Progress from planning to pharmaceutical

When two different friends mentioned in one day that “I guess we all just have to wait for a vaccine to solve our crisis”, it didn’t sit right with me. First, waiting around doesn’t register with me hardly ever. Plus, I am a scientist and there is always something we can do to try and solve a problem. Studying it, educating folks, and engaging with scientists far and wide are surely tasks in my wheelhouse. Science as a day job and sharing hope is also in my wheelhouse. Thanking and encouraging the scientists, healthcare workers and diverse supporting staff is necessary and a role EVERYONE could actively do.

Since facts often get lost in the volume of news (and don’t even get me started about my Facebook feed lately– filled with conspiracy theories and angst), it’s good to hear directly from the frontline scientists and healthcare experts providing insights into the real science. I was grateful to receive, watch, and share a recent comprehensive discussion and Q&A session video on the progress fighting SARS2-CoV-2 in a panel discussion by Cornell University’s Weill Medical Center in NYC. These are doctors who have multiple roles, treating the most critically ill and also researching and implementing potential cures.

A friend of a friend of a friend is currently battling COVID19. It is like the “six degrees of separation” challenge”, but rather than connecting how many movie roles away a particular actor is from Kevin Bacon,  folks wonder how close they have come in contact with anyone harboring virus particles. So it is VERY encouraging that there are many candidate vaccines in the works, including viral vectors (reconstructed cold viruses modified to express SARS2 spike protein genes), recombinant protein materials, modified messenger RNA molecules, and inoculants made from the virus itself. Some vaccine candidates have made it through to the next stages of the process, which include: “Phase I” (first tests in humans for safety), “Phase II” (tests to see if the materials make an immune response in humans), and finally “Phase III” (tests to see if that human immune response is effective to protect the person from the actual virus). THIS PROCESS TAKES TIME!!! Recently, many major pharmaceutical companies working on vaccinations have even signed a pledge to not rush the process, examine the data and be safe. Surely the dedication to move drug candidates rapidly forward has never been stronger.

Here is where the waiting occurs, accumulating and studying the data which should tell the scientists if the particular vaccine plays out as a good candidate by statistically reducing the numbers of symptomatic cases. Phase I and Phase II involve a small selection of people, but once a promising candidate reaches Phase III it takes tens of thousands of people, some with a placebo and some with the vaccine candidate. Then professional clinicians and statisticians interpret the findings, often performed as double-blinded studies, so as to not bias the results. No one is purposefully exposed to viruses in these trials but the people live in the world as they normally would. “Hot spot” areas are generally better to administer the Phase III tests than areas of less community viral spread. That is why a control group is vitally needed in these trials.

Acceleration of vaccine studies does NOT mean the drug manufacturers should or are skipping safety studies. The health considerations are VERY rigorous. Acceleration means that they are overlapping studies and actually producing the vaccine and bottling it ahead of time, in case it does work. These are pro-active steps, a term and frame of mind for us to champion as we “wait” for a safe and effective vaccine. Guidance by the FDA in the United States, specifically the Center for Biologics Evaluation and Research (CBER), requires scientifically sound control testing. Candidate vaccine products must meet the statutory and regulatory requirements for quality, development, manufacture, and control. The vaccine product must be adequately characterized and its manufacture in compliance with applicable standards, including current good manufacturing practice (cGMP). If the particular vaccine is given the green flag, the scale up process begins. Deciding whom to vaccinate becomes the next challenge. The video, mentioned above, includes info for volunteering if you live in the Manhattan area. Many are volunteering to partake in these studies in randomized control groups. Helping the process takes people.

Whether the people are behind the scenes or in the trials, progress is people-driven. Planning, support and safety—that is where everyone’s participation really matters.

Encouragement is people-driven too.