This is the beginning of the end of the pandemic. Vaccination of workers is underway. It’s important to understand how we got here, why you can trust the vaccines, and the kinds of misinformation you’ll be hearing. First up is vaccine production.
Vaccine development typically goes through many complex stages.
It all starts with a vaccine concept: what disease will be treated, how common is it, what technology could be used, and what is the market. Medical researchers look at it from the perspective of what is possible, whereas pharmaceutical companies look for profits. This process never ends as new ideas emerge.
Next is the research phase, using cell cultures, animal models, and now computer simulations using the recently developed tools of data science and supercomputers. This cutting edge technology is one of the latest big breakthroughs and had a big role in some COVID-19 vaccines.
If a potential vaccine emerges, human clinical trials begin with the official FDA approval process. Phase 1 clinical trials involve small groups, as few as a couple dozen volunteers, receiving small doses of the test vaccine under very controlled circumstances. The goal of this phase is safety, screening for serious reactions. If there are major problems at this stage, back to the drawing board.
Phase 2 clinical trials begin studying the effectiveness of the test vaccine. Does it stimulate the immune system and create effective immunity? At what dose? Safety continues to be the highest priority, as larger numbers of volunteers receive the vaccine. More test subjects are critical because immune system response is as unique as each of our genetic codes. One person can respond, and another not with the same vaccine, just because of their unique genetics. Understanding how and why this happens is another exciting area of vaccine research.
If Phase 2 generates strong evidence of positive effect with minimal negative side effects, then it is on to Phase 3 where even larger numbers of people, hundreds to thousands, receive the vaccine and even more data is collected regarding effectiveness and safety. This is the stage where you may discover rare side effects, as more diverse patient groups are enrolled. A vaccine can still fail here if very serious, but rare side effects occur.
Success with phase 3 results in application for approval to release the vaccine. At all of these phases there are very elaborate requirements for data submission, review and approval, and oversight requiring hundreds of people and mountains of documentation that can ordinarily take years to work through.
If approved, data collection continues in Phase 4 after release, continuously watching for unusual effects. Using a Federal government system called VAERS (Vaccine Adverse Event Reporting System), the company and the FDA continue collecting data through hospitals, health departments, providers, and even individuals. VAERS data ensures vaccines are safe long after they are approved and released.
Operation Warp Speed (OWS) was a major success. It accelerated COVID-19 vaccine development and production using several aggressive interventions by multiple government agencies.
First, because of prior planning and organization, existing federal and private sector research and development (R&D) efforts on rapid vaccine development already existed. The Department of Defense, NIH, CDC, Health and Human Services, and a low profile organization called BARDA (Biomedical Advanced Research and Development Authority) all had existing programs and staffing, which were all brought together and coordinated to speed up COVID-19 vaccine development.
OWS took control of private sector R&D and standardized the vaccine development protocols for all the pharma companies, which they usually control. This streamlined data collection and review of the clinical trials without cutting corners on safety.
OWS also forced the pharma companies to take more financial risk by developing the vaccine production capability while the clinical trials were still underway, rather than waiting for results, saving enormous amounts of time. Ordinarily, production investments would wait until the pharma companies knew a vaccine survived the early clinical trial phases. OWS backstopped those investments with massive grants of hundreds of millions of dollar. To date, over $10 billion has been distributed to pharma companies for vaccine and therapeutics development and production.
Last, OWS picked the vaccines to accelerate, taking that decision out of private sector hands. All in all, it is akin to the New Deal in the scope of government intervention into the private sector.
It wasn’t perfect, and you will hear in coming months about all sorts of financial improprieties and shady dealings, but on the whole, it was a massive success. Unfortunately, we shouldn’t be in this totally predicted and largely preventable mass death event.
The vaccine development process was successfully accelerated by 1) federal forward funding to reduce financial risk; 2) creating production capacity in parallel with testing, and 3) having experts pick winners and losers, instead of industry. It’s a great example of how big government can work to solve big problems, even when self-inflicted.
Dr. Robert Wack is a physician who writes from Westminster. He can be reached at Robert.email@example.com.