The solution to ending the COViD-19 pandemic rests with a vaccine. Since this was a novel coronavirus, efforts to introduce a vaccine have only recently begun. Most respected officials say that a COVID-19 vaccine is 12-18 months away from being commercially available.
Some of these experts point out that even 12-18 months for a vaccine would be an unprecedented accomplishment. Typically vaccines take much longer to be brought to market. Many have literally taken decades. The development of the Mumps vaccine, thought to be amazingly quick, took four years. The Ebola vaccine, again thought to have been rapidly developed, took five years. But recent advances in technology have allowed for the quicker discovery of candidates using DNA and RNA sequences for vaccines. Although since this is new technology, the ultimate success of these efforts is still uncertain. To date, no vaccine has ever been successfully brought to market using this new genetic sequencing technology.
Vaccine development is a complex process. First a potential vaccine is tested in animals in what is called a pre-clinical phase. If the results show an immune response, the candidate enters human trials in up to three phases. In phase 1 testing is done in healthy volunteers primarily to demonstrate safety. Phase 2 trials are designed to test the efficacy of the vaccine in a relatively small population of patients. To eventually get to market, a vaccine must then be shown to be safe and effective in a phase 3 clinical trial that is more extensively tested for safety and efficacy.
A number of steps have been taken to reduce the usual time to market for the COVID-19 vaccine. For example, the World Health Organization has published protocols to test multiple vaccine candidates in phase 2 and 3 clinical trials at the same time. Artificial intelligence can now be integrated into platforms (from companies like Saama Technologies) that can analyze clinical trial data to find answers sooner. New technology lets researchers identify potentially effective genetic sequences for COVID-19 and allows for much faster development than in past years. For example Moderna (Cambridge Mass) used new technology to create a mRNA sequence for SARS-COV2 that already entered human trials on March 16th. Moderna has said that it may enter phase two trials in the spring and potentially have a vaccine ready by the Fall of 2020.
There are at least 70 separate efforts currently underway to develop a vaccine. Five vaccines are already entered the clinical testing phase, while the rest remain in preclinical phases of development. Besides the Moderna vaccine which as mentioned is in phase 1 testing, some of these others are advancing at an unprecedented rate.
CanSino Bio, a Chinese company, started phase one trials in March. Their vaccine is an adenovirus type 5 vector that expresses an S protein to stimulate an immune response. Testing in phase 1 has begun in 108 healthy people to look for adverse events. Phase two trials are now expected to begin later this month on 500 people to test for antibody response to the vaccine, with half of the people placed in a placebo arm.
Inovio pharmaceuticals (Plymouth Meeting PA) has developed a synthetic DNA plasmid vaccine that encapsulates a piece of the genetic code of the COVID virus and also has entered a phase 1 clinical trial.
Shenzen Geno Medical Institute in China has two potential vaccines that have entered phase 1 trials. They are both lentoviral derivatives.
The Migal Galilee Research Institute in Israel has also announced plans to releases a vaccine that would enter clinical testing in the next few weeks. Oxford University too has stated that they will likely have a vaccine ready by September
Some big companies, with extensive vaccine development experience, have also announced plans to soon enter phase 1 clinical trials. Johnson and Johnson, through their Jansen division, plans to use their AdVAC and PER.C6 technologies to introduce a candidate of their own, and then if successful, move towards mass production of a vaccine.
Many of these efforts are being undertaken by small companies that have not successfully brought vaccines to the market before. This combined with the use of new untested technologies being used, could provide some false hope. However, it is more likely that the unprecedented number of private and public efforts to bring a COVID-19 vaccine to market will yield a positive outcome. My prediction is that this will be sooner than most experts think. That will be good news for all of us.