COVID19: Discovery of The Coronavirus Vaccine

Discovery of The Coronavirus Vaccine

Coronavirus Vaccine

Coronavirus Vaccine

What is a virus?

A virus is a very microscopic, non-living, biological particle. Impossible to see with the naked eye but can be seen under a microscope. Then the question arises, how do they grow in any animal or plant even though they are not living? Viruses do not reproduce, so how do you copy them? Simply put, in any living body (animal or plant) then cell division goes on that’s it, from one cell to two, from two to four. Living cells contain receptors. Viruses stick to this receptor. They then move into living cells. As the virus enters a cell, the same divisions continue, and so many infected cells are formed from a single particle of the virus.

A virus is a layer of proteins and the DNA or RNA in that layer. Your cells are always making copies of DNA. In the same way, once in the cell, the virus makes many copies of itself using DNA or other material in the RNA cell. Each copy is a new virus. When the material in a cell runs out, these viruses break out of the cell wall and come out. The animal in whose body all this was going on, gradually gets sick.

Gradually, the virus spreads throughout the body. If you get a vaccine or an antidote, then death is certain. The virus’s DNA can penetrate into an animal’s DNA and cause genetic changes by altering the DNA sequence. A lot of infected cells are made from a single particle of the #Corona virus. Corona is a spherical structure. It has a lot of spikes on its surface. A virus is a layer of proteins and the DNA or RNA in that layer. Your cells will always make copies of DNA.

What is protein?

Proteins are formed when a large number of amino acids combine to form hydrogen bonds (H-H). All enzymes are proteins. There is a famous sentence in chemistry for that. “All enzymes are protein but all protein is not enzyme”.

If the virus is not alive then how to kill it?

To kill the virus, it is first necessary to destroy the same protein sheath. So if it is caused by a chemical or liquid, it can be used in that Antiviral Drug. When that membrane is destroyed, the virus does not stick to any cell and is destroyed.  If a virus does not get a host, it automatically destroys itself in the air.

Why the name Corona?

The corona is a spherical structure. It has a lot of spikes on its surface. All in all, it looks like a crown. In Latin, Crown is called Corona. Hence the same name Corona (Crown like appearance).

#Covid-19 Naming: Co-Corona; Vi-Virus; D-Disease; 19-Found in 2019

Viruses are host specific, meaning that viruses that infect one species do not necessarily infect another. Studies said bats contain a lot of viruses. The corona found in the bodies of two animals, the bat, and the pangolin, it is similar to the current Covid-19.

What does the vaccine do?

There are different receptors on human cells and virus cells. This causes the interaction between the virus and human cells. Then the whole body becomes infected by doing two, four, eight in one cell. Some vaccines inactivate this receptor. If the receptor becomes inactive, there will be no interaction between the two and the virus will be destroyed. Some vaccines break down the protein shell of the virus. So only DNA or RNA remains and there is no interaction with any cell and the virus is destroyed. If a vaccine destroys the virus’s DNA or RNA, the virus cannot replicate it.

How did the virus spread from animals to humans?

It is difficult to say, but the first speculation is that the virus may have been transmitted to humans by drinking soup or eating uncooked beetroot. You know what is being eaten in China. It is also speculated that the virus may have been transmitted to humans through the eating of scaly cats and the eating of scaly cats by humans. But no one has yet agreed to both cases.

What is the mutation?

The mutation is a sudden genetic change in the genetic material of an organism. But mutation is very difficult to get into a virus on its own. The virus must be exposed to either a chemical or a physical mutagenic agent. E.g. chemicals like UV rays, EMS, Azide, or Acridine dyes. Even if there is genetic drift, is such a big drift really possible?

Why is the discovery of Coronavirus Vaccine is taking time? What is the general time required to discover a vaccine? What are the challenges scientists are facing to discover Coronavirus Vaccine? Before I delve into the topic, I will explain in detail about the drug discovery process.

Difference between Vaccine & Drug:

coronavirus vaccine

Difference between Vaccine & Drug

What is the vaccine? A vaccine is a biological preparation that provides active acquired immunity to a particular infectious disease. What is Pharmaceutical medication/Drugs? Medication is a drug used to diagnose, cure, treat, or prevent disease. The first and foremost step in the process is discovery & development.

