Understanding Vaccine Production.
A massive global effort is currently underway to create a vaccine for COVID-19. There are 35 companies and academic institutions, across the world, that are racing to produce a vaccine that can help us fight this virus. Four of these labs will be conducting human trials shortly. Experts believe that it could be anywhere between 12 to 18 months for the COVID-19 vaccine to be ready. At the moment that timeline may seem rather long, but in the world vaccines, that is a very good time frame.
United diagnosticss
To understand why, let’s first go through the basics. How do vaccines work?
Understanding vaccine production
A vaccines helps fight pathogens by preparing the body’s natural immunity to recognise and fight viruses and bacteria, by first introducing enough information about the pathogen in the body. The pathogen forces the body to produce a response to fight it, without causing an illness. This prepares the body for a future invasion by the same pathogen.
How does a vaccine work
There are several ways to develop a vaccine and scientists need the actual pathogen to create any vaccine. The process to design a vaccine and ensure it is safe for human use, takes anywhere between 10 to 15 years. Which is why an 18 month timeline is actually really fast. There are two common ways to create vaccines – Attenuated and Inactivated.
How is a vaccine developed?
Attenuated vaccines are created by rearing a weaker strain of the virus or bacteria, usually outside the body, which is then extracted into a single dose ready for human use. Measles and tuberculosis vaccines are made this way.
Attenuated Vaccines
Inactivated vaccines on the other hand are derived by studying the genetic make-up of a dead pathogen, identifying the active protein in it and then mass replicating the protein. Vaccines created this way often require multiple doses at regular time intervals. Polio and rabies vaccines are created using this method.
Inactivated Vaccines
There is a lot of newer and advanced technologies of creating vaccines that are being explored and used across the world, of which the nucleotide based vaccines take lesser time to be created. These vaccines replicate the DNA/RNA of the pathogen and stimulates the body to create the same pathogen. Zika virus vaccine was created using this method.
Nucleotide-based vaccine
The race to create the COVID-19 vaccine is happening at an expedited speed, partially thanks to Chinese scientists who shared the genetic sequence of SARS-CoV2, the virus that causes COVID-19, in January. Leading the race is the U.S based biotech firm Moderna which in collaboration with National Institute of Allergies and Infections (USA) took only 42 days to move from vaccine design to human testing. That is a record breaking speed.
The COVID-19 Vaccine
There are also companies that exploring alternative approaches to designing a vaccine. Trying different and varied methods vaccine creation increases the probability of finding a vaccine that gets approval.
But despite the urgency to have a vaccine ready, and the breakneck speed at which scientists are trying to find a solution, vaccine clinical trials need to be conducted with precision and care, to ensure the safety & efficacy of the vaccine, once it hits the market.
Safety and Efficacy of Vaccines
For a vaccine to move from design stage to be ready for use, there are three stages of human trial that it needs to pass. Each stage tests the safety and efficacy of the vaccine. In the first stage, the vaccine is tried on a small number of healthy people, and scientists watch for safety and immunity response for different doses. This stage, under normal circumstances, takes between one to two years, but because of the urgency we face, for COVID-19 vaccine, this expected to take around three months.
Stage One of Vaccine Trial
The second stage of human trials, is conducted with a much larger group of people. The methodology used is a randomised, double blind, placebo-controlled study of hundreds of people. At this stage, scientists evaluate safety, efficacy, the optimal dose and the proposed vaccine schedule. And this stage usually takes between two and three years. But for COVID-19 vaccine, it is expected to take around 8 months.
Stage 2 of Vaccine Trial
Stage three of vaccine trial is similar to stage two, except that it is conducted on an even larger group. This stage usually takes anywhere between two to four years, but for COVID-19, it is expected that this stage will be clubbed with Stage 2.
Stage 3 of Vaccine Trial
Once the vaccine passes the three stages of trial, it has to undergo regulatory review, where a government body has to approve the new vaccine. This usually takes one to two years, but this stage will likely be expedited for the COVID-19 vaccine.
Regulatory review of a new vaccine
The International community has banded together, like never before to create a vaccine. If a vaccine is ready in the next 12 to 18 months, we will be able to prevent a recirculation of coronavirus, protecting millions of lives and helping the world get back on its feet.
But, what will also become true, is that this innovative, multi-stakeholder way of creating a vaccine, could fundamentally change how scientists develop and ready a vaccine, in a rapid and efficient way.
