Jakarta: The Food and Drug Supervisory Agency (BPOM) is waiting for the results of clinical trials for the corona virus vaccine candidate (covid-19). After the clinical trial results come out, vaccine immediately distributed.
“The clinical trial data starts from phase 1, phase 2 and phase 3. We sincerely hope that this phase 3 clinical trial data can provide evidence that the vaccine is efficacious and safe,” said Director of Drug Registration for BPOM Lucia Rizka Andalusia in a virtual discussion entitled ‘Continuation Development of Vaccine Clinical Trials Covid-19‘broadcast through the YouTube account’ Kemkominfo TV ‘, Wednesday, October 21, 2020.
Lucia said BPOM will strictly ensure vaccine safety. The percentage of potential side effects will also be studied.
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However, the most important thing is to ensure the efficacy of the vaccine. Especially related to the formation of immunity.
Read:Vaccines for Children, the Elderly, and Comorbids Wait for Research Results
“This immunity enhancing power is what it is called immunogenicity and measurements, “said Lucia.
This data underlies the approval that the vaccine is suitable for use. He asked that the validation of vaccine testing data was strictly maintained, along with data on the quality of vaccine products.
To ensure that, BPOM has sent a team to monitor the production process of vaccines abroad, one of which is in China. Vaccines from Sinovac, China, will be imported at the end of 2020. The purpose of monitoring the BPOM is to ensure vaccines are in accordance with Good Manufacturing Practice (GMP).
“So between the quality proven by the GMP manufacture, efficacy, and safety. These three aspects are the basis for granting approval for the use of the vaccine,” said Lucia.
(ADN)
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