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Vaccination against COVID-19 has started in Poland. The vaccine produced by Pfizer and BioNTech was the first to be accepted by the head nurse of the hospital of the Central Clinical Hospital of the Ministry of Interior and Administration in Warsaw, Alicja Jakubowska. The public is concerned about information about possible side effects of vaccination, such as severe allergic reactions. Experts say that you should always reckon with such reactions. This does not mean, however, that the preparation is underdeveloped. The public opinion is also reassured by Polish virologists, immunologists and infectious diseases.
- The COVID-19 vaccine was created quickly as scientists took advantage of off-the-shelf technology being developed for other coronaviruses
- Possible side effects were checked, documented and verified at all stages of the tests
- Prof. Anna Piekarska, head of the Department of Infectious Diseases and Hepatology, Medical University of Lodz: this vaccine may be one of the safest that has been offered in the history of medicine
- More current information can be found on the Onet homepage.
What do we know about the safety of the COVID-19 vaccine?
The US and European regulatory authorities that oversee the marketing of vaccines and drugs ensure thatall vaccines are as safe as possible. The American FDA and the European Medicines Agency (EMA) cooperate with manufacturers during the process of developing and then authorizing the vaccine. This cooperation covers several key areas:
Thorough tests. All vaccines undergo clinical trials to verify their safety and effectiveness. In the case of the COVID-19 vaccine, the FDA has set rigorous standards that tested preparations must meet.
Authorization for use. Vaccines that meet safety and efficacy standards can be administered in the United States and the European Union.
– If the tests are successful and nothing happened along the way, the vaccine is registered – told us a few months ago, Dr. n. med. Tomasz Dzieciatkowski. – The organization responsible for authorizing medicinal products, i.e. in the case of the EU, the European Medicines Agency (EMA), collects the results from all centers and summarizes (what is the immune response, what dose, what side effects may occur, what percentage people, etc.). After the registration is completed, the preparation is admitted to the market.
Continuous monitoring of problems and side effects. After the vaccine is approved for use, its performance is still monitored to detect problems or side effects that were not experienced during clinical trials. However, usually any imperfections are caught early in the formulation testing, when it can be improved without harming anyone.
– Then the research of the fourth phase begins – explains Dr. Dzieścitkowski. – This phase of research takes place during the normal use of the vaccine and affects tens or even hundreds of thousands of people. The fourth phase continues until the vaccine is replaced by another, more effective one. It can therefore be said that vaccines are tested from design until they are replaced by a different, more effective formulation.
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What are the side effects of the vaccine?
During the research on vaccines by Pfizer and Moderna, fully independent councils monitoring their safety were in place, and the incoming vaccination data is verified.
Before the vaccine is sent to regulatory authorities that authorize its use, the vaccine goes through several stages of testing – from the exploratory stage, through the preclinical stage (animal testing), to the clinical stage (which includes three stages). The vaccine is tested for toxicity in animal studies. How the body responds to it is checked to determine a safe dose before testing the vaccine in humans.
In human studies, scientists look for “adverse events”, in other words, undesirable side effects. These are not to be confused with the mild, temporary effects of having the vaccine.
– Post-vaccination adverse reactions are a whole series of body reactions, ranging from pain or redness at the injection site, through headache, and at an increased body temperature for a day or two – explains Dr. n. med. Maciej Przybylski, virologist. – However, these symptoms disappear quickly.
Dr. Thomas Clark of the CDC released a report saying that by December 19, following vaccination in the US, there were six cases of anaphylaxis out of 272 people vaccinated. Britain has reported two similar cases.
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– Apart from a few people with anaphylaxis, there are no reports of serious side effects – emphasized the immunologist Dr. Paweł Grzesiowski. – This is the best evidence for safe immunization.
– This vaccine may be one of the safest that has been offered in the history of medicine – said the head of the Department of Infectious Diseases and Hepatology at the Medical University of Lodz, Prof. Anna Piekarska. – There are no additives in it and thanks to this technology it does not contain everything that caused vaccine reactions in other vaccines. We should use it, she added.
The CDC recommends vaccinations for people who are allergic to certain foods, insect bites, latex, and other common allergens. However, those who have had a severe allergic reaction (anaphylaxis) in the past should discuss the risks with their doctors. According to the CDC, anyone who is severely allergic to any of the ingredients in the Pfizer / BioNTech vaccine should not get it.
Due to the pace of work, could the vaccine have disadvantages?
In the past, it took many years to develop a vaccine. However, the relatively rapid development of the coronavirus vaccine does not mean that some safety measures have been deliberately overlooked. There are several reasons why COVID-19 vaccines were developed faster than others.
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Vaccines that contain viral messenger RNA, such as vaccines from Pfizer, have been in development over the years. Initially, work on them involved other infectious viruses, but thanks to this a workflow for the production process was ready in the early stages of the pandemic.
– The vaccine is the result of 30 years of work of many scientists, and its safety had to be tested at the stage of long-term and meticulous clinical trials – says Dr. Maciej Przybylski. – Vaccination gives us immunity, bypassing, and in a very effective way, all the disadvantages associated with infection with the virus itself.
China read and released the coronavirus genetic code back in January, giving vaccine makers the opportunity to start work immediately. Pfizer has allocated huge funds for equipment – including $ 200 million for special machines that enclose the mRNA in a lipid envelope. The company tested many ideas at the same time in case one didn’t work out. And she cut the vaccine production process by several months by putting mRNA in disposable bags instead of steel containers.
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Governments gave money to vaccine makers upfront so that companies would also have their own resources. And thanks to social media, volunteers were quickly recruited for research. As many people wanted to help, we managed to test the COVID-19 vaccine on a higher-than-average sample. In the case of Pfizer, it was over 43 thousand. people, while the average for the third stage of the research is 30 thousand.
The coronavirus is highly contagious and spreads rapidly, so many volunteers who received the vaccine have come into contact with it. And thanks to multiple exposures, testing of vaccine effectiveness could have been shorter.
In addition, production started before obtaining the authorization for use, so immediately after authorization, the preparation was distributed.
– The vaccine is generally safe – said the Prime Minister’s COVID-19 advisor, Prof. Andrzej Horban. – Cases of complications can happen, but they will be isolated and possibly not related to vaccination at all.
– In every vaccine, in every solution there are some preservatives, which are chemicals, extremely rarely they can cause something called anaphylactic shock – added Prof. Horban. – Such cases are recorded. (…) This is routine. Therefore, at every vaccination point there is a team that knows how to respond and there are drugs that can be administered responsibly. The professor also emphasized that in the pre-vaccination interview, we should inform about any complaints, including allergic diseases. And after the vaccine is given, you should be in the sight of specialists for some time.
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