Columbia Memorial | Health Compass | Winter 2021

Readying them is a step-by-step process Vaccines help protect us from many diseases, and that makes our lives a lot better. Have you ever wondered what it takes to get a vital new vaccine to market in the United States? It’s a rigorous testing and approval process. The basic steps: 1 . Exploratory and preclinical research. In the earliest stages of development, lab scientists conduct basic research — they begin to explore the feasibility of a new vaccine. A candidate vaccine may then be studied in cell or tissue cultures and in animals, but not yet in humans. 2 . Clinical trials. Next, if allowed by the U.S. Food and Drug Administration (FDA), a promising vaccine may be studied in people. Among other things, scientists will assess the vaccine’s safety and ability to provide immunity, the number of doses needed, and any side effects. Most clinical trials happen in three phases: ● Phase 1: The vaccine is given to a small group of adult volunteers. (Later, children also may get the trial vaccine, if it is intended for them, after it is first tested in adults.) ● Phase 2: The vaccine is given to hundreds of people, and some of the participants are similar to those for whom the new vaccine is intended. These trials are randomized and well-controlled and include a placebo group. ● Phase 3: The vaccine is given to thousands of people and compared to a placebo. The trials are randomized and double blind — neither the trial participants nor the health officials know which participants are receiving the vaccine and which are getting the placebo. 3 . A new vaccine is ready. Once the clinical studies are complete, if it is found to be safe and effective, and if its benefits outweigh its side effects, a candidate vaccine may be licensed for use by the FDA. 4 . Ongoing monitoring. Even after a new vaccine is licensed, the FDA will continue to monitor it for safety — a kind of quality assurance process. This includes periodic inspections of the vaccine maker’s production facilities. In addition, the FDA and the Centers for Disease Control and Prevention (CDC) track side effects linked to the new vaccine that are reported by individuals, doctors and others. How long does the process last? Vaccines can take several years to develop. But as we’ve seen with efforts to develop a coronavirus vaccine, the process can sometimes be fast-tracked. Additional source: The College of Physicians of Philadelphia Why masks and more still matter Once you’ve received your COVID-19 vaccine, you can take off your mask and stop social distancing, right? Not quite yet. Health experts are urging that everyone continue taking precautions not to spread the virus, even after they’ve received their shots. Why is that? It may take a while before everyone has had a chance to get a vaccine. In the meantime, people are still vulnerable to the virus. And because no vaccine is 100% effective, you may still be at risk, too. “When we get a vaccination, we are not immediately immune,” says Regina Mysliwiec, MD, CMH Emergency Department Medical Director. “The vaccine takes weeks to allow our bodies to build up the appropriate level of antibodies so that we can fight off the infection.” We need to continue using every tool we have to fight the spread of COVID-19. When can I stop wearing a mask? We don’t know enough about the vaccine or the virus yet to predict when it will be safe to stop wearing a mask or social distancing. But at least two things need to happen first: 1 . A large number of Americans need to get the shot. 2 . We need to be sure the vaccine offers long-term protection. Once those things happen, we may begin to see herd immunity, which occurs when enough people are protected against a virus that it’s unlikely to spread widely anymore. It’s not yet clear how many people will need to be vaccinated before we reach herd immunity. But once we do, we should be able to stop wearing masks and socially distancing. Until then, help keep your community safe by masking up, washing your hands and staying six feet from others. Sources: Centers for Disease Control and Prevention; Johns Hopkins University How vaccines are developed 6 HEALTH COMPASS WINTER 2021