The first step in the development of the Coronavirus Vaccine: Discovery & Development

The first step in the process of drug discovery is Discovery & Development. In this first step, the companies choose a molecule Such as a gene/protein to target with a drug. Many tests of molecular compounds to find possible beneficial effects against any of a large number of diseases.

At this stage of the process, scientists test thousands of molecular entities, small molecules, natural products, or plant extracts and look for a potential molecule for the development of the drug. Once a molecule is discovered the researcher will look for a promising compound for development to match with Coronavirus Vaccine, they conduct experiments to gather information on things like absorption, distribution, metabolism, and excretion.

Discovery & Development

coronavirus vaccine

Its potential action, dosage, the best way to take drugs (like in the form of tablets or injection). The drug side effects/ adverse effects & how it will act on different age groups, gender, race or ethnicity. The interactions with other drugs & their effectiveness compared with similar drugs.

Second Step in the development of the Coronavirus Vaccine: Pre-clinical Research

The second step in the development of the Coronavirus Vaccine involves Pre-clinical Research. In this second step the scientists divide the pre-clinical study into two parts, the first part involves an In-vitro study. The in-vitro study is nothing but testing the drug molecule in glass, as in a test tube. An in-vitro test is one that is done in glass or plastic vessels in the laboratory. Here, the researchers are testing the drug only in a laboratory without involving a study on living organisms.

The second part of the pre-clinical study is In-Vivo Study. In-Vivo Study is nothing but testing in the living organism i.e. an experiment that is done in vivo is done in the body of a living organism. In-vivo is the opposite of In-vitro.

In-vivo studies are performed on animals like Rats, Mice’s, Guinea pigs, Rabbits, etc. This study involves a complete study of the Coronavirus Vaccine/drug on animals. For example, if researchers want to develop a drug on diabetes, then scientists inject diabetes into a healthy rat and then the drug trials will start. The animal is under observation, blood and urine samples are collected at regular intervals to test the efficiency of the drug. An estimated 26 million animals are used every year in the United States for scientific and commercial testing.

Coronavirus Vaccine

Pre-Clinical Studies on Animals

Usually, preclinical studies are not very large. However, these studies must provide detailed information on dosing and toxicity levels. After preclinical testing, researchers review their findings and decide whether the drug should be tested in people. This step is very important since scientists move forward to crucial human studies for Coronavirus Vaccine in the next phase.

Step 3 in Coronavirus Vaccine Development: Clinical Research

This is the most important step in the development of the Coronavirus Vaccine/drug. Here scientists will follow a protocol that is developed by a researcher or manufacturer. Before the clinical research phase starts the researchers will research questions & objectives like the selection of participants, how long the study will last, how the drug will be given to patients & dosage, data analysis, and review.

coronavirus vaccine

Testing on Humans: Coronavirus vaccine

Then the drug developers must submit Investigational New Drug (IND) applications to FDA before beginning clinical research for Coronavirus Vaccine/drug. In this application, the developers include things like animal study data, toxicity, side effects, manufacturing information, study plan & information about the investigator is mentioned.

Here the clinical research for Coronavirus Vaccine/drug is divided into three phases:

In the first phase, 20-100 healthy volunteers with the disease conditions will be selected, the length of study ranges for several months. The purpose of this phase is to study the safety & dosage of the Coronavirus Vaccine.

In the second phase up to several hundred people (100-500 people) with the disease are selected. The length of the study will range from 1-2 Years. The purpose of this study is to determine the efficacy & side effects of the Coronavirus Vaccine/drug.

In the third phase, 300-3000 volunteers who have the disease are selected. The length of the study ranges from 1-4 years. The purpose of this study is to examine the efficacy & monitoring of adverse reactions. If the new drug performs the desired function, but only at a shallow level, the FDA may reject the application in favor of a formulation that performs better.

