COVID-19 Vaccine may come soon: Why and How Serum Institute plans to make this happen.

[Authored by: Mandar Garge, Apr 30, 2020]

Pune based Serum Institute of India (SII), world's largest vaccine producer, recently announced that it is preparing a setup to mass manufacture COVID-19 vaccines as early as Sept-end/mid-October.

There is lot of confusion and questions about how a new vaccine which usually takes between 6-12 years (or even more), can be made so quickly by any company? Moreover, SII plans to start manufacturing vaccines in millions within 2-3 weeks from it's final approval. 

This write-up tries to explain how.

The news is True. Serum Institute has jump-started its production process to be ready to produce COVID-19 vaccine in May 2020 and bring it to the market by Sept (in anticipation that the vaccine will get its final approval by mid-to-end of Sept 2020)

Serum has tied up Jenner Institute of UK's Oxford University to give themselves a jump start. If all goes well, we are likely to see a COVID-19 vaccine hit the market in Sept or Oct of 2020. Wonderful, isn’t it?

How is such an early production of Vaccine possible? Let me try to explain the how and why of this story.

What is a vaccine?

In simple words vaccine is a dose of mutated form of a virus (similar to the harmful virus for which the vaccine is being created) injected into the human body to make human body produce anti-bodies to build immunity against the real virus.  (Important: The real virus is not injected into the patient as it would lead to infection in that patient. So a harmless variant has to injected)

What could be a COVID-19 Vaccine?

One that would inject a virus like the COVID-19 virus (from Corona-virus family) into the human body. The key point is that the injected virus is a one of the closest matching virus tweaked to neutralize it enough to render it harmless to the humans. It is mutated further to make it look like the real Corona virus (the ‘villain’ virus). When this genetically modified corona virus is injected into the human body, the body assumes it is the real Corona (villain) Virus and prepares anti-bodies to fight that virus and build complete immunity against it. When the real villain virus attacks such a body, the body has built a long-term fortification against it already. 

Why does a vaccine take that long (6-10 years or even more)?

A vaccine development has the following steps:

1. Exploratory stage
2. Pre-Clinical stage
3. Clinical trials
4. Regulatory approvals
5. Manufacturing

Stages #1 and #2:

• The lab creating the vaccine needs to create the correct genetically modified version of a suitable virus.
• Then it needs to do some tests in the lab, by mimicking a human-body like setup.
• Multiple such tests (each running for multiple weeks) lead to the most promising one over the rest.

Stages #3 – Clinical trials:

This is the longest stage usually spanning across 3 to 4 phases

• Phase – 0: Trial on animals (rats, monkeys) for safety before trying on humans.
• Phase – 1: Trial is run on small number of *healthy* volunteers (up to few 100s) and the vaccine is tested for *safety* (that’s why healthy volunteers because they stand minimum risk to its possible side effects). They are observed and monitored for up to 6 months.
• Phase –2: Vaccination to a larger group of people (including those with some pre-medical conditions (tests last up to 12 months). Volunteers are monitored for development of immunity.
• Phase –3: Vaccination expanded to thousands of people. This is the longest period (2-3 years) where the community infection is monitored (whether the injected people have developed an immunity strong enough to not infect others. Hence the longer period).

Stage #4 – Regulatory approvals

• The Food and Drug Administration (FDA) or equivalent authority of that country needs to approve the results of the trial.
• The vaccines must be monitored in all phases for side effects (it can cause other ailments).
• This is a multi-stage process involving granting of multiple licenses to the vaccine-making firm.
• Inspection of manufacturing facility before giving a consent to mass production.

Stage #5 – Manufacturing

• A multi-month process where manufacturing lines are setup to create the vaccine in mass production. (this is a large and complex setup).
• Ensuring enough quality measures.

Stage #6 – Distribution

• Although this is not part of the core vaccine-development process, it still takes a measurable time to transport vaccines to hospital and clinics through a proper supply chain.

Now you see why things add up to 10-12 years or even more.

Why is Jenner Institute at Oxford University is ahead of others?

The researchers at Jenner Institute have managed to extract a strain of corona virus from chimpanzees many years ago and modify it genetically to neutralize it and then variants of it have been tried on MERS patients (MERS is also caused due to a corona Virus and is much more lethal than COVID-19).

• Various variants of it have been tested several times on different diseases (caused by variants of corona virus).
• It has proven to be safe for humans.
• It has been tried on monkeys which then were exposed to COVID-19 virus. The tests were successful. Monkeys could resist COVID-19.
• Proven Safety would mean faster clinical trials.
• Already tried on 1000+ volunteers.
• Plan to try on around 5000 more patients (phase 2) in June of 2020.

One US-based vaccine lab modeled their candidate virus on the one used for Influenza and Zika vaccines.

FDA would also bend its regulations (an exception):

• FDA is ready to waive animal testing phase (round of testing on animals is not always mandatory for every vaccine, but recommended).
• FDA has accepted the safety aspect (Phase-1) already will not need to wait for 6 months. Phase-2 will start within a month FDA has agreed to allow combining Phase-2 and Phase-3 of clinical trials.
• FDA has agreed to grant licenses faster.
• FDA would also fast track its Manufacturing Inspection process to give a go-ahead for manufacturing by mid to end of Sept 2020.

Serum Institute's Jump-start:

• Serum institute is preparing the manufacturing setup to start mass manufacturing as soon as FDA gives a go-ahead to this vaccine, anticipating that the approval will indeed happen.
• Serum is watching the Oxford progress very closely to ensure that they tweak their production processes to enable mass production ready within 2-3 weeks of the final go-ahead.
• Serum Institute is willing to take the risk of the vaccine *not* getting approved, an admirable decision.

Moreover Serum plans to sell it at Rs. 1000 a piece. A very reasonable price indeed. 

A vaccine development drastically reduced from From 6-12 years to 6 months. That is simply amazing. This is an excellent initiative by Serum Institute worthy of serious admiration. This is also an excellent progress by Jenner Institute of Oxford University.

[Authored by: Mandar Garge, Apr 30, 2020]

Credits:

• The Jenner Instiute (https://www.jenner.ac.uk/)
• COVID-19 Vaccine Trails (https://covid19vaccinetrial.co.uk/ )
• Shekhar Gupta, Chief Editor, The Print (Cut the Clutter Episode #456)
• MedicineNet (https://www.medicinenet.com/)

** Please also read my other blogs at this link.