Tag: trendy

Unheard Part – 1

Horror Fiction, story

Horror Fiction by Palak Thakur

have you ever heard something unheard…

Sometimes they call us, sometimes they watch us, sometimes they talk to us, sometimes they…..

They exist??

Yess, they do exist like you and me, they too exist!!

Just imagine, we cross a number of roads, alleys, buildings, people, houses, lanes and more but have you ever heard something UNHEARD. You may have heard people saying their is something in here, in this place, a different kind of noise or sound comes when we cross….

How will it be stopped!! If they have faced something tragic, something very painful,

something beyond our imagination….

Something that has captured them, and they remained creating this dreadful noises. If you ever visit there, you will found a weird kind of vibe, like someone from a parallel universe is calling you, saying something to you, or just want you to be with them…ALWAYS and ALWAYS!!

The noises behind the door of every holy terror place!!

Just like one of them there’s a place called NORTHERN SENTINEL ISLAND which is one of the Andaman islands, an archipelago in the Bay of Bengal. It is home to the Sentinelese, an indigenous people in voluntary isolation who have rejected, often violently, any contact with the outside world. They are among the last tribal people to remain virtually untouched

by modern civilisation.

It is said that just one encounter with any of sentinelese, and GAME OVER!!

India has banned its citizens from visiting North Sentinel Island or attempting to make contact with the people who live there. Going within three miles of the island is illegal.

WHAT IS THE SECRET BEHIND THIS??

In search of this, an American John Allen Chau landed on this island with a motive to convert the uncivilized people as Christians. Breaking every rule he went inside the island in search of this people,

he took out his camera and started shooting as he was an adventurous blogger. He started shooting the beach, the ocean, and then went inside the forest and was thinking this is gonna be soo

exciting, but probably he was unaware of happenings that are going to be happen with him. And now it was time for dawn…..

So he prepared for a tent and thought of watching the video that he shot. So he started watching them and suddenly!!!

He saw something UNIDENTIFIED and WEIRD in the video like someone has put hands on his shoulder, he got shocked when he saw this and got frightened and…….

Why is Phase-3 of Vaccine Trial Complicated?

Uncategorized

Written by Inshaa Siddiquee

The Covid-19 outbreak has proved to be one of the most challenging phases in our lives. However, many companies are racing towards developing a safe and effective vaccine to protect against Covid-19. Moreover, Phase 3 trials of investigational vaccines are underway.

How are vaccines developed?

New vaccines are tested in clinical trials to determine that they are both safe and effective. After the successful completion of clinical trials, they get licensed in US.

A lot of testing is done before a vaccine ever gets tested in humans. There is a long process of development in the laboratory.

The vaccine is firstly tested on various animals like mice, rabbits, hamsters and primates that have similar human physiology. After which their responses and reactions are studied. Because it is unclear whether these vaccines will work or not, a very structured set of clinical trials begins.

If the vaccine has proven itself it enters the Phase-1 studies.

What Happens in clinical trials?

The phase involves healthy volunteers who are informed about how and why these vaccines are being tested and also about a new potential harm. This process is called Informed Consent taken place before entering the trial.

The clinical trial comprises of 4 phases.

PHASE -1

PHASE -1 includes human pharmacology and safety. Testing takes place among a small group of people (roughly 30-60). It’s given in small doses and monitored to see if it is safe and well-tolerated.

However, a drug’s side effects might be subtle or restricted to a few people. In reference to this Phase-1 trial are not expected to identify all the side effects

PHASE -2

Phase-2 includes testing with a large group of people around 100-300 to determine the safe dosage range to get the desired response.

In reference to Covid-19, AstraZeneca vaccine had been put at halt at this stage. The pause was due to a harmful side effect reported by a volunteer in US who had been injected with the vaccine.

Nevertheless, promising vaccines that are safe and generate strong immune response move into phase-3 trials.

PHASE-3

Phase-3 is a larger version of phase-2 trial. It is held in multiple locations to capture the demographic variability in the population. It a complete randomized and double-blinded trial. Half of the volunteers are given the vaccine, whereas the other half are given placebo (salt water). As the process is double-blinded, neither the participants nor the study staffs are aware about who is getting which type of injection.

Furthermore, the study compares the rate of infection and placebo groups. It tells us whether the vaccine will be able to prevent the infection and if so, if it is effective enough in all of the volunteers or only a sub-group. Along with the safety data that is collected in all phases of vaccine studies, this efficacy data is used by the FDA to decide if the vaccine should be licensed.

In the case of Covid-19, there is an occurring trial of the US-MRNA vaccine.

The CEO of Moderna, Stéphan Bancel said, “The phase-3 for vaccine is a typical clinical trial, it’s a very large one of 30,000 people, 15,000 will receive the vaccine, whereas 15,000 will receive placebo and we will be able to see through data what is the safety of a vaccine and what is the efficacy of a vaccine”.

Across Europe, Brazil and other locations the Oxford vaccine is likely to be tested in the same way.

PHASE-4

A vaccine which clears all the phases is further sent for approval and license. After which the entire company is devoted to creating the vaccine in bulk, safely without it degrading or losing potency.

Post marketing studies delineate additional information, including the treatment’s risks, benefits, and optimal use. As such, they are ongoing during the drug’s lifetime of active medical use.