Tag Archives: German

Challenges and problems in vaccine strategy | Instant News


At the Leipzig University Hospital, pharmacy students Anne Brandt (m) and Sarah Schulz prepared six syringes from the SARS-CoV-2 Biontech / Pfizer coronavirus vaccine vial for vaccinating medical staff. There is currently more demand for vaccination appointments than can currently be offered.

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Since Germany started its vaccination program in late December, together with other EU members, Germany has faced many logistical challenges.

Now, almost a month into the program, its sluggish progress is causing frustration and concern among some German lawmakers and health professionals.

Health Minister Jens Spahn has targeted 300,000 injections a day, but so far the country has failed to achieve that target. Data from the public health agency, the Robert Koch Institute, published Tuesday showed that in the preceding 24 hours, more than 62,000 vaccinations (most of which were the first dose) were administered.

In total, since Germany started vaccination in its 16 states on December 27, nearly 1.2 million people in Germany (the priority group for now are health workers, nursing home residents and staff and the elderly) have received their first dose of the coronavirus. of the vaccine and nearly 25,000 have received a second dose.

In contrast, the UK, which was the first country in the world to approve and launch the Pfizer-BioNTech vaccine (partly developed in Germany), and later the University of Oxford-AstraZeneca candidate, started its Covid vaccination program earlier in December, has so far been vaccinated more than 4 million people with their first dose of vaccine (over 450,000 having received a second dose), and exceeded 300,000 vaccinations per day towards the end of last week.

Various kinds of problems

The EU follows a policy of purchasing coronavirus vaccines as a block, but several countries, including Germany, are also making additional purchase agreements of their own.

Nonetheless, supply issues had become a problem even at the start of the vaccination campaign in Germany, with the lack of available vaccines seen in certain centers, as well as other difficult logistical issues surrounding the vaccination of priority groups, such as the elderly. This has resulted in an uneven distribution of the vaccine from state to state in the country.

Stefan HE Kaufmann, a well-known immunologist and microbiologist in Germany, and founding director of the Max Planck Institute for Infectious Biology in Berlin, told CNBC on Tuesday that the vaccination process faced challenges from the start.

“The number one priority (in the vaccination effort) at the moment is the elderly and people with severe pre-discharge disease, especially in nursing homes. This process is ethically good, but very time consuming. It also includes health workers and medical staff. “in nursing homes and hospitals. Apparently some nursing home staff are hesitant about vaccination,” he said.

Fenna Martin (C) Marielotte Kilian (L), 87, and Richard Kilian (R), 86, vaccines against Covid-19 at a vaccination center installed at the congress center in Wiesbaden, west Germany, on January 19, 2021, as a federal state western Hesse opens its first six vaccination centers amid the new coronavirus.

ARNE DEDERT | AFP | Getty Images

So far, only vaccines made by Pfizer and BioNTech, as well as Moderna have been approved by the European Medicines Agency for use in the block. Candidates that are easier to store and transfer (and cheaper) from AstraZeneca and the University of Oxford have not been approved.

Timing is critical when it comes to vaccine launches, especially amid the spike in cases due to more infectious mutations that have already occurred. However, Germany has recorded fewer cases than many of its neighbors, recording more than 2 million infections to date. The death toll reached 47,958.

For the UK and EU, the main problem is that supply cannot meet current demand for vaccines, and Germany is no exception, with early reports of people struggling to get vaccination appointments amid under-dosing. But vaccine makers have promised to increase production and have millions more doses delivered in the next few weeks and months.

Meanwhile, however, “the doses that are secured for immediate use are insufficient,” Kaufmann says.

“While so-called vaccination centers have been established all over Germany, there is currently a shortage of vaccines for the maximum rapid vaccination coverage in these centers. The hope is that the process will be accelerated once the difficult and time-consuming vaccination (in nursing homes) has been achieved, “he said, noting that the speed of the German vaccination program” would be faster if more doses of BioNTech and Moderna could be obtained. “

“In my opinion, everything needs to be done to secure more doses for immediate or short-term use. This is even more important because of the increasing incidence of mutant strains that can evade the vaccine-induced immune response,” he warned.

Political criticism

Germany is not alone in seeing a slow start in its vaccination efforts. There has been criticism across the European Union of the European Commission for not getting enough vaccines for the bloc.

