Your COVID-19 vaccine: $13.20 per shot planned by Indian biotech firm

HIGHLIGHTS

  • There’s a long way to go before a COVID-19 vaccine is finally out
  • Some scientists say they won’t count on a vaccine “soon”, but it’s also true that biotech has advanced immensely through sharing of open databases and cheaper, highly reliable genetic sequencing/editing techniques
  • When a vaccine does come out, enough must be made to protect everyone
  • Serum, an Indian biotech firm, is at the forefront of vaccine manufacturing, girding up for hundreds of millions of shots

How would you celebrate when a COVID-19 vaccine is finally out?

To answer that question, let’s backtrack a bit. Polio had afflicted mankind for millennia. When the long-awaited polio vaccine finally arrived in 1955 — proven both safe and effective — it was reported the people ran out to cheer, and church bells rang.

Back to 2020, COVId-19 is not expected to go away any time soon. We’re all squeezed amidst various forms of lockdown for months now, so the entire world is keeping an eye out for the leading candidate vaccines.

The countries in different stages of vaccine trials now include China, US, UK, Italy, France, Mexico, Denmark, among others.

Who will reach the finish line first? The answer is currently the world’s favourite guessing game.

COVID-19 vaccine race
Image Credit: Gulf News

But here’s the point: With a specific antidote against a debilitating infectious disease, the world had been there before — solving human affliction as ONE.

The science was shared. The manufacturing scaled up. The vials are distributed such that everyone has access.

The objective is to make it affordable and as widely available as possible — this was the case with smallpox, polio, DPT, measles, and a host of other crippling or deadly diseases.

Vaccine monkey 091 Oxford’s ChAdOx1 nCoV-19 vaccine uses the common cold virus (adenovirus) that causes infections in chimpanzees. 
Image Credit: Gulf News

The next challenge: Manufacturing

Following the rigorous tests done on thousands of human volunteers, the winning vaccine/vaccines will be declared. It has to pass two main hurdles — safety and effectiveness.

The next challenge: Manufacturing the vaccine. The world needs literally tens of millions of shots. It is possible the manufacturing will be farmed out to different biopharma firms across the world.

DNA material The 'construct' of ChAdOx1 nCoV-19 vaccine carries the genetic material of the SARS-CoV-2 virus that makes the spike protein.
Image Credit: Gulf News

Who will manufacture the vaccine?

One possible manufacturer is Indian biotech firm Serum Institute of India (SII), based in Pune, a leader in the mass production of vaccines for the global market.

Serum Institute of India (SII) is the world’s largest maker of vaccines by volume.  It is mass-producing ChAdOx1, currently  a leader in the global race to develop an antidote to the novel coronavirus.
Image Credit: Gulf News

SII is preparing to mass produce the leading vaccine candidate, Oxford’s ChAdOx1 nCoV-19.

On April 23, Oxford University kicked off Phase-1 human clinical trial of it vaccine against SARS-CoV-2.

In the trial, 1,112 healthy volunteers will be given one dose each. The objective is to study the vaccine’s safety and ability to produce immune response.

The trial, from April 23, 2020, involves 1,112 healthy volunteers, given one dose each.
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Researchers in the UK — the country that gave the world the smallpox vaccine in 1796 and penicillin, the first true antibiotic, in 1928, — are pumped up expecting a positive outcome of the trial.

When will the first Oxford vaccine be ready?

If the trial goes as planned, Oxford plans to get millions of doses of the vaccine out — before the end of 2020 — even while waiting for results of the final phase of the trial (Phase-3).

If the trial goes as planned, Oxford plans to get millions of doses of the vaccine out —  before the end of 2020 — even while waiting for results of the final phase of the trial (phase-3).
Image Credit: Gulf News

The vaccine, developed by the Oxford University’s Jenner Institute, began trials in a joint project with the University’s Oxford Vaccine Group.WHO IS JENNER?Edward Jenner (17 May 1749 – 26 January 1823) was an English physician known as the pioneer of immunisation. He was the key contributor to the development of the smallpox vaccine and popularised the practice of vaccination.

Since then, vaccination has been used in nearly all parts of the world to prevent several diseases.

He used a method that was validated in immunology (branch of medicine and biology concerned with immunity) before the discovery of germ theory. His work has saved many lives. It was reported that during Jenner’s time, smallpox killed around 10% of the British population, with the number as high as 20% in towns and cities where infection spread more easily.

How was the vaccine made?

Oxford’s ChAdOx1 nCoV-19 uses the common cold virus (adenovirus) that causes infections in chimpanzees.

While the Oxford's ChAdOx1 nCoV-19 vaccine is yet to be proven to protect against COVID-19 infection, Serum decided to start making it after it had shown pre-clinical promise and had progressed into human trials.
Image Credit: Gulf News

The adenovirus has been genetically altered so that it does not grow once injected. The “construct” carries the genetic material of the novel coronavirus that makes the spike protein.

The spike protein is found on the surface of the virus and plays a crucial role in binding to specific human receptors found on cell surfaces and entering the cells.

Serum Institute of India (SII), the world’s largest maker of vaccines by volume, envisages a price of Rs1,000 ($13.20) per vaccine — but governments would give it to people without charge, said SII's Dr. Cyrus Poonawalla.
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VACCINE: WHERE DID THE TERM COME FROM?The terms “vaccine” and “vaccination” were derived from ‘Variolae vaccinae’ (smallpox of the cow).

Edward Jenner, known as the father of immunisation, devised these terms to denote cowpox.

