May 27, 2020
When is King County going to move to Phase 2 of reopening?
In order to move to Phase 2, which includes restaurants at 50% capacity (remember eating at restaurants?), meet-ups of groups of 5, hair salons and nail parlors, and non-essential retail stores, multiple criteria have to be met.
These criteria include:
- COVID-19 disease burden is low and decreasing (a county must have less than 10 new cases of Covid-19 per 100,000 residents, over the span of 14 days)
- Health care system readiness (empty ICU and floor beds and available ventilators)
- Testing capacity and availability
- case and contact investigations
- ability to protect high-risk populations (including shelters and nursing homes)
- Once these criteria are all met, the governor will issue an order to allow the county to move to Phase 2 of re-opening. King County’s data dashboard is tracking these metrics. Washington’s coronavirus dashboard is also tracking things on the state level.
We are doing relatively well with health care system readiness, and testing capacity and availability continues to increase (although we are not there yet). The state is busy hiring and training investigators for case contact tracing (630 people so far – and you can volunteer to help). The ability to protect the vulnerable continues to be a challenge, and we continue to have more than 10 cases per 100,000 over the past 14 days. Specifically, King County, with a population of approximately 2.3 million, must have less than 230 cases over 14 days, and we have had more than double that, although the numbers are falling, which is encouraging.
All of this means we are not going to be one of the counties that progresses to Phase 2 on June 1, but if we continue to Stay Home and Stay Healthy, we may get there in a few more weeks.
Human Challenge Trials
The typical timeline to demonstrate a vaccine is safe and effective conflicts with the aspirational timetable put forth by some politicians – 100 million vaccine doses ready as early as November. That’s why we wanted to learn more about the growing movement to use human challenge trials to hasten the COVID-19 vaccine timeline. In human challenge trials, vaccinated volunteers are deliberately exposed to the virus in order to cut to the chase. The movement is embodied in the website https://1daysooner.org/.
A conventional vaccine timeline, without a human challenge trial, goes like this: a phase 1 vaccine trial, to assess safety, often takes several months but under pandemic conditions seems to be completing faster, after 2-3 months. Once that phase 1 vaccine trial establishes preliminary safety, a phase 2 trial begins and enrolls thousands of people within an area that has a higher rate of active infection and compares those vaccinated against those having received a placebo instead of a vaccine. A handful of phase 2 trials for COVID-19 have been announced already. Historically phase 2 vaccine trials take several months or longer. Following a phase 2 trial comes, you guessed it, a phase 3 trial of yet larger scale and often longer duration. In the interest of urgency, there are ways to combine the phase 2 and phase 3 trials, or at least overlap them, and save a few months. Still, anyway you slice it, we’re into 2021, even well into 2021.
A vaccine timeline that replaces the conventional phase 3 trial with a shorter duration human challenge trial would, at least in theory, subtract many months from the vaccine approval process, according to scientists authoring journal articles such as this and this. Last month, 35 members of the House of Representatives wrote the FDA in support of human challenge trials (https://tinyurl.com/y9yrrp7t). Through the 1daysooner website, some of us at Wise Patient have pledged our willingness to volunteer to be in a human challenge trial.
The last time a human challenge trial was proposed for a vaccine: 2016, for Zika virus. Result: denied by ethics panel (https://tinyurl.com/yavofyfw). Infectious diseases for which human challenge trials have been used in the past to test vaccines or treatments, as described on the 1daysooner website: smallpox, influenza, cholera, malaria, typhoid fever, and dengue fever (a weakened version).
Typical arguments in favor of using human challenge trials to hasten the COVID-19 vaccine timeline include:
The more we flatten the curve through social distancing, the longer a conventional vaccine trial will take (as in, better to test a vaccine in early April in NYC than currently in Seattle, knock on wood).
The ethical standard to instruct participants in conventional vaccine trials to practice infection prevention behavior and hygiene prolongs the trials further. “You don’t want them to get infected — but you do,” says Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. (https://tinyurl.com/ya9dhd6s)
There are ethical issues within a conventional phase 3 trial that counter balance those of a human challenge trial, such as the probability of COVID-19 deaths in the placebo arm of the conventional trial.
Typical arguments against using human challenge trials to hasten the COVID-19 vaccine timeline include:
There is yet no treatment for COVID-19 proven to prevent deaths, thus no proven way to prevent death in vaccinated volunteers of a human challenge trial who get severe COVID-19 after intentional exposure to SARS-CoV-2.
The amount of time needed for scientists to create a “challenge model” for COVID-19 (identify and safely grow the strain of SARS-CoV-2 to be used in the challenges, decide on inoculum amount, standardize the ‘delivery system’ that exposes the volunteer to the virus, etc) will offset the amount of time saved.
FDA regulation of a human challenge trial is its own time consuming process.
Challenging young healthy volunteers to SARS-CoV-2 (perceived as necessary to lower the risk of death within the trial) may not teach us if the vaccine would be protective in higher risk older age groups.
Even within the conventional vaccine trial framework, the FDA can hasten the timetable by granting early emergency use of a vaccine in high risk groups like health care workers and residents of skilled nursing facilities, before formal completion of a phase 3 trial.
No easy answers.
Hello Wise Patients! A popular request amongst you all have been recipes that our community has been using. We know a ton of you caught the “baking bug” earlier in the quarantine period and if you have any recipes and pictures of your culinary creations, send them to us so we can feature a couple in some upcoming newsletters. This week, our very own, Dr. Naomi Lee has chosen a couple recipes that she loves, to share with all of you! Check it out: https://cooking.nytimes.com/recipes/1015257-falafel
Her helpful tip? Serve the falafel with fresh homemade pita bread and a Tahini sauce to take it to the next level!
Your weekly dose of pets from your patient community!