Florian Hense, European economist in Berenberg, told CNBC that the approval and procurement process means that the EU is behind, or at least behind other countries including the UK and the US, in terms of receiving vaccine supplies.

“Because the EU negotiates with pharmaceutical companies and approves vaccinations on behalf of its member countries, Germany’s vaccination program will always be ‘not German’, regardless of what you associate with the term,” he told CNBC Monday.

Parents who have just been inoculated to fight COVID-19 wait a moment if side effects occur before leaving for the vaccine center at the Messe Berlin trade fair on the day of the center’s opening during the second wave of the coronavirus pandemic on January 18, 2021 in Berlin, Germany. This center is the third to open in Berlin. Three more will open in the coming weeks as Pfizer / BioNTech and Moderna vaccine deliveries increase.

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“I suspect that later EU approval delayed the start of vaccination and has since limited the speed of vaccination per day because vaccinations have arrived in the EU at a slower rate than what happened (per capita) in the UK, US.”

Needless to say, there has been criticism from other lawmakers of the government’s overall strategy. Janosch Dahmen, a doctor and member of the German parliament from the Green Party, told CNBC that he was “very concerned that Germany is falling behind.”

“The progress of the vaccination campaign is too slow and one reason is shortages of supply, but the more pressing problem is that the vaccination infrastructure shows many problems, most of all under staffing, distribution problems in federal states and far too many centralized approaches,” he said.

“As a doctor and politician, I am very concerned about the situation here and apart from all the efforts we need to carry out a more effective national vaccination campaign we need to build bridges because of testing, self-testing and We need to put more effort in the field of contact tracing that is is another important part of fighting this pandemic, ”said Dahmen.

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Opinion: Wait until summer, in the midst of a German lockdown. | Opinion | DW | Instant News


The color of the blazer may change, but the message remains the same: German Chancellor Angela Merkel and the prime ministers of Germany’s 16 states announced, once again, that the country must remain locked. The fight against the coronavirus pandemic has seen the lockdown extended for the third time in three months. What is next? It all depends on the level of infection.

Does anyone really believe that everything will looks much better on February 14th, that infection rates will be low enough to open schools, shops and restaurants? Certainly not. In March? Probably not. Easter? Maybe, but with conditions. By early April, it likely won’t be warm enough to bring life to the outside – not to mention that not enough people will be vaccinated by then.

Avoid new variants

As we all know, expanded immunity is the only way to deal with the virus. If and when we achieve it also depends on how quickly and substantially it changes. How long will the vaccine be effective against the mutation? Europe has bought too few bottles to immediately vaccinate millions – a fatal mistake in a race against time.

Sabine Kinkartz of DW

The urgency is even stronger with the new – and more contagious – variant of COVID-19 originating in the UK, which is now becoming is on the rise in Europe. With such high stakes, virologists, ahead of a meeting of state prime ministers, urged leaders to impose a total lockdown, dubbed a “mega-lockdown.”

But the country’s leaders have decided not to follow their advice.

Politics during a pandemic

The new restrictions rely more on mandatory masks, social distancing and working from home – measures that only reinforce what already is. But is that enough? The infection and death rates have decreased slightly, but are far from acceptable.

Policy makers have a dilemma. On the one hand, the threat is still great, maybe even bigger than before considering the new variant. But to be able to enforce tough measures in a free liberal democracy, the support of citizens is absolutely necessary – and it will collapse.

Germany is no longer the country where the pandemic started. The first wave of COVID-19 infections was both surprising and motivating. There are concerted efforts to contain the outbreak. The fear of the virus keeps everyone at home, at least those who can afford it. Most of the economy was closed. The city center is deserted, the streets are so empty that individual lanes are declared bike lanes, and you can safely walk the highways.

But during the second wave, the city streets were bustling. Certain sectors of the economy are up and running, if not at full speed, and that is what political leadership wants. Even Germany unable to take the second economic hit due to the harsh lockdown, which put further pressure on the national budget.

Nearly a year since the start of the pandemic, people have learned to cope with new routines and live in constant emergencies. We are more numb to danger, but, at the same time, pandemic exhaustion and depression. And now, many will have to muster strength and resilience over the coming weeks, either in the loneliness of one household or in the chaos of a family amid school closings.

