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EU approval of Russia's Sputnik V vaccine delayed, sources say

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European Union approval of Russia's Sputnik V coronavirus vaccine will be delayed because a 10 June deadline to submit data was missed, two people familiar with the matter told Reuters, diminishing the shot's prospects in the EU's pandemic response, write Andreas Rinke and Emilio Parodi.

One of the sources, a German government official, said the failure to provide the necessary clinical trial data to the EU medicines watchdog would postpone any go-ahead in the bloc until at least September.

"Approval of Sputnik will be delayed probably until September, maybe until the end of the year," the official said, speaking on condition of anonymity.

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The European Medicines Agency (EMA) had previously been expected to conclude its review of the Russian vaccine and issue a decision in May or June.

A second source said the 10 June cut-off date not been met and that the vaccine's developer, Russia's Gamaleya Institute, said it will file the requested data next week or at the latest at the end of the month.

The Russian Direct Investment Fund (RDIF), which markets the vaccine, said the EMA review was on track.

"All of the information on the Sputnik V vaccine clinical trials has been provided and GCP (General Clinical Practice) review has been completed with positive feedback from the European Medicines Agency," the RDIF said.

"While it is up to EMA to decide on the timing of the approval procedure, the Sputnik V team expects the vaccine approval with the next two months," it added. EMA was not immediately available for comment.

German Chancellor Angela Merkel's government has held talks to buy Sputnik V but has made any purchase contingent on EMA approval. Read more.

Frustrated by a sluggish immunisation campaign, some regional German states including Bavaria earlier this year flagged interest in placing orders for Sputnik V, but vaccination has since picked up speed.

Slovakia became the EU's second country after Hungary to start inoculating people with Sputnik V this month, despite lack of EU approval. Read more.

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Republican report says coronavirus leaked from China lab - scientists still probing origins

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A computer image created by Nexu Science Communication together with Trinity College in Dublin, shows a model structurally representative of a betacoronavirus which is the type of virus linked to COVID-19, shared with Reuters on 18 February 2020. NEXU Science Communication/via REUTERS

A preponderance of evidence proves the virus that caused the COVID-19 pandemic leaked from a Chinese research facility, said a report by US Republicans released on Monday (2 August), a conclusion that US intelligence agencies have not reached, write Jonathan Landay and Mark Hosenball, Reuters.

The report also cited "ample evidence" that Wuhan Institute of Virology (WIV) scientists - aided by US experts and Chinese and US government funds - were working to modify coronaviruses to infect humans and such manipulation could be hidden.

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Representative Mike McCaul, the top Republican on the House Foreign Affairs Committee, released the report by the panel's Republican staff. It urged a bipartisan investigation into the origins of the COVID-19 coronavirus pandemic that has killed 4.4 million people worldwide. (Graphic on global cases and deaths).

China denies a genetically modified coronavirus leaked from the facility in Wuhan - where the first COVID-19 cases were detected in 2019 - a leading but unproven theory among some experts. Beijing also denies allegations of a cover-up.

Other experts suspect the pandemic was caused by an animal virus likely transmitted to humans at a seafood market near the WIV.

"We now believe it's time to completely dismiss the wet market as the source," said the report. "We also believe the preponderance of the evidence proves the virus did leak from the WIV and that it did so sometime before 12 September, 2019."

The report cited what it called new and under-reported information about safety protocols at the lab, including a July 2019 request for a $1.5 million overhaul of a hazardous waste treatment system for the facility, which was less than two years old.

In April, the top U.S. intelligence agency said it concurred with the scientific consensus that the virus was not man-made or genetically modified. Read more.

US President Joe Biden in May ordered US intelligence agencies to accelerate their hunt for the origins of the virus and report back in 90 days. Read more.

A source familiar with current intelligence assessments said the US intelligence community has not reached any conclusion whether the virus came from animals or the WIV.

