Guarding the Quality, Safety and Efficacy of Vaccines

KOMPAS/Dokumentasi BPOM

Head of the Food and Drug Supervisory Agency (BPOM) Penny K Lukito

In implementing Covid-19 vaccination in Indonesia, the Food and Drug Supervisory Agency (BPOM) acts as a “referee” that oversees the entire vaccination process, from testing to vaccine distribution. The vaccination cannot be carried out if there is no emergency use authorization from the agency.

BPOM has to step up. We also carry out a number of tasks that should not be the responsibility of the BPOM to ensure that the quality, safety and efficacy of vaccines are guaranteed and their implementation is in accordance with the stipulated time," said BPOM chairperson Penny K. Lukito. The following is an excerpt of an interview between Kompas and the head of BPOM in Jakarta, Friday (15/1/2021).

How do you ensure that the vaccines given to the public are guaranteed in their safety, quality, and efficacy?

In terms of quality, the BPOM has conducted direct inspections at the facilities where the vaccines are produced. For the Sinovac vaccine, we went to China in November 2020 to ensure that the production process, raw materials, products and the production method of good drugs are in line with quality requirements.

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On the aspects of safety and efficacy, the BPOM oversees the clinical trial process of vaccines. From this process, we can get results regarding the efficacy and immunogenicity levels of the vaccines. If all data are complete, starting from clinical trials of the first, second and third phases with interim reports of three months, the BPOM can only ensure quality, safety and efficacy through the issuance of an emergency use authorization (EUA).

The government set the date of the initial vaccination before the EUA came out? Is there any pressure on the BPOM to immediately issue an EUA?

I guarantee that the independence of the BPOM is maintained in the issuance of the EUA for the Covid-19 vaccine made by Sinovac. In the whole process, we uphold the independence, credibility and professionalism of the BPOM. The validity of the EUA being issued can be trusted.

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The BPOM not only researchs but also analyzes and prepares all raw materials related to the clinical trial process of the research team. In the processing, we also do a check and recheck.

KOMPAS/KRISTIAN OKA PRASETYADI

Medical officers prepare to inject the Covid-19 vaccine, Friday (15/1/2021) at the Kitawaya Field Emergency Hospital, Manado, North Sulawesi.

We clearly do coordination with the government. Jan. 13, 2021 was determined as the date of initial vaccination because there was a timeline that had been prepared in advance. Alhamdulillah, the timing was right.

What are the requirements for granting the EUA?

The EUA can be granted if the government determines that a country is experiencing a public health emergency. Then there is strong evidence from the safety, quality, and efficacy aspects of the drugs, in this case vaccines. Besides that, the benefits of vaccines have been proven to outweigh the risks and there have not yet been approved alternatives for diagnosis, prevention and treatment of disease.

Another requirement is that the vaccine has gone through preclinical trials, clinical trials in phase 1, phase 2, and phase 3 for at least three months of monitoring after the second injection is given. To ensure vaccine efficacy, evidence of vaccine efficacy and immunogenicity is needed to be monitored for up to six months in order to decide to get a full distribution permit.

Efficacy level

Can the efficacy and immunogenicity be explained?

Efficacy is an estimate of the percentage on the reduction of the incidence rate of disease for a group of people in a clinical trial who are vaccinated versus those who receive a placebo. Meanwhile, immunogenicity is the ability of vaccines to form antibodies and neutralize the incoming virus.

From the results of clinical trials, the efficacy of the Covid-19 Sinovac vaccine tested in Indonesia is 65.3 percent, while the efficacy in Brazil and Turkey is different. What does that mean?

Kompas

A nurse prepares an injection of the Chinese made Covid-19 vaccine Sinovac at the Sabiha Uzun Maternal Child Health Center in Ankara on January 15, 2021.

Frequently people misinterpret this efficacy percentage. The level of efficacy of a vaccine cannot be compared in each country with different studies. Let alone if the type of vaccine being studied is different. That is because the testing situation is different, both in terms of the number of volunteers tested, the background of the volunteers, and the level of transmission in the area where the test is conducted.

