According to the World Health Organization, over 40 different candidate vaccines for COVID-19 are in development. These include an inactivated vaccine being developed in China (Sinovac) using purified COVID-19 virus killed with formaldehyde (a chemical).
There are multiple other vaccine candidates under development that use DNA, RNA, viral vector and subunit protein platforms.
During a pandemic, expecting vaccines the same year or the next, illustrates the power of technology, human hope, media hype — all at unprecedented frenzy.
How long does it take to develop a vaccine?
It can take years to develop vaccines first in laboratories to show proof-of-concept, then developing a manufacturing process to make stable and a highly pure product to be tested in animals and humans, and finally for the market.
The COVID-19 vaccine has been fast-tracked into humans without prior testing in animals.
WHO chief scientist warns against ‘vaccine nationalism’:
Chief Scientist at the World Health Organisation (WHO) raised the need to have a multilateral or global approach to vaccine deployment and distribution, rather than a more nationalistic approach.
The argument they are making is that the virus is everywhere in the world and it would be impossible for the world to go back to normal, and for the economy to recover if only pockets of people are protected.
Today, 10% of all infections have occurred in healthcare workers. It would be unfair not to protect them before everyone else gets a chance.
This was an ongoing dialogue happening globally, and getting a consensus was a challenge.
There are a large number of vaccine candidates in development. Some of them are big companies; multinationals have the resources and expertise to run their own trials, while smaller companies may not get the same opportunities. We want to provide a platform for vaccines to be tested
India will have to deliver vaccine on a scale never seen before: Where India stands in vaccine delivery?
Globally, innumerable vaccine trials are progressing; in India, two candidates have advanced considerably.
An inactivated coronavirus vaccine was created by Hyderabad’s Bharat Biotech. It is safe and immunogenic (stimulates anti-coronavirus antibody) in laboratory animals and humans, to be re-confirmed in a phase 2 trial; phase 3 will assess the vaccine’s safety and protective efficacy against COVID-19.
Pune’s Serum Institute of India (SII) is testing Oxford University-AstraZeneca’s vaccine using a Trojan horse approach, spiking chimpanzee adenovirus type 5 with coronavirus spike glycoprotein genes.
When injected, adenoviruses are detected and devoured by immune system cells patrolling for invading microbes. The smuggled genes force these cells to synthesise and spew out spike protein that is immunogenic.
This adenovirus is harmless in humans. The SII is ready to upscale production after regulatory clearances in the United Kingdom and India.
Vaccine nationalism is ‘measles of the world’:
Some wealthy nations made bilateral financial agreements with manufacturers in order to hog vaccines.
Such vaccine nationalism is ‘measles of the world’, borrowing the phrase from Einstein.
Global public good should not be hijacked by wealthy nations. Gavi, the global vaccine alliance, created COVAX — a funding facility to ensure up-scaling vaccine production and its access to low income countries as soon as regulatory approvals emerge.
COVAX will support the SII with funds to bring down selling-price to $3 per dose.
With good news on supply side, what about the delivery side?
India’s Universal Immunisation Programme is a vaccine-delivery platform for children and pregnant women, funded by the central government but implemented by State governments.
However, the COVID-19 vaccine is for all age groups, necessitating an innovative platform, prioritised on the basis of need.
For India: Define policy for vaccine delivery should be in clarity:
- The first step is policy definition leading to a plan of action blueprint. The time to create them is now it costs nothing, but will save time when a vaccine becomes available.
- Policy emerges from objective(s) for vaccine use in individuals and community.
- Priority for individual need is to protect those at high risk of death (senior citizens and those with medical co-morbidities) and front-line workers who expose themselves to infection while providing health care.
- Children may be vaccinated before schools reopen to protect them and prevent infection from being carried home.
- Vaccine availability will be limited at first, when we must ensure that those on the priority list receive it.
- Information should be made available to the individual and the health management system, for which computerised data are critical.
- A nationwide database with unique identification details already exists, a valuable resource to identify those who need not be vaccinated.
- Identifying past asymptomatic infections requires systematic screening for IgG antibody.
- Antibody positives need not be vaccinated (no harm if vaccinated). All data should be saved permanently.
- Area-wise estimates of the numbers who need vaccination on a priority basis are necessary. Now is the time for State governments to capture all such data.
Getting a plan ready:
We need a vaccine-delivery platform to fulfil all such needs.
- A practical method is vaccination camps, supervised by a medical officer, staffed by health management and local government, and having the list of people who need vaccination.
- Information should be updated regularly, deleting those who got infected recently.
- Enumeration and registration of eligible persons can be started now. Vaccination by appointments will ensure that vaccination is without overcrowding and with minimum waiting time.
- Post-injection, vaccinated subjects should wait for half-an-hour in case of immediate side effects; emergency drugs to tackle side effects should be readily available.
- In India, careful documentation of all side effects in all individuals, senior citizens, those with co-morbidities, and children must supplement trial data on vaccine safety.
- This ‘post-marketing surveillance’ must be built into the vaccine roll-out.
A community’s need for vaccination is two-fold:
All those who must rebuild essential activities, i.e. economic, educational, trade, transport, sociocultural and religious, must be protected.
A more ambitious aim is to break the novel coronavirus transmission and eradicate the disease altogether.
With India’s notable representation in decision-making bodies of the World Health Organization, India is uniquely positioned to play a crucial role in advocating global eradication of COVID-19.
India would play a major role in manufacturing and scaling of vaccines apart from the research and development that was happening.
The vaccine regulatory agency should take a call on the special question of vaccine safety during pregnancy.
One vaccine is an inactivated virus and the second is a live virus but non-infectious. Both may be assumed to be safe; yet safety in pregnancy must be ascertained in bridge studies that must be conducted as soon as possible.