Are We Very Near to the Breakthrough for Coronavirus Vaccine?

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Are We Very Near to the Breakthrough for Coronavirus Vaccine?

 Are We Very Near to the Breakthrough for Coronavirus Vaccine?

The COVID-19 pandemic has exposed humanity against the deadly virus, which has left the whole world under shambles. The kind of destruction the world has witnessed in the last few months in terms of health, wealth and well-being is quite unprecedent.

Many corporate stalwarts and philanthropists across the world such as Bill Gates – the co-founder of Microsoft Corporation (MSFT: NASDAQ) and Chairman and co-founder of Bill & Melinda Gates Foundation have called this pandemic a war-like situation. Gates, who has been fighting the microbicide for almost two decades said that there is one exception in this war and all other wars, that we all are on the same side.

In a TED Talk which came in 2015, the visionary leader then had said that the next world war which would kill millions of people would not be a nuclear war, instead, it would be a novel virus which will take millions of lives and the world healthcare system is not ready for fighting against that novel virus.

Indeed, it became the novel virus COVID-19, which emerged in the Wuhan City, Hubei Province of China and now had spread in over 220 countries and territories around the world. As on the date of writing this article total, infected cases across the world crossed the 3 million mark, and almost 228,500 have reportedly died so far. Yet, we do not have any exact vaccine to cure the spread and help in the recovery of those who are still struggling for life over death around the world.

Historically, vaccines have saved millions of people against any epidemic rather than any other tool.

So, the question is despite the huge evolution of technology, why we cannot have a vaccine very soon. To better understand the development of the vaccine, we should first need to know about the stages of vaccine development.

Generally, the time frame for vaccine development for a newly found disease is over five years, which can be called a big span of time. This process is divided into six different steps.

  1. Making a Candidate Vaccine: A candidate vaccine virus is an influenza virus that is prepared by the Centre for Disease Control and Prevention (CDC) or another public health partner. The creation of a candidate vaccine for a new virus is a multistep process that takes months from start to finish.
  2. Testing vaccine on animals: Testing vaccine on animals is a scientific test and is also known as in-vivo testing. This approach involves field studies as well, in which animals are observed in their natural environments or habitats. This also takes months to get the surveys done.
  3. Safety testing on the small number of people (Phase 1 clinical trial): Phase-I clinical trials of a new vaccine are usually the first that involve people. The phase I studies are primarily aimed to find the maximum dose of the new treatment that can be given to the person being tested in a safe manner without serious side effects. This study normally lasts for a number of months.
  4. Safety and efficacy testing in medium numbers (Phase II Clinical trial): Generally, a batch of 25 to 100 affected persons with the same type of illness get the new medication in Phase II clinical trial. These batch of patients undergo treatment using the similar process and exact dose which had been found to be innocuous and most effective in clinical trials of phase I. All the volunteers are generally given the same dose in Phase II as well.
  5. Safety and efficacy testing in large numbers (Phase III Clinical Trial): Phase III clinical trials involve a large number of patients and these studies are often done in many places across the country or across the world at the same time. Also, these safety and efficacy testing have a long spell of study than Phase I and Phase II studies.
  6. Final regulatory approval and post making surveillance (Phase IV Study): Post a Phase-III clinical trials show a new drug/vaccine is more effective or safer, then a new drug application (NDA) is submitted to the Food and Drug Administration (FDA) for final approval and production ramp-up. The clinical trial results are reviewed by the FDA, through other pertinent piece of evidence related to it. Once the FDA approves the drug or the vaccine, they are made available for the doctors, who on their part, advise them to the patients for use based on the prevailing condition of the patient. However, all do not end here, a Phase-IV study may still be required to uncover several other facts and these studies may require thousands of people for trial.

So, given the meandering and a rather lengthy process of vaccine development, it does not seem that a COVID-19 vaccine is going to be available before 2021.

However, the researcher can save time by constricting the phase 1 and phase II trials at the time of conducting the animal trails and start building the manufacturing capacity simultaneously. Despite that no one can predict certainly that which vaccine approach will be workable; therefore, a number researcher needs to be funded so that vaccine development can be advanced at full speed. In the case of COVID-19 vaccines, the regulatory bodies have to decide how big the safety database needs to be agreed upon for a Coronavirus vaccine.

Nearly 70 COVID-19 candidate vaccines are being tested globally, and six candidate vaccines are in clinical evaluation trial phase.

Platform

Type of candidate vaccine

Developer

Coronavirus target

The current stage of clinical evaluation

NonReplicating Viral Vector

Adenovirus Type 5 Vector

CanSino Biological Inc./Beijing Institute of Biotechnology

COVID-19

Phase 2/Phase 1

DNA

DNA plasmid vaccine Electroporation device

Inovio Pharmaceuticals

COVID-19

Phase 1

Inactivated

Inactivated

Beijing Institute of Biological Products/Wuhan Institute of Biological Products

COVID-19

Phase 1

Inactivated

Inactivated + alum

Sinovac

COVID-19

Phase 1

NonReplicating Viral Vector

ChAdOx1

University of Oxford

COVID-19

Phase 1/2

RNA

LNPencapsulated mRNA

Moderna/NIAID

COVID-19

Phase 1

(Source: WHO Publications)

The University of Oxford leaps ahead in the race for a COVID-19 vaccine

University of Oxford vaccine trials is moving ahead in the global race for a vaccine to cure Covid-19, whereas other players have to start small clinical trials on a few of hundreds of respondents. But scientists at Oxford University had a head start on a vaccine. That has allowed them to go ahead and plan tests of their new coronavirus vaccine, which would be having the involvement of over 6k people by the end of next month, hoping to show not only that it is safe, but also that it works. The Oxford scientists are of the view that once they obtain an on-demand emergency consent from regulators, the initial couple of million doses of their vaccine could be available by as early as September this year, much earlier than any of the other announced efforts (if it proves to be successful in all respect).

GlaxoSmithKline (GSK) says millions of doses will not be available until late 2021

The world’s biggest vaccine producer said that there would be no mass coronavirus vaccines until late 2021, GSK’s CEO Emma Walmsley, chief executive of GlaxoSmithKline, said millions of doses would not be produced until the second half of 2021 even if things go right.

However, US-based Pfizer on April 29th, 2020 announced that it might have a COVID-19 vaccine ready by the autumn and the company has already started mass manufacturing of doses and is aiming to have hundreds of millions of doses ready by the end of the year.

There is a lot of speculation related to COVID-19 vaccine, and more clarity will come once few researchers move to phase III trials and get FDA approvals.

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