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COVID-19 Delta variant gains prevalence in Italy - health institute

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People rest without wearing masks as Italy lifts mandatory masks outdoors thanks to a decline in the coronavirus disease (COVID-19) cases and hospitalizations, in Matera, Italy, 28 June. REUTERS/Yara Nardi

The highly contagious Delta variant of the coronavirus has gained dominance in Italy, the National Health Institute (ISS) said on Friday (30 July), releasing data showing it accounted for 94.8% of cases as of 20 July, writes Emilio Parodi, Reuters.

The variant, first identified in India in December 2020, is now dominant worldwide and has led to a spike in infection rates that has stoked concerns over the global economic recovery.

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In the previous survey based on data from 22 June, the Delta variant represented just 22.7% of cases. By contrast, the Alpha variant accounted for 3.2% of cases as of July 20 against a previous prevalence of 57.8%.

"It is essential to continue the systematic tracking of cases and to complete the vaccination cycle as quickly as possible", ISS President Silvio Brusaferro said in a statement.

The ISS said its survey did not include all variant cases but only those detected on the day it was carried out. It added that the Gamma variant, first identified in Brazil, fell to 1.4% of cases from 11.8% in the past survey.

The institute also pointed out an "extremely small increase" in cases of the Beta variant, first identified in South Africa, which it says is characterised by partial immune evasion.

Italy has registered 128,029 deaths linked to COVID-19 since its outbreak emerged in February last year, the second-highest toll in Europe after Britain and the eighth-highest in the world. It has reported 4.34 million cases to date.

Almost 59% of Italians over 12 years were fully vaccinated as of Friday, while about 10% are awaiting their second dose.

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Thousands protest against COVID-19 health pass in France

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Thousands of people protested in Paris and other French cities on Saturday (31 July) against a mandatory coronavirus health pass for entry to a wide array of public venues, introduced by the government as it battles a fourth wave of infections, write Lea Guedj and Yiming Woo.

Protesters injured three police officers in Paris, a police spokesperson said. Interior Minister Gerald Darmanin said on Twitter that 19 demonstrators were arrested, including 10 in Paris.

It was the third weekend in a row that people opposed to President Emmanuel Macron's new COVID-19 measures have taken to the streets, an unusual show of determination at a time of year when many people are focused on taking their summer break.

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The number of demonstrators has grown steadily since the start of the protests, echoing the "yellow vest" movement, that started in late 2018 against fuel taxes and the cost of living.

An interior ministry official said 204,090 had demonstrated across France, including 14,250 in Paris alone. This is about 40,000 more than last week.

"We're creating a segregated society and I think it is unbelievable to be doing this in the country of human rights," said Anne, a teacher who was demonstrating in Paris. She declined to give her last name.

A protester holds a sign reading "Vaccinated to freedom", during a demonstration called by the "yellow vest" (gilets jaunes) movement against France's restrictions, including a compulsory health pass, to fight the coronavirus disease (COVID-19) outbreak, in Paris, France, July 31, 2021. REUTERS/Sarah Meyssonnier
Protestors attend a demonstration called by the "yellow vest" (gilets jaunes) movement against France's restrictions, including a compulsory health pass, to fight the coronavirus disease (COVID-19) outbreak, in Paris, France, July 31, 2021. REUTERS/Sarah Meyssonnier

"So I took to the streets; I have never protested before in my life. I think our freedom is in danger."

Visitors going to museums, cinemas or swimming pools are already denied entry if they cannot produce the health pass showing they have been vaccinated against COVID-19 or have had a recent negative test.

Parliament approved a new law this week that will make vaccinations mandatory for health workers and extend the health pass requirement to bars, restaurants, trade shows, trains and hospitals.

About 3,000 police officers were deployed in the capital, with anti-riot officers striving to keep demonstrators on authorised routes.

Authorities sought to avoid a repeat of events last week, when scuffles between police and demonstrators broke out on the Champs-Elysees. Read more.

Protesters were also out in other cities like Marseille, Lyon, Montpelier, Nantes and Toulouse, shouting "Freedom!" and "No to the health pass!".

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