COVID Transmissions for 12-11-2020

Pfizer vaccine authorized in the US

Dec 11, 2020

Good morning! It has been 390 days since the first documented human case of COVID-19.

Today, we’ll focus on the topic of yesterday’s FDA meeting to recommend authorization of the Pfizer vaccine.

As usual, bolded terms are linked to the running newsletter glossary.

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Now, let’s talk COVID.

Pfizer vaccine is to be authorized for emergency use in the US

The FDA committee met yesterday and decided to recommend that the agency authorize the use of the Pfizer COVID-19 vaccine in limited emergency circumstances. The vote was 17 for, 4 against, and 1 abstaining. The FDA will almost certainly heed the committee’s recommendation.

Detailed reporting on the proceedings of that meeting is available at CIDRAP: https://www.cidrap.umn.edu/news-perspective/2020/12/fda-panel-oks-pfizer-covid-vaccine-emergency-use

A very detailed live blog of the meeting is also available from STAT: https://www.statnews.com/2020/12/10/tracking-the-fda-advisory-panel-meeting-on-the-pfizer-biontech-covid-19-vaccine/

Here are the highlights that I think are worth noting:

People with past serious reactions to vaccinations were not included in the Pfizer trial; therefore, there is some concern about potential allergic reactions—this will need to be a conversation that patients have with their doctors about their allergy status
Continued safety monitoring structures will be in place not only from the first moment the vaccine is available, but also from beforehand, because the vaccine trial continues to monitor safety and efficacy as we speak
Patients in the placebo arm of the vaccine trial will be offered the active vaccine at the time that it becomes available to them according to local authorizations
- This means that a healthcare worker in the Pfizer trial who got the placebo might be offered the full vaccine as soon as it is available, while the typical person with few risk factors might continue in the trial without being offered the vaccine for some time
- This will affect the ability of the trial to continue to monitor efficacy and safety, eventually; right now it’s likely that few participants would be eligible for the vaccine from the placebo arm, but over time more and more people will become eligible
- Still, we will get some additional safety and efficacy information over time, which I hope will add more data to be optimistic about and generally improve confidence in the vaccine

Side note, you’ll notice that I’ve used the word “authorized” and not “approved.” This is deliberate. FDA approval is a formal process that this vaccine has not yet passed through. This is an emergency authorization; the FDA’s provision of that authorization is based on the understanding that it will start off in a limited population only, which will allow additional data to be accrued before it goes into a wider population.

Care is being taken to make sure this vaccine is effective and safe while still offering as many people as possible our current best tool against COVID-19.

What am I doing to cope with the pandemic? This:

Planning a Chanuka Party!

I’ve had a very small part in planning a Chanuka party for my synagogue. It’s very elaborate, and it is entirely taking place on Zoom. There will be a candle lighting, songs, a raffle, and breakout rooms with various activities for children and adults. There may even be a magic show—a few details are still being worked out.

It’s been a nice thing to look forward to, and we’ve actually raised a lot of money through the raffle for a local anti-hunger charity, something that is needed in this difficult time. I only had a minor part to play, but I’m glad that I’ve been a part of this.

Robert Berger left a comment on yesterday’s issue that taught me something cool about what a phone can do these days:

Some phones (like my Samsung Galaxy Note 9) are able to perform the pulse oximeter function. When using the Samsung Health app, there is an option to measure your "stress level". Running that test actually provides your heart rate and oxygen level, and even provides a means of tracking your readings over time. Very convenient.
The caveat:
I compared a few readings on my phone to those I took simultaneously with an inexpensive ($35 on Amazon) pulse oximeter. In most cases, the heart rate readings were within 1% of each other, which is fine, given that heart rates can make wild swings just by doing things like looking for your pulse oximeter. However, the oximeter readings were often 2% apart, with the dedicated device showing, say, 97%, and the phone showing 95%. A few minutes later, while still simply sitting and going through emails and a good daily Covid blog, the readings were 99% and 97% respectively. Given that there is only a 5% range of acceptable percentages, a cheap pulse oximeter or your phone should only be used as a guide, and not as definitive gauge of your actual oxygen levels.

My reply was a lot more limited in scope than usual:

Very good points, Robert--these devices give you an approximate reading, certainly. It's always best to consult with a professional if you get a reading that looks off. I think for the home pulse oximeter, where I'd really start to worry is if it's reading in the low 90s or lower consistently.
Also it's cool that there are phones that can do this--I didn't know that!

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