Bio Farma Called Covid-19 Vaccine Clinical Trials Involving Five Countries

JAKARTA, KOMPAS.com – PT Bio Farma’s Senior Manager for Research and Development Integration Neni Nurainy said, clinical trials the Covid-19 vaccine not just implemented in Indonesia, but also done in four other countries, namely Bangladesh, Turkey, Chile and Brazil.

“For the vaccine, there are five countries participating in Bangladesh, Turkey, Chile, Indonesia and Brazil,” said Neni in a virtual discussion entitled ‘Waiting for Covid-19 Vaccine‘, Saturday (15/8/2020).

“It is hoped that with this large enough number, we will see the full picture of this vaccine,” he continued.

These five countries are carrying out clinical trials of the Covid-19 vaccine almost simultaneously, namely in July and August 2020.

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“StartingThere are those in July, we can do it in August, “he said.

In Indonesia alone, the vaccine candidate was tested on 1,620 volunteers who are people of Bandung.

“One day ago, when the President arrived, there were 19 people, 20 means that in a day, maybe we can multiply it, maybe 100 volunteers have arrived. We target a total of 1,620 in December,” said Neni.

From the target of 1,620 volunteers, they will be divided into two groups, namely the vaccine test group and the placebo group for comparison.

According to Neni, this phase three clinical trial was conducted to see the response of the vaccine injected to volunteers with a larger population.

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“If those who use the vaccine are given the vaccine, if the placebo is only given injection water, that’s the difference. So later after in this third phase with a larger population, we’ll see earlier about its safety, immune response, and the efficacy of the vaccine,” said Neni. .

Volunteers who were injected with the Covid-19 vaccine can still carry out their normal activities and will be able to report their symptoms to researchers.

“They are free to do activities, but every time they have to be contacted for questions, for example, there are complaints or intensive complaints to researchers,” he concluded.

Reportedly, the phase three clinical trial of the Covid-19 vaccine officially began Tuesday (11/8/2020). This was marked by a review of the facilities and production capacity of the Covid-19 vaccine by President Joko Widodo.

In addition, President Jokowi directly saw the swab test and initial injection of vaccine candidates to 20 volunteers held by the Faculty of Medicine, Padjadjaran University (Unpad).

“Indonesia is entering an important stage in efforts to deal with the Covid-19 pandemic. Not many countries or research institutions have reached stage three clinical trials,” said BUMN Minister Erick Thohir in a release received by Kompas.com, Tuesday (11/8/2020).

Also read: The Story Behind Covid-19 Vaccine Volunteers, Heavy Drowsiness and Reasons for the Deputy Mayor of Bandung to Cancel

The Committee for Handling Covid-19 and National Economic Recovery (KCPEN) also explained that currently it is only a matter of waiting for the process in the next six months.

“Please support and pray for the vaccine which I make sure this is lawful,” he said.

If the phase three clinical trial goes well, his party will prepare registration to the POM to be mass produced and used to overcome the Covid-19 virus.

Director of Bio Farma Honesti Basyir said the world is currently in need of a Covid-19 vaccine.

Of the hundreds of research institutions that have developed the Covid-19 vaccine, not many research institutions have reached phase three clinical trials. One of them is Sinovac from China.

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“Phase three clinical trials are needed before a Covid-19 vaccine can be produced,” he said.

This vaccine has gone through several stages. Starting from pre-clinical trials, stage one clinical trials to stage two clinical trials in China and the results are already known to the POM RI.

Honesti said that Sinovac was chosen because of the similarity in the production platform with Bio Farma, namely the inactivated vaccine.

Another reason, Sinovac has experience in developing vaccines in pandemic conditions, such as the SARS vaccine. Sinovac also has products that meet WHO pre-qualifications.

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