LAST UPDATE ON THE DEVELOPMENT OF THE COVID-19 VACCINE

Covid-19 has become a global health problem. As of 26 November 2020, nearly 60 million cases have been confirmed with nearly 1.5 million deaths. The Covid-19 vaccine is currently the only hope to break the chain of transmission. More than 150 types of vaccines for Covid-19 have been developed around the world. The World Health Organization (WHO) has also coordinated vaccine development, and is expected to deliver 21 billion doses of vaccine by the end of 2021 to the world's population.

            Under normal conditions it takes about 10 to 15 years for vaccine development to reach the market. The fastest vaccine development in history was the development of the Mumps vaccine in 1960 which took 4 years. Vaccine development must go through three stages of clinical trials before obtaining approval from competent authorities such as the Food and Drug Administration (FDA) or BPOM. Once a vaccine is approved, other issues to think about are production, distribution, and which population should get the vaccine first, and how much it costs. Several vaccine developers run the clinical trial phase concurrently to shorten the time. Meanwhile, the FDA appears hesitant in issuing emergency use authorization (EUA) which allows vaccines that have not been approved for use in an emergency setting in any vaccine candidate. The FDA also says that a vaccine is likely to be available in mid-2021.

            Vaccines aim to induce a stronger immune system than what occurs through natural infections. Vaccines also have fewer health consequences than natural infections. Some vaccines are developed using all parts of the Corona virus that are attenuated or killed, some use protein components or fragments of the virus. Another method is to use another harmless virus as a vector. Here are some vaccine developers who have reached their third phase of clinical trials even though they haven't announced the final results yet.

            Pfizer is one of the largest pharmaceutical companies in the world based in New York. This vaccine candidate is a messenger RNA (mRNA) vaccine which is part of the genetic material of the Corona virus. This type of vaccine injection can trigger the production of viral proteins that resemble the Corona virus and train the immune system to recognize viral proteins. Two injections are required with an interval of 21 days.

            The University of Oxford from the UK is collaborating with AstraZenica, a biopharmaceutical company to develop a vaccine with Adenovirus as a vector. The research team transferred the "spike protein", a protein that helps the Corona virus to attack cells, into an attenuated Adenovirus vector. It is hoped that when the vaccine containing the "spike protein" is injected into humans, it can trigger an immune response. AztraZenica and the University of Oxford have announced a phase two clinical trial that has been published in The Lancet, this vaccine candidate produces a strong immune response in the adult age group including older adults with mild side effects such as headache and fatigue.

            In their phase three clinical trial, they recruited up to fifty thousand volunteers in the UK, Brazil, South Africa and also the United States. On 23 November 2020, the company announced the results of a phase three clinical trial at two different sites, first, in the UK this vaccine demonstrated 90 percent effectiveness in preventing Covid-19. But in the second trial in Brazil the effectiveness was only 62%. AztraZenica and Oxford University claim to be able to produce three billion doses of vaccine in 2021. The vaccine is said to be stored at normal refrigerator. The company also plans to register the "emergency use of the authorization" to WHO.

            Sinovac is a biopharmaceutical company from China that developed a vaccine for Covid-19 under the name CoronaVac. This vaccine uses a non-infectious type of Corona virus to trigger an immune response. A preliminary clinical trial report published in The Lancet states that this vaccine is safe, but produces a moderate immune response and results in lower levels of antibodies than antibodies formed in natural infections. The phase three clinical trial was conducted in July 2020 and recruited nearly nine thousand volunteers in Brazil, Bangladesh and Indonesia.

            Moderna Therapeutics, in collaboration with the National Institutes of Health, is a biopharmaceutical company based in Massachusetts. This vaccine is an mRNA vaccine. This vaccine is given twice at an interval of 4 weeks. From the phase one clinical trial, it was found that giving this vaccine to healthy and elderly subjects can produce antibodies against the Corona virus. The company started its phase three clinical trial in July, recruiting thirty thousand volunteers in the US. On November 16, 2020, the company announced that this vaccine was 94.5% effective in preventing Covid-19 and preventing the occurrence of severe cases with mild side effects. The vaccine is said to be stored in the normal refrigerator for 30 days. Moderna also plans to submit an “emergency use of authorization” to the FDA. The company hopes to produce 20 million doses of the vaccine by mid-2021.

            The Gamaleya National Center of Epidemiology and Microbiology is a research institution in Russia that receives direct funding from the state. The vaccine for Covid-19 is known as Sputnik V. The institute has developed a vaccine with attenuated Adenovirus as a vector to introduce the SARS-CoV-2 "spike protein" into the body. This vaccine requires two injections with an interval of 21 days to increase the immune response. The results of phase one and two clinical trials published in The Lancet Journal show that the vaccine can produce antibodies and reactions from T lymphocytes. In August, the Russian government granted permission for widespread use. Russia claims that Sputnik V is the first vaccine to be registered on the market, although little evidence has been published. On November 11 Gamaleya announced the interim results of the phase three clinical trial and found that the Sputnik vaccine was 92% effective. However, according to experts, the data is less convincing because it is only based on 20 cases.

            How is the development of vaccines in Indonesia? Indonesia with a large population is important to have a vaccine independently. Six institutions in Indonesia, consisting of: Bandung Eijkman Institute, Indonesian Institute of Sciences (LIPI), University of Indonesia (UI), Gajah Mada University (UGM), Bandung Institute of Technology (ITB), and Airlangga University (Unair), are also developing. The "Merah Putih" vaccine using a virus isolate that was transmitted in Indonesia. The development was also carried out by experts from Indonesia. However, until now there has been no published scientific data. Several biopharmaceutical companies in Indonesia have also collaborated with several foreign companies such as Biofarma with Sinovac from China, Kalbe Farma with Genexine from South Korea, and Kimia Farma with G42 from the United Arab Emirates. Biofarma targets the production of 250 million doses of vaccine in mid-2021.

            The Indonesian government has prepared a vaccination program for Covid-19, the Ministry of Health has trained around seven thousand health workers as vaccinators, also in vaccine management and cold chain. According to the Committee for Handling COVID-19 and National Economic Recovery, Indonesia already has adequate infrastructure for the vaccination program. Meanwhile, the public must be patient until the announcement of the results of the phase three clinical trial which is the basis for the issuance of a permit by the BPOM before the Covid-19 vaccine can circulate in Indonesia.