First, A Calendar Item: Next Monday, December 14, from 7-8PM PST the Spokane Chapter of FairVote Washington is holding a Zoom meeting explanation of Ranked Choice Voting. I just attended (by Zoom) a similar chapter meeting. I found it very informative. You will find it an hour well spent, especially if, like me, you are really tired of negative campaigning. Ranked Choice Voting as an election method is spreading across the United States. This is your chance to learn about it. Sign up here: https://www.mobilize.us/fairvotewa/event/364899/ I understand Vicki Dalton, the highly respected Spokane County Auditor–who oversees elections–is planning to attend.
Also THIS EVENING, After we made national news again with a politically motivated terrorist issuing a bomb threat and setting fire in the Spokane Democratic Headquarters.
Support the Spokane County Democrats on Zoom!
TOMORROW, Friday, December 11th
5:15PM – 6:00PM
By Zoom
Sponsor Levels: $1,000, $500, $250, $100
Sign-up to sponsor the event today! Contact Katherine@electbobferguson.com to let us know of your sponsor level.
You can sign up with a donation of ANY size online here: https://act.myngp.com/Forms/-770535090633570560 We will be joined by Spokane Democrats Party Chair Nicole Bishop and State Rep. Marcus Riccelli for an update.
Today’s Post:
The big news yesterday was the hearing and vote of the FDA’s Vaccines and Related Biological Products Advisory Committee. They recommended approval of Emergency Use Authorization for the mRNA vaccine produced by Phizer and its German partner BioNTech for people 16 and over. The FDA is highly likely to take the advice of this committee and grant approval this weekend. That should set the ball rolling for the first immunizations in the U.S. to occur next week.
I did not attend the meeting, but I did peruse some of the materials presented at the meeting, including the 53 page FDA Briefing Document. More comforting and much easier to read was the peer reviewed presentation of the Phase III trial of the vaccine published in the New England Journal of Medicine, entitled “Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine.” It is worth a click, just to get some idea of what is entailed in a study like this.
A total of 43,548 volunteer participants in the U.S., Brazil, Argentina, and South Africa were randomized to receive two injected doses three weeks apart of either the vaccine or placebo. Since Covid-19 is widespread in all these countries sending the participants out to live in the community in the way they had done before their injections offered exposure to the virus (and avoided any need for intentional exposure). At the time of publication (the study is ongoing) the median followup after the second injection was two months.
We hear “95% protection”? What did that actually mean in the real world of these volunteers? With a median follow up of 2 months and some followup out to around 3.5 months, counting those with symptomatic, test-proven Covid-19 that appeared at least 7 days following the 2nd injection, 162 people in the placebo group became ill and only 8 in the vaccine group. 95% = (162/170)*100. Starting a little earlier (7 days after the 1st injection), there were a total of 10 cases of severe Covid-19, 9 of them in the placebo group and one in the vaccine group. The graph of time vs. accumulating disease incidence is striking. The accumulating disease in the placebo group is a nearly straight line with a slope of about 45 degrees while the vaccine group’s line goes nearly flat (hardly any new cases) two weeks after the first injection. You can find this graph in the NEJM paper or, better, at the end of Betsy Brown, M.D.’s Update from an Epidemic December 9 post, along with some additional interesting commentary and links.
Reading the detail in the New England Journal article gives a clear idea what the odds of various reactions to the vaccine are with both the first and second dose. (Hint: plan on feeling crummy for a couple days after each dose.) In the “Discussion” section, the article also provides an update on a couple of lingering questions:
“These data do not address whether vaccination prevents asymptomatic infection; a serologic end point that can detect a history of infection regardless of whether symptoms were present (SARS-CoV-2 N-binding antibody) will be reported later.”
If the vaccine induces an immune response that keeps people from having an asymptomatic infection they could possibly pass along to the non-immune population, that would quell the spread in the population more quickly than if it does not. We do not have that information yet, but it’s coming!
“Although the study was designed to follow participants for safety and efficacy for 2 years after the second dose, given the high vaccine efficacy, ethical and practical barriers prevent following placebo recipients for 2 years without offering active immunization, once the vaccine is approved by regulators and recommended by public health authorities. Assessment of long-term safety and efficacy for this vaccine will occur, but it cannot be in the context of maintaining a placebo group for the planned follow-up period of 2 years after the second dose.”
In other words, it sounds like the folks in the study who received placebo will be offered the vaccine, instead of being left to face the ongoing threat of becoming infected. That seems only fair. One hopes that the 162 people in the placebo group who developed symptomatic Covid-19 so far (including 8 with severe disease) will be some of the last few of the volunteers who have to become ill. We are indebted to these volunteers and wish a speedy and complete recovery to all those who became ill in both groups.
Obviously, we cannot yet know if some long term complication of the vaccine might show up, but I find these early results and all the detail that comes with them very encouraging. If I were offered the first dose of this vaccine tomorrow I believe I would step right up. I am so done with this…
Keep to the high ground,
Jerry