WHO wants to review Russian vaccine safety data
GENEVA, Switzerland — The World Health Organization said any WHO stamp of approval on a COVID-19 vaccine candidate would require a rigorous safety data review, after Russia announced Tuesday it had approved a vaccine.
President Vladimir Putin said Russia had become the first country to approve a vaccine offering "sustainable immunity" against the new coronavirus.
"We are in close contact with the Russian health authorities and discussions are ongoing with respect to possible WHO pre-qualification of the vaccine," said the United Nations health agency's spokesman Tarik Jasarevic.
"Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data," he told reporters in Geneva at an online press briefing.
Russia's Sputnik V vaccine has been developed by the Gamaleya research institute in coordination with the country's defence ministry.
A total of 168 candidate vaccines are being worked on around the world, according to a WHO overview published Tuesday.
Of those, 28 have progressed to the various phases of being tested on humans, of which six are the furthest ahead, having reached Phase 3 of clinical trials.
The Gamaleya candidate, which is among the 28 in clinical evaluation, is listed as only being in Phase 1.
Kirill Dmitriev, the head of the Russian Direct Investment Fund which finances the vaccine project, said Phase 3 trials would start on Wednesday, industrial production was expected from September and that 20 countries had pre-ordered more than a billion doses.
'Stamp of quality'
"Every country has national regulatory agencies that approve the use of vaccines or medicines on its territory," Jasarevic explained.
"WHO has in place a process of pre-qualification for vaccines but also for medicines. Manufacturers ask to have the WHO pre-qualification because it is a sort of stamp of quality.
"To get this, there is a review and assessment of all required safety and efficacy data that are gathered through the clinical trials. WHO will do this for any candidate vaccine."
The pandemic has seen an unprecedented mobilisation of funding and research to rush through a vaccine that can protect billions of people worldwide.
"We are encouraged by the speed by which several candidate vaccines have been developing and as we have been always saying, we hope some of these vaccines will prove to be safe and efficient," said Jasarevic.
"Accelerating progress does not mean compromising on safety," he said.
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
- Latest
- Trending
