DOH: Review of Sinovac application for vaccine trial won't stop despite Brazil suspension of study
MANILA, Philippines — The review of Sinovac’s application to conduct Phase 3 clinical trial in the Philippines will not be halted as the government waits for an official report from the Chinese drugmaker on the adverse effects of its vaccine candidate, the Department of Health said Wednesday.
Sinovac is the only company that has hurdled the preliminary review of the vaccine expert panel chaired by the Department of Science and Technology to conduct late stage clinical trial in the country. It has yet to secure approval from the ethics boards and the local Food and Drug Administration.
Health Undersecretary Maria Rosario Vergeire said the Chinese firm needs to submit an official report on the “serious adverse incident” involving a volunteer recipient, prompting Brazil’s health regulator to suspend the study of one of the most advanced vaccine candidates.
Vergeire said the country’s vaccine expert panel and FDA will review the document once received.
“It will be evaluated by our vaccine expert panel and the FDA and then that’s the time when we will decide if we will still push through with the clinical trial or not,” the health official said.
“Hindi porket it was claimed in some countries there is adverse effect, we will immediately stop it. The manufacturer has to inform us, we will have discussions with them and we will have our experts evaluate,” she said.
Butantan Institute, Sinovac’s Brazilian partner, called the halt of the clinical study unwarranted and said the death of the participant was not related to the vaccines.
Sinovac also said the incident was unrelated to its vaccine candidate CoronaVac, adding it is “confident in the safety of the vaccine.”
According to the World Health Organization, 10 vaccine candidates are going through Phase 3 clinical trials.
The Philippines has so far recorded 401,416 COVID-19 cases, with 363,217 recoveries and 7,710 deaths. — with report from Agence France-Presse
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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