Tuesday, November 17, 2020

Yesterday a second vaccine announced a milestone in the development process. This time it was Moderna that boosted the stock market by announcing a 94.5% efficacy rate. The press release announced that this meets interim criteria for the phase three trial by detecting 95 confirmed cases of COVID-19 in a study of 30,000 volunteers. This announcement parallels Pfizer’s press release last week which announced an efficacy rate of greater than 90% in its phase three trial that detected 94 confirmed cases in its study of 43,538 participants.

Both evaluations coming at this particular point in the clinical trials is not a coincidence of course. The guidelines are set up with the NIH, FDA, and the oversight of an independent data monitoring board. (To learn more about this complicated process, start with the CNN article listed below). The next evaluation will be when each study reaches a statistically significant number of cases (164 for Pfizer and 151 for Moderna), and then continues to follow up while applying for an EUA or Emergency Use Authorization from the FDA.

We will hear about more clinical trials soon, although probably not next week. There are 54 vaccines in human clinical trials all over the world and 87 in earlier trial phases. Two in the U.S. that may be reporting by the end of the year are Johnson & Johnson (Janssen COVID-19 vaccine) and the vaccine under development by AstraZeneca and the University of Oxford.

Not only individuals but entire industries hurt by COVID place great hopes on these outcomes. Still, caution is warranted while we wait for studies on the efficacy, safety, and durability of vaccines to play out over the next four to six months. In the meantime, we are facing a winter surge of COVID cases with the concomitant hospitalizations, deaths, and long-term consequences. And the holidays are coming, which make our decisions even more difficult.

The news media are full of holiday-related suggestions, some more useful than others. I have a hard time, for example, taking seriously a suggestion to put on your mask between each bite. On the other hand, it does seem reasonable to limit the number of people at any gathering and keep the area well-ventilated. So the number of people matters.

COVID-19 Risk Assessment Planning Tool

Where you are matters as well, because your chances of contracting COVID are directly related to the relative concentration of cases in the community. You can enter your location and the number of guests into an interactive risk assessment map that has been widely publicized. My first thought was that this would only work if the people at your gathering are random. But actually anyone who ever goes to work, school, church, or a grocery store is part of random community exposure. So the map, put out by Georgia Tech, Stanford, and Applied Bioinformatics may be of some value. You find it at https://covid19risk.biosci.gatech.edu/ . At least it gives you a relative idea of risk across the country.

Ten is the lowest number of people you can enter, so I entered 10 for our (my son and I) Thanksgiving dinner in San Diego with my youngest son, daughter-in-law, and baby. It gave a risk of 8%. Just for comparison, the risk for the same group would be 52% in Casper, Wyoming and 4% in Honolulu. This bodes well for my oldest son’s visit over Christmas.

We are all weighing risks and benefits this year. Patience and understanding needed all around.

Today’s Notable Headlines

“What to know if your employer wants you to get vaccinated for Covid,” CNN Business, Nov. 16, 2020. https://www.cnn.com/2020/11/16/success/employer-require-covid-vaccination/index.html

“How a Covid-19 vaccine could change travel for good,” CNN Travel, Nov. 16, 2020. https://www.cnn.com/travel/article/covid-vaccine-travel/index.html

“When snow meets fall: Beautiful photos capture ‘snowliage’ in Yosemite,” SFGate, Nov. 17, 2020. https://www.sfgate.com/california-parks/article/yosemite-winter-fall-snowliage-park-california-15731195.php

“COVID-19 Event Risk Assessment Planning Tool,” https://covid19risk.biosci.gatech.edu/

Useful References:

Moderna Press Release: “Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study.” Nov. 16, 2020: https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy

Pfizer and Biontech Press Release,: “PFIZER AND BIONTECH ANNOUNCE VACCINE CANDIDATE AGAINST COVID-19 ACHIEVED SUCCESS IN FIRST INTERIM ANALYSIS FROM PHASE 3 STUDY,” Monday, Nov. 9, 2020. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against

“The secretive group at the center of the nation’s largest vaccine trials,” CNN, Oct. 3, 2020. https://www.cnn.com/2020/10/03/health/dsmb-role-coronavirus-vaccine-trial/index.html

“Coronavirus Vaccine Tracker,” The New York Times, updated Nov. 16, 2020. https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

“Johnson & Johnson Initiates Second Global Phase 3 Clinical Trial of its Janssen COVID-19 Vaccine Candidate,” Johnson & Johnson, Nov. 15, 2020. https://www.jnj.com/johnson-johnson-initiates-second-global-phase-3-clinical-trial-of-its-janssen-covid-19-vaccine-candidate

Why am I doing this?

The coronavirus pandemic will be indelibly written on our memories just as the Great Depression or the Battle of Britain left their mark on past generations. It is my intention to journal the pandemic experience from three perspectives: as a retired medical technologist, a historian (Ph.D., 2014), and an ordinary person living through an extraordinary crisis.

You are on History’s Edge.

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