Tag Archives: VACCIN

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

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.

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

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.

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

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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