The news of the death of 6 people during the “Pfizer” vaccine trials shocked the public opinion, especially after the announcement of the start of the vaccination campaign in Britain, and this news grabbed the headlines of newspapers and news sites 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 have to submit to it or reject it? Is the cause of death a placebo treatment or a vaccine? Many questions we ask in a world of accelerated events and dark scenes.
Dive into the world of epidemics and viruses is a difficult and exhausting task, scientific details and data that may fluctuate the metrics, what do we need to know, and were the deaths due to the vaccine or other reasons? Conflict of information 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 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 US Food and Drug Administration, FDA, confirmed yesterday the effectiveness of the “Pfizer-Bionic” vaccine. 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 about 30,000 volunteers of all ages, and during the follow-up period, deaths were recorded and they are 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 and the vaccine had nothing to do with their deaths, while two deaths were recorded for two 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 it again after making sure that the stroke that a volunteer was exposed to was not related to the vaccine.
In the search for conditions for continuation or suspension of these clinical studies, the basic rule is the emergence of symptoms or a serious undesirable thing, bearing in mind that these matters are expected in any clinical study, especially in large studies.
The “Pfizer” vaccine has come a long way, but is awaiting official approval for the license, 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 the rotavirus, before it was withdrawn from the market as a result of the appearance of serious symptoms on 3 children.”
As a result of this incident or experience, a fourth stage was included in vaccines and their experiments, and it was called post marketing surveillance, meaning post-marketing surveillance requires pharmaceutical companies to follow up and monitor people after they receive the vaccine after it is put on the market to ensure that no side effects appear or are recorded. In the event that any of these symptoms appear, the Food and Drug Administration requires the vaccine to be withdrawn from the market immediately.
Adeeb stresses that “in the event that one death was recorded as a result of the vaccine after it was put on the market, it would be withdrawn immediately and the reasons responsible for that would be discussed. It is not permissible for a person to die from the vaccine, this is not permitted. Every death or disease must be studied to ascertain the cause and whether the death was actually due to the vaccine or other health problems. The same happened with the two death cases that were recorded in the experiments. It was ensured that the vaccine was not related to death. Otherwise, the company would not have been allowed 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 may appear as a result of the large number of people who receive the vaccine, while the number is limited. With 30,000 volunteers in the third phase of clinical trials before obtaining a license. Therefore, symptoms or side effects may appear after millions of people receive the vaccine, which imposes an evaluation and study to research the need to withdraw it, as happened in the rotavirus vaccine, which was withdrawn from the market after reporting 3 serious symptoms recorded in 3 children. It took 4 years to work with it before it could be put back on the market.
Post-marketing surveillance is to be 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 demand huge compensation for this damage.
The coming months will be sufficient to provide us after monitoring the data and the condition of people who underwent the vaccine and knowing the occurrence of any symptom or side effect. This explains why the Chinese and Russian vaccines were not accepted because they did not share with anyone the results of the experiments, the risk ratio, and the volunteers ’data, and were satisfied with announcing their effectiveness without publishing any other details. And the vaccination campaign today in Russia is part of the third phase of clinical trials that test the vaccine on its own population.
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