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On Tuesday, the European Medicines Agency announced to Ema that it would decide on the approval of the Covid-19 vaccine from Biotech and Pfizer on December 21. If approved, the first people could be vaccinated in 2020. The decision had previously been made by December 29.
Corona vaccines are considered a crucial tool to roll back the virus or at least to prevent severe courses. The more people who are willing to get vaccinated, the better it will work. However, with approval looming, skepticism among the population in Germany is mounting.
According to a representative survey by the University of Erfurt, the willingness to vaccinate has steadily declined since April. In a special survey on December 8-10, only slightly less than half of those surveyed said they would (more likely) get vaccinated if the opportunity exists. The willingness to vaccinate is, among other things, higher among people who are confident in the safety of the vaccine.
Here are the answers to the most important questions about admission at a glance.
How is the safety of the vaccine checked?
From July 27 to November 14, Biontech and Pfizer provided more than 20,000 subjects ages 16 to 89 with the BNT162b2 mRNA vaccine in a large-scale phase III study. A good 42 percent of the test subjects were over 55 years old. At the same time, about 20,000 comparable people were given an ineffective placebo.
The experts then compared the degree of development of the infection rates and the health of the study participants in both groups. The results were published in the New England Journal of Medicine (Nejm). Consequently, the vaccine prevents around 95 percent of Covid 19 illnesses and is very safe (more on this below).
The UK and US have already issued emergency approvals for the BNT162b2 vaccine. They offer the opportunity to commercialize vaccines in emergency situations before the important phase III studies are completed.
Before a vaccine is approved, it must be clinically tested in three phases. In order for the Paul Ehrlich Institute to approve a possible vaccine for a clinical study in humans, the manufacturer must first submit data that the substance has already been sufficiently tested preclinically, for example, in animal experiments.
Phase I: The vaccine is given to a small group of healthy volunteers. It is observed if the agent reaches the target area on the body and there are no acute side effects.
Phase II: Only if phase I was successful can the phase II vaccine be administered to a larger number of participants who come from the risk group. In the case of Covid-19, they would be the elderly or people with previous illnesses. This phase tests the efficacy of the vaccine to prevent disease and the proper dose.
Phase III: The vaccine can then be tested on a representative group of volunteers: up to 10,000 subjects will be vaccinated. In phase III, the efficacy, safety and dosage of the vaccine is confirmed. Adverse events, such as a particularly severe course of disease due to the administration of the vaccine, can be ruled out.
In Europe, BNT162b2 will likely receive regular approval. This means that the same safety data must be submitted with the same quality as for the approval of other vaccines.
The only difference is that the EMA already began examining the first data in the so-called continuous review process before the study was completed. That should save time. The decision is only made later.
The fact that the approval of corona vaccines is going so quickly is also due to the fact that the phase I to III clinical studies were conducted in part in combination.
What side effects are known?
The most common side effects of BNT162b2 in the large phase III study (see above) were, similar to other vaccines, injection site pain, fatigue, and headache. Symptoms were generally mild or moderate.
3.8 percent of those vaccinated complained of severe exhaustion in the days after vaccination and 2 percent of severe headaches. In all other areas, the frequency of severe symptoms was less than two percent, including severe fever.
What was surprising: Younger people between the ages of 16 and 55 were more often affected by these side effects than subjects over 55.
Serious side effects were extremely rare, around 0.5 percent, and to the same extent in the active ingredient group as in the placebo group. These included sensory disturbances in the legs or cardiac arrhythmias.
The study was designed in such a way that even very rare side effects, occurring once in 10,000 vaccinated people, should have been noticed with an 83 percent chance.
How are the long-term effects controlled?
Subjects should be observed for a total of two years after vaccination. At the time the data was released in early December, half of the study participants had received the second dose of vaccination, with which immunization was initially completed, two months ago.
According to the study, a small subgroup has been under observation for more than three months. By the end of December, most test subjects will have received their second vaccination at least three months ago.
“The thing to know is that serious damage to vaccines often occurs very quickly,” said vaccine expert Florian Krammer of Moint Sinai Hospital in New York City, USA, in a detailed information video. . “So we are not talking about 15 years after vaccination, we are talking about days or months after vaccination.”
MRNA vaccines have been tested in humans since 2013 and are considered to be well tolerated. In relation to corona vaccine studies conducted by the Biontech / Pfizer and Moderna companies alone, around 35,000 people worldwide have received this type of vaccine to date with no known troublesome side effects (read more here).
The safety of drugs such as vaccines is monitored even after approval. Suspected cases of undesirable reactions to vaccination are documented with the health authorities and sent to the Federal Institute for Vaccines and Biomedical Medicines, Paul Ehrlich Institute (PEI). Doctors are required to report suspected cases.
Who can get vaccinated?
Since initially there will not be enough vaccination doses available for everyone, the Standing Commission on Vaccination (Stiko) of the Robert Koch Institute is currently working on recommendations for the procedure. On December 7 he presented a draft.
Consequently, residents of nursing homes and retirees are vaccinated first. In addition, people over 80 years of age receive the vaccine, announced the Federal Ministry of Health.
People in the health professions will also receive preferential treatment for the vaccine. According to Stiko’s list, this includes hospital staff at high risk of exposure, for example people who work in an emergency room.
In addition, healthcare workers who are in close contact with risk groups should be vaccinated first, for example transplant doctors, nursing staff in outpatient care for the elderly, or staff in homes with contact with residents.
In total, Stiko assumes that approximately 8.6 million people will receive the vaccine first. However, by the end of January, only four million cans will be available in Germany. Since two shots are required for immunization, that’s enough for two million people.
Only when the volunteers in the prioritized groups have been vaccinated, the rest of the population has the opportunity to be vaccinated. Currently it can be assumed that there will be no vaccination recommendations for pregnant women and children under 16 years of age.
Does vaccination spell the end of the AHA rules?
It is currently unclear whether the vaccines prevent infections with the Sars-CoV-2 coronavirus or only the severe courses of Covid-19. The latter is essential to reduce the number of seriously ill and deceased people, but carries a risk as long as vaccination has not yet been carried out in all settings.
The problem: If people who have been vaccinated may still be infected, but develop no or barely any symptoms, they can easily pass the virus to the public without their realizing it and then infect groups that continue to face serious illness.
As long as it is not clear if the vaccine protects against infection or if a large proportion of people are vaccinated, the AHA-L rule will continue to be necessary to slow the spread of the virus.
For the moment, it will also apply to vaccinated people: keep your distance, observe hygiene, wear a mask for daily use and ventilate.
