FILE PHOTO: A sign marks the headquarters of Moderna Therapeutics, which develops a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, USA, May 18, 2020. REUTERS / Brian Snyder / File Photo
(Reuters) – Moderna Inc said on Tuesday UK health regulators had started a real-time review of its experimental COVID-19 vaccine.
The company has begun submitting rolling data of its vaccine candidates to the UK’s Medicines and Health Products Regulatory Agency (MHRA) to initiate an independent assessment of evidence as and when it becomes available.
Such a process allows for faster treatment approval, while maintaining the same standards of safety and effectiveness.
Moderna is one of the pioneers in the race to develop vaccines for new coronaviruses, including Pfizer Inc, Johnson & Johnson and Astrazeneca – all in final stages of trials, preliminary data are expected in the coming weeks.
“Even though (Moderna’s) preliminary data assessment has begun, it does not guarantee that this vaccine, or anything else, will be available by 2020,” said Stephen Evans, professor of pharmacacoepidemiology at the London School of Hygiene & Tropical Medicine.
“But if phase 3 results are good, then this unusual approach, if not unprecedented, will allow a vaccine to be available sooner,” said Evans.
Moderna said earlier this month it would submit a real-time review of the experimental COVID-19 vaccine to Europe. It has also been applied for a similar review in Canada.
Evans also explained that Moderna will have the opportunity to answer MHRA’s questions about the preliminary data, while the final pilot phase continues.
The results of Moderna’s final stage study can only be seen by the data and safety monitoring board and no data will be released outside of the proper process, he added.
Reporting by Trisha Roy in Bengaluru and Kate Kellend in London; Edited by Shinjini Ganguli
FILE PHOTO: A sign marks the headquarters of Moderna Therapeutics, which develops a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, USA, May 18, 2020. REUTERS / Brian Snyder / File Photo
(Reuters) – Moderna Inc said on Tuesday UK health regulators had started a real-time review of its experimental COVID-19 vaccine.
The company has begun submitting rolling data of its vaccine candidates to the UK’s Medicines and Health Products Regulatory Agency (MHRA) to initiate an independent assessment of evidence as and when it becomes available.
Such a process allows for faster treatment approval, while maintaining the same standards of safety and effectiveness.
Moderna is one of the pioneers in the race to develop vaccines for new coronaviruses, including Pfizer Inc, Johnson & Johnson and Astrazeneca – all in final stages of trials, preliminary data are expected in the coming weeks.
“Even though (Moderna’s) preliminary data assessment has begun, it does not guarantee that this vaccine, or anything else, will be available by 2020,” said Stephen Evans, professor of pharmacacoepidemiology at the London School of Hygiene & Tropical Medicine.
“But if phase 3 results are good, then this unusual approach, if not unprecedented, will allow a vaccine to be available sooner,” said Evans.
Moderna said earlier this month it would submit a real-time review of the experimental COVID-19 vaccine to Europe. It has also been applied for a similar review in Canada.
Evans also explained that Moderna will have the opportunity to answer MHRA’s questions about the preliminary data, while the final pilot phase continues.
The results of Moderna’s final stage study can only be seen by the data and safety monitoring board and no data will be released outside of the proper process, he added.
Reporting by Trisha Roy in Bengaluru and Kate Kellend in London; Edited by Shinjini Ganguli
European politicians and pundits tasked with fighting the coronavirus pandemic are raising awareness that countries across the continent are on the brink of a “runaway” disease revival.
As several countries have seen record increases in infections – including some previously lauded for the effectiveness of their responses – a series of increasingly grim warnings was offset by announcements about tightening restrictions.
Between the voices was a head German The Robert Koch Institute, Lothar Wieler, which said the country was facing a “very serious” increase in cases as it reported a record 11,287 infections.
That Czech Republic The Prime Minister, Andrej Babiš, warned of a “big spike” as he apologized for reimposing tough restrictions that the Czechs had been told would no longer be needed. He said that without such action, the country’s health care system would soon “collapse”.
The Czech government is likely to ask parliament to extend the powers of the state of emergency which expire on November 3. “I apologize even for the fact that I put this option aside in the past because I can’t imagine it might happen,” said Babiš. “Unfortunately that has happened and now, above all, we must protect the lives of our citizens.”
Spanish Health Minister Salvador Illa added to the growing sense of crisis across the region, saying “drastic” action was needed to combat the new wave of the pandemic. The government is considering new restrictions including a curfew after Spain became the first country in western Europe to set a record more than 1 million cases from viruses.
“The second wave is a reality. In many areas of our country, the epidemic is out of control, “Illa told Onda Cero radio.
In Netherlands, more than 9,000 new cases were recorded in 24 hours, a new record. The Dutch hospital system, which is reportedly under increasing pressure from receiving the coronavirus, said it was expected to start transferring some patients to German for treatment in two days.
