after the relaxation of strict Covid-zero regulations sparked a surge in cases.
The vaccine, developed by CSPC Pharmaceutical Group Ltd, has been approved for "emergency use" by Beijing's health regulator, the company said in a statement.
It showed high efficacy in a trial in which it was used as a booster shot for people who have been given other types of vaccines, the company added, without offering further details. — AFP
COVID-19 vaccine maker Novavax raises doubts about its ability to continue its business, announcing plans to cut spending after struggles in rolling out its coronavirus jab.
Shares of Novavax plummeted 25 percent in extended trading, after the company reported fourth-quarter earnings that missed analyst estimates.
While the firm should have enough money to fund operations, the situation is "subject to significant uncertainty," it says in a statement. — AFP
The protection against Covid-19 from being previously infected lasts at least as long as that offered by vaccination, one of the largest studies conducted on the subject says.
Ten months after getting Covid, people still had an 88% lower risk of reinfection, hospitalisation and death, according to the study published in the Lancet journal.
That makes this natural immunity "at least as durable, if not more so" than two doses of Pfizer or Moderna's vaccines, the study says.
The authors nevertheless emphasized that their findings should not discourage vaccination, which remains the safest way to get immunity. — AFP
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