There seems to be only a distant memory of the dangerous pathogen here

There seems to be only a distant memory of the dangerous pathogen here

Corona rules: These relaxations apply in your state

 Sanofi is researching a dead vaccine with genetically engineered virus antigen. It has been tested in a phase I / II study in the USA since the beginning of September and, according to the French pharmaceutical company, should cost less than ten euros per dose. A final price has not yet been determined, said the President of Sanofi France, Olivier Bogillot, on the radio station France Inter at the beginning of September.

US and EU enable accelerated vaccine approval

The chances of getting a drug in the near future seem to be steadily increasing – also because several drug authorities are now enabling accelerated procedures in order to be able to get an active ingredient on the market even faster.

The US Food and Drug Administration (FDA) recently published specific guidelines that a potential vaccine candidate must meet. This guide is intended to help accelerate the manufacture, clinical development and approval of a safe Covid-19 vaccine.

The guidelines have a catch, however. The FDA is not betting on a super vaccine that will protect every vaccinated person for a lifetime. Instead, the requirement is modest: the active ingredient must prevent infection or reduce the severity of the disease in at least 50 percent of those vaccinated – provided that large studies have shown it to be safe, effective and well tolerated. The agency’s guidelines also allow accelerated approval in certain cases if it has been proven that the vaccine candidate activates an immune system response or can at least be used clinically for other purposes.

Nevertheless, the following applies: even if a vaccine could be approved soon, it might not protect everyone from infection with SARS-CoV-2.

EU also enables faster approval

For Germany, guidelines like those of the FDA do not yet exist. For the EU, however, the European Medicines Agency (EMA) enables accelerated procedures for Covid-19 treatments and vaccines. To this end, the authority has formulated guidelines on rapid test procedures for development and approval. "These fast track processes can expedite each step of the regulatory process while ensuring that robust evidence of efficacy, safety and quality is created to support scientific and regulatory decisions", says the EMA based in Amsterdam.

The agency has already taken a first step in the treatment of people seriously ill with Covid-19: at the end of June, it recommended approval of the active ingredient remdesivir (known under the trade name Veklury) subject to conditions, not as a vaccine but as a drug.  

The vaccine should be distributed as quickly as possible

Should a safe and effective vaccine be found in the foreseeable future alongside the active ingredient from Russia, there is still another challenge ahead: the rapid production of large quantities of vaccine doses and their distribution in the population, even in poor countries.

The WHO director for public health, Maria Neira, recently assured in an interview with the Catholic News Agency that her organization would ensure a fair worldwide distribution of the vaccine. "Rich countries will have to pay for the vaccine. For poor countries that cannot do this, we are setting up mechanisms and subsidies so that everyone has access."

According to Neira, the WHO has an initiative called together with the EU and other states and organizations such as the Bill and Melinda Gates Foundation "ACT Accelerator" started. 

Large-scale production of vaccines is already starting now

In order to accelerate broad-based production, several companies and research institutes want to expand their production capacities for a Covid-19 vaccine. Some, including Moderna and Oxford University, have announced that they will begin large-scale production of vaccine candidates before human testing is complete – despite the risk of having to discard the doses produced in the event of negative test results.

In addition, companies that are not researching their own Covid-19 vaccine have also agreed to support the manufacture of vaccines from other companies. These include the Japanese company Takeda and the Bayer company.

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Not all experts believe in vaccine soon

As long as no active ingredient is found and approved, the restrictions in the corona pandemic are likely to continue to accompany us. Anyway, some experts are skeptical that the coronavirus could soon be eradicated by an effective and side-effect-free antidote. They point to the unsuccessful search for a vaccine against HIV, malaria or dengue fever.argumentative essay outline template doc

"We cannot be certain that a vaccine will be found or, if it is discovered, that it will pass all tests for effectiveness and safety", David Nabarro, professor of world health at Imperial College London and World Health Organization special envoy for Covid-19, recently told CNN.

Sources used: Own research Federal Institute for Drugs and Medical Devices Food and Drug Administration (FDA): "Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines"European Medicines Agency (EMA): "Guidance for medicine developers and companies on COVID-19"European Center for Disease Prevention and Control: "Covid-19"The Lancet: "Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomized controlled trial"Federal Ministry of Health: "Current information on the coronavirus"WHO: "Coronavirus disease (COVID-19) outbreak"Federal Center for Health Education: "Answers to frequently asked questions about the novel coronavirus"European Union: "Coronavirus Global Response"German Center for Infection Research Association of Research-Based Pharmaceutical Manufacturers (vfa) The Lancet: "Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomized, first-in-human trial"Robert Koch Institute: "Answers to frequently asked questions about the SARS-CoV-2 coronavirus"Robert Koch Institute: "COVID-19 overview"News agencies AFP, dpa and Reuters show more sources less sources

Nobody wants a second lockdown. Yet many fear that he will come. Now, in the heat, everyone is crowding around the bathing lakes. Can it work? 

