JAKARTA, SENAYANPOST.com – The vaccine development process for the Covid-19 corona virus is still ongoing.
Launching The Guardian (14/10/2020), so far there are more than 170 vaccines being researched, and as many as 11 candidates have reached stage 3.
Here’s the list:
1. Oxford / Astra University
2. Zeneca BioNTech / Fosun Pharma / Pfizer
4. CanSino Biologics Inc./Beijing Institute of Biotechnology
5. Modern / NIAID
7. Wuhan Institute of Biological Products/Sinopharm
8. Janssen Pharmaceutical Companies
9. Gamaleya Research Institute
10. Beijing Institute of Biological Products/Sinopharm
11. University of Melbourne/Murdoch Children’s Research Institute
Many people wonder, does the vaccine manufacturing process take such a long time?
What are the processes that must be followed until a vaccine that is approved is ready to be distributed and used?
Launching Kompas.com from ABC, a vaccine will be declared safe, effective, and ready for widespread use when it is proven safe and effective enough for humans to use to maintain immunity from viruses.
To find out whether vaccines are safe and effective, experts or development companies will test vaccines on animals and humans in several stages.
Usually for human testing will consist of three stages, the implementation of which takes up to years.
In the first stage, the number of people who volunteer to receive the vaccine is still small, then the number increases with each subsequent stage.
After being given in three stages, an evaluation of the trial results will be carried out.
Are there certain reports that come from the volunteers after receiving the vaccine, for example side effects, infections, complaints, or everything is going well, and so on.
In addition, of the number of volunteers available, not all received the actual vaccine, some others received placebo or blank drugs for research control.
If the volunteers who received the placebo were infected or had more severe infections while the vaccine recipients did not, it means that the vaccine was working effectively.
This is because vaccines are designed to reduce the potential for infection and relieve the symptoms of those who are already infected.
For your information, throughout the trial phase 1-3, the process is regularly evaluated by a special agency that has the authority to end the trial process, if the results shown are too dangerous.
If the results show the effectiveness and safety of use, the existing data is then submitted to the Food and Drug Administration for further review and obtaining a license or approval.
The US Food and Drug Administration (FDA) says vaccines must protect a minimum of 50 percent of people vaccinated for consideration and full approval.
There, the data will be examined by an Advisory Committee consisting of 15 experts, most of whom are infectious disease specialists.
After that, the recommendations will be forwarded to the Center for Biological Evaluation and Research, then returned to the FDA Commissioner, Stephen Hahn.
“I promise you that when the data is available, the FDA will review it, using a rigorous and deliberate scientific process,” he said.
“We hope that by the end of October there will be enough data to say whether (the vaccine) is working or not. If that is enough, we can say whether the product is safe and effective and send it immediately for approval,” said Pfizer CEO Albert Bourla.
However, sending this data does not mean that the vaccine is ready for distribution and use by the community.
“The assumption that the vaccine will be ready for use in late October or early November, I think is ridiculous. That is not possible,” said Professor of Bioethics from New York University, Arthur Caplan.
Except, if there is any political pressure or pressure that makes the FDA issue an emergency use agreement, it is not based on full consent.
For example, US President Donald Trump, who urged a vaccine to be available immediately before the presidential election, November 3, 2020.