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Vaccinations against the coronavirus can now also start in the European Union. The EU Commission granted the preparation of Mainz-based company Biontech and its US partner Pfizer conditional marketing approval, as EU Commission President Ursula von der Leyen said in the evening. “Today we are adding an important chapter to the fight against Covid-19.”
It is the first coronavirus vaccine that can be used in the EU. In the afternoon, the European Medicines Agency EMA recommended a conditional marketing authorization. The EU Commission has now followed this recommendation. The EMA wants to make a decision on the preparation of Moderna before January 6. In addition to the 300 million cans from Biontech, the EU has also obtained 160 million cans from this company.
Spahn: vaccinations should start on Sunday
Germany will receive the first delivery from the agent Biontech on Saturday. That day, 151,125 doses of vaccines would be delivered, the Berlin Senate Health Department announced Monday evening. Federal Health Minister Jens Spahn (CDU) briefed the state health ministers conference on this.
On December 28, 521,625 cans will be delivered and on December 30, 672,750. In the first calendar week of 2021, 672,750 more doses of vaccines will follow. Spahn confirmed that vaccinations should start next Sunday.
So many cans are planned for Germany so far
In the first quarter of next year, Health Minister Jens Spahn (CDU) expects between eleven and 13 million doses of vaccines. Since the preparation has to be administered twice, this amount would be sufficient for approximately 5.5 to 6.5 million people. In total, the federal government has insured more than 300 million cans, from Biontech and other manufacturers, through national and key agreements across the EU.
This logistics is planned for the distribution of vaccines.
The vaccine is manufactured in places in Germany like Mainz, Idar-Oberstein, and Marburg. In Puurs, Belgium, it is finally processed, bottled and labeled. The company said it would take a week to make the vaccine. Quality control and approval took another three weeks. Then it must be taken to a central delivery point in Germany.
From there it goes to the distribution centers in the federal states – a total of 27 locations are planned depending on the proportion of the population. From that moment on, the states are responsible for storage and distribution, as well as for the acquisition of vaccination accessories such as solvents, syringes and needles.
The vaccine must be stored at minus 70 degrees, which is why vaccination is not possible in the practice of all physicians and it was necessary to establish regional vaccination centers. The preparation can be transported at these temperatures for up to 15 days in specially developed shipping boxes. It can be stored in the refrigerator for up to five days.
Tests assume 95 percent protective effect
The same applies to the Biontech and Pfizer mRNA vaccine as it does to other vaccines: after vaccination, there may be temporary side effects such as headache, fatigue, or soreness at the vaccination site. Vaccination experts say: It is not pleasant, but it is not of great concern either.
Probably two to three weeks after vaccination, full protection should be given. Based on previous analysis and testing, Biontech serum protects against Covid 19 disease with a 95 percent effectiveness.
According to PEI president Cichutek, you can still get infected after a vaccine, but the risk is significantly reduced. This also applies to the transmission of viruses. The investigation has yet to reach a final conclusion. Experts assume that there could still be mild corona symptoms, but no more serious disease courses.
How safe is the vaccine?
The vaccine was studied from late July to mid-November in a study involving a total of 44,820 men and women. About half of the subjects received the vaccine twice, and the other half an ineffective placebo. The participants were at least 16 years old, almost half were over 55 years old. In general, the side effects were mild to moderate and resolved in a short time. 66 to 83 percent of subjects reported pain at the injection site.
There were differences according to the age group and between the first and second doses. Five to seven percent showed redness or swelling at the puncture site. Participants also complained of fatigue (34 to 59 percent) and headache (25 to 52 percent), chills (6 to 35 percent), diarrhea (8 to 12 percent), muscle pain (14 to 37 percent) and pain in the extremities (9 to 22 percent).
The participants (eleven percent of the elderly and 16 percent of the young) developed a fever, particularly with the second dose of vaccine. These side effects are common with vaccines, as Stefan Kaufmann, director emeritus of the Max Planck Institute for Infection Biology, says: “You can’t do without them.” The tests also showed that people 55 and older found the vaccine more tolerable and complained of fewer side effects than younger people.
The tolerability of the vaccine will continue to be tested after approval. For this, the responsible Paul Ehrlich Institute relies on reports from manufacturers, doctors, but also from patients. The easiest way is through the platform “Nebenhaben.bund.de”. There will also be an observational study through a reporting application. Those who participate will be “contacted several times and asked for information on possible reactions,” said a PEI spokeswoman.
