The pros and cons of the covid vaccine plan

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Currently the whole world is looking forward to the availability of a COVID-19 vaccine. Various research institutions around the world are competing to complete the manufacture of the vaccine. Meanwhile, a number of countries have begun planning to buy and provide vaccines for their citizens. The Indonesian government is no exception, which has announced that it will immunize the COVID-19 vaccine in November 2020.

Currently, there are at least nine vaccine candidates that are in phase III clinical trials. Among the vaccine candidates, three have indeed been approved for limited use or emergency use. The three vaccine candidates are the CanSino Biologics vaccine and the Sinovach Biotech vaccine from China and the Gamaleya Research Institute vaccine from Russia.

However, none of them have passed the phase III clinical trial and are ready to be distributed massively as an antidote to infection with the SARS-CoV-2 virus.

Then, is there a risk if the vaccine that has not passed the clinical trial is circulated massively? Will Indonesia's plan to carry out this vaccination will solve the pandemic or will it cause new problems?

Plans for the COVID-19 vaccine immunization and protests from various collegiate doctors

The Indonesian government plans to start injecting the COVID-19 vaccine gradually starting November 2020. The Ministry of Health's Director General of Disease Prevention and Control, Achmad Yurianto, said it would ensure the availability of vaccines for 9.1 million Indonesians.

As an initial stage, as many as 3 million vaccines will arrive in two stages in the period November and December 2020. This vaccine is a vaccine imported directly from Sinovac Biotech, China, not the vaccine currently being used in the phase 3 clinical trial process in Bandung under the auspices of Bio Farma.

Meanwhile, the plan to purchase vaccines from AstraZeneca, CanSino, and Sinopharm was canceled because no business agreement was found.

The vaccine from Sinovac Biotech is planned to be given to health workers aged 19-59 years and who do not have any comorbidities.

The plan for the COVID-19 vaccine immunization is considered rushed considering that no vaccine has yet been declared to have passed all the test stages. Several medical colleges have even sent letters to the government to review this plan.

The Association of Indonesian Internal Medicine Specialists (PAPDI) in its letter to the Executive Board of the Indonesian Doctors Association (PB-IDI) stated that the vaccination program requires a vaccine that has been proven to be effective and safe. The evidence must go through the appropriate clinical trial stages.

"To achieve these goals requires sufficient time so there is no need to rush while continuing to remind the public to stick to health protocols," wrote PB-PAPDI, Tuesday (20/10).

In addition, the Indonesian Lung Doctors Association (PDPI) also sent a similar letter to PB-IDI.

"PDPI urges all types of vaccines that enter Indonesia to go through clinical trials on the Indonesian population before being injected into Indonesians," wrote PDPI.

Meanwhile PB-IDI directly responded to the disagreement with this plan by writing to the Ministry of Health of the Republic of Indonesia. This doctor's association provides three points of recommendation that should be considered in the COVID-19 vaccine immunization plan so that it is safe and not rushed.

IDI emphasizes that there must be evidence of safety, immunogenicity, and effectiveness of vaccines through the published results of phase 3 clinical trials.

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The risks of using vaccines that have not passed clinical trials

To date, there is no vaccine that has passed the stage 3 clinical trial and is permitted for massive use by WHO. The Ministry of Health said the phase 3 clinical trial of the Sinovac vaccine in Brazil had been completed on 9,000 people.

However, these results still have to wait for the phase 3 test to be completed on 15,000 people according to the original plan. A new test report publication will also be issued together with the overall results.

"We see that the precautionary element is also being exercised in other countries by waiting for more data from the results of phase 3 clinical trials," wrote PD-IDI.

Experts fear that the massive immunization plan launched this November uses a vaccine that skips critical steps that are key proof of its safety and effectiveness.

Receiving immunizations from untested vaccines carries the risk of creating new health problems. Even though they have passed the phase 1 and 2 clinical trials, they could be hampered or fail the phase 3 trials. For example, the Astrazeneca vaccine, which during phase three clinical trials caused at least two problems.

They first reported the onset of an unexplained disease in Astrazeneca vaccine volunteers in England. Second, there is a case of a vaccine volunteer who died who was a 28 year old doctor and possibly cleared of dangerous comorbids. However, clinical trials are continuing.

A report published in the medical journal BMJ, said the average first-generation COVID-19 vaccine candidate had 30% efficacy alone with an antibody response of just a few months.

"None of the currently underway vaccine trial schemes are designed to be able to detect whether the vaccine has contributed to a reduction in the number of COVID-19 patients requiring hospitalization, ICU admission, or a reduction in mortality," the journal wrote. "Nor is there a vaccine being studied to determine whether that candidate vaccine can stop transmission of the virus or not."

Potential risk of ADE effects

Besides the risk of mysterious complications, there is also a risk of having an effect antibody-dependent enhancement (ADE). Namely the viral strategy to avoid the antibody trap created by the vaccine and then the virus will turn to find another way of entering.

If SARS-CoV-2 has an ADE effect, the antibodies from the vaccine can actually make the virus more virulent because it will enter through macrophages (white blood cells) instead of the respiratory tract. This condition could theoretically exacerbate infection from the virus and potentially cause damage to the immune system (immunopathology).

Concerns about the effects of ADE were voiced by many experts, including the head of the Chinese Center for Disease Control and Prevention, Gao Fu.

Gao Fu said that the effect of ADE is one of the biggest challenges facing vaccine development today. "We must remain vigilant with ADE in vaccine development," he said at the Vaccine Summit in Guangdong Province, China.

However, there are currently no references from within or outside the country that examine whether there is an effect of ADE on SARS-CoV-2 which causes COVID-19.

Professor of Molecular Biology at the University of Airlangga, Chaerul Anwar Nidom, also warned several times about the possible effects of ADE. He reminded the government not to rush to immunize the COVID-19 vaccine.

According to him, there is still enough time to research further data on imported vaccines before they are massively injected.

One of the vaccines to be imported into Indonesia said there was no effect of ADE in the preclinical tests carried out on monkeys. However, Nidom doubts the statement because he thinks there are logical irregularities in the vaccine report.

"Indonesia imports but don't lose basic data. We, as a country that receive vaccinations, need to repeat (the test), for example with the same animal model, "said Nidom in a Talking Scientist program on Kompas TV, Wednesday (21/10). What do you think about the COVID-19 vaccine plan?