Poland The health ministry reported a record 12,107 new coronavirus infections and 168 deaths within 24 hours.
Croatia reported the largest daily count of infections, nearly half of which occurred in the capital. Zagreb recorded 705 new cases, more than double the 337 the previous day.
The World Health Organization’s latest epidemiological update, published earlier this week, noted a continued rapid increase in cases and deaths in Europe, with the region now accounting for 38% of all new cases reported worldwide and deaths increasing by 29% from the previous week.
Most striking is the situation in Germany, which is widely considered to have handled the pandemic well. While the infection rates in Germany remain lower than in much of Europe, they are on the rise.
Authorities have tightened restrictions, such as banning large gatherings. Local restrictions were also imposed: in Berlin, it is now mandatory to wear a mask on certain busy streets.
Wieler, of the Robert Koch Institute, blames private gatherings, especially among young people, for the recent increase in cases. “The more people gather in private circles, the more the numbers will increase and the further the virus will spread,” he said, adding that “young people are currently the most exposed to this virus”.
In Sweden, where cases are also rising, the government said on Thursday it would tighten nightclub rules to force them to limit the number of partygoers to 50. “The party at the nightclub is over now,” said the prime minister, Stefan Löfven.
In Belgium, Sophie Wilmès, the foreign minister, who was the interim prime minister during the first wave of the coronavirus, has treated in intensive care.
The 45-year-old man tested positive for Covid-19 last week and has been in self-isolation, but his condition worsened and on Wednesday night he was taken to a Brussels hospital.
“He was conscious and he was able to communicate,” said his spokesman, confirming that Wilmès was receiving intensive care. A source in his office said his condition is stable.
FILE PHOTOS: Nordic Entertainment Group (NENT) sign seen at their headquarters in Stockholm, Sweden October 1, 2018. REUTERS / Olof Swahnberg
STOCKHOLM (Reuters) – Media company Nordic Entertainment Group (NENT) moved its streaming registration and broadcast license to Sweden from the UK to ensure viewers across Europe have access to its services after Brexit, he said on Wednesday.
Under European Union (EU) legislation, the country of origin principle allows media companies to offer services across the EU while being regulated in one EU jurisdiction. This will no longer apply in the UK at the end of the Brexit transition period.
The Swedish company said its services, currently regulated by Britain’s Ofcom, will be regulated by the Swedish Press and Broadcasting Authority for the first time starting January 1.
“This move ensures NENT Group’s services will remain available to viewers after Britain leaves the European Union,” he said in a statement.
Shares of NENT, whose streaming service Viaplay is its biggest growth driver, have surged more than 100% since mid-March when people in Europe and elsewhere were urged to stay home to help curb the COVID-19 pandemic, which is spurring viewers.
NENT, which also offers free and paid TV and radio, last month raised its new 2020 subscriber target for Viaplay to over 700,000. Viaplay has more than 2.5 million paying subscribers in the Nordic region.
Companies have scrapped dividends and scrapped lucrative growth prospects in 2020 due to the pandemic, but increased streaming offset the negative effects of canceled sporting events and a weak advertising market.
NENT separated from E-sports and the MTG gaming group in 2018.
Reporting by Helena Soderpalm; editing by Emelia Sithole-Matarise
If you have followed the news about the Coronavirus pandemic closely, chances are you already have strong opinions about Sweden’s approach to managing the spread of COVID-19.
But the experience of some Australians currently living in Scandinavian conditions may be different.
When the pandemic hit, Sweden made the unusual decision not to impose a lockdown, unlike most of its European neighbors.
Instead, the strategy relies heavily on people taking personal responsibility for protecting themselves and those around them from the virus.
His decision to go his own way made him a popular topic of debate for international health professionals, news organizations and political pundits.
Those who oppose the lockdown point to it as an example other countries should follow, but others supporting stringent public health measures highlight the country’s coronavirus death toll, which is significantly higher than that of its Nordic neighbors.
So what is it like to live through Sweden’s mighty coronavirus experiment? The ABC spoke with several Australian expats living across the country to get their opinion.
‘People don’t seem to be breaking the rules’
Wendy Luttrell, her daughter and partner live in the Swedish rural town of Skellefteå.(Provided)
Wendy Luttrell lives in Skellefteå, a town of about 32,000 people in the northeast of the country, with her Swedish partner and their newborn baby.
Ms Luttrell has only lived in Sweden since December, and said she was initially critical of the country’s response, especially after hearing about Australia’s approach.
He said he questioned why the country was not under lockdown, and why no one was wearing a mask, but he said he had since changed his mind.
