Table of contents:
- The mission to resolve the pandemic, Bio Farma applies for the emergency use of the Sinovac vaccine
- 1,024,298
- 831,330
- 28,855
- What does the emergency use of vaccines mean?
- Can vaccines solve all pandemic problems?
Read all articles about coronavirus (COVID-19) here.
The manufacture of the COVID-19 vaccine is rushed, the target time is being pursued. The trial series has been accelerated and some candidates have even conducted phase 1 and phase two clinical trials at the same time. The acceleration of vaccine trials is carried out in order to resolve the COVID-19 pandemic which has infected almost the entire world.
But will hasty manufacture produce a vaccine that is potent enough? Can a vaccine quickly solve the COVID-19 pandemic?
The mission to resolve the pandemic, Bio Farma applies for the emergency use of the Sinovac vaccine
Bio Farma is working on getting the Sinovac vaccine to get an emergency use permit (Emergency Use Authorization) in Indonesia.
"We are currently in discussion, if Indonesia could get first access to the vaccine," said Director of Bio Farma, Honesti Basyir, in a meeting with the DPR in Jakarta, Monday (5/10).
Currently, Bio Farma and the Faculty of Medicine, Padjadjaran University are conducting phase 3 clinical trials on the Sinovac vaccine, a biotechnology company from China.
Phase 3 clinical trials on this vaccine have been running since last month, involving 1,620 volunteers. Researchers will monitor the test participants for six months with two vaccine injections. It is estimated that data on the results of this phase 3 clinical trial will only be visible in May 2021.
Even though it has only been running for one month, Bio Farma intends to apply for a permit so that the COVID-19 vaccine can be distributed immediately. The application for this permit is made with the initial report on monitoring of phase 3 clinical trials conducted in Indonesia during the past month.
The emergency use of the Sinovac vaccine in Indonesia is intended for injection at medical personnel and groups at high risk of contracting COVID-19.
COVID-19 Outbreak updates Country: IndonesiaData
1,024,298
Confirmed831,330
Recovered28,855
DeathDistribution MapWhat does the emergency use of vaccines mean?
Phase 3 clinical trials aim to determine whether the vaccine candidate can provide protection from COVID-19 infection. Phase 3 clinical trials must be conducted on a large scale to prove that no harmful side effects have arisen.
An emergency use permit means that it allows the use of vaccines that have not been proven and have not passed the stage 3 clinical trials. This means that the safety of the vaccines has not been truly tested.
Until now, the World Health Organization (WHO) has not issued a single permit for the widespread use of the COVID-19 vaccine candidate.
However, there are two COVID-19 vaccines that have been used with a limited use permit, namely the Gamaleya vaccine from Russia and Sinovac for use in China.
Russia's decision to use a vaccine that has not passed clinical trials is considered a dangerous decision for experts. Unlike experimental drugs that are given to certain people when they are sick, vaccines are given to healthy people en masse.
So vaccines must pass high safety standards. It is feared that vaccines that have not passed clinical trials will not solve the pandemic but actually cause dangerous side effects in many people.
Even though it has passed the phase 1 and stage 2 clinical trials, the vaccine is not certain that it will pass the stage three clinical trial smoothly. As a recent example, Oxford University's Phase 3 clinical trial of the COVID-19 Astrazeneca vaccine has recently caused rare side effects in UK test participants.
Economy Minister Airlangga Hartarto had said that the Indonesian government was prepared to pay a down payment for vaccine procurement from AstraZeneca. The amount to be issued is US $ 250 million or around Rp. 3.67 trillion.
"We will procure a vaccine from AstraZeneca, the contract is 100 million vaccines and the government will pay for it down payment 50 percent at the end of this month, the cost will be approximately US $ 250 million, ”he said in a webinar held by the Gadjah Mada University Alumni Family, Sunday (11/10).
Can vaccines solve all pandemic problems?
The government's attitude that seems very focused on the procurement of vaccines, both from Sinovac and AstraZeneca, has drawn a number of criticisms. In a webinar, epidemiologist Pandu Riono said that, "The vaccine is not a short-term solution, not a magic solution that can immediately stop a pandemic."
Apart from that, he also questioned the vaccination planned by the government. "WHO stated that there are no vaccine candidates that are recognized as effective and safe. Colleagues from the Eijkman institution also doubt the benefits of the vaccine, "Pandu wrote in his upload.
Pandu is worried that the marketing of vaccines that have not been tested for their effectiveness and safety will actually endanger the public. Because until today there has been no vaccine that has passed the stage 3 clinical trial and is permitted to be used massively by WHO.
Now the Indonesian government has imported 1.2 million Sinovac vaccines, which are still undergoing phase 3 clinical trials and have not proven their effectiveness. In his tweet, Pandu Riono said that vaccines could make it difficult to handle a pandemic. "The illusion of vaccines as a short-term solution is strengthening. The seriousness of strengthening Test-Trace-Isolation and 3M is still sub-optimal and is increasingly being neglected. The pandemic will not be ignored yet. "
