But the PEI expert reassured her
Powis stressed that the warning was purely a precautionary measure, as is common with new vaccines. The drug was developed by the Mainz-based pharmaceutical company Biontech and its US partner Pfizer.
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The responsible supervisory authority announced that the warning applies to people who have been in the past "significant" have shown allergic reactions – called anaphylactic shocks – to medicines, foods or vaccines. Also meant are people who have to carry an adrenaline pre-filled syringe – an auto-injector – with them – like the two NHS employees concerned. As a consequence, all people who are to receive a vaccination should now be asked about allergies before administration. A patient information sheet indicates possible allergic reactions. Symptoms include an itchy rash, shortness of breath, and swelling of the face or tongue.
A Pfizer spokesman told the German Press Agency: "In the pivotal Phase 3 clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the Independent Data Monitoring Committee. More than 44,000 participants have participated in the study to date, of whom more than 42,000 received a second vaccination."
Great Britain was the first country in the world to grant Biontech and Pfizer emergency approval for their corona vaccine, and the agent has been used nationwide since Tuesday. Hundreds of people were vaccinated on the first day, British media reported.
It should not stop with the Biontech / Pfizer agent alone. "We anticipate a portfolio of three or four vaccines that we can use by mid-year (2021)"Government medical advisor Chris Whitty told the committee. The Swedish-British pharmaceutical company Astrazeneca, for example, developed vaccines together with the University of Oxford and the US company Moderna.
Time and again, vaccines are not available in Germany for weeks or even months. Such bottlenecks also affect standard vaccinations for children. An expert from the Paul Ehrlich Institute explains which preparations are affected and why the dilemma recurs regularly.
"Sold out!", "Out of stock", "Currently not available at the time!" – Such attributes are normally only known from innovative and highly sought-after consumer goods. But most of them are not aware that such market bottlenecks also occur with drugs, especially vaccines.
This makes it all the greater for many – especially parents of babies and small children – that the necessary immunizations cannot be carried out because a certain active ingredient is simply not available and therefore not available to the doctor.
Paul Ehrlich Institute provides information about bottlenecks
As an important point of contact, the website of the Paul Ehrlich Institute (PEI) offers an initial orientation: http://www.pei.de/DE/arzneimittel/impfstoff-impfstoffe-fuer-den-menschen/ Lieferengpaesse/listen- Lieferengpaesse- human vaccines / listen-node.html).
The institute, which as a federal authority is also responsible for the approval and evaluation of vaccines, has been providing information there since October 2015 about the current availability of immunizing agents against infectious diseases in humans. In summary tables you can also find out when a vaccine is likely to be available again and which alternative means are available. The contact addresses of the pharmaceutical companies are also given.
In its information, the PEI always relies on the information of the marketing authorization holders who have committed themselves to reporting: This means that a supply bottleneck is reported by a pharmaceutical company as soon as the chain for the delivery of a vaccine by the manufacturer has been for a period of is interrupted for at least two weeks.
Recommendations for action by Stiko: Non-medical professionals need "Translation aid"
How large the inventory of available vaccine doses is in the branches of the pharmacy wholesalers or in individual pharmacies and doctor’s practices is not recorded centrally anywhere, according to the Robert Koch Institute (RKI). Its area of responsibility includes the regular publication of the recommendations for action of the Standing Vaccination Commission (Stiko). These explanations are primarily aimed at doctors and are difficult to understand at first sight for laypeople.
Vaccines are subject to high quality requirements
But how can it happen in a medically highly developed country like Germany that standard drugs such as vaccines, which are part of basic health care, become scarce? "There are many causes of temporary vaccine shortages", explains Susanne Stöcker from PEI.argumentative essay
"To do this, one has to realize that vaccines that are administered to healthy people must meet particularly high quality requirements and are therefore checked particularly intensively – both by the manufacturers and by the authorities.
In Germany, the Paul Ehrlich Institute is responsible for this. Above all, however, the manufacture of vaccines is very complex and (time) consuming. The flu vaccine, for example, takes around six months to manufacture. The vaccines, which protect against four, five or six diseases at the same time, take much longer to manufacture, around two to three years, according to Stöcker.
Increasing production volumes is complicated
The system is slowed down if, for example, conspicuous results are shown during production or the associated strict quality controls. In the worst case, this can lead to entire batches of up to several 100,000 vaccine doses having to be discarded. The expert adds that this cannot simply be dealt with quickly and easily. The time expended up to then was lost.
Switching to alternative products only helps for a short time
A further complicating factor is that, due to the complex processes, the production volume cannot simply be multiplied when there is an increased demand. "It is currently the case that the bottlenecks have rocked each other up"says Stocker.
"Initially, a bottleneck in a vaccine could be compensated for by an identical product from another manufacturer, which led to increased demand there. The result: the inventory was sold out faster. Unfortunately, not enough new vaccine could be produced during this time. So there was also a bottleneck in the alternative product."
Many pharmaceutical companies shy away from the complicated business with vaccines
Another cause of the vaccine dilemma is that, despite the continuously growing world population, only a few manufacturers produce vaccines: Essentially, four large corporations in Europe and North America share over 95 percent of the global market: These include GlaxoSmithKline (GSK), Sanofi , Pfizer and Merck.