He used it in 1798 in the long title of his “Inquiry into the Variolae vaccinae known as the Cow Pox”, in which he described the protective effect of cowpox against smallpox. He first made experiments two years before that, in 1796.

The year 2020 marks the 224th year since Jenner pioneered the practice. [https://bit.ly/36oHObl]

What is the timeline for the trial?

  • The Phase-1 trial is expected to be completed in end-May if transmission remains high in the community.
  • The Phase-2 trial may be completed by August-September.
  • The Phase-3 trial is when the vaccine is given to thousands of people and tested for efficacy and safety.

If the Phase-1 trial results are encouraging, Phase-2 and Phase-3 trials may get combined, according to Suresh Jadhav, Executive Director of SII.

The US is also ramping up its own vaccine trials under the so called “Project Warp Speed.”

On Thursday (May 21, 2020), AstraZeneca received more than $1 billion from the US Department of Health’s Biomedical Advanced Research and Development Authority to beef up research under US President Donald Trump’s “warp speed” vaccine development initiative.

China has five different candidates now in different stages of trial on humans — basically infecting healthy people with coronavirus, in order to speed up trials.

One vaccine candidate developed in China has also shown “promise”, according to findings from the Phase 1 trial published Friday (May 22, 2020) in the peer-reviewed medical journal The Lancet.

Results show the candicate vaccine called “Ad5 nCoV”, funded by China’s National Key R&D Program, National Science and Technology Major Project, and CanSino Biologic and listed on the clinicialtrials.gov database, induced binding antibodies in most of the patients within 28 days — and appeared to be “safe and well-tolerated”.

Serum Institute will produce around 3-5 million doses per month, from now till September. The company says the Indian government will share some risk and fund the production with Serum. The company is set to spend between Rs300 million to Rs400 million to produce that volume.
Image Credit: Gulf News

When will Serum Institute start manufacturing the vaccine?

According to Suresh Jadhav, Executive Director of SII, the company will start manufacturing the vaccine the moment the Phase-3 trial (vaccine given to thousands of people) or the combined Phase-2/Phase-3 trial begins.

If the last two stages of the trial are combined, then it would start manufacturing the vaccine by end-June.

400 million doses planned  Serum Institute of India plans to make the vaccine at its two manufacturing plants in the western city of Pune.  The company aims to produce up to 400 million doses in 2021,  if all goes well.
Image Credit: Gulf News

Millions of doses will be ready year-end. The company is confident of manufacturing 60-70 million vaccine doses before 2020 is over, with up to 400 million doses by 2021.

“Since we will begin manufacturing when the last phase of the trial is initiated, we will have millions of vaccine doses ready by the time the trial ends,” Jadhav told Reuters.

What’s the latest on the Oxford vaccine? 

The first phase of ChAdOx1 vaccine trial — clinical studies involving 160 healthy volunteers ages between 18 and 55 — are progressing very well, according to Prof. Andrew Pollard, head of the Oxford Vaccine Group.

Update:

Oxford scientists now want to recruit up to 10,260 people across the country for Phases II and III. These next two stages will involve ramping up the number of volunteers.

It will also further widen the age range, to include older adults and children.

Prof. Pollard said told the British media on May 22, 2020: “The clinical studies are progressing very well and we are now initiating studies to evaluate how well the vaccine induces immune responses in older adults, and to test whether it can provide protection in the wider population.”

Sarah Gilbert, professor of vaccinology at the Jenner Institute, said: “We have had a lot of interest already from people over the age of 55 years who were not eligible to take part in the Phase-1 study, and we will now be able to include older age groups to continue the vaccine assessment. We will also be including more study sites, in different parts of the country.”

Saul Faust, professor of paediatric immunology and infectious diseases at the University of Southampton, which is also working on the trials, said: “We would now very much like to invite people from the Southampton area whose work brings them into possible contact with Covid patients or who are healthy and in the older age groups to take part in the next stage of trials of this Oxford Covid vaccine.”

“This is one of only four vaccine trials underway worldwide and could pave the way for a vaccine to be delivered later this year.”

TAKEAWAYS

  • Much about the coronavirus remains little understood. So it may be premature to celebrate.
  • Sure, hope springs eternal…and vaccines can now be developed sooner, in months instead of years as scientists collaborate (aided by cloud databases, sharing information in a flash) while vaccine makers have had decades of experience in mass production.
  • An effective COVID-19 vaccine should follow the same route started by Dr. Edward Jenner in the 1790s and Dr. Hilary Koprowski with polio in the 1950s, in order to save lives, with no regard for race, creed.
  • What the world needs right now is a COVID-19 vaccine that works for everyone, is safe and effective, without causing harm.
  • Any advances must be available to all countries — and distributed evenly — so the world can get back on its feet.
  • A heightened collective effort is needed to prepare for the next potential pandemic.
  • Research on viruses should have greater oversight, preferably by a global body, and should not be the exclusive discretion or domain of one nation.
  • Open science, a regime of shared resources, should be adopted in research on viruses, especially those with pandemic potential, instead of obfuscation and muzzling/punishing scientists or clinicians who report it.
  • A global platform to report the first signs of a fresh outbreak would be immeasurably helpful in this regard.
  • Failing to do so would increase mistrust, and result in more pain for the world.
  • Mistrust could lead to an undesirable “new normal”, where individual states may resort to instant lockdowns at the earliest hint of another viral outbreak, crushing human development, and worse — possibly triggering a catastrophic conflict nobody wants.
  • Vaccine development should not a for-profit exercise.
  • No company should be allowed to patent a virus, such as the coronavirus, or its isolated genes. Laws that allow it should be on the table for review.
Brief History of Vaccines
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