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EXCLUSIVE S.Korea in talks with mRNA vaccine makers to make up to 1 bln doses -govt official

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South Korean senior citizens receive their first dose of the Pfizer-BioNTech coronavirus disease (COVID-19) vaccine at a vaccination centre in Seoul, South Korea April 1, 2021. Chung Sung-Jun/Pool via REUTERS

SEOUL, July 5 (Reuters) – South Korea is in talks with mRNA vaccine makers including Pfizer (PFE.N) and Moderna (MRNA.O) to produce COVID-19 shots in the country and is ready to offer the capacity to make up to 1 billion doses immediately, a senior government official said.

The plan, if agreed, would help ease tight global supply of COVID-19 vaccines, particularly in Asia which lags North America and Europe in vaccine rollouts, and put South Korea a step closer to its ambition to become a major vaccine manufacturing centre.

South Korea already has deals to locally produce three coronavirus vaccines developed by AstraZeneca (AZN.L)/Oxford University, Novavax (NVAX.O), and Russia. It also has a vaccine bottling and packaging deal with Moderna.

“We’ve been holding frequent talks with big pharmaceutical companies to produce mRNA vaccines,” Lee Kang-ho, director general for the global vaccine hub committee under South Korea’s health ministry, told Reuters in an interview.

“There are only a few mRNA vaccine developers – Pfizer, Moderna, CureVac and BioNTech. Thus there’s a limit to how much they can produce to meet global demand… South Korea is keen to help by offering its facilities and skilled human resources,” Lee said.

It’s not immediately clear how advanced these talks are and whether and when a deal will be agreed.

BioNTech (22UAy.DE) declined to comment, Moderna and CureVac (5CV.DE) did not reply to Reuters’ requests for comments.

A Pfizer spokesperson said the company is making efforts to enhance its COVID-19 vaccine supply chain but added “we do not have anything specific to announce at this time.”

Lee declined to name local vaccine makers which have the capacity to produce mRNA vaccines immediately, but a government source said they include Hanmi Pharmaceuticals Co Ltd (128940.KS) and Quratis Co Ltd.

Hanmi confirmed that it has a big capacity reserved for Sanofi’s (SASY.PA) diabetes drug and it can be used for COVID-19 vaccine production as the Sanofi project has stalled.

“We happen to have this facility available right now because our clinical trial (with Sanofi) was discontinued in the middle of last year,” Kim Soo-jin, senior vice president of Hanmi, told Reuters.

“It’s very timely that we have a fully ready, GMP, state-of-the-art facility available,” she said, referring to good manufacturing practice.

Quratis, which makes a tuberculosis vaccine, said its new factory built last year can now be used for mRNA vaccine production.

Shares in Hanmi erased early losses and rose nearly 4% on Monday after the Reuters report.

COLLABORATION WITH WHO

South Korea has stepped up its effort to produce more vaccines since U.S. President Joe Biden in May agreed with South Korean President Moon Jae-in on a comprehensive partnership on COVID-19 vaccines. read more

Lee said his team is having frequent video conference calls with the vaccine makers and the World Health Organization (WHO).

WHO spokesman Tarik Jasarevic told Reuters the organisation is “talking with South Korea and other countries,” but did not elaborate.

The WHO said last month it will set up a hub in South Africa to manufacture mRNA vaccines within 9-12 months that will give companies from poor and middle-income countries the know-how and licenses to produce COVID-19 vaccines. read more

Lee said mRNA vaccine makers may be reluctant to share their technology, but they can take advantage of South Korea’s raw material suppliers to address a global shortage of such ingredients as lipids, nucleotides and capping reagents.

“They’re capable of manufacturing and developing such raw materials to help vaccine makers… and the South Korean government is committed to provide all necessary support including financial and administrative aid.”

Lee said the country also has a capacity for at least another 500 million doses of fill-and-finish vaccines apart from the deal Moderna announced with Samsung BioLogics (207940.KS) in May.

Reporting by Sangmi Cha in Seoul; Additional reporting by Stephanie Nebehay in Geneva, Michael Erman in New York and Ludwig Burger in Frankfurt; Editing by Miyoung Kim and Raju Gopalakrishnan

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World

India’s Bharat Biotech says vaccine 93.4% effective against severe COVID-19

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July 3 (Reuters) – Phase-III trials of a vaccine made by India’s Bharat Biotech showed it was 93.4% effective against severe symptomatic COVID-19, the firm said on Saturday, a finding that could boost people’s acceptance of Covaxin.

The data demonstrated 65.2% protection against the Delta variant, first identified in India, that led to a surge in infections in April and May, and the world’s highest daily death tolls.

India’s homegrown vaccine also showed effectiveness of 77.8% against symptomatic COVID-19 in the trial.

Last month, vaccine maker AstraZeneca Plc (AZN.L) also said its vaccine was effective against the Delta and Kappa variants, citing a study.