“[Culturally], they’re naturally almost ready for it. “
Wendy Luttrell said people in Sweden were culturally prepared to deal with pandemic conditions.(Provided)
There were a total of 1,141 coronavirus cases and 31 deaths in the country where Skellefteå is located, according to figures from the Swedish Public Health Agency, out of a total population of about 270,000 people.
However, the numbers are much more worrying elsewhere in the country.
While Sweden’s population of around 10 million is less than half that of Australia, it has reported 102,407 cases – about four times the 27,371 cases here.
Sweden also has the highest number of coronavirus-related deaths and cases when compared to other Nordic countries.
As of Friday, more than 5,910 people have died from COVID-19 in Sweden compared to 278 in neighboring Norway, 675 in Denmark and 346 in Finland – even though Sweden has a population that has doubled.
Sweden has the 14th highest per capita mortality in the world, only one position lower than Italy, according to the latest figures by the University of Oxford.
Many of the deaths occurred in elderly care settings or in homes where people received professional care.
Less strict rules are difficult to emulate in Australia
Restaurants, pubs and even nightclubs are allowed to remain open in Sweden.(Reuters: Anders Wiklund)
In the capital, Stockholm – about a nine-hour drive from Skellefteå by car – fellow expat Andrew Digges said the regulations were not as stringent as countries like Australia.
Swedes are told to work from home if they can, stay home if they have any symptoms, and while restaurants, pubs and even nightclubs have been allowed to stay open, they can only provide table service that is socially distant.
Simon Keane, a PhD student from Melbourne who lives in the city of Skövde, Sweden.(Provided)
Simon Keane, a PhD student from Melbourne living in the city of Skövde, said although he supports the Swedish approach to managing COVID-19, he doesn’t think it will work in Australia.
“I think most Swedes believe that government agencies will make good, reasoned and well-founded decisions,” he said.
“And while they may not like decisions or rules, they are at least following them. I don’t think people in Australia have the same level of respect for government institutions.”
As a plus, Keane said he thinks Swedes’ natural inclination to keep their distance may also benefit them – a fairly common observation of expats as well as Swedes.
Free to travel at home and abroad
Ethan Brooker lives in the small town of Lidköping with his Swedish colleague, who is a doctor at a local hospital.
Australian expat Ethan Brooker recently returned from a short vacation in France.(Provided)
In a sign of how different the pandemic-related regulations in Sweden are from Australia’s, Brooker recently traveled to the southern city of Malmö for a christening, and took a week-long holiday in France last month.
Despite the relative freedom they enjoy during the European summer, he said people in Lidköping have been working hard to limit the spread of COVID-19.
Life in a city of about 25,000 people changed significantly at the start of the pandemic, when local residents started working from home and avoided public places such as libraries, shopping malls and cinemas.
“The town has been pretty empty for months,” said Mr. Brooker.
He said the coverage he saw of Sweden’s pandemic policies in the Australian media – which often focused on the country’s decision not to impose a lockdown – did not seem to be of much help to him.
“I feel like [it] doesn’t help improve the quality of the debate in Australia… It’s pretty black and white, focusing on the idea of ’locks versus no locks’, when in fact there are more components to a successful public health response. “
‘A little panic’
Clint Grundy said that many of his friends and family are struggling in Australia.(Provided)
For Melbourne father Clint Grundy, the decision to move to Sweden with his family last year was almost accidental.
Mr Grundy, a construction project manager, currently lives on the island of Gotland and says his experience is very different from that of his extended family and friends back home.
“A lot of family and friends are having a really bad time,” he told the ABC.
Grundy said there was “no panic” in Sweden, and the Swedish Government’s approach domestically was “less political” than in Australia.
Mr Grundy now coaches his son’s ice hockey team on the weekends.(Provided)
Grundy’s family life in Sweden is very different from what they would have experienced if they had remained in Melbourne.
“We’re actually traveling in a couple of weeks, we’re going to Prague … one of the biggest and fastest growing places for COVID, but I kind of decided to move on rather than sit there for too long,” he said.
Not all industries are left untouched
Sweden’s decision to go its own way has made it a popular topic of debate among international healthcare professionals.(Reuters: Stina Stjernkvist)
However, life in Sweden during the pandemic has remained relatively unchanged for everyone.
Stockholm chef Gaeton Graham told the ABC he lost his job because of COVID-19: he works for the Gröna Lund theme park, which has not been able to stay open due to a ban on public gatherings of 50 or more people.
“I am in the unfortunate situation of working for an employer that cannot be legally disclosed,” Graham said.
On the plus side, Graham says he spends a lot of time with his children, even though most schools remain open in Sweden.
“School policy is that young children should remain at home for all flu-like symptoms, and then for 48 hours without symptoms,” he said.
“We have two small children, so we often take them home.”
