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CureVac’s Covid Vaccine Carried out Badly in Trial, In Half As a result of Variants

German company CureVac on Wednesday delivered disappointing preliminary results from a clinical trial of its Covid-19 vaccine, tarnishing hopes of meeting the world’s great needs.

The study, which included 40,000 volunteers in Latin America and Europe, estimated that CureVac’s mRNA vaccine was only 47 percent effective, one of the lowest ever reported by any Covid vaccine manufacturer. The study will continue as researchers monitor volunteers for new cases of Covid, with a final analysis expected in two to three weeks.

“We’re going into full swing for the last reading,” said Franz-Werner Haas, CEO of CureVac, in an interview. “We are still planning to submit the permit.”

CureVac plans to first apply to the European Medicines Agency for approval. The European Union reached an agreement last year to purchase 405 million doses of the vaccine if the agency approves it.

However, independent experts said it would be difficult for CureVac to recover. Natalie Dean, a biostatistician at the University of Florida, said the vaccine’s effectiveness could improve somewhat by the end of the study. However, since most of the data are already available, the vaccine is unlikely to offer high protection. “It’s not going to change dramatically,” she said.

And with such a low rate of efficacy – far less than the roughly 95 percent of competing mRNA vaccines from Pfizer-BioNTech and Moderna – the results aren’t a good sign that CureVac’s vaccines will be adopted.

“It’s pretty devastating for them,” said Jacob Kirkegaard, a vaccine supply expert at the Peterson Institute for International Economics, a Washington think tank.

The news was disappointing to experts who had hoped the company could provide vaccines to low- and middle-income countries that don’t have nearly enough. CureVac had several advantages over the other mRNA vaccines, such as the month-long shelf life in the refrigerator. In addition, CureVac’s vaccine uses fewer mRNA molecules per injection compared to its competitors, reducing its cost.

The study results published on Wednesday were based on data from 135 volunteers suffering from Covid. An independent panel compared the number of people who had received a placebo with those who had received the vaccine. Although the vaccine appeared to offer some protection, the statistical difference between the two groups was not great, giving an effectiveness rate of 47 percent.

In comparison, annual flu vaccinations can be 40 to 60 percent effective. Both the World Health Organization and the Food and Drug Administration set a threshold of 50 percent effectiveness for considering Covid vaccines for emergency approval. If CureVac ended up staying at 47 percent, it wouldn’t meet that standard.

The results surprised the scientists. CureVac’s recordings have shown promising results in animal studies and early clinical studies.

“This is a bit of a head scratch,” said Dr. Dean.

Dr. Haas blamed the disappointing results on the high number of virus variants in the countries where the vaccine was tested. Of 124 of the Covid-19 cases that the company’s scientists have genetically sequenced, only one was caused by the original version of the coronavirus.

More than half of the cases were caused by variants that have been shown to be more transmissible or can make vaccines less effective. CureVac volunteers have also been infected by variants that have yet to be carefully investigated. Lambda, which has dominated Peru for the past few weeks, made up 21 percent of the samples.

Dr. Haas said the results should serve as a wake-up call to the threat that new variants can pose to vaccine effectiveness. “It’s a new Covid reality, that’s for sure,” he said.

Moderna and Pfizer-BioNTech were tested last year before variants emerged, which could partly explain their much higher rates of effectiveness. However, studies have shown that their effectiveness in practice falls only moderately in view of variants.

Dr. Kirkegaard predicted that it would be challenging for CureVac to compete with others Covid vaccine under development, manufactured by Novavax. Novavax reported Monday that its non-frozen vaccine was 90 percent effective in a study in the United States and Mexico.

“I suspect that it will be difficult for them to really get a significant market for developing countries,” said Dr. Kirkegaard.

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Western Warnings Tarnish Vaccines the World Badly Wants

South Africa immediately copied the American break in Johnson & Johnson vaccinations and enraged doctors who still call for gunshots, especially in remote parts of the country. In February, health officials dropped the AstraZeneca vaccine there because of its limited effectiveness against a dangerous variant.

To date, only half of 1 percent of the population is vaccinated and only 10,000 shots are fired a day. At this rate, it could be weeks, if not longer, for a single rare case of blood clotting to occur, said Jeremy Nel, an infectious disease doctor in Johannesburg. He was dismayed by the decision to pause the shooting, given the risk of building confidence in vaccines in a country where two-fifths of the population say they don’t intend to vaccinate.

“The slower you go, the more that failure is measured in terms of death,” said Dr. Nel. “Even if you are late by a week, there is a non-trivial chance that will cost your life.”

The solution in many European countries – stop using apparently riskier vaccines in younger people who are less at risk of Covid-19 – would not be practical in Africa, where the average age in many countries is under 20.

Further restrictions would tighten the hurdles for Covax, including a lack of funding for any part of vaccination programs beyond doses at airports.

Mali, in West Africa, has administered 7 percent of the AstraZeneca doses administered by Covax. Sudan in East Africa has given 8 percent of the doses it has received.

Analysts fear that dissatisfaction with AstraZeneca and Johnson & Johnson vaccines could fuel demand for recordings made in Russia and China, which are far less well known. Some global health officials have turned their attention to the Novavax vaccine, which is not yet approved but makes up a third of the Covax portfolio.

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Merkel’s occasion fares badly in state elections, third Covid wave hits

Chancellor Angela Merkel (CDU) on September 30, 2020 in Berlin.