As another large company, Novartis had given up most of this line of business in 2015. It is rather unlikely that further large pharmaceutical manufacturers will be added in the near future. Because the demands on safety and tolerability – after all, the handling of extremely sensitive microorganisms – are significantly higher and therefore more costly than with other pharmaceuticals.
"As complex as the production of a space shuttle"
"Making a conventional drug is as difficult as building a car"a GSK manager recently told the Ärztezeitung. "The production of a biological (note: a new class of drugs. They intervene in the immunological processes in the body by mainly blocking inflammatory processes) is similar in difficulty to the production of an A 380. The production of a combination vaccine is as complex as that Construction of a space shuttle."
For patients and doctors, the recurring vaccine shortages mean that waiting times have to be accepted. The supply is not only difficult with the classic child vaccinations. "Vaccines from all categories are affected, i.e. both standard vaccines for basic immunization as well as for booster, but also travel and indication vaccines. In some cases, however, only individual pack sizes are not available – this can change constantly", knows Stocker.
Primary immunization has priority
Parents of babies are particularly alarmed by the situation. They fear that their children will not be able to be immunized against dangerous pathogens in the allotted time frame. But the PEI expert reassured her. Fortunately, it has not happened so far that vaccinations had to be canceled completely.
"So there are currently no 5-fold vaccines – even for a long time – (note: against tetanus, diphtheria, polio, HiB and whooping cough). But it is possible to vaccinate the babies with the 6-fold vaccine. This also contains the component against hepatitis B. So far, it has always been possible to avoid a real supply bottleneck – also with the help of the recommendations for action from Stiko." Stöcker emphasizes that the primary immunization of infants and small children is always of particular importance. Refreshments, on the other hand, can often easily be postponed to a later point in time.
There is also no reason to worry, adds the expert, if the substitute vaccines given in the PEI lists were used. These are identical vaccines from another manufacturer, so that the effectiveness, quality and tolerability correspond to one hundred percent of the original product that is currently unavailable.
"Basically, we always advise all parents concerned to first find out more about the delivery bottlenecks on the PEI website and then, if necessary, to discuss Stiko’s recommendations for action with their doctor."
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Berlin (dpa / tmn) – There is still no vaccination against the new Sars-CoV-2 coronavirus. However, experts advise older and chronically ill people in particular to get vaccinated or to check their vaccination status – against whooping cough, pneumococci and also against the regular flu.
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The reason: These vaccinations do not protect against Covid-19, but against other lung infections. If someone was already suffering from the lungs, infection with Sars-CoV-2 would be particularly dangerous and the treatment of the disease Covid-19 would be difficult, according to the statement of the Berlin health administration, which has issued a corresponding recommendation.
"Vaccinations that protect against lung infections are particularly important during this time", said Prof. Lothar Wieler, President of the Robert Koch Institute (RKI) on Thursday (February 27) in Berlin.
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These vaccinations are recommended
The Standing Vaccination Commission (Stiko) recommends vaccination against whooping cough or pertussis for all babies and young children. The vaccination should then be refreshed once in preschool and adolescence. Adults should then be vaccinated again against whooping cough as part of the tetanus diptheria vaccination, which is due every ten years.
The vaccination against pneumococci is generally recommended for all children in the first two years of life and for all people over 60. For older people, the vaccination protection must be refreshed every six years.
A flu vaccination, recommended by Stiko for all people aged 60 and over and all chronically ill people, even has to be repeated every year. November is considered the ideal time – it takes about 14 days for the vaccination to fully develop its protective effect. If you haven’t had a vaccination this winter, you can and should get it now anyway.
The reporting from t-online.de alarmed the CDU Berlin: The recently accepted lawyer Markus Roscher-Meinel is said to be kicked out of the party again due to connections to the right-wing scene. What was known about him there?
The CDU Berlin wants to revoke the admission of the lawyer Markus Roscher-Meinel, who was previously rejected by the AfD. State chairman Kai Wegner said that the party had no place for his views. The district board announced that he felt himself "deceived and abused". Roscher-Meinel himself deleted a tweet that said a board member had known him for a long time.
The inclusion of Roscher-Meinel, which t-online.de first reported, triggered incomprehension and outrage inside and outside the CDU. For many, the CDU has a similar construction site to the case of Robert Möritz, an ex-member in Saxony-Anhalt with a suspected neo-Nazi past. Möritz announced his resignation on Friday, saving the CDU further discussions. Roscher-Meinel is now also an occasion at the CDU to examine the admission procedure. It should be looked more closely.
No fear of contact with the identities
The lawyer Roscher-Meinel, who was aiming for a Bundestag candidacy with the CDU in 2002, had been committed to the AfD since 2013. The AfD federal board had finally decided in August not to accept him. Roscher-Meinel had no reservations about appearing in joint videos with the identity Martin Sellner and the hater of Islam, Michael Stürzenberger, who was convicted of sedition. It also belonged to that "Hercules circle" with Björn Höcke. In November he had the CDU on Twitter as "Anti-Germany party" designated. In November he also submitted his membership application.
A few days ago, he became a member of the CDU’s local branch in Bernauer Strasse and, according to one participant, was praised for how active he was at the Christmas party.
District executive wants to try to revoke the admission
The district executive is now at a distance: "People who represent views like the Lord are not wanted as members of the CDU Mitte"According to a message. Before that, the CDU state chairman in Berlin, Kai Wegner, had apparently also intervened. The district executive reacted in close coordination with him, said Wegner.