The vaccination against SARS CoV2 is not the solution to all the problems of the Corona pandemic, but it will bring us a good deal closer to normality. It is now up to the attitude of each individual whether the vaccination campaign leads to a rapid and sustainable success.
Is the rapid approval of the vaccine a problem?
After at the beginning of the pandemic almost 80% of German citizens stated that they would get vaccinated if a vaccine was available, the willingness to get vaccinated has paradoxically decreased with the availability of an effective vaccine. The main argument you hear as a justification for this is safety concerns – it just can’t be right that if vaccine development under normal conditions takes years, a market-ready Corona vaccine is now available after just one year.
The answer to these concerns is quite clear: everything was done properly! We witnessed what is possible when the global community works together, when everyone has a goal and pulls together – this is something to be proud of, there is certainly no cause for concern.
Vaccine development (without the pressure of a pandemic) takes so long because the different phases of clinical testing are usually worked through one after the other. At the end of the testing phase, a dossier is compiled which is submitted to the regulatory authorities (in Europe this is the European Medicines Agency EMA) for examination. The authority evaluates the dossier within a given timeframe, which can also be extended by queries or additional requests from the authorities. In addition, the pharmaceutical vaccine manufacturer bears the entire financial risk of development – therefore, after each phase, it is carefully assessed whether further development is worthwhile and whether there is a corresponding market that justifies the development costs – this economic component also often leads to a significant extension of the development time.
All these barriers are currently suspended due to the pandemic. First and foremost, money plays a subordinate role – the need for the vaccine exists, the pharmaceutical industry can currently develop without risk. This resulted in the different phases of clinical testing being carried out partly in parallel, which has resulted in a great saving of time. And finally, communication with the authorities was much more dynamic than in normal times – through a so-called “rolling review” process, the data packages were immediately evaluated by the drug agency as soon as they were available. This too has contributed significantly to the acceleration of the approval process.
The statement of the Federal Minister of Health is therefore completely correct that the same high quality criteria applied and apply for the approval of the new vaccine as for any other drug that is to be approved in normal times. We are experiencing a significant acceleration of the entire process due to the maximum cooperation of all institutions involved – as is also necessary due to the situation.
This success story within the dark time of the pandemic should rather encourage us than unsettle us. Perhaps in the future we will be able to bring about a similar dynamic and pragmatism in dealing with other pressing problems – such as climate change.
Fear of genetic engineering?!
Anyone who nowadays goes around with a blanket fear of “genetic engineering” in medicine is simply stupid and backward-looking. Genetically engineered drugs have been a reality in clinical medicine for decades and are an integral part of the treatment of many diseases. Insulin for the treatment of diabetes mellitus is produced using genetic engineering methods, as are Tysabri and Ocrevus for the treatment of MS.
Genetic engineering methods have also found their way into vaccine development many years ago, in this respect the new COVID19 vaccine is no exception. A novelty, however, is vaccination by means of mRNA (messenger RNA) – although one should not overlook the fact that mRNA technology has been intensively researched for decades, albeit more with a view to therapeutic “vaccinations” against certain forms of cancer – this was also the primary focus of companies like Biontech and Curevac, which have now driven the development of mRNA vaccines against COVID19.
The principle of the new vaccine is that the injected mRNA contains the “blueprint” of an essential virus feature (so-called spike protein). The mRNA transmits the information for the production of this feature to our cells, which then produce the virus protein and present it to the immune system. The immune system recognizes this protein as foreign and is stimulated to an immune response. When the body then comes into contact with the real virus, the immune system can immediately react and render the corona virus harmless before it can lead to an infection.
By the way, this principle has no potential to change our genetic material – as some vaccine opponents claim. Anyone who paid attention in biology class knows that mRNA is read from our DNA (which is where our genetic blueprint is stored) and then transported from the cell nucleus into the cell interior to provide the blueprint for proteins. The decoding of this blueprint takes place in the protein factories (the ribosomes) inside the cell and is constantly happening in our body cells to maintain the functional and structural metabolism. The few mRNA molecules that enter a cell from the outside through the vaccination (with the blueprint of the virus molecule) are decoded in the ribosomes in the same way as the body’s own mRNA – with the difference that then not a human (own) protein is produced, but the virus protein (foreign protein).
mRNA is also relatively unstable and is completely broken down after a few hours – so there can be no question of a longer-term change in our cells or even our genetic material. Nevertheless, the short dwell time is sufficient to produce so much virus protein that our immune system can react with an immune response that can protect us from infection with the real corona virus. Ultimately, a brilliant principle that is in no way inferior to traditional vaccines – considering the current data, it may even be superior.
… and the side effects?
Most people who are skeptical about vaccinations point to possible serious side effects of vaccinations. This issue is also at the forefront of vaccination against COVID19 – especially with the reference that given the short duration of the study, one cannot yet estimate what side effects the vaccine has.
The study that led to the approval of the Biontech/Pfizer vaccine has now been published (Polack et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. DOI: 10.1056/NEJMoa2034577), so you can read well what is currently known about the tolerability and safety of the vaccine – and this information is not alarming.
In general, one must expect a vaccination reaction (pain/swelling at the injection site, elevated body temperature, fatigue, etc.) – this was usually mild to moderate and less frequent and milder in older adults than in younger adults. The systemic reaction (fever, fatigue, malaise) was more frequent and severe after the second dose than after the first dose, although the local reaction at the injection site was similar after both doses. Severe general symptoms were observed in about 4% of vaccine recipients – but all these symptoms were, as is usual with vaccination reactions, temporary.
Serious side effects occurred in the vaccine group and the placebo group with 0.6% and 0.5% respectively – in 4 of the approx. 18,000 vaccinated subjects a connection with the vaccine was assumed. These cases were a shoulder injury due to the injection, a swelling of the lymph nodes in the armpit, an intermittent cardiac arrhythmia and a numbness in the right leg. Two vaccine recipients died (one from arteriosclerosis, one from cardiac arrest), but also four placebo recipients (two from unknown causes, one from a cerebral hemorrhage and one from a myocardial infarction). The study doctors saw no connection between the deaths and the administration of the vaccine or the placebo injection.
The subjects whose results have now been published were observed for 2 months after the 2nd vaccination dose – the study is planned for two years in total. Therefore, it is correct that rare side effects can only be assessed with sufficient certainty in the further course. On the other hand, the time is certainly sufficient to assess typical immunological side effects that can be caused by a vaccine. Because typical vaccination complications such as anaphylaxis or an immunological late reaction (such as acute polyneuritis) would have to have occurred within 6 weeks after the vaccination, otherwise a connection with the vaccination is extremely doubtful.
In addition, one should of course also question whether one can really withhold a vaccine because of very rare side effects that are not yet known, which is capable of effectively protecting people from a virus that causes a lethality of up to 30% of those infected in the population group of over 80-year-olds. Also from this point of view, the approval at this point in time is absolutely correct – a sensible benefit-risk ratio (as we would call it as doctors) is given.
