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Health And Family

WHO set to restart Sputnik COVID-19 vaccine analysis

Agence France-Presse
WHO set to restart Sputnik COVID-19 vaccine analysis
A picture taken on December 4, 2020 shows the production of Russia's Gam-COVID-Vac vaccine against the coronavirus disease (Covid-19) registered under trade name Sputnik V, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in coordination with the Russian Defence Ministry, at the facility of Russia's biotech company BIOCAD in Strelna outside Saint Petersburg.
AFP/Olga MALTSEVA

GENEVA, Switzerland — The World Health Organization said on Thursday it was about to restart the process of approving Russia's Sputnik V Covid-19 vaccine following a series of problems with the dossier.

WHO authorisation has been sought for the Sputnik V jab created by Russia's Gamaleya research institute, which is already being used in 45 countries, according to an AFP count.

Several Covid-19 vaccines have been given the WHO green light for emergency use during the pandemic: Pfizer-BioNTech, Janssen, Moderna, Sinopharm, Sinovac and AstraZeneca in various plants.

For Sputnik V, "the process was put on hold due to the lack of some legal procedures", said Mariangela Simao, the WHO assistant director-general for access to medicines, vaccines and pharmaceuticals.

"In negotiations with the Russian government, this problem is about to be sorted out," she told a press conference.

"As soon as the legal procedures are finished, we are able to restart the process."

WHO emergency use listing is the green light that gives countries, funders, procuring agencies and communities assurance that a vaccine has met international standards.

The listing paves the way for countries to approve and import a vaccine for distribution quickly, especially those states without an international-class regulator of their own.

- Dossier incomplete -

Sputnik V is already being used in countries including Algeria, Argentina, India, Iran, Mexico, Pakistan, the Philippines, Sri Lanka, the United Arab Emirates, Venezuela and Russia itself.

"There are still the issues around complete information on the dossier that has to be provided by the applicant," said Simao.

"Then there is also the issues regarding the final finalisation of the inspections in the different manufacturers in Russia, but I'm happy to say that the about the process is about to be restarted."

In June, the WHO said it conducted nine inspections of Sputnik V manufacturing sites and uncovered various problems at the Pharmstandard Ufa Vitamin Plant in Ufa, southern Russia.

Moscow insisted the problems had since been resolved.

Russia is among the countries hardest-hit by the coronavirus pandemic, with the fifth-highest number of recorded deaths according to an AFP tally on Thursday: 213,549 fatalities from 7,690,110 cases.

Several Russian vaccines including Sputnik V have been available for months, but authorities have struggled to immunise a vaccine-sceptic population.

COVID-19 VACCINES

SPUTNIK V

WORLD HEALTH ORGANIZATION

As It Happens
LATEST UPDATE: June 16, 2022 - 8:48am

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)

June 16, 2022 - 8:48am

A panel of experts convened by the US Food and Drug Administration unanimously recommends Covid-19 vaccines  for children under five, the final age group awaiting immunization in most countries.

Formal authorizations should follow soon, with the first shots in arms expected early next week, just over a year-and-a-half after the first Covid vaccines were greenlighted for the elderly in December 2020.

"This recommendation does fill a significant unmet need for a really ignored younger population," says Michael Nelson, a professor of medicine at the University of Virginia, one of the 21 experts asked to vote for the milestone meeting. — AFP

June 15, 2022 - 9:24am

A panel of US medical experts recommends the Moderna COVID-19 vaccine for use in children aged six through 17.

Formal authorization should soon follow, at which point families will have a second option against the coronavirus, as Pfizer's vaccine was given the greenlight for teens and younger children last year.

After weighing available data, 22 experts convened by the US Food and Drug Administration unanimously agreed that the known benefits outweighed the known risks when Moderna's vaccine was administered as two shots at the adult dose of 100 micrograms to those aged 12-17, and half of that for children 6-11. — AFP

June 8, 2022 - 10:16am

A panel of experts convened by the US drug regulator recommends the Novavax COVID-19 shot, a late runner in the fight against the virus that could nonetheless play a role in overcoming vaccine hesitancy.

Three vaccines are currently approved in the United States: Pfizer and Moderna, which are based on messenger RNA, and Johnson and Johnson, which recently received a recommendation against broad use becase of links to a serious form of clotting.

Experts voted 21 in favor of the Novavax vaccine, with none against, and one abstention, despite some concerns it may be linked to rare cases of heart inflammation. — AFP

June 4, 2022 - 6:04pm

The Food and Drug Administration voices concern about myocarditis being potentially linked to the Novavax COVID-19 vaccine, just as experts are to weigh its use in the United States. 

The Novavax vaccine is already authorized in other countries, particularly in Europe. In the United States, an independent committee convened at the request of the FDA is to meet Tuesday to evaluate data from the clinical trials of Novavax and give its recommendation. 

In advance of that, the agency published a lengthy document on Friday analyzing these results, as it had done for the three other vaccines already authorized in the country. — AFP

April 14, 2022 - 9:19am

The head of US pharmaceutical giant Pfizer says a COVID-19 vaccine effective against multiple variants is possible before the end of 2022.

Chairman Albert Bourla says the firm was also working on producing a vaccine that could provide good protection for a whole year, meaning people would come back annually for boosters, as with influenza shots.

"I hope, clearly by autumn... that we could have a vaccine" that worked against not only the dominant Omicron but all known variants, he says. — AFP 

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