A homemade depiction of the coronavirus hanging on a street in Schwerin

The corona virus continues to swell in Germany

Resistance is growing

Many policy mistakes have been made – not least in communicating regulations. More and more people are questioning the steps that are sometimes contradictory and difficult to understand. Why do hairdressers have to stay closed, but at the same time people are allowed to jostle through the checkout lines at supermarkets? Why are people not allowed to go to restaurants, but can get onto crowded buses and trains? Why are the most vulnerable, the elderly and the sick, better protected? What about high-quality medical masks and mandatory home testing? This can be done faster.

Resentment also grows in the business community. A locked industry is in dire financial straits; many of them may have to file bankruptcy immediately. Arts and culture, and the entire event industry, are practically gone. Calls for help were ignored – and bitter awareness was growing that the government was not helping the gastronomic and cultural industries as fast. While Lufthansa airline has billions of euros in guarantees, many small business owners are still waiting for the financial support promised in November.

The hardest months

Even in times of prosperity, politicians can no longer score points. Calls for easing lockdown measures have become more intense. More work from home for employees? Don’t be too fast, because it can become a habit after a pandemic. Even if employers now have to offer staff the opportunity to work from home, hard-hearted employers will find ways to get around this, even amid rising infection rates.

Back in December, we were told the next few months would be the toughest. That realization now had a profound impact.

People need goals. Positive goals. The things they can look forward to. It was cold and wet and gray outside. So what if they are cheerful and sociable inside, one should be able to imagine their next vacation. None of that is on the horizon at the moment. Otherwise. Politicians rely on the principle of hope – and on everyone who grins and holds him a little longer.

This article was translated from German.

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Germany will speak with Biden’s team to secure a change to vaccine distribution – POLITICO | Instant News


The German government “wants to hold talks” with the new US government to agree to a change in US policy prioritizing local supplies of the coronavirus vaccine at US production facilities, according to documents from the German health ministry.

In a lengthy document published Tuesday responding to inquiries from the German Social Democrats, the health ministry explained why the US could secure an additional supply of BioNTech / Pfizer vaccine for a certain date, whereas an increase in EU supply would come “in 2021.”

The health ministry stated that an executive order from the US president stated that production facilities in the country were “encouraged to provide vaccines for supply in the US”. This means that BioNTech / Pfizer vaccine production sites in Europe, as well as Moderna vaccines, need to supply worldwide, apart from Europe.

“The company as well as the federal government would like to hold talks with the new US government to reach an adjustment,” wrote the health ministry.

The document also discusses the bilateral agreement Germany has with BioNTech / Pfizer – something related to that The commission has let Germany escape, although it appears to be at odds with the block’s efforts to develop an integrated vaccine strategy.

The problem, the health ministry explained, was the funds BioNTech received from the German ministry of education and research. This cash means BioNTech will have to provide a portion of the vaccine to Germany. As a result, the health ministry had to issue a pre-contracted intention letter in the form of a memorandum of understanding on September 8 for an additional 30 million doses of vaccine, the health ministry wrote.

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Merck KGaA, Darmstadt, Germany Announces Update on INTR @ PID Clinical Program Including Lung Study 037 | Instant News


DARMSTADT, German, January 20, 2021 / PRNewswire / – Not intended for UK based media

Merck KGaA, Darmstadt, German, a leading science and technology company, today announced an update on Phase III [email protected] Lung 037 studied and extensive [email protected] clinical trial program for potential first-class investigative bifunctional immunotherapy for alpha bintrafusp, in difficult-to-treat cancers, including bile duct cancer (BTC) and cervical cancer.

Comprehensive [email protected] This program is designed to assess the impact of alpha bintrafusp on various types of cancer and settings in which TGF-β is thought to play a driving role. TGF-β is a cytokine that is known to be associated with tumor propagation and metastatic potential such as local immunosuppression, fibrosis, tumor vascular growth and chemo resistance or radiotherapy via several mechanisms. Trapping TGF-β in the tumor microenvironment on top of PD-L1 blockade is considered transformative in different clinical settings.

