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Controversy over vaccine side effects
Pfizer vaccine allergic to two vaccines in the UK
Guanwasa symptoms also appear in clinical trials in the US.
Astrado raises the question of efficacy in clinical trials
Government “no security problem”
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Concerns about the safety concerns of the new vaccine against coronavirus infection (Corona 19) are increasing. With some side effects occurring in the UK, where vaccination was started, there is a situation where there is a debate about the introduction of the vaccine in Korea.
According to foreign media such as Reuters, on the 10th (local time), the UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) announced that it would ban the Pfizer-Bioentech vaccination of people with a history of serious allergic reactions to drugs or food. .
In the UK, where vaccination has already started, two allergic reactions have been reported since Pfizer-Bioentech’s COVID-19 vaccine was first launched in the world. Anaphylaxis is a severe allergic reaction to foreign substances such as foods, medications, and vaccines, and is one of the typical side effects of vaccines. Antigen-antibody immune reactions are the cause, causing symptoms such as coughing, shortness of breath, loss of consciousness and rash. In particular, emergency situations such as a drop in blood pressure, shortness of breath and loss of consciousness can occur. Anaphylaxis shock can lead to death in severe cases, so you must rush to the ER and receive epinephrine injections. For this reason, MHRA Commissioner Jun Ray emphasized that “people with a history of anaphylaxis in vaccines, drugs and food should not receive the Pfizer-Bioentech vaccine.”
After the UK, a case of Guanwasa (facial nerve palsy) was reported in the Pfizer vaccine clinical trial on 9 (local time) in the US According to the US Food and Drug Administration. (FDA), as a result of a clinical trial of a COVID-19 vaccine conducted in the United States, 4 of 21,720 people who took the drug showed symptoms of facial paralysis. US health officials said: “The clinical results are lower than the usual prevalence of facial paralysis.” However, in the case of taking a fake drug during clinical trials, there are no participants showing symptoms of facial paralysis, which raises concern.
There are also concerns about the domestically produced AstraZeneca vaccine. Currently, unlike Pfizer and Modena, AstraZeneca has not completed the Phase III examination in the United States and it is anticipated that it will be difficult to obtain federal approval in the United States this year. Furthermore, on the 23rd of last month, controversy was generated by announcing the interim results of a phase 3 clinical trial that showed that the group that received a lower dose of vaccine had a greater preventive effect.
Despite this situation, the quarantine authorities maintained the position that the introduction would not be delayed in Korea regardless of US approval. On that day, the Ministry of Food and Drug Safety said: “When an application is received for the approval of a product, we will fully review the safety and efficacy and decide whether to approve it independently.” said. Currently, AstraZeneca has only submitted non-clinical trial data for Corona 19 vaccine to the Korea Food and Drug Administration. Yoon Tae-ho, Head of Accident Control Headquarters, said: “If there are no serious side effects, we will thoroughly analyze and approve the benefits.”
/ Reporter Woo Young-tak and Maeng Jun-ho [email protected]
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