OBSERVATION: Biologics can take a long time to develop but COVID vaccines have been in development for almost 50 years and novel approaches were used to develop these vaccines.
Vaccines typically take 10 to 15 years to develop, test and release to the public. The coronavirus vaccines, however, took less than a year. Why?
First, a novel approach was used that didn’t require traditional vaccine production in cell cultures or eggs. Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control.
Traditionally, vaccines are developed by weakening it or killing a virus, or producing part of the lab’s virus. However, this is time-consuming. These vaccines were developed using different “platform technologies” that involve slotting genetic material from the virus into a tried and tested delivery package. Once introduced into the human body, the protein-making machinery uses this genetic material in our cells to churn out the coronavirus “spike protein,” triggering an immune response.
While such platform technologies are a non-traditional approach, that does not mean they are untested. “The mRNA vaccine platform technology [which the Pfizer/BioNTech vaccine uses] has been in development for over two decades”.Dr Zoltán Kis, of Imperial College London.
Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. In the case of the Covid vaccines, they have overlapped, making the process faster.
Then there are the finances. A key consideration is funding – public and private cash has been poured into the race for a Covid vaccine, pushing aside the usual financial concerns facing pharmaceutical companies.
All vaccines go through clinical trials to test safety and effectiveness. For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet. According to John Hopkins, this infographic from the National Institutes of Health shows the four phases a vaccine must go through before it is released to the public.
The power of social media also came into play. Social media enabled companies to reach out to and enroll study volunteers, and plenty of people wanted to help, so there were enough research participants to test the COVID-19 vaccines. Because the SARS-CoV-2 coronavirus is so contagious and widespread, many volunteers who got the vaccine were exposed to the virus. With so many exposures, the trials took a shorter time to see if the vaccine worked.
Let’s also remember that pharma is going to make a LOT of money on these vaccines. It’s estimated that the COVID 19 vaccine market could be worth almost $100 billion. That’s a hell of an incentive.
This morning I’m watching the news, which is showing hundreds of people online for the vaccine. Rather than have patients fill out the paperwork online and get a specific time for their shot, Florida uses the cattle car mentality, leading to people waiting overnight.