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Rigorous process guides development of COVID-19 vaccines

It is becoming increasingly clear that a COVID-19 vaccine will not likely be widely available this year.

Public health experts are also uniform in their guidance that a vaccine or vaccines for COVID-19, at least in the intermediate term, will be just one potential tool in a broader toolbox for combating the pandemic.

Historically, vaccine development has taken years leading up to the approval and use of a vaccine. This process includes laboratory work leading to a potential vaccine candidate followed by three phases of so-called clinical trials involving volunteers. These phases begin with safety testing in dozens of participants followed by safety and effectiveness testing in hundreds of volunteers. The final stage involves testing in thousands of volunteers from different demographic groups and locations who are randomly assigned to receive the vaccine or a placebo.

During a clinical trial of a candidate vaccine, an independent group of science experts review the information from the study. This group, known as a Drug Safety Monitoring Board, can intervene to halt the study if potential safety concerns arise or if it becomes clear that the vaccine is better than placebo.

To date, there are more than 100 candidate COVID-19 vaccines in various stages of development or testing throughout the world. Six promising candidates have received financial support from the U.S. government to facilitate testing, manufacturing and distribution, if and when one or more of them prove safety and effectiveness in preventing COVID-19 infection.

Vaccines are produced via different methods or so-called platforms. These fall into two general categories – classical and next-generation. Classical platforms are those developed mostly in the 20th century and which often can require years of development and manufacturing because of logistical factors.

Next-generation vaccine platforms rely on advances in science and vaccine technology in the last about two decades. An example includes the Ebola vaccine tested in West Africa in 2015 and approved for use in 2016. This vaccine played a role in ending the West Africa Ebola epidemic that started in 2013. That said, the vaccine was only one part of a broader successful public health effort that included such elements as use of personal protective equipment, contact tracing and the creation of isolation zones.

COVID-19 vaccines in development and testing include classical and next-generation platforms. You may have heard about two high-profile trials halted to investigate potential safety issues. This is a good sign because it means the processes put in place to ensure safety are being followed closely.

I can’t tell you when a vaccine will be available for use. It could happen later this year or sometime next year. What I can tell you with reasonable confidence is that if and when it does roll out, just as now, it will need to accompany public health measures such as mask use, social distancing, hand hygiene, testing, contact tracing and isolation for infected people.

Dr. Matthew A. Clark is a board-certified physician in internal medicine and pediatrics practicing at the Ute Mountain Ute Health Center in Towaoc.