India has been administering the AstraZeneca vaccine, made domestically by the Serum Institute of India, which said last month it planned to step up monthly production from July, to nearly 100 million doses.

Bharat Biotech now estimates it will make 23 million doses a month.

The Phase-III data came as Ocugen Inc (OCGN.O), which is co-developing Covaxin with Bharat Biotech for the U.S. market, prepares to file a request for full U.S. approval.

India, with a tally of 30.45 million infections, is the second most affected nation after the United States, with 33 million. The south Asian nation’s death toll has now crossed 400,000.

Reporting by Maria Ponnezhath in Bengaluru; Editing by Clarence Fernandez

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World

Australia to halve arrivals from overseas, offers COVID-19 exit roadmap

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  • Australia to cut arrivals from overseas to 3,000 a week
  • NSW reports 31 new cases, biggest daily rise for 2021
  • Brisbane lockdown extended for another day

SYDNEY, July 2 (Reuters) – Australia will halve the number of arrivals from overseas as its coronavirus hotel quarantine system creaks under pressure from outbreaks of the highly transmissible Delta variant, Prime Minister Scott Morrison said on Friday.

The new restrictions on travel come as Australia fights outbreaks of the Delta variant simultaneously in three state capital cities, meaning nearly half of all Australians are currently under strict orders to stay at home. Most recent outbreaks have been traced to leaks in hotel quarantine.

Australia shut its international borders early last year largely to non-citizens. Permanent residents and returning Australian travellers, except those exiting New Zealand, have to quarantine in hotels for two weeks at their own expense.

Morrison said Australia will now only accept about 3,000 travellers from overseas per week. Lowering the cap will be finalised by July 14, he said, though some states can move earlier.

Speaking after a meeting of the country’s national cabinet, Morrison also said a four-phase plan had been agreed to reopen Australia after lockdowns triggered by the latest outbreaks. He said this would be based on achieving vaccination levels aimed at suppressing COVID-19 to a stage where it would be managed like other infectious diseases like the flu.

“Our mind-set on managing COVID-19 has to change once you move from pre-vaccination to post-vaccination. That’s the deal for Australians,” Morrison told reporters in Canberra.

The four-phased approach could give fully vaccinated people more freedoms, he said, including shorter quarantine period after arriving from overseas.

New South Wales (NSW) capital Sydney, Australia’s largest city and home to a fifth of the country’s 25 million population, is half-way through a two-week lockdown imposed in a bid to contain the Delta variant.

On Friday it warned residents to brace for an increase in COVID-19 infections over the next few days as it reported the biggest daily rise in locally acquired cases recorded so far this year.

Thirty-one local cases were reported in NSW on Friday, so far the biggest daily rise in cases during the latest outbreak and for 2021. Total infections have grown to more than 200 since the first case was detected more than two weeks ago.

“We are anticipating there could be an increase in numbers over the next few days, then hopefully early next week we should see the impact of the lockdown really turning and having a positive impact,” NSW Premier Gladys Berejiklian told reporters.

Queensland officials said lockdown rules will be eased in parts of Queensland from Friday, although they have been extended in state capital Brisbane and a neighbouring region for another day after three new cases were reported.

Lockdown in Darwin, the Northern Territory capital, will also be lifted on Friday. Restrictions in Perth will be reviewed later in the day.

Lockdowns, swift contact tracing and tough social distancing rules have helped Australia to suppress prior outbreaks, but the fast-moving Delta strain has alarmed authorities amid a sluggish nationwide vaccination drive.

The rollout, mired in confusion and frustration due to frequent changes in medical advice for the AstraZeneca (AZN.L) vaccine, has become a flashpoint in relations between the federal government and state leaders. read more

Reporting by Renju Jose; Editing by Kenneth Maxwell

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Business

CureVac COVID-19 vaccine records only 48% efficacy in final trial readout

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A dose of CureVac vaccine or a placebo is seen during a study by the German biotech firm CureVac as part of a testing for a new vaccine against the coronavirus disease (COVID-19), in Brussels, Belgium March 2, 2021. REUTERS/Yves Herman

June 30 (Reuters) – CureVac (5CV.DE) said its COVID-19 vaccine was 48% effective in the final analysis of its pivotal mass trial, only marginally better than the 47% reported after an initial read-out two weeks ago.

The German biotech firm said that efficacy, measured by preventing symptomatic disease, was slightly better at 53% when excluding trial participants older than 60 years, an age group that is by far the most severely affected.

CureVac said on June 16 its COVID-19 vaccine, known as CVnCoV, proved only 47% effective in an initial trial read-out and that new variants had proved a headwind, denting investor confidence in its ability to take on rival shots.

That wiped billions of euros from its market value.

Wednesday’s news sent U.S.-listed shares of the company 10.2% lower to $66 after the bell.

