Tag Archives: PUBHEA

Health

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

Leave a comment

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

Our Standards: The Thomson Reuters Trust Principles.

Read original article here

World

Germany could ease travel curbs as Delta variant takes over

Leave a comment

People walk past a colonnade on Museum Island during warm temperatures, amid the coronavirus disease (COVID-19) pandemic, in Berlin, Germany May 30, 2021. REUTERS/Annegret Hilse

BERLIN, July 1 (Reuters) – Germany expects the Delta variant of COVID-19 to account for up to 80% of infections this month and could ease travel restrictions from countries like Portugal and Britain where it already dominates, its health minister said on Thursday.

Jens Spahn told a news conference that Germany could reduce the current 14-day quarantine requirement that it imposes on travellers from countries with high levels of the Delta variant once it is sure that vaccinated people are protected.

Spahn said the move could happen soon, without specifying.

Germany’s STIKO vaccination commission said later on Thursday that UK studies show that two vaccines doses seem to provide as much protection against the Delta variant as against other COVID-19 variants. read more

Spahn reiterated the importance of speeding up vaccinations, noting that 37% of Germany’s population has now received two shots, while 55% has had a first dose.

About half of German coronavirus cases are currently Delta variant and Spahn said it will dominate later this month.

Germany last week declared Portugal and Russia to be “virus-variant zones”, meaning only German residents can enter the country from those countries and still face a mandatory two-week quarantine even if they are fully vaccinated or test negative.

That had prompted German tourists there to rush home and airlines to cancel flights.

Germany also classifies Britain as such a “virus variant” zone. Chancellor Angela Merkel is due to discuss travel restrictions when she meets British Prime Minister Boris Johnson on Friday.

Spahn suggested these countries could be shifted to a designation as risk areas, meaning people can travel if they are fully vaccinated or have recovered from COVID-19, or be released from quarantine after five days if they test negative.

The European Commission said on Tuesday that Germany should not impose a travel ban on Portugal but limit itself to imposing testing and quarantine requirements to be in line with the European Union approach meant to ease summer travel.

Reporting by Emma Thomasson and Thomas Escritt; Editing by Maria Sheahan and Catherine Evans

Our Standards: The Thomson Reuters Trust Principles.

Read original article here

Business

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

Leave a comment

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

Our Standards: The Thomson Reuters Trust Principles.

Read original article here

World

Brazil to suspend Indian COVID-19 vaccine deal as graft claims probed

Leave a comment

RIO DE JANEIRO, June 29 (Reuters) – Brazil will suspend a $324-million contract for COVID-19 vaccine from India that has mired President Jair Bolsonaro in accusations of irregularities, the health minister said on Tuesday, following guidance by the federal comptroller, the CGU.

The deal to buy 20 million doses of Bharat Biotech’s Covaxin shot has become a headache for Bolsonaro after whistleblowers went public with alleged irregularities. One health ministry official said he alerted the president about his concerns.

Bolsonaro, whose popularity has faded as Brazil’s COVID-19 death toll climbed past 500,000, has denied any wrongdoing, saying on Monday he was not aware of any irregularities.

But thorny questions persist, and may pose problems for him ahead of next year’s presidential vote.

Health Minister Marcelo Queiroga told a news conference his team would investigate the accusations during the suspension.

“According to the preliminary analysis of the CGU, there are no irregularities in the contract but, for compliance, the health ministry chose to suspend the contract,” the ministry said in a statement.

CNN Brasil had earlier reported that the ministry had decided to cancel the contract.

Brazilian federal prosecutors have opened an investigation, citing comparatively high prices of about $15 a dose, quick talks and pending regulatory approvals as red flags.

In a statement, Bharat Biotech said it had followed a “step-by-step” approach for the regulatory approval and supply contract of its vaccine in Brazil, and had not received advance payments from the health ministry.

It added that the pricing of Covaxin had been set between $15 and $20 a dose for supplies to governments outside India.

The deal is also being probed by a Senate panel investigating Brazil’s handling of the pandemic.

One leading opposition senator on the panel, Randolfe Rodrigues, filed a formal criminal complaint against Bolsonaro with the Supreme Court on Monday.

He asked the court to investigate why Bolsonaro “did not take any action after being notified of the existence of a giant corruption scheme in the Health Ministry.”

($1=4.9403 reais)

Reporting by Gabriel Stargardter and Pedro Fonseca; Additional reporting by Uday Sampath in Bengaluru; Editing by Bill Berkrot and Clarence Fernandez

Our Standards: The Thomson Reuters Trust Principles.

Read original article here