Waiting for COVID-19 Vaccine
Pediatrician; Head of the Children’s Infectious and Tropical Diseases Division of the Department of Pediatrics of the Medical School of Airlangga University (Unair)/Dr. Soetomo Regional General Hospital (RSUD), Surabaya
Ever since Edward Jenner began the history of modern vaccines by injecting an 8-year-old boy, James Tibbs, in England, quite a number of infectious diseases have been dealt with.There are three infectious diseases that we have managed to essentially defeat, namely smallpox (since 1978), polio – except in two countries that still have cases to this day – and rinderpest on cattle. The role of vaccines is difficult to deny.
In the case of other infectious diseases, vaccines have proven to be effective in reducing cases to a very minimal level. In countries with good immunization coverage, diphtheria and tetanus sufferers are already very few in numbers and newborns with rubella are unheard of in many countries.
In the field of public health, vaccines are one of the two most efficient and effective efforts with high levels of success. Unfortunately, in the world today there are only about 40 vaccines for humans. Even though the number of infectious diseases is so large, the medicine circle has not succeeded in making vaccines for many diseases. This is proof that making vaccines is not simple and clearly cannot be instant.
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The COVID-19 disease or SARS-CoV-2 has been the most horrendously formidable opponent for the past six months. Since its emergence in late 2019 in China, medical practitioners have been working toward creating a vaccine to fight this disease. If bacteria is combated with antibiotics, viruses must be treated with antivirals. History teaches that there are so many viruses that we are unable to overcome with drugs. Only a few antivirals are truly potent, as indicated by HIV or antiretroviral drugs. The rest of the antivirus is not really able to kill satisfactorily. Every time a drug issue cannot be overcome, the role of the vaccine becomes even more meaningful.
Favipiravir, one of the candidates for the COVID-19 drug, is a drug for influenza but has not quite been successful. Remdesivir, which has just been approved by the US Food and Drug Administration (FDA), is a drug for Ebola but is also unsatisfactory. Lopinavir ritonavir is an anti-HIV drug that is being examined for COVID-19. Oseltamivir is a drug for influenza virus that may not be suitable for COVID-19 due to enzyme differences. All of the drug candidates, including Remdesivir, are actually in doubt. WHO indeed recommends the search for drugs that are already on the inventory list rather than looking for new ones, considering the time available is so short and given the frightening scale of the disease.
The failure to get an effective antivirus leaves convalescent plasma as a hope of treatment, but of course provisions at a large scale are not possible. The only hope is in vaccines. WHO’s official announcement from June 2, 2020, dealt with inventory of 136 COVID-19 vaccine candidates from all over the world. China as the first country to face the pandemic might have more relevant data. Several Chinese companies and academic institutions are among the most advanced in the race to get the vaccines. There are at least eight methods used by researchers to make the vaccines. Several researchers make use of protein from the S bulge in the virus, which is used to attach to receptors in the body.
In line with medicine, there are several stages that must be followed to deliver a vaccine that is circulated in the community. Briefly, after the vaccine candidate is made or purified in a laboratory, tests are carried out on animals and then humans. At least four stages must be passed in humans. The parameters evaluated are mainly two aspects, security and benefits.There are 10 vaccines that have currently passed the animal phase and most of these 10 vaccines come from China. The farthest vaccine is already in phase 2b and will soon be entering phase 3 in humans. The vaccine candidates are from the initiative of Oxford University in England. Phase 3 in humans is a stage that will involve thousands of participants. If we see phase 1 in humans only began at the end of March, this vaccine step is really very fast. Oxford University has actually even made a cooperation agreement with a vaccine company in India for large-scale production if the vaccine is successful.
If vaccines for animals cause death or miscarriage, for example, the possibility of using the vaccine still exists. That is not possible in humans.
Since the tragedy of the first generation of rota vaccine, clinical phase 3 vaccine trials have been carried out with extreme care, involving at least 30,000 participants. This is to ensure that side effects that are rare can be detected. The large scale will make the vaccine research process longer, more expensive, and technically more difficult. All of that is a demand because the subjects who will use the vaccine are humans. If vaccines for animals cause death or miscarriage, for example, the possibility of using the vaccine still exists. That is not possible in humans.
One company that will also enter phase 2 for product testing has cooperated with Indonesia so that it will enable our country to produce and have a vaccine in a short period of time. Oxford University itself uses the adeno virus as a vehicle to enter the body and is infiltrated with components from the COVID-19 virus.
