The development of several potential COVID-19 vaccines is nearing the final stage. Should the vaccines get produced, fair access to the vaccines must be realized.
By
KOMPAS TEAM
·6 minutes read
COURTESY OF UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE VIA AP, FILE
FILE - This May 4, 2020, file photo provided by the University of Maryland School of Medicine, shows the first patient enrolled in Pfizer\'s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore. On Monday, Nov. 9, 2020, Pfizer said an early peek at its vaccine data suggests the shots may be 90% effective at preventing COVID-19. (Courtesy of University of Maryland School of Medicine via AP.
Geneva, Tuesday – The World Health Organization (WHO) has talked about the importance of fair access to and distribution of COVID-19 vaccines. The organization pointed out as well the challenge that Asian and African countries would face in distributing the vaccines.
WHO director general Tedros Adhanom Ghebreyesus asserted that access to COVID-19 vaccines must be equal following the announcement of a potential vaccine that would be reportedly distributed in the near future. The announcement was made by Pfizer, which has been developing a vaccine together with BioNTech.
“It is predicted that we would have a vaccine by the end of this year,” said Ghebreyesus during a meeting between the health ministers of WHO member states on Monday (9/11/2020) evening in Geneva, or Tuesday morning according to Western Indonesian Time (WIB).
Ghebreyesus’ concern over access to vaccines is founded upon, among other reasons, the fact that Pfizer has a contract worth millions of dollars with the US and a portion of European countries. The contract automatically puts the US and several European countries as the first recipients of the vaccine.
In a number of international forums, Indonesia has touched upon the issue of equal access to vaccines as well.
The WHO worries about the way the COVID-19 vaccines will be distributed. Another concern is the fact that the vaccine developed by Pfizer and BioNTech must be stored at a temperature of minus 70 degrees Celsius or below. This requirement will pose great difficulties in Asian and African countries with warm climates. The WHO has encouraged the international community to provide aid for African countries so that the distribution challenges could be overcome in the region.
It is predicted that we would have a vaccine by the end of this year.
DAVID DEE DELGADO/GETTY IMAGES/AFP
People walk by the Pfizer headquarters on November 9, 2020 in New York City. Pharmaceutical company Pfizer announced positive early results on its COVID-19 vaccine trial and has proven to be 90% effective in preventing infection of the virus.
Clinical trials
Other than Pfizer and BioNTech, there are several other pharmaceutical companies that are at a late stage in vaccine development. This includes Sinovac, which currently has its vaccines clinically tested in several countries. The clinical trials of the Sinovac vaccine in Brazil, however, have been temporarily put on hold by Brazil’s National Health Surveillance Agency, Anvisa, since Monday.
Sinovac’s partner in Brazil, Butantan Biomedical Institute, said the suspension of the clinical trials was not related to the vaccine itself. Butantan director Dimas Covas explained there had been an incident involving one of the volunteers participating in the clinical trials. Regardless, the incident had been investigated and it is confirmed that the incident was not correlated with the vaccine.
Sinovac has pledged its commitment as well to address the issue together with Butantan and Avinsa. “The clinical trials in Brazil will be continued under a strict mechanism that is in line with good health management,” said Sinovac.
Previously, Sinovac and Butantan announced that the clinical trials of Sinovac’s vaccine would involve around 130,000 people in Brazil. Meanwhile, in China, tens of thousands of people have been injected with potential vaccines developed by several pharmaceutical companies. However, many have voiced out their concern about the side effects of the potential vaccines, which have been developed in a hasty manner.
In Indonesia, the phase III clinical trials of Sinovac’s vaccine in Bandung, West Java, are still ongoing. There has yet to be a report on volunteers suffering from serious side effects post-vaccination. As many as 1,620 volunteers in Bandung were injected with the first dose of the potential vaccine or a placebo. After this, the second dose of vaccine was injected to 1,603 volunteers. Now, 1,335 volunteers are being monitored so that their immunity and the vaccine’s efficacy and safety could be examined.
“There has yet to be any reports on serious post-immunization accidents (KIPI),’ said Rodman Tarigan, the spokesperson of the Padjajaran University team conducting the phase III clinical trials of Sinovac’s vaccine, on Wednesday (11/11) in Bandung. The health condition of volunteers has been closely monitored by the team.
AP PHOTO/NG HAN GUAN
Syringes of SARS CoV-2 Vaccine for COVID-19 produced by SinoVac are displayed during a media tour of its factory in Beijing on Thursday, Sept. 24, 2020. A Chinese health official said Friday, Sept. 25, 2020, that the country\'s annual production capacity for coronavirus vaccines will top 1 billion doses next year, following an aggressive government support program for construction of new factories.
The clinical trials of Sinovac’s vaccine in Bandung started back in August and were predicted to conclude within six months. If it successfully passes the clinical trials, the vaccine will be produced by PT Bio Frame in the first quarter of 2021, with a production capacity of 250 million doses per year.
Novilia, a member of PT Bio Farma’s pharmacovigilance expert team, affirmed that post-immunization accidents might occur, both for vaccines that are widely marketed and those under trial. If accidents happen during clinical trials, they will be reported to the Ethics Committee, the Food and Drug Monitoring Agency (BPOM) and the Data Safety Monitoring Board.
We are waiting for the results of clinical trials in Bandung.
According to Novilia, further investigation is required regarding the post-vaccination accident that took place in Brazil to ensure whether or not the accident was related to the vaccine. In this regard, postponing the clinical trials is in line with the standard procedure for investigation into serious post-vaccination accidents.
On a separate occasion, Health Ministry secretary-general Oscar Primadi said the procurement of COVID-19 vaccines continued to be pursued. “We have to wait for a joint decision pertaining to vaccine procurement. As for when and where the vaccinations will occur, as well as which potential vaccines will be used, this is still being deliberated. We are waiting for the results of clinical trials in Bandung,” said Oscar.
A woman holds a small bottle labelled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020.
Virus mutation
The virus has continued mutating, which may adversely impact potential vaccines’ effectiveness. The genomes of 50 percent of the virus’ samples in Indonesia have been tested, and it is found that the virus’ membrane proteins have mutated. In Europe, two new virus mutations have reportedly triggered a second wave of the COVID-19 pandemic and caused two-way human-to-mink transmission.
“"The C26735T mutation is located in the membrane protein (M) of the 71st amino acid sequence, namely Y71. The mutation occurs quite dominantly. It occurs in 50 percent of the 108-genome sequence data from Indonesia, as published in GISAID,” said Riza Arief Putranto, a molecular economic researcher and founder of Aligning Bioinformatics.
This mutation has not changed the amino acids and the virus structure.
The mutation was first detected in a sample analyzed between July and August. Other than in Indonesia, the C26735T mutation has also been frequently found in Malaysia. However, the mutation is rarely found in other countries, including the US and Brazil. “This mutation has not changed the amino acids and the virus structure,” explained Riza.
As a ribonucleic acid (RNA) virus, SARS-CoV-2 will continue to mutate. Previously, S D614G mutation had been detected, which made the virus more contagious. This mutation has also been found in Indonesia. "Currently, mutations that are more alarming are the S Y453F and S A222V mutations found in Europe," said Riza.
