Positive Vaccine News

KOMPAS/RONY ARIYANTO NUGROHO

A medical worker prepares to give a Covid-19 candidate vaccine in a series of simulation tests at the Tapos Community Health Center (Puskesmas) in Tapos district, Depok city, West Java, on Thursday (22/10/2020). The simulation aims to prepare the infrastructure for the Puskesmas. When the vaccine is available, Depok will become one of the main destinations in the West Java region for its distribution. The vaccine is currently still in the clinical trial stage. The West Java region, especially Bogor, Depok, Bekasi, is still the location with the most Covid-19 cases nationally, with 70 percent of the total number in Indonesia.

The announcement of a COVID-19 vaccine candidate that is more than 90 percent effective based on its initial trial results has swept the globe. A scientific publication of the vaccine candidate is awaited.

NEW YORK, TUESDAY — The COVID-19 vaccine candidate developed by US pharmaceutical company Pfizer and German biotechnology company BioNTech is reportedly 90 percent effective. While the initial results of its clinical trials are promising, a number of questions remain and need to be answered.

More comprehensive scientific data is needed to answer questions regarding the body’s immune response, the safety and efficacy of the vaccine candidate as well as its effects on populations of different ethnicities and age groups.

“If the claims of Pfizer and BioNTech are true, then this is good news. We now have to wait for scientific publications regarding the immune response, efficacy and safety,” said Dicky Budiman, global health expert and Indonesian epidemiologist at Griffith University, Australia, on Tuesday (10/11/2020) in Jakarta.

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Vaccinations must then be carried out with caution due to the large implications. Apart from safety and efficacy, other factors that must also be considered include storage and delivery.

Jesse Goodman from Georgetown University and former head of the vaccine division at the United States Food and Drug Administration (FDA) also agreed that the results of Pfizer and BioNTech’s vaccine candidate were promising. However, it is still unknown how long the antibodies are present in the body and the effectiveness of this vaccine in the elderly.

KOMPAS/RONY ARIYANTO NUGROHO

A volunteer receives a vaccine injection during a series of simulation tests for a Covid-19 candidate vaccine at the the Tapos Community Health Center (Puskesmas), Tapos district, Depok city, West Java, Thursday (22/10/2020). The simulation aims to prepare the infrastructure for the Puskesmas. When the vaccine is available, Depok will become one of the main destinations in the West Java region for its distribution. The vaccine is currently still in the clinical trial stage. The West Java region, especially Bogor, Depok, Bekasi, is still the location with the most Covid-19 cases nationally, with 70 percent of the total number in Indonesia.

According to the World Health Organization (WHO), this announcement brings very good news. WHO warned that inequality in funding of US$4.5 billion could slow down the development of test kits, drugs and vaccines in countries with low-middle economies.

Another challenge for developing countries is that the Pfizer and BioNTech vaccine candidate must be distributed and stored in extremely cold temperatures, which requires a cold chain facility to ensure the vaccine’s quality is maintained. In fact, even in the US, not many hospitals have this facility.

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In a written statement on their website, Pfizer and BioNTech said their mRNA-based vaccine candidate, BNT162b2, showed evidence of efficacy against COVID-19. This data is based on their first efficacy analysis of a phase 3 clinical trial by an external Data Monitoring Committee (DMC) on 8 November 2020.

“The first interim analysis of our global phase three trial proves this vaccine can be effective at preventing COVID-19. This is a win for innovation, science and global collaboration,” said Ugur Sahin, CEO and co-founder of BioNTech. The company collected further data according to the final planned analysis, namely with a total of 164 COVID-19 cases.

The trial consisted of 42 percent global participants and 30 American participants of diverse racial and ethnic backgrounds.

Individuals who received two injections of the COVID-19 vaccine within three weeks, or 28 days, experienced 90 percent fewer COVID-19 symptoms than those who received a placebo or no medication. The BNT162b2 phase 3 clinical trial started on 27 July with 43,538 participants, 38,955 participants of whom received a second dose of the vaccine on November 8, 2020. The trial consisted of 42 percent global participants and 30 American participants of diverse racial and ethnic backgrounds.

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Pfizer and BioNTech have both stated that they did not find any serious side effects from the clinical trials. Thus, the vaccine candidate is expected to be used immediately through the emergency use authorization (EUA) before the distribution permit is issued in December 2020.

If the distribution permit is issued, Pfizer and BioNTech estimates that it will produce 50 million doses this year to protect 25 million people. By 2021, they target to produce 1.3 billion doses. Pfizer CEO Albert Boula and BioNTech CEO Ugur assessed that these initial results proved that the vaccine candidate could stop the spread of COVID-19. “We are one step closer to stopping this pandemic,” said Boula on Monday (9/11) night.

This announcement was welcomed by the research community, infectious disease experts and epidemiologists. “If its efficacy remains at 90 percent, it means that its level of efficacy is higher than that of the common flu vaccine. This vaccine then has a significant impact in reducing the spread of the disease,” said Yale Institute Global Health Director Saad B. Omer, as quoted by The New York Times.

KOMPAS/WAWAN H PRABOWO

Medical officers take a swab sample during a free drive-thru swab test at the Genomik Solidaritas Indonesia (GSI) Laboratory, Cilandak, Jakarta, on Monday (11/2/2020). The free swab test is part of a joint donation program from the Tanoto Foundation and Singapore-based Temasek Foundation International. This program is a form of solidarity to accelerate the mitigation of Covid-19 in Indonesia and to increase the capacity of the GSI Laboratory, which is currently able to provide 5,000 polymerase chain reaction (PCR) swab tests per day.

However, a number of researchers and experts have reminded the public to not put too much faith in this vaccine. University of Reading microbiology professor Simon Clarke warned that Pfizer and BioNTech have not yet scientifically published their data on the clinical trials. “Without data provided by Pfizer and BioNTech, we can only see what they claim,” Clarke said, as quoted by The Guardian.

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This view was shared by leading infectious diseases and biotechnology expert William Haseltine. He regretted that Pfizer and BioNTech’s announcement was not supported by complete data, including details of side effects produced by the vaccine candidate.

Clinical trials

The Indonesian Doctors Association’s Mitigation Team head Adib Khumaidi said that health workers were awaiting a COVID-19 vaccine that has completed clinical trials in Indonesia, compared to using emergency use authorization (EUA). “We hope that the government will focus on prevention and controlling the cases through testing, tracing and isolation. Vaccines can wait if they are safe and effective enough,” he said.

KOMPAS/RIZA FATHONI

A number of health workers from the Indonesian Military (TNI) and National Police and civilian volunteers and medical officers shout after participating in a Heroes Day commemoration ceremony at the Wisma Atlet Covid-19 Emergency Hospital (RSD) complex, Kemayoran, Central Jakarta, on Tuesday (10/11/2020) . The ceremony was carried out with adherence to health protocols. A total of 1,719 patients infected with the coronavirus were treated at the Wisma Athlete Covid-19 Emergency Hospital.

Dicky reminded the Indonesian government not to rush in importing and administering vaccines to the public prior to the completion of phase 3 clinical trials in Indonesia. Scientific evidence from abroad can be taken into consideration.

Separately, it was reported that Brazilian health authorities have suspended clinical trials of the COVID-19 vaccine candidate developed by Chinese company Sinovac Biotech. This was done following an incident deemed detrimental to the volunteers who participated in the trial.

In its official statement, Sinovac Biotech expressed confidence in the safety of the vaccine candidate it was developing. Other reports claim that the incident was unrelated to the vaccine and that the company would continue to communicate with Brazilian authorities regarding the matter.