In the final & fourth phase participants ranging from 3000 to several thousand volunteers who have the disease are selected. The clinical trials are conducted to study the safety & efficacy of the drug among a large section of people. This study will last for several years.

Fourth Stage in the Coronavirus Vaccine Development: FDA Review

Once the new drug has been formulated for its best efficacy and safety, and the results from clinical trials are available, it’s advanced for FDA review. At this time, the FDA reviews and approves, or does not approve, the drug application submitted by the drug development company. If the new drug performs the desired function, but only at a shallow level, the FDA may reject the application.

coronavirus vaccine

FDA Review: Coronavirus Vaccine

Fifth Stage in the Coronavirus Vaccine Development: FDA Post-Marketing Safety Monitoring

Following drug approval and manufacturing, the FDA requires drug companies to monitor the safety of its drug using the FDA Adverse Event Reporting System (FAERS) database. FAERS helps the FDA to implement its post-marketing safety surveillance program. Through this program, manufacturers, health professionals, and consumers report problems with approved drugs.

So, to complete the whole process it will take almost 12-15 years and in some cases 15-20 years to discover a new drug following stringent rules and regulations by the FDA. In most of the cases even after discovering the drug and made available to the people still, some drug gets banned due to its undesirable and dangerous side effects. Discovering a vaccine and drug is not an easy process since it requires a lot of investments ranging from billion to trillion dollars. FDA should consider approving the Coronavirus Vaccine soon. 

So, discovering a drug/vaccine for Coronavirus takes considerable time. If the global scientist fraternity comes together and works extensively round the clock, the discovery of the Coronavirus Vaccine/drug may consume less time. Since it is an outbreak and a new disease, scientists are bewildered with its nature and symptoms, because the symptoms are unique for a different section of people.

Scientists strongly claim that 85% of the coronavirus cases heal by themselves if we boost the immune system.

Since the discovery of the drug is in the initial stage, controlling this pandemic has become a herculean task. Vaccines take typically years to develop but there are reasons to be hopeful that we could have a vaccine against the coronavirus pandemic in record time.

Current Progress on  Coronavirus Vaccine:

More than 40 vaccine candidates are being developed currently according to WHO. At the basic level of the development of a vaccine, scientists went from testing a weakened or killed version of the virus to injecting a protein that can fight against the virus.

When we think of the SARS outbreak in 2002-2003, it took about 20 months to go from genetic sequence to that first patient being dosed in a first clinical trial. Upstart Moderna a biotech company is leading the invention with a vaccine already in clinical trials. That is a record-breaking pace in about two months. So, this happened about 10 times quicker compared to the traditional discovery.

Scientists are working on mRNA technology to discover a new drug swiftly. Since it is a new technology, we need to wait for the people responding to this type. We call it an evolution of vaccine development. This technology works by creating copies of proteins with your own cells. The antibodies that can fight against the virus.

coronavirus vaccine

mRNA Technology

I have already mentioned that there are no approved mRNA vaccines on the market for Coronavirus Vaccine, so this is an experiment & unproven technology that will be tested in real-time against the coronavirus. There are about six or seven companies that hope to start clinical trials this year to discover Coronavirus Vaccine

So this phase will start in the late summer and the responses will be collected thoroughly. The initial data collected will focus more on safety and focusing on side effects and its tolerability levels on human beings. Additional studies have to be run to test if it works.

Some of the biggest drugmakers in the industry, including Sanofi & Johnson & Johnson have also jumped in the mix on Coronavirus Vaccine. Johnson is looking to start a clinical trial in November. Sanofi is estimated to start a clinical trial in early 2021. So those are much longer timelines as far as starting a clinical trial for Coronavirus Vaccine.

The competition is like a tortoise and the rabbit situation, where they have proven technology, they’ve done this many times, they have the resources of big pharmacy companies to pump out this to a mass market of hundreds of millions of people if needed. So those approaches are also worth watching and they’re moving as fast as they can on that front to work on Coronavirus Vaccine.

Funding for The Coronavirus Vaccine:

Vaccine/ Drug development is really expensive, and with infectious diseases, it’s hard to know the return on investment (ROI) for these companies. So there’s a big funding gap with vaccine development for Coronavirus Vaccine that remains unanswered. It’s worth considering the case of Merck, one of the biggest drugmakers in the world.

