It appears that politicians and news media will make coronavirus vaccine available by magic out of a hat. The author intends to dwell upon this important subject.  There have been attempts to mislead the public by promising something which is not there as yet. We even come across people complaining worthlessness of Doctors and Scientists for not providing a medicine / vaccine.  Covid-19 pandemic has indeed thrown up challenges.

Let us remember that this Coronavirus is a new phenomenon having appeared recently in December 2019 in China. Development of vaccines is a long and tedious process which needs  to be explained to public at large. With advent of present information technology, people expect solutions to be available at a click!

News reports screaming that India would have a coronavirus vaccine in place by 15^th August  have been in circulation. Director of ICMR (Indian Council of Medical Research) Mr Balram Bhargava reportedly ordered 12 hospitals to begin trial so that the vaccine would be ready by 15^th August. Named Covaxin, this has been developed by Bharat Biotech, a Hyderabad based company in partnership with ICMR’s laboratory National Institute of Virology.

Dear reader, you must have guessed that the Director of ICMR probably wants to please the present Government so that this announcement can be made from the Red Fort on Independence Day. Or else, maybe, some astrologer has predicted the date of 15^th August.

Future of entire human race may be compromised if processes are not followed for quick gains. There are inherent risks in rushing through such matters.

Historical Perspective

Development of vaccines is a long and complex process taking even 10 to 15 years.

Vaccines for small pox, rabies, plague, cholera and typhoid were developed by end of 19^th century. The first smallpox vaccine came to India from England in the year 1802. Earlier India had its own version of inoculation for smallpox called variolation which was found to be unsafe and banned by the British. In China inoculation for smallpox existed as early as around 1000 AD.

Biologics Control Act was brought in the U.S.A in 1902 to regulate quality of drugs. There were two tetanus outbreaks – one from diphtheria antitoxin in St Louis and the other from contaminated smallpox vaccine in New Jersey. Investigations revealed that contaminated vaccine by the manufacturer was the culprit. This lead to the need for regulation.

There are several stages in the development of a vaccine which are dealt briefly below.

Initial   Stage

Scientists in laboratories identify antigens (which help produce antibodies) which help in prevention or treatment of a disease.  This research led identification may take upto 4 years.

Pre Clinical Stage

Generally animals are used to test the vaccine for triggering immunity from the disease. Rats and Monkeys are generally used in these experiments. Based upon detailed studies of these experiments decisions are made for the next stage of trials.

Trials at this stage generally take upto 2 years. Many vaccines fail at this stage and do not go to the next stage.

Vaccines successful at this stage go for clinical trials with humans in subsequent 3 stages.

Phase 1 Vaccine Trials

Target population for this phase is generally upto 100 persons. Assessment is made regarding safety of the vaccine and type of immunity response triggered in the man. Participants are infected with the pathogen (agent causing disease). Studies are carefully monitored in controlled condtions. Only when the results are promising one goes to the next stage.

Phase 2 Vaccine Trials

A larger group of several  hundreds  is taken at this stage. Those identified to as risk prone (likely to catch the disease are also included at this stage). These trials are randomized and controlled.

Aim of this phase is to study-

.Safety of the Vaccine

.Immunity Response

.Proposed Doses

.Frequency of Immunization

.Method of administering

Phase 3 Vaccine Trials

Vaccine found acceptable in stage 2 trials now go for further extensive trials. Group of persons (participants) now may go upto several thousands.

At this stage side effects of a vaccine often get noticed on account of the large population. At this stage vaccines are assessed for-

.Does it prevent disease

.Does it prevent disease with the pathogen

.Type of immune response / production of antibodies

After positive outcome of this stage the vaccine can go for commercial production and usage as per law of the respective country.

Here it is necessary to bear in mind that the participants have to be inclusive of male, female , females in different stages of pregnancy, different age groups, persons with identified medical conditions and of identified risk group.

It is indeed a challenge for any vaccine to succeed.

We should allow the scientists to work diligently on the development. Politicians and media should watch and report cautiously as lives are at stake.