29 June 2021 – 12:28
FDA announces Sinovac vaccine Only one injection site was found as 110 bottles of white gel lumps caused by storage. Lean quality is still normal, harmless and has not been injected to the public.
Dr. Surachoke Tangwiwat, Deputy Secretary-General of the FDA clarified that the problem with the vaccine Sinovac vaccine, production version C202105079, found a problem with a clear gel shake. Only a single injection site was found in 110 vials, and emphasized that in the problem areas “I didn’t inject it to the people” because it was detected first. Therefore, all 110 bottles have been returned.
Deputy Secretary-General of the FDA revealed that the problem This is not due to the quality of the vaccine. Because checking in the same production model in every other injection point, found that the quality is still normal. At other points no problem.
After analyzing it, the FDA’s deputy secretary-general said it had inspected companies that transport vaccines to hospital storage. It controls the temperature at 2-8 degrees Celsius, which is the temperature of a normal refrigerator. But the problem was caused by transportation from the hospital. to the injection point outside the hospital and when it arrived injection point outside the hospital Ice is used to cool vaccines, but ice is “cold” than the ideal temperature to store vaccines. make the temperature inappropriate
So the problem with these 110 bottles of vaccine is that it’s too cold to store vaccines. Because keeping vaccines from dead germs contains aluminum. harmless but it is not appropriate to inject
Deputy Secretary-General of the FDA reiterated that the FDA’s issuance of documents does not say that the vaccine that has been injected has a problem. but issued a document to remind about the storage of vaccines and injection points and to warn the staff who will inject and reiterating the public’s confidence that before each vaccination The person in charge of the vaccination will double check every dose of vaccine first.
FDA confirms the quality is still normal, no danger
Dr. Surachoke Tangwiwat, Deputy Secretary-General of the Food and Drug Administration (FDA) made a statement to the press. To the case of the most urgent letter, signed on June 28, subject to alert for surveillance of CoronaVac vaccine storage, registration number 1C 3/64 (NBC) that the issuance of such a letter Since 110 vials of coagulation vaccine were found at an out-of-hospital vaccination point, the FDA has informed the FDA to suspend the injection in the part of the vial that has been found to clot. already mentioned and collect samples Department of Medical Sciences Received such a lot of vaccine to check, found that the main reason why the vaccine is a clear gel coagulate. There are 2 reasons: storage at too cold temperature because storage must be at a temperature of 2-8 degrees. Celsius or it may be caused by the pH of the vaccine.
From the inspection In the same production model, it was found that the quality of the vaccine in the clear gel Still meets the standard of normal vaccines and only found a problem at one point of vaccination service. which made inquiries to other vaccination points I did not find any such problem.
Therefore, it was concluded that the cause such clear gel Caused by storage problems because in transportation, the temperature will be maintained. to meet the requirements But at the service point, ice may be placed to maintain the temperature, but it is expected to keep the temperature below 2 degrees Celsius, so the vaccine will form a clear clot.
However, the FDA would like to emphasize that people know Every time the vaccine is released, the staff will check every step. If there is a problem, stop it. To assure people that will receive the most suitable and quality vaccine
Follow good content like this at
