DOH: Safeguards on vaccines will be in place even without Phase 4 clinical trials
MANILA, Philippines — The Department of Health said safeguards such as safety surveillance and pilot implementations will still be in place after it recommended doing away with the final stage in the clinical trials for potential coronavirus vaccines.
Lawmakers inserted a waiver in the proposed Bayanihan to Recover as One Act that allows the government to purchase coronavirus vaccines even if they are yet to undergo Phase 4 clinical trials or the final stage in the vaccine development process in a bid to fasttrack procurement.
The waiver will overrule the Universal Health Care Act, which bars the government from buying drugs and vaccines that did not pass Phase 4 trials.
The DOH, along with the Health Technology Assessment Council and the Food and Drug Administration, said it recommended waiving the requirement of a Phase 4 in the clinical trials. In Phase 4 or the post marketing surveillance trials, the long-term safety and the effectiveness of a drug or vaccine are evaluated.
“We were part of that group which has recommended for the exemption for the Phase 4 clinical trial. This is for us to expedite the process so we can use the vaccines as soon as possible once it reaches the country,” Health Undersecretary Maria Rosario Vergeire said in a media briefing Monday.
Vergeire added the accelerated process of clinical trials has been done before in responding to threats of Ebola and meningitis.
The health official assured the public that even without the final stage, safeguards will be in place. These include safety and surveillance monitoring following the recommendations of the World Health Organization, the setting up of a database of recipients of the vaccine, risk communication on the benefits and risks of vaccine and the conduct of a pilot implementation before mass roll out.
“These are the safeguards that we have included. It will be just like having Phase 4 clinical trials. The process has been slightly relaxed but the safeguards are still there,” Vergeire said.
The country is in talks with 16 pharmaceutical companies that are developing coronavirus vaccines worldwide.
Last week, the WHO Western Pacific office urged countries to focus on improving their response to slow the spread of COVID-19 instead waiting for a vaccine to be developed and distributed.
The country’s coronavirus caseload reached 189,601, with 131,459 recoveries and 2,998 deaths.
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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