When reviewing the totality of data from ongoing clinical trials [email protected] Lungs in the first-line care of patients with stage IV non-small cell lung cancer (NSCLC) who have high PD-L1 expression, the Independent Data Monitoring Committee recommends 19 January 2021 to stop clinical trials. Based on these recommendations, Merck KGaA, Darmstadt, German have made the decision to discontinue clinical trials, because they are unlikely to meet co-primary end points, particularly development-free survival. The recommendations from the Independent Data Monitoring Committee and the Company’s decisions relate only to this clinical trial.

“We have pioneered the science behind the alpha bintrafusp, and now through strategic alliances some uncorrelated parallel hypotheses are being evaluated across multiple indications in our extensive research. [email protected] clinical program, “says Danny Bar-Zohar, MD, Head of Global Development for the Healthcare business of Merck KGaA, Darmstadt, German. “We remain committed to further evaluation of the alpha bintrafusp, and the data is from [email protected] Lung 037 will provide important insights that can be applied for future studies. “

Current and New Clinical Trials

  • BTC: Topline results for [email protected] Study BTC 047 is planned for Q1. Additionally, a phase II / III study of alpha bintrafusp in combination with chemotherapy as first-line treatment for BTC ([email protected] BTC 055), assessing different hypotheses from second-line monotherapy studies, have completed enrollment in Phase II and are on track for Phase III sections. In 2020, the Japanese Ministry of Health, Labor and Welfare granted the SAKIGAKE ‘fast-track’ designation for the alpha bintrafusp at BTC, a regulatory designation that allows expedited review and is linked to indications with limited standards of care.
  • Cervical cancer: Stage II cervical cancer study ([email protected] CERVICAL 017) starting in 2020 is currently underway with registration almost complete. This study evaluated the alpha bintrafusp for the treatment of patients with advanced and inoperable cervical cancer that developed during or after chemotherapy containing platinum. Human papillomavirus (HPV) infection is closely associated with increased TGF-β expression in various solid tumors, including cervical cancer.1 Promotes the efficacy of the alpha bintrafusp in HPV-related malignancy reported of the Phase I combined analysis ([email protected] SOLID TUMOR 001) fund NCI Phase IIexperiment led.2 New Phase I study in locally advanced / advanced cervical cancer as combination therapy ([email protected] CERVICAL 046) also starting in 2020.
  • NSCLC: The alpha bintrafusp lung program is designed to assess patient populations who may benefit from a dual mechanism of action focused on combination studies ([email protected] LUNG 005, [email protected] LUNG 024). In addition to studying combinations with standard of care, [email protected] The LUNG 024 study will be expanded to include new combinations, including combining with VEGF inhibitors, CTLA-4 targeted immunotherapy, and PARP inhibitors.
  • New Study: Recently initiated monotherapy studies include a Phase II monotherapy study in patients with triple-negative breast cancer expressing the AT-hook 2 (HMGA2) high mobility group ([email protected] BREAST 020) and Phase I monotherapy studies in advanced / metastatic urothelial cancer ([email protected] UROTELIAL 152). A Phase I multi-arm platform study combining alpha bintrafusp with GSK’s iCOS (feladilimab) is underway.

*Alpha Bintrafusp is currently under clinical investigation and is not approved for use anywhere in the world.

About Biliary Tract Cancer (BTC)
BTC is a rare group of aggressive gastrointestinal cancers associated with poor outcomes and limited treatment options. There is currently no globally accepted standard of care in second-line settings and chemotherapy and immunotherapy have shown low response rates to BTC. Epithelial to mesenchymal transition (EMT), a sign of tumor development and drug resistance, plays an important role in BTC and has been shown to be triggered by TGF-β signaling.

About Cervical Cancer
The human papillomavirus (HPV) is responsible for more than 90 percent of cervical cancer cases and is one of the most common and deadliest cancers among women worldwide. The TGF-β pathway is often not regulated in HPV-related malignancies, including cervical cancer, and can contribute to the development and progression of cervical cancer and result in resistance to immunotherapy. There is no globally accepted standard of care for recurrent / metastatic cervical cancer after first-line systemic therapy.

About Non-Small Cell Lung Cancer (NSCLC)
Non-small cell lung cancer remains one of the leading causes of cancer death worldwide with a low five-year survival rate. There were significant treatment advances with checkpoint inhibitors, but the majority of patients did not respond.

