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The news of the death of 6 people during the trials of the “Pfizer” vaccine shocked public opinion, especially after the announcement of the start of the vaccination campaign in Great Britain, and this news grabbed the headlines of newspapers and websites. news under “Victory Day”.
Yesterday what was a point of light and hope suddenly turned into fear, anxiety and doubt. What is the relationship of the vaccine to these deaths? Do we submit to it or reject it? Is the cause of death a placebo treatment or a vaccine? Many questions are asked in a world of fast-paced events and dark scenes.
Diving into the world of epidemics and viruses is a difficult and exhausting task, scientific details and data that can make metrics fluctuate, what do we need to know and were the deaths due to the vaccine or other reasons? Information conflict and headlines shocking forces to stop and confirm what is happening and inquire about these events that are expected in such studies and large experiments.
In the early hours of the morning, the US Food and Drug Administration announced the death of 6 people during trials of the “Pfizer” vaccine for the Corona virus, hours after the launch of the vaccination campaign in Great Britain.
In details, according to the report, four of the six deceased received a fake drug and two were vaccinated with the real drug, according to The New Daily.
Before registering the deaths, the Food and Drug Administration of the United States, FDA, confirmed yesterday the effectiveness of the vaccine “Pfizer-Biontech”. The 53-page report states that the drug showed an adequate level of safety and there are no obstacles to its use in emergency situations.
The FDA confirmed that the vaccine is 95% effective, as reported by “Pfizer – Biontech”, at least 7 days after receiving the second dose.
However, there was not enough data before the Food and Drug Administration to evaluate the effectiveness of the vaccine in children under 16, pregnant women, and people with immune diseases.
Professor Salim Adeeb, professor of epidemiology and community medicine at the American University of Beirut, explains to Al-Nahar that “the company conducted a test on some 30,000 volunteers of all ages and, during the follow-up period, deaths and deaths were recorded. it is considered to be expected in such experiments. Consequently, the death of 6 people during the tests is an expected matter in epidemiology, especially since 4 of them received a placebo treatment and the vaccine had nothing to do with their deaths, while two deaths were recorded for two people who received the vaccine.
As we already know, Johnson & Johnson suspended clinical trials of a coronavirus vaccine to infect a participant with an “unexplained disease”, and resumed after ensuring that the stroke a volunteer was exposed to was not related to the vaccine.
In the search for conditions for the continuation or suspension of these clinical studies, the basic rule is the appearance of symptoms or something serious undesirable, considering that these issues are expected in any clinical study, especially in large studies.
The “Pfizer” vaccine has come a long way, but is pending official licensing approval, because, according to Adeeb, “and as a result of past experience with one of the vaccines that were put on the market in 2000, specifically rotavirus, before it was withdrawn from the market as a consequence of severe symptoms that appeared in 3 children. “
As a result of this incident or experience, a fourth phase was included in the vaccines and their experiments, and it was called the post-marketing surveillance phase, which means that post-marketing surveillance requires pharmaceutical companies to monitor and control people after receive the vaccine after it is marketed to make sure no side effects occur or are recorded. And in the event that any of these symptoms appear, the Food and Drug Administration requests that the vaccine be withdrawn from the market immediately.
Adeeb emphasizes that “in the event that a death was recorded as a result of the vaccine after it was placed on the market, it would be withdrawn immediately and the reasons responsible for it would be discussed. It is not allowed for a person to die from the vaccine, this is not allowed. Each death or illness must be studied to determine the cause and whether the death was actually due to the vaccine or other health problems. The same happened with the two cases of death that were recorded in the experiments, it was ensured that the vaccine was not related to death, otherwise, the company would not have been able to apply for a license from the Food and Drug Administration.
In the opinion of the professor of epidemiology and community medicine at the American University of Beirut, “this phase that was added after the year 2000 is considered necessary and important, because the vaccine becomes available to thousands of people and thus the side effect can appear as a consequence of the large number of people receiving the vaccine, while the number is limited. With 30,000 volunteers in the third phase of clinical trials before obtaining the license. Consequently, symptoms or side effects may appear after millions of people receive the vaccine, which requires an evaluation and study to investigate the need to withdraw it, as happened with the rotavirus vaccine, which was withdrawn from the market after reporting 3 severe symptoms reported in 3 children. It took 4 years to work with it before it could be marketed again.
Post-market surveillance is expected, and this is what Pfizer will do today. And that any cover-up of the cases would cost the company millions as a result of the lawsuits filed against it and would demand huge compensation for this damage.
The next few months will be enough to provide us after monitoring the data and the status of the people who underwent the vaccine and knowing the occurrence of any symptoms or side effects. This explains why the Chinese and Russian vaccines were not accepted because they did not share the results of the experiments, the risk ratio and the data of the volunteers with anyone, and they were content to only announce their effectiveness without publishing any other details. And today’s vaccination campaign in Russia is part of the third phase of clinical trials testing the vaccine in its own population.
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