Head of the Food and Drug Supervisory Agency (BPOM) Penny Lukito said the plan for distribution of the Covid-19 vaccine targeted for December has been delayed and would be postponed until January 2021.
This is because the Emergency Use of Authorization (EUA) permits issued for urgent purposes will not be granted by the end of this year.
“We have conveyed to the government, the President and the Minister of Health that (required) data cannot be obtained for the third week of December 2020, so that EUA cannot be granted by the 2,d or 3rd week of December 2020,” said Penny in a meeting with The Indonesian House Of Representatives Commission IX.
President Joko Widodo previously stated that he would strive to provide a Covid-19 vaccine in December 2020.
“We are trying but we have to hang on, as I said, until the vaccine can be provided, God willing in December or January,” said Jokowi on September 30.
Penny said, the incomplete data included the results of the Sinovac Covid-19 vaccine clinical trial which has been ongoing in Bandung, as well as the results of the mid-term clinical trial analysis.
Penny stated that if the relevant data is received, EUA permission could be granted in the third week of January 2021.
“If we move back to the initial schedule for the EUA to be granted by in the third week of January 2021, with required data (confirmed). If all data can be completed properly, we can provide it in the third week of January 2021,” she explained.
Penny also elaborated on a scenario where the Covid-19 vaccine is available in Indonesia in November or December. According to Penny, the Covid-19 vaccine can be provided based on compassionate use or if drugs or vaccines that are still in development already have sufficient data related to quality.
“We have confirmed the quality has met the requirements and also have enough data related to safety. Compassionate use can be provided with a request from the Ministry or Health facility with access to drugs undergoing trials available for specific requirements,” explained Penny.
Several types of vaccines produced by a number of countries claim to be ready to be imported to Indonesia, namely Cansino, G42 or Sinopharm, as well as Sinovac.
Among several vaccine candidates purchased by Indonesia, Sinovac has completed its final phase clinical trials in several countries including Brazil and China.
In Indonesia, the final stage of clinical trials is targeted for completion in December 2020.
Meanwhile, Sinopharm has completed its final stage clinical trials in the United Arab Emirates (UAE) and Turkey. CanSino has completed its final stage clinical trials in Canada, China and Saudi Arabia.