Late-stage trials of BioNTech/Pfizer (22UAy.DE), (PFE.N) and Moderna (MRNA.O) vaccines, which like CureVac’s are based on mRNA technology, had efficacy rates of well above 90% across all age groups but took place when the original version of the coronavirus was dominant.

Data on their products have, however, so far suggested only somewhat weaker protection against new variants.

The CureVac study, which involved about 40,000 adult volunteers in Europe and Latin America, showed that efficacy was 77% in the age group below 60 years of age when considering only moderate to severe symptoms and excluding mild cases.

CureVac said it had sent the data to the European Medicines Agency (EMA) as part of an ongoing dialogue with the EU drugs regulator.

CureVac previously said that the regulatory hurdle was 50% efficacy in principle but that various other considerations would come into play.

“In this final analysis, CVnCoV demonstrates a strong public health value in fully protecting study participants in the age group of 18 to 60 against hospitalization and death and 77% against moderate and severe disease – an efficacy profile, which we believe will be an important contribution to help manage the COVID-19 pandemic and the dynamic variant spread,” said Chief Executive Officer Franz-Werner Haas.

CureVac had registered 228 infections overall for the final analysis, after 134 cases for the interim analysis.

Public health representatives across the globe are pushing for a fast deployment of available vaccines to counter highly contagious mutations of COVID-19 such as the Delta variant that first emerged in India.

The EMA has said it would not impose a 50% efficacy threshold for vaccines and that full trial data was necessary for it to make a sound assessment on the benefits and risks of a shot. read more

Under CureVac’s only major supply deal for the product tested in the trial, the European Union secured up to 405 million doses of the vaccine in November, of which 180 million are optional.

In a bet on CureVac’s technology, Britain placed a conditional 50 million dose order in February on yet-to-be-developed vaccines that build on the product tested in the trial. read more

CureVac had lined up a network of manufacturing partners including Celonic Group of Switzerland, Novartis (NOVN.S), Bayer (BAYGn.DE), Fareva, Wacker (WCHG.DE) and Rentschler Biopharma SE.

($1 = 0.8377 euros)

Reporting by Ludwig Burger, Editing by Rosalba O’Brien

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World

Modi appeals to keep Hindu festival symbolic as India’s COVID-19 infections surge

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Indian Prime Minister Narendra Modi on Saturday appealed to devotees to keep a key Hindu festival symbolic, amid worries about the spread of COVID-19 infections as the country reported more than 200,000 new cases for a third straight day.

Criticism has mounted over the Indian government’s handling of the health crisis, as religious festivals and election rallies continue despite reports of shortages of hospital beds, oxygen cylinders and vaccination doses. read more

India reported 234,692 COVID-19 infections over the last 24 hours, taking the total number of cases to nearly 14.5 million, second only to the United States.

Deaths from the disease rose by 1,341 to 175,649.

After hundreds of thousands of ascetics and devout Hindus gathered for several days along the banks of the Ganges for a religious festival Kumbh Mela, Modi on Saturday called for restraint, saying on Twitter the festival should now be kept “symbolic”.

Responding to Modi’s appeal, one of the religious leaders Swami Avdheshanand urged devotees to not gather in large numbers. Devout Hindus believe bathing in the holy Ganges absolves people of sins, and during the Kumbh Mela, brings salvation from the cycle of life and death.

Those returning to Mumbai in western Maharashtra state from the Kumbh Mela will have quarantine in hotels, Mumbai’s mayor Kishori Pednekar said. Maharashtra accounts for quarter of India’s coronavirus cases and is the worst hit region.

Experts have warned about the spread of more contagious variants of the disease, especially during large-scale gatherings for religious festivals and political rallies.

On Saturday, Modi was scheduled to hold two rallies in eastern state of West Bengal where state polls are ongoing. In recent weeks, such rallies have attracted thousands of people, few of whom follow COVID-19 safety protocols.

“Stop spreader rallies,” the Times of India said in an editorial on Saturday, adding: “Business as usual is an unaffordable luxury until this virus is conclusively tamed.”

India’s daily COVID-19 vaccinations have slowed from their record high early this month and many state governments have requested more doses.

Federal Health Minister Harsh Vardhan assured states there were no shortages and 11.6 million doses would be made available in a week, adding that 125 million doses have already been administered.

Some state governments in India have raised concerns over hoarding and black marketing of anti-viral drug Remdesivir. read more

Nawab Malik, a minister from Maharashtra, accused Modi’s federal government on Twitter for restricting Remdesivir supplies to the state. A minister in Modi’s cabinet, Mansukh Mandaviya, denied the allegation, saying adequate supplies were being arranged.

After imposing one of the world’s strictest lockdowns for nearly three months last year, India’s government relaxed almost all curbs by the beginning of 2021, although many regions have now introduced localised restrictions.

“This is Narendra Modi’s biggest crisis yet. It is bigger than any security threat, external or internal, or even the economic attrition of 2020,” prominent editor and political commentator Shekhar Gupta wrote in a column on Saturday.

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