Situation in Indonesia
Indonesia is trying to have its own vaccine candidates. This is important to show the ability of the nation and avoid heartbreaking events such as during the bird flu outbreak several years ago. Another reason is the possibility of differences in viral gene sequences circulating in Indonesia.
There are at least three institutions in Jakarta and one in Surabaya that have started the vaccine work. The method used also varies so that failure in one institution does not have to stop another institution. Regulatory support, facilities, and funds are provided by the government to facilitate the research process. Several international institutions have been invited to join for large jobs that will also allow the process of technology transfer.
There is an impression that the government wants the vaccine research be accelerated. Some parties even want the vaccine to be obtained before the year ends. This seems impossible considering the vaccine research process that has been described above. The desire to get quick results should not sacrifice humans as vaccine recipients.
When swine flu fever struck Mexico and the US, vaccine production had been carried out in less than a year. If Indonesia really wants to be able to produce vaccines before 2021, the most realistic way is to work with companies that are already in phase 2 or 3. In fact, we have already done this. It is likely that one out of 10 vaccines that have already been tested in humans will make our country one of the phase 2 clinical trial locations.
COVID-19 vaccine solution
There are several significant obstacles in the process of finding the COVID-19 vaccine. First, we have never had a vaccine for the coronavirus. Efforts to make the vaccine began when two coronaviruses previously hit the world and some COVID-19 vaccine candidates make use of the already available vaccine candidates. When SARS struck in 2002, a number of vaccine candidates had already been made but later the disease disappeared.
Another coronavirus, MERS-CoV, which has been occurring in Saudi Arabia since 2011 and to this day has not disappeared, also has several vaccine candidates even though none have passed clinical tests. That means that in the world there is not a single vaccine for the coronavirus.
Second, as a new disease, some immunological mechanisms are not fully understood. In fact, the immunological aspect is the main key to the vaccine. Fortunately, the availability of modern technology shortens the otherwise usually long process. Viral gene sequences, receptor identification, discovery of several important proteins, and discovery of antibody components in humans can be quickly resolved, relatively speaking.
That is one thing that has hindered the discovery of the dengue vaccine for years.
Third, for security aspects, there is a possibility COVID-19 shows the character of the dengue virus. Immunity that is not optimal will only aggravate pain. That is one thing that has hindered the discovery of the dengue vaccine for years.
Fourth, several methods of making vaccines, such as using genetic components, are the most modern methods and have never been used before. Some people are still doubtful over whether the latest method can really be used. Theoretically, this new method is indeed promising. In reality, the Moderna company that started using ribonucleic acid as a vaccine is the first to have conducted clinical trials on humans.
Fifth, some results on animals are not as good as expected, both in terms of safety and benefits. "Immunological tinkering" is sought to improve this outcome.
Evaluation of the benefits of vaccines, which is usually measured by how many people are sick, even if they have received vaccination, is unlikely to be done for the COVID-19 vaccine. It is sufficient for the evaluation to be represented by the level of antibodies in the recipient\'s body after a certain period of time.
In history, there have been a number of vaccines that have showed brilliant results in phase 2 but failed miserably in phase 3. The most recent example is an HIV vaccine that was initiated by the US and had to be stopped halfway because it did not show benefits to the group receiving the vaccine. Indeed, all phases must be undertaken and evaluated properly given the risk of failure.
The issue that is currently being circulated is whether all countries in the world have the same opportunity to get the vaccine. When bird flu struck, Indonesia as the owner of the virus became the country that did not get priority to receive the vaccine. At that time this had been revolutionized and is expected not to be encountered again. Oxford University has guaranteed large-scale production aimed at meeting the needs of the entire world. Some Chinese companies have also cooperated with large vaccine companies in a number of countries to guarantee production.
Before the COVID-19 pandemic struck, the world was facing problems over falling immunization coverage in many developed and developing countries. Measles is rampant again in America and Europe, the Philippines is troubled by a variety of diseases that were previously under control, and countries in a war situation can no longer maintain their pre-war conditions.
The big question is whether after the COVID-19 vaccine is available, there will be rejection in several community groups for various reasons. Government decisiveness is urgently needed to keep this thing from appearing in our country. It can be said that almost all experts agree that there is high hope for a vaccine. The hope of billions of people now is to witness that this deadly disease can be conquered. Hopefully this effort will soon get satisfying results.
Dominicus Husada, Pediatrician; Head of the Children’s Infectious and Tropical Diseases Division of the Department of Pediatrics of the Medical School of Airlangga University (Unair)/Dr. Soetomo Regional General Hospital (RSUD), Surabaya