COVID-19 Update: Friday, October 22nd

The scoop on Boosters

You probably think I disappeared into the abyss - lol, but I'm still here. And today is a very good day to discuss boosters. I suspect, at some point in the future, they won't be viewed as boosters but we will consider the vaccine a series just like we do vaccines such as Hepatitis and DTaP but we shall see.

As a quick refresh on the process, the FDA reviews the drug - is it safe, is it effective, does it do what it says it does, and is it necessary. The CDC reviews the actual vaccine schedule recommendation. So what are the public health benefits and necessities? They too will review safety and efficacy data but the FDA has the responsibility of approving the drug, while the CDC has the responsibility of approving the booster/vaccine series for the public.

First we will look at the recommendations for who - then below we can look at which booster to get.

Moderna:

A 1/2 dose booster for adults 65 and up,

A 1/2 dose booster for ages 18-64 who are high risk for severe COVID

A 1/2 dose booster for adults 18-64 with frequent occupational and institutional exposure

Booster should be given 6 months after completing the other 2 shots. So 6 months after the second shot. It is ok if it has been longer than 6 months.

Considerations: the Moderna data presented to the FDA was pretty small numbers. Similar data were presented by Israel and those numbers were compelling, which was the incentive for most of the approval process here. But the numbers actually presented to the FDA were very small. Additionally, the study was not very diverse and did not include anyone with a history of chronic cardiovascular disease, chronic pulmonary disease, HIV, diabetes, or a history of hypertension. With that said, there were no safety issues identified.

I will post a link to that information at the bottom if you are interested in reviewing it.

Johnson & Johnson:

Boosters for anyone 18 and over who received J&J for their first dose.

Booster should be given 2 months after the first shot. Some data suggests that giving the booster 6 months after is actually more effective with better results - but that data is limited.

Considerations: Data was limited and again, the decision was based largely on what happened in the Israel study. The J&J data reviewed by the FDA was actually the smaller data set of the three options. There were also a limited amount of data for those under 40.

Pfizer:

65 years and older

Age 18+ who live in long-term care settings

Age 18+ who have underlying medical conditions

Age 18+ who work or live in high-risk settings

Booster should be given 6 months after completing the other 2 shots. So 6 months after the second shot. It is ok if it has been longer than 6 months.

Considerations: Like the Moderna data, the sample size was small (link below) and not diverse. The recommendation leaned heavily on data presented out of Israel and not the clinical study itself. There was no real data for minors included. No safety concerns were noted.

BOOSTERS themselves - can be mixed without serious concern. I have pasted the link below to the study that was used to determine that. There were 458 people in the study. Some were given the same type of booster as they had the original vaccine and some were given a different booster. There were 9 group combinations. Reactogenicity (negative side effects) was similar to that reported for the primary series. Injection site pain, fatigue, headache, and body aches occurred in more than half the participants. - So you should expect you may feel down in the dumps for a bit after the booster. People who got a different booster than the original shot seemed to have stronger overall immunity. Currently, the recommendation is to get whichever booster you want and/or can find.

Considerations: No one in the study had previously had COVID - so that is still a question.

As always, I am open for questions.

FINAL THOUGHTS: As you know, I am attempting to teach my daughters to drive. This morning daughter B was going to drive us to school. Now our driveway is treacherous. Honestly, it is the hardest part of the experience most days. Today, I no more than got the words, "you're too close to the wall, on that side" out of my mouth when I heard the horrific scrapping of the vehicle on said wall. She stopped and the world stood still for a second. Her eyes were wide and I could hear the tears starting to rise. I had two choices, care about the car, or care about the child. I chose the child.

You see, I have hit that wall before. In fact, every driver in our home, and most people who visit us, hit "the wall" that is our driveway at some point or another. The night before, daughter A returned home from her driving practice and then cried. She had hit a curb leaving the driveway. That small mistake rattled her and she was stressed and anxious the rest of the drive. I did not want daughter B to feel stressed and anxious as she drove us the rest of the way, nor did I want her to spend her day at school feeling that way. So today I am reminded of two important lessons from these experiences.

1) Don't let the little mishaps rattle you. Those little things and mistakes we make don't define us. Learn to move past them. Let them go or they can ruin your day, your week, your life. Forgive yourself, forgive others. Move on. 2) Sometimes people's emotional responses have nothing to do with you - it's about the stuff they are carrying around. It's about the way they have been beating themselves up inside. So if someone flips out on you, do a mental check. Did you do something wrong? If so, own it, and apologize. If not, offer encouragement and be a safe place for them to release a little of what is bogging them down. Together we are stronger.

Resources/Further Reading:

You can read the FDA statement here: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-additional-actions-use-booster-dose-covid-19-vaccines and for Pfizer here: https://www.fda.gov/media/152161/download

You can review the Moderna clinical trial data here: https://clinicaltrials.gov/ct2/show/NCT04405076

You can review the J&J clinical trial here: https://clinicaltrials.gov/ct2/show/NCT04436276

You can read more about the Pfizer study/data here: https://www.nejm.org/doi/full/10.1056/NEJMoa2114255?query=featured_home (Israel study) and here: https://clinicaltrials.gov/ct2/show/NCT04368728

You can read the CDC recommendations here: https://www.cdc.gov/media/releases/2021/p1021-covid-booster.html

You can read the pre-print research study on mixing vaccines here: https://www.medrxiv.org/content/10.1101/2021.10.10.21264827v1