Possible Future Adverse Effects Are Not the Same as Confirmed Side Effects

 

A video on Facebook spreads disinformation about the effects of Covid-19 vaccines. The video went viral in a very short time, and at the time of our review, it had 2,900 reactions, 68 comments and 5,100 shares.

In the video, from 30 October,  journalist Boban Nonkovikj introduces to the public, as he puts it “A study by the Center for Biological Evaluation and Research at the US Food and Drug Administration (FDA), called the Covid-19 Vaccine Monitoring Plan, their safety and effectiveness, signed by Steven Anderson, Head of the Office of Biostatistics and Epidemiology at the US Food and Drug Administration”.

The main problem, i.e. the main disinformation in this video are the many (more precisely 22) enumerated side effects that give the impression that they have already happened, i.e. that they were “determined by the FDA”, and, in fact, it is a plan of side effects that will be subject to future observation, during the vaccination process. That is why they are said to be possible side effects, and it is added that the list may change in the future depending on the situation. If it was something that has already been determined to have happened, i.e. if the listed side effects are a reality, then they could not be changed. But let us start from the beginning.

According to the author of the video, it is a “report on the occurrence of side effects from the vaccines that have already started to be given for Covid-19 in Great Britain, by AstraZeneca and Pfizer and BioNTech, those that should be kept at minus 70 degrees”. This is partly incorrect, as only the Pfizer and BioNTech vaccine is approved in the UK, not the AstraZeneca vaccine. Moderna and AstraZeneca have sought emergency regulatory approval in the United States and the European Union. It is also a lie that these vaccines should be stored at minus 70 degrees Celsius, as this only applies to the Pfizer and BioNTech vaccine.

Beware how many side effects were determined by a US authorized state agency. I will share them with you, so that we all know what we are facing. If we need to walk around shopping malls, work in private companies, travel outside the borders of our countries, we will have to be vaccinated. Not because I want to, but because I will be forced to and a COVID-19  vaccination card will be required which will show that I have been vaccinated and revaccinated, 21 days after the first one, Nonkovikj points out in the video.

This is also disinformation because the health authorities in the country emphasized that the vaccine will not be mandatory, but will be received on a voluntary basis. And, no one said there would be a “COVID-19 vaccination card “. Namely, the WHO does not recommend passports for immunity or testing for travel. The WHO is considering introducing electronic vaccination certificates, such as those being developed in cooperation with Estonia.

Estonia and the UN agency launched a pilot project in October to develop a digital vaccination certificate or “smart yellow card” as part of the COVAX initiative, which aims to promote coronavirus vaccination in developing countries.

We are intensively considering how to use the technology in response to the pandemic and one way is e-vaccination confirmation, said Dr Siddhartha Datta, Programme Manager at WHO for Vaccine-preventable Diseases and Immunization.

Another Senior WHO Official, Catherine Smallwood, said the agency was opposed to the passports as a means of normalizing traveling abroad.

We do not recommend an “immunity passport” or testing as a means of preventing cross-border transmission of coronavirus, Smallwood said, urging states to base travel recommendations on Covid-19 transmission data.

Later on, in his video, Nonkovikj dwells on 20 side effects of vaccines “determined by the FDA”.

Guillain-Barré syndrome, this is classical paralysis, encephalomyelitis, then there is inflammation of the spine, seizures, heart attack, narcolepsy and catalepsy, anaphylaxis, acute myocardial infarction, myocarditis or pericarditis, autoimmune disease, death. Impact on pregnancy and childbirth on acute diseases: non-anaphylactic allergic reactions, thrombocytopenia, means intravascular coagulation, blood clots, venous thromboembolism, arthritis or arthralgia, Kawasaki disease, multisystem inflammatory syndrome in children and various other diseases caused by this vaccine, or these vaccines because this is a general conclusion of the FDA regarding all previously tested and now available vaccines for Covid-19.

False again. The document presented by Nonkovikj, as he himself said at the beginning, is an official CBER Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness. This, in fact, means that the document is not a report or a conclusion on an already implemented plan.

If one reads the whole document, you will see that it lists all the methods, practices and ways in which the CBER (Center for Biologics Evaluation and Research) will conduct its vaccine safety check.

The list that Nonkovikj shares with “confirmed side effects” is, in fact, a draft list of potential adverse events that will be followed in the process of vaccine monitoring and evaluation. Adverse effects and side effects are different things. Adverse effects are events that vaccine recipients report occurring after receiving a vaccine, for which it is not confirmed that the cause is the vaccine itself, and side effects are confirmed as side effects from vaccination. So, it is not said here that these phenomena occurred during the testing of the vaccine, but only that the authorities will pay attention to their possible occurrence during the vaccination. If it was about phenomena that have already happened, then surely there would be percentage numbers, i.e. what percentage of the respondents had such phenomena. There is no such thing, as can be seen from the document.

Finally, the document does not mention any vaccine manufacturers, precisely because it is not intended to evaluate them, but only to state the process that all those who wish to obtain FDA approval will have to go through.

Given all this, it can be concluded that the views presented in the video are nothing but one big disinformation. Such false claims in the context of a coronavirus pandemic can cause serious damage to general public health and especially to the vaccination process, which is the only world hope for a return to normal life.

 

 

 

 

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