Clinical trial for a plausible vaccine to begin by May with the results coming in by 2020 end

The frontline workers are working hard to take care of the infected patients but all their efforts could go in vain if there is no treatment or vaccine found for the novel coronavirus. That is where scientists and researchers step in and rise up to the challenge. The progress being made in this field has quickened and they are running against an invisible, ticking clock.

When asked about a possible vaccine, health experts have parroted one answer - 12-18 months but only if conditions are conducive. It takes time to figure out a vaccine sequence, conduct trials and then observe if the patients will get ill or not. It is an extremely slow-paced wait and watch game.

And now, a vaccine to beat the novel coronavirus might be closer than anticipated.

A clinical trial to test a possible COVID-19 vaccine is going to begin by May and the team conducting the trials are already making big headways. They have got the combined financial backing of the two of the United Kingdom's biggest national research bodies - National Institute for Health Research (NIHR) and UK Research and Innovation (UKRI).

The clinical trial process

A new clinical trial, involving a group of 500 volunteers will soon begin. The group range, for phase one, begins from the ages of 18 to 55 and it will include patients who show early to mild COVID-19 symptoms in a randomized controlled trial. The second phase will look at volunteers aged between 55-70 with the last phase looking at people who are in the range of over 70. Phase 3 is supposed to expand to involve 5000 volunteers and the results from all the earlier trials will be included in the final result.

A randomised controlled trial is a type of scientific experiment that aims to reduce certain sources of bias when testing the effectiveness of new treatments by randomly assigning participants into an experimental group or a control group. As the study is conducted, the only expected difference between the control and experimental groups in such a trial is the outcome variable being studied.

The trials will use ChAdOx1 nCoV-19 vaccine. It is a recombinant viral vector vaccine that is made from a non-threatening virus that has been altered to "produce the surface spike protein of the pandemic-causing SARS-CoV-2 virus. The vaccine acts by priming the immune system to recognize and attack the coronavirus, stimulating a T-cell response. It uses the same technology as a shot Gilbert’s team previously developed for the related MERS coronavirus. That vaccine appeared to be safe in animal and early-stage human testing, giving confidence for the coronavirus version," reported Bloomberg.

Where do you begin?

By mid- January, the Chinese scientists had releases the genetic sequence of the novel coronavirus and Sarah Gilbert, from Oxford University and her team began work on finding a vaccine.

In March, the Oxford team was given a 2.2 million pound (Rs 20,97,44,106) grant from the NIHR and UKRI, to scale up her and her team’s efforts to move into COVID-19 vaccine research.

The lead researcher, Gilbert is a professor of vaccinology said they are still waiting on the final safety tests and approvals before the tests can begin. Till then they have been permitted to recruit volunteers, take blood tests, explain the process and check their health status reported The Independent.

In an interview with BBC’s Andrew Marr Show, Gilbert said, “The prospects are very good, but it is clearly not completely certain.”

Gilbert hopes to receive the all-clear and finish vaccinating the first group by mid-May in order to have the results out by the end of this year. This will also allow them to manufacture the vaccine in large amounts if all goes well. However, she does warn that the timeframes are not set in stone and things can change.

She is also looking to take the trial to the international level which will also let them understand the 'vaccine efficacy.'

The possibility of a vaccine

There is a timer for all vaccines and this one is no different. The team needs their patients to be healthy before they start the trial and if they do get infected over the course of the trial, this will help them find out if it works.

Gilbert in an interview with The Lancet said, “Ideally, we need the clinical trial to be taking place when the majority of volunteers have not been exposed to the virus. We will exclude volunteers who have a positive PCR test for SARS-CoV-2, or who have had fever or cough in the past month. Some will inevitably have been exposed, and that is useful too, as we want to know what the vaccine means for people who have been exposed to the coronavirus."

A lot is riding on this vaccine trial and Gilbert and her colleagues at Jenner Institute know this which is why they have stopped all the other vaccine research in order to make COVID-19 vaccine priority.

from Firstpost Tech Latest News https://ift.tt/2yve1kl