Michele Tantussi | Getty Images News | Getty Images

Chancellor Angela Merkel’s party collapsed after defeating two important state elections on Sunday, which put the country’s leadership in even more distress as Germany appears to be facing a “third wave” of coronavirus infections.

The ruling party of the Christian Democratic Union (CDU) in Germany recorded the worst performance since the Second World War in the state elections this weekend and was behind the center-left Greens and the Social Democrats (SPD) in the vote in Baden-Württemberg Rhineland-Palatinate.

The results largely confirmed the political status quo in both federal states, with the incumbent Prime Ministers – Winfried Kretschmann from the Greens in Baden-Württemberg and Malu Dreyer from the SPD in Rhineland-Palatinate – winning the elections. The CDU took second place in both regional votes, followed by the right-wing alternative for Germany, although their support also declined.

Results of the state elections in Germany

CNBC

Paul Ziemiak, Secretary General of the CDU, admitted that the results for the center-right party were disappointing and said: “To be very clear, this is not a good election night for the CDU. We would have different and better results in the State wanted. ” Elections in Baden-Württemberg and Rhineland-Palatinate. “

The party’s poor performance can be seen in the preparations for the national elections in September – with four more state elections beforehand – and for the period after Merkel. The Chancellor announced in 2018 that she would not run for a fifth term, creating uncertainty about who would succeed her to take over Europe’s largest economy.

Arne Jungjohann, political scientist and member of the Green Academy of the Heinrich Boell Foundation, told CNBC that the results signaled that the CDU could get into trouble with the national vote in September.

“The CDU party under Angela Merkel built the image of being indispensable, of being the natural governing party, and this image has faded since last night (Sunday evening),” he told CNBC’s “Squawk Box Europe”. “We saw in both states … that the parties can actually form governments without the CDU, and that is the signal from last night.”

Push election year

For some parties in Germany, however, the latest results are encouraging, especially for the environmentalists Greens, who also achieved good results in the local elections in Hesse this weekend.

This could herald a change in the political landscape later this year as the Greens are likely to become a coalition partner for the CDU in the next government. Jungjohann told CNBC that the Greens had established themselves in Germany as a “hinge party” that could rule both center-left and center-right. They are already part of coalitions in 11 out of 16 federal states. “They have become a federal political force despite being in opposition at the national level,” he noted.

Robert Habeck, green The party’s co-chairman said the results were “a great start to the super election year for us, and hopefully we’ll be able to take the tailwind of Baden-Württemberg and Rhineland-Palatinate with full sails and continue to gain momentum in the US. ” Months to come. “

He added that the results reflected a loss of public confidence in the ruling CDU party due to what he described as “mismanagement” of the government during the pandemic and a corruption scandal that the party had in recent weeks over allegations made by several CDUs Legislators have taken advantage of deals to procure face masks in the early days of the pandemic. The allegations have led to several resignations.

Winds of Change?

After the results of the weekend, the CDU is likely to be looking for the soul, as it is considering who could fill Merkel’s shoes as Chancellor after the elections in September.

Merkel, arguably the strongest and most respected leader in Europe, was generally seen as a safe couple during her leadership and is helping steer the euro zone through the financial crisis. However, she has been criticized in Germany for her decision to allow hundreds of thousands of migrants to enter the country in 2015. This move was seen as increasing support for the right-wing party Alternative für Deutschland.

The CDU has not yet selected who it will lead in the federal elections, although the main candidates are Armin Laschet, chairman of the CDU, and Markus Soeder, chairman of the CDU’s Bavarian sister party, the Christian Social Union.

Angela Merkel (CDU, lr), Armin Laschet (CDU), Prime Minister of North Rhine-Westphalia, and Markus Söder (CSU), Prime Minister of Bavaria, talk to the heads of government.

Image Alliance | Image Alliance | Getty Images

A decision is expected in April or May, although the CDU’s defeats this weekend will increase the pressure on party leaders to quickly nominate a candidate, according to Carsten Brzeski, global macro chief at ING.

“With the results on Sunday, the chances of the Bavarian Prime Minister Markus Söder of being the third Bavarian to lead the CDU to national elections have increased significantly,” he said in a note on Monday.

“In our view, Sunday’s state elections … showed clear dissatisfaction with the national government,” he said, noting that “the main message for the September elections is that the electorate is seeking continuity, but it is unclear what continuity exists. “

Coronavirus suffers

Germany was lauded last year for dealing with the coronavirus pandemic and for its robust system of tracking and quarantining contacts that helped contain the spread of the virus and modern hospital infrastructure that helped prevent the high number of deaths contributed, seen praised in other European countries, particularly Italy, Spain, Great Britain and France.

However, in recent months, like other countries, it has had to grapple with the spread of more infectious variants of the virus, which in some cases has spiked it, aided by the winter season and a slow roll-out of Covid vaccines across the country .

National surveys show that support for the CDU rose at the beginning of the pandemic and has remained relatively high over the past 12 months. Whether this continues, however, could be determined by the government’s handling of a third wave of infections, just as citizens are desperate to get their lives back to normal. On Friday, the head of the German health department warned that a third wave had already started.

The political scientist Jungjohann noted that support for the CDU is now waning. “Most people are now saying that the vaccination rollout is not going well and now we’ve seen the corruption scandal unfold and it’s still going on. It is still unclear who will try to follow Angela Merkel,” he said . “It looks like a moment of crisis (against this backdrop) towards the elections.”