Sunday , September 20 2020
COVID-19 vaccine
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Covid-19 vaccine development regulations

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. People infected with the COVID-19 virus will experience mild to moderate illness related to the respiration system and recover without any special treatment. Those with underlying medical problems like chronic respiratory disease, cardiovascular disease, diabetes, and cancer, and older people are more likely to develop serious illness.

Protect yourself and others from infection by social distancing, washing your hands or use an alcohol-based rub frequently and not touching your face is the best way to prevent and slow down the transmission of coronavirus.

Covid-19 primarily spreads through droplets of saliva or discharge from the nose when an infected person sneezes and coughs, so it’s important that you also practice respiratory etiquette.

At this time, there is no specific vaccines or treatments for COVID-19, however, there are many ongoing trials on treatments and vaccines. The most effective way to prevent diseases is vaccination. A vaccine helps the body’s immune system to fights pathogens like viruses and bacteria, which then keep us safe from the diseases they cause. Diseases including polio, measles, tetanus, diphtheria, meningitis, influenza, typhoid, and cervical cancer are cured by vaccination.

Vaccination for Coronavirus (COVID-19):

Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private bodies. At the end of the 19th century, several vaccines for humans had been developed they were smallpox, rabies, plague, cholera, and typhoid vaccine.

But as per now, there is no specific vaccine came out for coronavirus (COVID-19). There are a number of trials that are going on for testing of vaccination and treatment.

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Currently, about 140 vaccines are in different stages of trials around the world. According to the World Health Organisation (WHO), 16 vaccines candidates enter into the last stage trials – clinical trials. Of these 16, five are being studied in China, three in the United states of America, two in the United Kingdom and one each in Australia, Germany, and Russia.

Besides, in a major development for India, India’s first vaccine candidate against (COVID-19) virus has received a nod from the drug controller general of India (DGCI) for further clinical trials phases 1 and 2 in infected people. Hyderabad-based biotechnology firm Bharat Biotech in collaboration with the Indian Council of Medical Research(ICMR) and the National Institute of Virology(NIV) are working together on this underdeveloped vaccine.

The clinical trials of the experimental coronavirus vaccine in humans are scheduled to begin in July 2020. In a note, it is said by Bharat Biotech: “COVAXIN has been expedited through national regulatory protocols and subjected to “pre- clinical studies” which reports that the results are “promising” and “show effective immune responses and extensive safety. Indian government leader Prime Minister Narendra Modi directly taking the reports of vaccine development.”

Vaccine development and testing follow a standard set of steps, it is a long way process research and testing can take up to 10 years.

Stages of a clinical trial:

First step: Laboratory and animal studies

Exploratory stage: This stage involves basic laboratory research and often lasts up to 4 years. Privately funded and government scientists identify the natural or synthetic antigens that might help to disaffect and treat disease. These antigens could include virus-like particles, weakened viruses or bacteria, weakened bacterial toxins, or other substances derived from the pathogens.

Pre-clinical stage :  Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response.animal subject may include mice and monkeys. These studies give scientists an idea of the cellular responses they might expect in humans. They may suggest a safe method for administering the next phases of the trial. Researchers may adapt the candidate vaccine during the pre-clinical state to try to make it more effective.they may also do challenge studies with the animals, meaning that they vaccinate the animal and then try to infect them with the target pathogen.

Also Read : Footprints of COVID-19 on environment

The pre-clinical stages often last up to 2 years, many vaccines candidates never progress beyond this stage because of failure in producing the desired immune response.

Next stage: Clinical studies with human subjects. Clinical studies with human subject divide into three parts.

First phase : The first phase of the clinical trial involving humans as a subject usually involves a small group of adults, of between 20-80 subjects.if the vaccine is intended for children, researchers will first test it on adults and then gradually step down the age of test subject until the required results found.

Phase 1 trial goals are to assess the safety of the candidate vaccine and to determine the type and extent of the immune response that the vaccine provokes. In a small minority of phase 1 vaccine trials, scientists may use the challenge model, attempting to infect the participants with the pathogen after vaccinating them. These studies are carefully monitored and conditions are controlled. An effective and promising phase 1 trial will progress to the next stage.

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Second phase : After a promising phase I trial researchers lead to the second phase in which a larger group of several hundred individuals participants in phase II testing. Some of the individuals may belong to group at risk of acquiring the disease. These studies are randomised and well controlled and include a placebo group.

The goals of phase II trial are to study the vaccine’s safety, immunogenicity, proposed dates, immunisations schedule and delivery method.

Third phase : Successful candidate vaccines move to the third phase of trial means larger trial, involving thousand to tens of thousand people. These phase III tests are randomised and double blind and involve the experimental vaccine being tested against a placebo (the placebo may be a saline solution, a vaccine for another disease, or some other substance). Phase III goals is to asses vaccine safety in a larger group of people. Certain rare side effects might not surface in the smaller groups of subjects tested in earlier phases.

Vaccine efficacy is tested as well. These factors might include:

1) Does the candidate vaccine prevent disease?
2) Does it prevent from infection of pathogens?
3) Does it lead to production of antibodies or other types of immune responses related to pathogens?

Last stage is the approval and licence from the drug controller, after they monitor the supply chain and proper distribution of vaccine. Vaccines are developed, tested and regulated in a very similar manner to other drugs. In general, vaccines are even more thoroughly tested than non vaccine drugs because the number of human subjects in vaccine clinical trial is usually greater.

Conclusion:

Coronavirus is becoming very dangerous day by day for human species, cases are increasing rapidly and death trolls are raised, this is a pandemic situation which people all over globe are facing a major vaccine development is required to control, reduce and cure the coronavirus effects and we hope our researchers and scientist find out a solution before coronavirus (covid-19) become uncontrolled.

– Nimit Saroha is a third year law student at Law College Dehradun, Uttaranchal University

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