They have the only FDA-approved Ebola vaccine that took several years of clinical trials at an unimaginable scale. Merck pharma invested hundred & millions of dollars to get this done and it essentially a net loss for the company financially.

One group that helped accelerate the pace of vaccine development is called CEPI- The coalition for epidemic preparedness innovations. This was started by the Bill & Melinda gates foundation along with a lot of other philanthropic support in 2017. This funding has helped in the progression of drug development in the early stages. So, a lot of funding is required for Coronavirus Vaccine.

coronavirus vaccine

Funding for Vaccine/Drug

There’s a lot of unknown surroundings of Coronavirus Vaccine if we get to that point with a vaccine candidate what happens next? How much data will the FDA require? Could the FDA offer emergency Approval for Coronavirus Vaccine? What would pricing & accessibility look like? Particularly if small biotech like Moderna or some of these other small companies is progressing candidates into the clinic in 2020, if one of those vaccines is found to be safe & effective, how can a small biotech scale that up to deliver a Coronavirus Vaccine to hundreds & millions of people.

If these companies need to run much larger clinical trials enrolling thousands of people for Coronavirus Vaccine. How will they pay for that, how much will it cost, can they make a return of investment on that, and make a business case for that? Or will philanthropic sources like CEPI, private funding organizations step in to fund the research work? The discovery for Coronavirus Vaccine takes time as I mentioned if a new technology comes to light may be a Coronavirus Vaccine will emerge soon.

Alternative Drugs for Coronavirus:

Many alternative drugs like anti-malarial & antiretroviral drugs are suggested to cure the pandemic coronavirus. Hydroxychloroquine is recommended for the treatment of Corona as alternative medicine and outcomes of this medication are giving hope to the scientists.

coronavirus vaccine

Hydroxychloroquine Tablets

The sudden demand for this drug is making it scarce and the patients who are actually in need of this drug are suffering. Relying completely on this drug is not a fair idea, because the exact role of this drug in curing corona is unknown.

Is the corona a biological weapon?

Technology has not yet developed enough to make a virus into a biological weapon by hand. Second, SARS in 2003 and MERS in 2008 were both caused by corona. The Covid-19 is a variant of the Corona. Just as humans have characters, viruses have strains. Earlier it was called n-COVID 2019, which means the new strain of corona found in 2019.

Information found while writing on this, a tweet by Anand Ranganathan, Professor of Genetic Engineering at JNU on 31/01/2020. In that tweet, he said that the four proteins found in the coronavirus were inserted from HIV / AIDS. Insertion is also a type of mutation. The structure of HIV and corona looks very similar.

And the Thai scientist said that the patients who improved were treated with HIV and the flu drugs. Bioinformatics shows that four proteins are similar. While classifying the virus itself, HIV enters the Retrovirus and Corona Rhabdovirus. Then the viruses, which are different in classification, make the same protein, except for one, four. The main thing is that both of them have genetic material RNA.

The second and most noteworthy thing is that on December 1, the first corona patient was found in China and the news of the virus reached the whole world on January 17. In the same 47 days, China had transmitted itself to about six countries. Now there are only six countries left where the corona has not spread. And almost everyone says that the corona is a biological weapon.

Conclusion:

Corona infections heal faster if the immune system is good. Mortality Rate of this disease is Only 34 out of 1,000 people are being killed. Despite the lack of vaccines, 90,000 of the 250,000 people have been cured, and about 35,000 are recovering rapidly. Scientists have been able to isolate the corona’s RNA and proteins. So the vaccine will be ready soon but the testing time will take time.

We hope a new Coronavirus Vaccine will be in the market soon. Until then follow strict diets, Consume lots of water, take immune-boosting food, follow the necessary precautions, stay away from unnecessary gathering & be safe.

References:

  • https://www.nature.com/articles/nrd.2017.243
  • https://en.wikipedia.org/wiki/Drug_discovery
  • https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
  • https://www.modernatx.com/

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