Covid-19 cases are once again on the rise. Hospitalizations are increasing. The prospect of a brutal third wave seems more likely than ever. We are approaching a dangerous tipping point, and many are relying on a potential Covid-19 vaccine to help us return to normal.
We all need to wave the caution flags as much as we can. A vaccine will not get us through a pandemic dark winter.
We need to keep in mind one crucial detail: No vaccine has been approved outside of clinical trials. We have a long road ahead before we can rely on vaccine-induced immunity.
An AP poll in May showed only 50% of Americans would accept a vaccine. This statistic gets lots of media attention, but it is a false statistic. What is the value of polling American’s feelings regarding a vaccine that does not exist? None of the leading vaccine candidates have completed clinical trials or published safety and efficacy data.
The pivotal trials for Johnson & Johnson, Moderna, Novavax, and Phizer are not finished. We hear rumors of promising early data, but early, unpublished clinical trial data is not actionable.
We must answer fundamental questions before we pin our hopes on vaccines.
- Does the vaccine work, and to what extent?
- How long does the vaccine provide immunity?
- What are the side-effects and safety concerns?
- How many doses are required and in what intervals?
Let’s assume the phase 3 Covid-19 vaccine trials are completed during 2020. Then, the FDA authorization process begins. FDA director Stephen Hahn set the goals for a Covid-19 vaccine in a Washington Post Op-Ed, stating, “any authorized or approved Covid-19 vaccine would need to show that it prevents the disease or decreases its severity in at least 50 percent of people who are vaccinated.” We do not know if any of the vaccine candidates will meet these criteria.
Once the FDA approves a vaccine, the Operation Warp Speed distribution process can begin to get vaccines to 328.2 million Americans. The US government has partnered with McKesson Corp. to distribute coronavirus vaccines to state and local health departments.
The leading vaccine candidates require two doses one month apart with a three-week window to develop immunity inducing antibodies. This necessary dosing protocol extends the timeline from receipt of the vaccine until one can reliably count on immunity.
Even if a safe and effective Covid-19 vaccine were to be approved tomorrow, the timeline shows there is zero chance a vaccine plays a meaningful role in the next three months.
We can not stop fighting the virus until a vaccine is available. While we wait, we must continue to do what works to slow the spread. Public health entities must continue to identifying exposure, isolate those at risk, test, and treat.
Each American must follow the mitigation strategies to protect themself and others. Stay at home. Wash your hands. Practice social distancing. And remember wearing a mask is the easiest thing we can do to slow the spread of coronavirus and save others’ lives.
