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KOMPAS.com – Scientists from several countries compete to find a vaccine against the corona virus. However, nothing has currently been approved.
Reported New York Times, Thursday (9/10/2020), generally years of research and testing are required to make a vaccine, but scientists are racing to produce a safe and effective coronavirus vaccine next year.
Researchers are testing 38 vaccines in human clinical trials, and at least 93 preclinical vaccines are under active investigation in animals.
Researchers began searching for a vaccine in January by breaking down the SARS-CoV-2 genome. The first vaccine safety trials in humans began in March.
Here is the vaccine testing process:
1. Preclinical tests
Scientists test the new vaccine on cells and administer it to animals such as mice or monkeys to see if it elicits an immune response.
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2. Phase 1
It is at this stage that scientists administer the vaccine to various people to test its safety and dosage and to make sure the vaccine stimulates the immune system.
3. Phase 2 (extended experiment)
The scientists then administered vaccines to hundreds of people who were divided into groups, such as children and the elderly. This is to see if the vaccines work differently for them.
This follow-up trial is testing the safety and ability of the vaccine to boost the immune system.
4. Phase 3 (efficiency tests)
Scientists administer vaccines to thousands of people and wait to see how many become infected, compared to volunteers who received a placebo. These trials can determine whether a vaccine protects against the coronavirus.
In June, the FDA said a coronavirus vaccine must protect at least 50 percent of vaccinated people to be considered effective.
Additionally, the stage 3 trial is large enough to reveal evidence of relatively rare side effects that may have been missed in previous studies.
5. Limited use (advance approval)
China and Russia agreed on a vaccine without waiting for the results of the phase 3 trial. However, experts say the rushed process carries serious risks.
6. Approval
Regulators in each country review the results of the trials and decide whether or not to approve the vaccine. During the coronavirus pandemic, vaccines may receive an emergency use authorization before obtaining official approval.
Once a vaccine is licensed, researchers continue to monitor the people who receive it to make sure it is safe and effective.
7. Combined phase
There is also a combined phase. This is one way to speed up vaccine development. Some coronavirus vaccines are now in phase 1/2 trials, for example, where they are first tested in hundreds of people. Write phase 1/2 means a combination of phase 1 and phase 2.
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3 limited approved vaccines
One step before a vaccine is approved is limited use or early approval. According to search NOW, there are 3 vaccines that have entered this stage.
1. CanSinoBIO
Chinese company CanSino Biologics is developing a vaccine based on an adenovirus called Ad5 in collaboration with the Institute of Biology of the country’s Academy of Military Medical Sciences.
In May, they released promising results from a phase 1 safety trial. Then, in July, they reported that a phase 2 trial showed the vaccine produced a strong immune response.
This move was unprecedented. China’s military approved the vaccine on June 25 for one year as “especially necessary medicine.”
CanSino won’t say whether vaccinations will be mandatory or optional for soldiers.
On August 9, the Saudi health ministry announced that CanSino Biologics would conduct a phase 3 trial in Saudi Arabia and the following month trials also began in Pakistan.
2. Gamaleya Research Institute
The Gamaleya Research Institute is part of the Russian Ministry of Health. They launched a clinical trial in June with a vaccine they called Gam-Covid-Vac.
It is a combination of two adenoviruses, namely Ad5 and Ad26. Both were engineered with the coronavirus gene.
On August 11, President Vladimir Putin announced that Russia’s health regulators had approved the vaccine. The vaccine was later renamed Sputnik V.
Vaccine experts have denounced the move as a risky move. Russia then later retracted the announcement.
They replace it by saying that approval is a “conditional registration certificate” that will depend on the positive results of the phase 3 trial.
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The trial was originally planned for just 2,000 volunteers, then expanded to 40,000 volunteers.
On September 4, three weeks after Putin’s announcement, the Gamaleya researchers released the results of the phase 1/2 (combined) trial.
In a small study, they found that Sputnik V produced antibodies against the coronavirus and had minor side effects.
3. Sinovac
The private Chinese company Sinovac Biotech is testing an inactivated vaccine called CoronaVac.
In June, the company announced that a phase 1/2 trial of 743 volunteers found no serious side effects and resulted in an immune response.
Sinovac then launched phase 3 tests in Brazil in July, and another in Indonesia the following month.
Reuters reported that the Chinese government gave emergency approval for the limited use of the Sinovac vaccine in July.
Meanwhile, Sinovac is preparing to produce the vaccine. They reached an agreement with Indonesia to supply at least 40 million doses of vaccine by March 2021.
