Race for the Vaccine Part I
Vaccines are among the most successful and important pillars of public health. They are also some of the safest drugs in the world because they undergo rigorous testing. And while it usually takes a decade to develop a safe and effective vaccine, with the stakes so high, that time has been cut to months. Doctors and scientists are working to make sure this is being done safely, despite the warp-speed timelines.
Testing a vaccine starts with pre-clinical experiments; animals are given the vaccine to see if it provokes an immune response. Then the new vaccine goes to Phase I trials with small groups of people enrolled to determine safety, how it works, and what dose works well. Phase II expands this to a larger, more representative group of participants. And Phase III, with thousands of people, assesses whether the new vaccine actually works to prevent the disease in the real world (efficacy). (The FDA requires a minimum 50% protective efficacy for approval for a COVID-19 vaccine in the US.) Following Phase III trials, vaccines are monitored for years to check for side effects or any other problems.
Currently there are 8 vaccines in Phase III trials in 13 countries, 3 of which the US has chosen to fund this summer. The catch though, is that while time is of the essence, none of those phases can be skipped. Vaccine hesitancy (reluctance to use vaccines) is a public health threat. Any vaccine that does not live up to its promise will erode public trust. And that’s a problem because vaccines work best when most people in a population get the vaccine. Fortunately, the US government has outlined strict guidelines for ensuring COVID-19 drugs are safe and work well. Immunization is going to be critical in beating this disease, but we need to work safely and carefully in getting there.
Last update: Aug 11, 2020 01:00 pm ET
Science review: ERS, JAB