“We are optimistic that the clinical trial of the Merah Putih vaccine can be used for the fourth dose,” main researcher of the Merah Putih Vaccine at Airlangga University, Professor Fedik Abdul Rantam stated on Monday.
The COVID-19 vaccine, which was developed since May 12, 2020, would go through the third phase of clinical trials starting on June 28, 2022.
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The research team has collected 1,100 volunteers from a total of 4,005 required for clinical trial subjects that comprises one group of volunteers receiving the comparison vaccine and two groups of volunteers receiving the Merah Putih Vaccine.
“Phase three of the clinical trial process is ongoing. So far, the results are good. Currently, 1,100 volunteers have been recruited,” Rantam stated.
He noted that vaccine reactions among volunteers in the third phase of clinical trials will be observed at Dr Soetomo Hospital, Surabaya; Airlangga University Hospital, Surabaya; Saiful Anwar Hospital, Malang; Jember Lung Hospital; and Subandi Hospital in Jember.
Phase three of the clinical trial of the Merah Putih vaccine developed at Airlangga University was targeted to last a maximum of six months after the administration of the second dose of vaccine.
Production of the COVID-19 vaccine is targeted to start by the end of 2022 after having obtained an emergency use permit from the Food and Drug Supervisory Agency (BPOM), Rantam noted.
On a separate occasion, Head of the Merah Putih Vaccine Clinical Test Team at Airlangga University, Dominic Husada, stated that the use of the Merah Putih vaccine for booster vaccination could only be conducted after the completion of further clinical trials.
“Currently, it is in the phase 3. After that, the vaccine will be submitted for a distribution permit from BPOM. Only after that will further clinical trials be conducted for boosters,” Husada remarked.
Husada admitted to it being quite challenging to recruit volunteers in the third phase of the Merah Putih vaccine clinical trial since coverage of the COVID-19 vaccination was already high.
“It is very difficult to find participants, as many people had already received the COVID-19 vaccination,” Husada stated.
The World Health Organization (WHO) necessitates that clinical trials of vaccines be conducted on at least three thousand people to assess vaccine safety.
Artikel ini bersumber dari www.medcom.id.