About Bintrafusp Alfa
Bintrafusp alpha (M7824), found at home at Merck KGaA, Darmstadt, German, and currently in clinical development through a strategic alliance with GSK, is a potential first-class investigative bifunctional fusion protein designed to simultaneously block two immunosuppressive pathways, TGF-β and PD-L1, in the tumor microenvironment. This bifunctional approach is thought to control tumor growth by reversing and potentially enhancing the anti-tumor response. In preclinical studies, bintrafusp alpha has demonstrated antitumor activity both as monotherapy and in combination with chemotherapy. Based on their mechanism of action, bintrafusp alpha offers a potential targeted approach for treating the underlying pathophysiology of difficult-to-treat cancers.

About [email protected] Clinical Trial Program
[email protected] is a global clinical trial program investigating the potential for multiple inhibition of TGF-β and PD-L1 co-localized with alpha bintrafusp (M7824) in various tumor types. Current clinical trial information can be found at [email protected] website on www.intrapidclinicaltrials.com. To date, more than 1,300 patients with various solid tumor types have been treated globally in the alpha bintrafusp. [email protected] clinical development program.

That [email protected] The clinical development strategy is comprehensive and pursues a non-redundant hypothesis that is based on the findings of preliminary preclinical and clinical data that are continuously being explored and can yield clinically meaningful insights to patients in need, including exploring settings where targeting TGF-β and PD is simultaneous and synchronization -L1 may offer the key to expanding the potential of immunotherapy (lung cancer programs); focusing on the opportunities in which PD-1 / PD-L1 has suboptimal clinical and pathogenetic activity related to TGF-β biology (studies in BTC and urothelial cancer); and targeting specific tumors with biomarkers that are strongly associated with the TGF-β signaling pathway (studies on TNBC and cervical cancer).

All of Merck KGaA, Darmstadt, German, a press release distributed by email is at the same time available on the EMD Group Website. If you are a resident United States of America or Canada please go to www.emdgroup.com/subscribe to register your online subscription to this service due to our geotargeting requires a new link in the email. You can later change your options or stop this service.

About Merck KGaA, Darmstadt, German
Merck KGaA, Darmstadt, German, a leading science and technology company, operates in the fields of health care, life sciences and performance materials. About 57,000 employees work to make positive changes to the lives of millions of people every day by creating more enjoyable and sustainable ways of life. From advancing gene editing technology and finding unique ways to treat the most challenging diseases to enabling device intelligence – companies are everywhere. In 2019, Merck KGaA, Darmstadt, German, generating sales of € 16.2 billion in 66 countries.

The company holds global rights to the name and trademark “Merck” internationally. The only exception is United States of America and Canada, where the business sector of Merck KGaA, Darmstadt, German, operating as EMD Serono in health care, MilliporeSigma in life sciences, and EMD Performance Materials. Since its founding in 1668, responsible scientific and entrepreneurial exploration has been the key to the company’s technological and scientific progress. To this day, the founding family remains the majority owner of the public company.

Reference


1.

Allan S, Braiteh F, Calvo AE, et al. Evaluation of phase 1 bintrafusp alpha (M7824), a bifunctional fusion protein targeting TGF-β and PD-L1, in cervical cancer. Gynecol Cancer Int J. 2019; 29: A72-A73.

2.

Strauss J, Gatti-Mays ME, Cho BC, et al. Bintrafusp alpha, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with human papillomavirus-related malignancies. J Immunother Cancer. 2020; 8: e001395.

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SOURCE Merck KGaA, Darmstadt, German

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Germany agrees tax breaks worth 11 billion euros – Handelsblatt | Instant News


BERLIN, January 20 (Reuters) – Germany’s federal and state governments have approved tax breaks worth around 11 billion euros, the Handelsblatt business daily reported on Wednesday, citing a Ministry of Finance document.

The federal and state governments agreed on Tuesday, when they extended the closure of most shops and schools through February 14, that they needed to stimulate the economy further.

The tax breaks will benefit everyone working from home, Handelsblatt said, adding that between 2022 and 2026, the Ministry of Finance expects 11.7 billion euros in aid as a result of the measures. (Written by Paul Carrel Editing by Riham Alkousaa)

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