What does an allergy mean for coronavirus vaccination?
More than 100,000 people in the UK have already received the Biontech / Pfizer vaccine. Two of them, both employees of the British health service, had severe allergic reactions after vaccination, but probably survived unharmed. The authorities then advised people who had shown “significant” allergic reactions in the past not to get vaccinated for now.
The two people in the UK had a history of severe life-threatening allergies and always carried an emergency kit with them. These people are at high risk with every drug and every vaccine, and therefore were not included in the registry study.
Part of the shell of the vaccine can trigger an allergy.
The trigger for allergic reactions is probably part of the shell of Moderna and Pfizer / Biontech’s mRNA vaccines, namely the so-called “polyethylene glycols (PEGs),” says Olivia Merkel from the Department of Pharmaceutical Technology at Ludwig Maximilians University in Munich. . The body can form antibodies against these.
According to Merkel, it is conceivable that the immune response to PEG causes allergic reactions after the second dose of vaccination. That could be expressed in an eruption, for example. However, such allergic reactions occur immediately or a few hours after administration in highly sensitive patients who also react to PEG in cosmetics or food. Long-term consequences of PEG are not expected.
What does cancer mean for vaccination?
With the approval of the first coronavirus vaccine, vaccinations can begin. However, because the quantities of vaccine available are limited, vaccination must first be offered to risk groups and medical personnel. The Coronavirus Vaccination Ordinance names three groups whose family members can be vaccinated with priority.
Cancer patients belong to the group with the third highest priority (unless they fall into group 1 or 2 for other reasons), as do those over 60 years of age or those most at risk of a serious course of the disease , for example, due to a chronic illness. This group also includes general practice and laboratory personnel.
“The risk of a severe course of Covid-19 must be considered highly differentiated in cancer patients. Factors such as the type of cancer, the disease situation, the required treatment and concomitant diseases, as well as other risks such as age or smoking, play an important role. Therefore, a general classification is not possible We recommend that those affected request an evaluation from their treating physicians. In the case of strong immune suppression, for example, by high-dose chemotherapy, it is possible it may not be possible to vaccinate a cancer patient. So it may make sense to reduce the risk of infection by letting close relatives or. generally vaccinate people who live in the same household. ” Susanne Weg-Remers, Head of Cancer Information Service at the German Cancer Research Center
The efficacy of coronavirus vaccines, especially for cancer patients, cannot be answered with certainty at this time. The same applies to the tolerance of the vaccine in conjunction with certain cancer therapies such as chemotherapy or targeted drugs.
People whose immune systems are suppressed by cancer or cancer therapy were not represented as test subjects in the previous approval study. Therefore, there are no reliable data on the efficacy and safety of the vaccine for these groups of patients. More studies are required for this. The principle of action of mRNA vaccines is also harmless for cancer patients. Vaccines against tumors have also been developed for a long time, among others by the company Biontech, which are based on a similar strategy.
How do you get vaccinated?
There will be no mandatory vaccination. The federal states regulate the allocation of appointments. In Baden-Württemberg, for example, it is planned that, in addition to an app, registration can be done by phone using the national uniform number 116117 or directly at larger vaccination centers. Lower Saxony, on the other hand, has its own direct line. Some countries also write directly to their citizens.
According to the federal immunization ordinance, people over the age of 80 and residents of nursing homes should be able to participate initially, as well as staff in emergency rooms or crown rooms and care for the elderly. Overall, this group of the Standing Commission on Vaccination (Stiko) of the Robert Koch Institute (RKI) comprises around 8.6 million people.
Those who do not urgently need to be vaccinated generally include people under the age of 60 who have no prior illnesses, come into contact with high-risk patients, or meet many people for work. That corresponds to about 45 million people.
The number of people who can be vaccinated initially at the centers depends on the federal state. Bavaria and Hesse target up to 30,000 vaccinations per day at the centers. Health Minister Spahn expects enough vaccine for mass vaccinations next summer. The federal government bears the costs of the vaccines. That means they are free, regardless of whether and how someone is insured.
Does the vaccine work worse with a new variant of the virus?
Experts believe that this will probably not be the case. “At this time, there is no evidence to suggest that the vaccine will not work against the new variant,” said EMA Director Emer Cooke.
But more information should be gathered about the new variant of the virus. Berlin virologist Christian Drosten says of the mutation: “I’m not that worried about it at the moment,” but he’s also “in a somewhat confusing information situation.”