Norman Rogala is angry. The bald man sits in a beach shelter on the beach at Berlin’s Orankesees and curses. "Much more stringent measures would have to be taken", he says. People crowd in front of the lido cash desk. The snake is a good 50 meters long. It’s Friday afternoon, and many want to jump into the lake first because of the hot temperatures.

Nobody wears a mask here

They only keep the distance when the red markings on the floor indicate this – just before the cash register. Nobody wears a mask here. Norman Rogala reports that only he and one other man wore one. Inside it smells like french fries, children screech happily. Coronavirus? There seems to be only a distant memory of the dangerous pathogen here.

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"That’s irresponsible"says Rogala bitterly. He is 40 years old – and a risk patient. He had cancer. He received his last chemo treatment on July 20th. His immune system was weakened, he spent the time in the hospital alone, in a single room. Now he’s back outside and wants to enjoy the last few days of vacation with his daughter. Rogala upset how the lido is handling the influx of visitors. Still he says: "I’m not so scared that I won’t go out on the streets anymore." You shouldn’t panic. 

The Orankesee lido is located in the Hohenschönhausen district. All around are single-family houses, a large park connects the Oranke and Obersee. There are extensive sunbathing lawns in the lido, a beach section with a couple of beach chairs and – perhaps the highlight for children – a huge slide into the water. Corona shouldn’t spoil the fun. 

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That is why the bathroom continues to sell tickets at the box office. Everyone can stay as long as they want. There is no mask requirement anywhere. Just the call to pay attention to hygiene and to keep your distance. "We are currently allowed to let in around a thousand bathers"says boss Alexandra Barnewski. She doesn’t have time for more questions. She has to keep selling tickets.  

Risk patient Norman Rogala is skeptical. He looks around from his beach shelter. It is full everywhere, the places on the lawns are well occupied. "The bath is four acres. I don’t think there are only a thousand people in here right now."

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A woman walks by with her little daughter, she takes a look at the crowds on the beach and in the water. "It’s pretty full", she says. Do you worry? "Yes, I try to shield myself from it." 

Full sunbathing lawn in Berlin’s Orankesee lido: It is possible to keep your distance – but not easy with the rush. (Source: Madeleine Janssen)

According to "mirror"Poll, around 80 percent of Germans expect a second lockdown. Nobody should seriously want that. Nevertheless, people are drawn outside, to the cafés, to the beach. Air travel is unpopular this year. Travel in Germany, on the other hand, is even more common. That wouldn’t be a problem as long as the distance rules are observed. And that’s a problem in some places. Risk patients like Norman Rogala have a particularly keen sense for this. 

Jürgen Wolff has also had cancer. Colon cancer, twice, among other things. His heart no longer works properly either, stents and bypasses support him, a pacemaker helps him. A long scar can be seen on his suntanned stomach. Still – or because of the long medical history? – the 79-year-old doesn’t let himself be disturbed. He and his wife sit on the lawn. "We feel safe here"says Gisela Wolff. "The families stay among themselves, we hardly have any contact with other people."   

"Some say they’d like to have that much space"

While Berlin’s most beautiful anarchy prevails at Lake Orankesee, guests at the Weißensee lido have to go to the beach in a more structured manner. Masks are required at the entrance. Anyone who thinks they can settle where they want is wrong: every visitor is assigned a permanent place. Whether on the terrace or under the fixed parasols on the beach: each place is numbered. If it is occupied, this is recorded in the cash register system. "So we always have an overview of how many people are currently in the lido"says tenant Alexander Schüller. He is proud of his concept. "99 percent of the visitors praise us for the principle of allocating space. Some say they’d like to have that much space."     

Lido leaseholder Alexander Schüller: The 36-year-old has come up with a concept for how bathers can bathe in his company despite the Corona crisis. (Source: Madeleine Janssen)

There is little going on on Friday afternoon. A couple of retirees, a couple of teenagers, a couple of mothers with young children. The Weißensee lido normally has space for 1,200 visitors. In Corona times, only 350 people are allowed in at the same time.

At two in the afternoon the lido closes for an hour: cleaning action! Then Schüller’s employees grab the bottles with the disinfectant and clean tables and chairs. "We cannot afford to hire additional cleaners to clean all day long"says Schüller. 

Numbered and fixed parasols at the Weißensee: Visitors are assigned a fixed place at the entrance. (Source: Madeleine Janssen)

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The 36-year-old therefore also waives requirements that seem completely nonsensical to him: "We don’t have any deck chairs this year", he says. They would have to be in a so-called deck chair quarantine for 48 hours – the health department assumes that the corona virus could settle in the wood. But now he has to stop – the cleaning hour is about to begin.

Bather June Steinhöfel also packs her things. Your two grandchildren will get a pair of Viennese to take away. Steinhöfel enjoyed the tranquility in the Weißensee lido. "Just think of the Baltic Sea. People crowd like crazy." 

Sources used: own research

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