KONTAN.CO.ID – JAKARTA. The term emergency circulation permit has been circulating recently. The terminology of emergency use authorization (EUA), for example, circulates in the news about the interim results of clinical trials of vaccines developed by Pfizer Inc and Moderna Therapeutics.
From within the country, the press conference on the development of the Covid 19 vaccine clinical trial delivered by the Food and Drug Administration also touched on the issue of the emergency circulation permit, aka EUA.
Then, what is meant by the emergency circulation permit? EUA is a license for a vaccine for limited use. A drug regulatory agency in a country issues a limited distribution permit because the process of testing the safety and effectiveness of vaccines is still ongoing.
Under normal conditions, the process of developing a vaccine until it gets a distribution license, without emergency frills, can take a matter of years, even decades. However, during a pandemic, the World Health Organization (WHO) together with drug regulatory agencies in various countries designed a number of methods to enable the process of developing a vaccine against the Covid 19 virus to run faster. Of course, the decision to accelerate is based on the consideration of getting benefits that are greater than the risks faced.
Quoting the Associated Press, the drug regulatory agency in the United States, the Food and Drug Administration (FDA), stated that the corona virus vaccine developer must carry out follow-up procedures for half of the people involved in the clinical trial process. The procedure, which lasts at least two months, aims to ensure the safety and effectiveness of the vaccine.
The results of the monitoring data will be used by the FDA to determine whether the vaccine developer is entitled to an emergency distribution permit or not. The FDA will declare a vaccine effective, if the vaccine is able to protect 50% of the people involved in the clinical trial process.
By getting EUA, a vaccine can be injected into people who are considered susceptible to being infected with the corona virus. Groups that are considered to be at high risk are such as medical personnel or public service workers.
The Food and Drug Administration (Badan POM), as the agency authorized to permit the distribution of vaccines here, follows the EUA procedure for the corona vaccine, as drafted by WHO and various countries. Therefore, the procedure for issuing an emergency distribution permit here resembles the mechanism in place
Quoting the statement of the Head of the POM, Penny K. Lukito, vaccine developers must provide a complete report to the POM. The report consists of the results of phase 1 and phase 2 clinical trials, along with the results of interim analysis from the third phase of clinical trials over a period of three months after the last injection of the vaccine, Penny said, as quoted on the POM Agency website.
With reference to such a mechanism, the POM predicts that the vaccine developed by Sinovac will receive an emergency distribution permit in the third or fourth week of January at the earliest. Of course, this emergency distribution permit can only be issued if all data and aspects of the safety, efficacy and quality of the vaccine have been fulfilled.
So, as long as no vaccine has received an emergency distribution permit, the discipline of implementing health protocols is the only way for us to prevent being infected with the corona virus.
Moreover, the protocol which has proven effective in preventing the circulation of the corona virus is fairly easy to follow. We just need to wear masks in the right way, wash our hands with soap, and keep our distance and stay away from crowds.
Editor: Thomas Hadiwinata