COVID Vaccine

 Tamilnadu is waiting for Sundays, cricket fans are waiting for IPL and in particular Dhoni, US is waiting for Biden to take over, Japan is waiting for Olympics to start and if at all the whole world is waiting for something then it has to be COVID Vaccine. Covid-19 is something which has left no stone unturned irrespective of one’s social status, religion, country,  gender,  age etc., Initially it used to be a flash news that someone has been infected with Corona virus, then slowly it used to be friend’s friend, then friend ..Now pretty much every street has few cases in India and home quarantine has been so common which makes me feel many are eligible to participate in Big boss show. We had Nipah virus which was constrained to Kerala and it was categorized as ‘Epidemic’ making things lot easier though the state had to bravely fight and come out of it. COVID-19 is categorized as Pandemic which makes things very challenging since we are talking about diverse population spread across the globe.

 Let us look into different phases involved before a vaccine is introduced in the market. To start with preclinical research works happen pulling many parties together funded by many different groups together. Objective is to come up with a treatment that is safe and effective. It involves the following phases:

 Phase 0: Since this is the first phase a very small group of people (around 10 - 15 people) are considered. The aim is to see how a drug is processed and how it affects the body. 

 Phase 1: Less than 100 people are considered for this phase and the primary objective is to see the best dose of the new drug with the fewest side effects. Doctors start by giving very low doses to few patients and monitor them for side effects. This phase checks whether the body produces antibodies and at the end of this phase they must have figured out what is the optimal vaccine dosage. 

 Phase 2: This phase is carried out with hundreds of patients and some of the audience may be people belonging to a type of cancer. New combinations of drugs are tested. Apart from safety and effectiveness, dosage and immunization schedules are also taken care of this phase.  

 Phase 3: This phase is carried out with few thousands of patients and patients are categorized into different treatment groups. Computer program randomly picks individuals to form a treatment group and people normally have no clue which group they belong to. Every patient is studied carefully, and overall phase is 'Double blinded" which means neither clinical investigator nor the participant knows what sort of therapy is employed. This phase provides information to assess the benefits and risks of the new therapy before seeking approval from authorities. 

 Phase 4:  This phase happens post approval and helps to uncover any problem that would happen only when a large set of audience uses the drug. Doctors, Health practitioners learn more about how the drug works when used with other treatments. 

 

Status of current vaccines: Right now we have as many as nine vaccines in Phase 3, Fourteen in phase 2 and twenty four vaccines in phase 1 and hundreds of vaccines in preclinical stage. There are two vaccines in phase 3 which are showing promise.

As of now German company BioNTech, Pfizer based out of US and Chinese firm Fosun PhArma are jointly coming up with a vaccine and showing promising progress so far and they are raining with Funding measures from Trump administration.
Secondly Swedish company AstraZeneca and University of Oxford is coming up with a vaccine which looks promising as of now. US once again supported the effort by awarding a huge sum. AstraZeneca even went a step ahead and announced they may be able to deliver emergency vaccines by October based on their studies.

Let us look into the challenges in coming up with a vaccine:

 Side effects: This would be the topmost priority for researchers in making sure there are no side effects associated with the vaccine. Side effects may develop upon time so there is no other go other than to monitor closely how the vaccine is working. Being a pandemic, we may have a person having Fish & Chips in U.K; Triple whopper cheese sandwich in US and rice, rasam and potato fry in Tamil Nadu. Right from eating habits, lifestyle, and immune system everything matters in how side effects arise.  

Number of doses: If you look into other vaccine schedules like Hepatitis B, Typhoid, MMR, Varicella there are many doses one had to take and there is a pattern one has to follow before your body is fully resistant to such viruses. When it comes to Covid-19, by the time entire world came to know it was already March 2020.  So with the ongoing research if they establish a pattern that one has to take so many number of doses spread across a time interval then obviously it may take that much time before they say drug is effective.

 Strength of Dose:  We have several factors like age, gender, and people with co morbidity before determining strength of the dose. Once again research has to come up with solutions for this and can be a challenging task considering the virus is a pandemic.  

 Overall, I feel vaccine will take quite some time to come into the market. Since Covid-19 has pretty much got the entire world’s attention there is no problem as far as funding, manpower, manufacturing, logistics, warehousing, distribution etc., but the key is ‘Time’ required to come to a consensus; If a research proves that we need “3 doses of vaccine span across 12 months with equal intervals between each dosage” which means research took 1 year. Virus made its presence felt throughout the globe only by March 2020 and even if we assume research started in March then we are talking at least 12 months from that time with so many if’s and but’s to be considered in the equation. Assuming a vaccine will come any sooner is like trying to understand ‘Inception’ movie without reading Wikipedia – simply not possible.

 P.S: I will be super duper happy to get my opinion wrong as far as Vaccine’s timeline but if a vaccine comes now I will definitely doubt on its efficacy.