WHO (World Health Organization) sets an efficacy standard for issuing an EUA of at least 50 percent so that the level of efficacy on vaccines tested in Indonesia is good. A percentage of 65.3 percent means that people who are vaccinated will have up to 65.3 percent protection compared to those who are not vaccinated. So don\'t compare this percentage with the total population that only 65.3 percent of the population is protected.

Does efficacy affect the number of people who have to be vaccinated?

Of course. The lower the level of efficacy, the higher the number of the population who must be vaccinated. This aims to establish herd immunity in society. From the calculation, with an efficacy of 65.3 percent and a transmission rate of about 2 (one person can infect two people), it is estimated that 77 percent of the population has to be vaccinated. This number is almost similar to what has been set by the Health Ministry, namely 180 million people to be vaccinated.

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If someone has been vaccinated, is he protected from the virus so that he cannot catch and transmit it?

Vaccines cannot completely protect people from the risk of transmission. Each person has a different antibody response after being vaccinated. So it is possible that someone who has been vaccinated is still infected with the virus. However, because antibodies are formed from administration of the vaccine, the risk of malignancy will decrease.

There are still a lot of data that we need to know, especially regarding the level of immunogenicity of vaccine administration. From the results of monitoring three months after the second injection was given, the immunogenicity level of the Covid-19 Sinovac vaccine tested in Bandung showed a high number, namely 99.23 percent. However, we will have to see for six months and beyond to find out how long this vaccine has had such a high level of protection. This will determine when the boosters need to be given.

KOMPAS/ADITYA DIVERANTA

Sinovac vaccine stocks stored in the cold box of the Palmerah II Village Health Center, West Jakarta, DKI Jakarta, Friday (15/1/2021). The vaccine for Covid-19 must be maintained in a temperature range of 2-8 degrees Celsius.

So, is prevention with health protocols still necessary after vaccination?

That is clear. As long as the pandemic is still ongoing, health protocols must be carried out by still wearing masks, maintaining distance and washing hands. This is important not only to protect us, but also to others.

Other vaccines

What is the BPOM\'s plan after EUA is issued for the Sinovac vaccine? Does the same test apply to other vaccines?

The role of BPOM continues to safeguard the safety of vaccines. We are monitoring the clinical trials in Bandung until phase 3 of the clinical trials is completed, followed up with monitoring for six months which is expected to be completed by March 2021. We also keep an eye on the post-market when vaccines are circulating, especially in the event of post-immunization side effects. Until now there has been no report related to the post-immunization side effects. From clinical trials, only 0.1 percent to 1 percent had severe post-immunization side effects, such as diarrhea, headaches, and skin disorders. If in the implementation of vaccination there are reports of incidents with serious side effects and proven by the investigation, immunization can be stopped first.

From clinical trials, only 0.1 percent to 1 percent had severe post-immunization side effects, such as diarrhea, headaches, and skin disorders.

Moreover, supervision is starting to be carried out for the potential for other types of vaccines to be used but no clinical trials in Indonesia are needed. All data regarding the safety, quality and efficacy of vaccines are subject to thorough review. If the vaccine has received EUA in another country, it will be faster. BPOM has reliance (trust) with five countries, namely the United States, Canada, Europe, Britain and Japan. If the vaccine to be used has received EUA from these countries, approval is easier to give.

What are the obstacles to ensuring the quality, safety, and efficacy of vaccines given to the community?

First, the capacity for vaccine storage is limited in a number of regions. The current vaccination program requires large quantities of vaccines, so the volume of storage space for vaccines is also large. Currently, many of the available capacities have not been fulfilled, especially at the regency/city level.

Second, vaccine production capacity in Indonesia is also limited. The industry in Indonesia that can produce vaccines is only state-owned pharmaceutical company PT Bio Farma. As a country (with a large population), especially to face the possibility of a pandemic in the future, we need to increase the capacity of the pharmaceutical industry, especially to produce vaccines. Incentives need to be given by the government by ensuring that the vaccine products that will be produced will be purchased by the government.

This article was translated by Hyginus Hardoyo.