As early as today, we will begin to see validated COVID vaccine data released. I hope this letter provides a framework of knowledge to help understand the significance of what we may hear, as well as prepare us to discern evidence from exaggeration.
If you missed yesterday’s letter, START here. And a big welcome to those of you who are new! Now, let’s jump in.
How does the mRNA vaccine work?
Most simply, messenger RNA is a construction blueprint. Its job is to communicate building instructions to protein construction teams that live in our cells, called ribosomes. To use mRNA in a vaccine, this blueprint is covered in a fatty coating and injected into the body. Some body cells will absorb the instructions, some will not. Of the cells that do, the blueprints are passed to the ribosomes. For the COVID vaccine, ribosomes will use the instructions to construct of one small part of the SARS-CoV-2 virus, the spike protein. The mRNA is then degraded by the cell.
After being made, the new spike protein will move to the cell’s surface, allowing the immune system to recognize the spike as a foreign invader. After vaccination, antibodies are created to fight the spike. About 12 days after getting vaccinated, the immune system will be prepared to attack the spike protein of the actual SARS-CoV-2 virus and protect us from severe COVID-19 disease. mRNA vaccines will then require a booster dose to optimize response.
Do NOT confuse RNA with DNA. They are two very different biological entities with unique functions. The mRNA vaccine does not integrate or “alter” your DNA. It will not embed or change your genetic identity. mRNA is a tool to create proteins; used, broken down, and eliminated.
Also, there is no live virus in mRNA vaccine technology. You cannot get COVID-19 from this vaccine. This is cool because “growing” virus in a lab in order to use its parts is time-consuming and fraught with delay. Remember 2009? All the delays with the H1N1 vaccine? I do. Thankfully, the mRNA does not have this limit, companies can make mRNA for days and days. It’s the little glass jars to hold the vaccine that need to catch up. Plus, you will not be contagious after getting the vaccine since there is no viral particles in it.
Here’s a great graphic of the process that brings all of this science together.
By the way, there is not a microchip in the vaccine. Anyone who shares this crazy myth in your feed needs to be muted immediately.
Who is going to get it first?
In the US, distribution ultimately is determined by your State. Generally speaking, distribution plans will send first doses to health care providers and those in long-term care facilities. In addition, distribution of available vaccine products will be determined by population density.
The KC metro area straddles two States run by very different public health leadership. So, this should be fun. Here’s a copy of the Missouri and Kansas plan.
I’ve already survived COVID-19. Will I still need to be vaccinated?
One of the many bizarre things about SARS-CoV-2 is the range of reactivity to natural infection. Some individuals have a robust, dynamic response to the virus. Others develop a response so mild that they are susceptible to reinfection.
Although it is very true that natural infection may provide most of us with robust immunity without being vaccinated, we currently don’t have an accurate test to ensure immunity. With what we know today, it’s dicey to assume you are fully protected after natural infection.
What the vaccine provides is a calculable response to ensure our protection, without risking disability or death from the virus. Interestingly, there is initial evidence that the mRNA vaccine is creating a response BETTER than natural infection. We will see over time if this claim remains to be true. Although recommendations are not final, most experts expect the COVID vaccine to be for all people, even if you already had the disease. The urgency to vaccinate those who have survived infection, however, will be lower.
POP QUIZ: Currently, we have three routine childhood vaccines that provide better immunological protection than natural infection. Do you know which vaccines these are?
The answer will be posted in the comments.
What do we know about side effects?
Short term side effects have been reported for each mRNA vaccine, with Moderna reporting slightly higher side effects after vaccination than Pfizer.
We expect side effects. We are exciting the immune system when we vaccinate, so experiencing the effects of that stimulation are normal. Side effects are not going to stop most individuals from vaccinating, but it is important to know what to expect. Most trial participants experienced at least one of the following: fatigue, joint pain, headache, and soreness at the injection sight. The likelihood of these side effects were greater after receiving the second dose of vaccine.
As these vaccines roll out, we expect to see vaccinated individuals get COVID-19. As most of you know, it can take up to 14 days after being exposed to the virus to show signs of infection. Should vaccinated people develop COVID-19 after getting vaccinated, it is because they were infected prior to developing effective antibodies. It is sadly predictable that charlatans will use these reports to try to undermine the vaccine. Again, it’s impossible to get COVID-19 from this vaccination.
Concerns of long-term effects and long-term efficacy are valid. We all will be making the choice to vaccinate without long-term data. Personally, I’m weighing this concern against the known long-term side effects of COVID-19, including disability and death. These known effects of the disease are more real to me than theoretical side effects of the vaccine. Keep in mind, I’m also caring for ill patients and their families everyday and being exposed to SARS-CoV-2 more than I probably know. This work hazard may make my risk/benefit ratio very different from yours.
Finally, be prepared for news that the vaccine does not work as well as initially claimed. This is not a side effect, per se. But remember that most vaccine study volunteers are young and healthy. If an EUA is granted and millions of Americans begin to get vaccinated, the efficacy numbers will change as the “real” population is monitored over time.
How is the vaccine safety going to be monitored?
Very, very carefully.
Vaccines are one of the most tested and monitored medications we use. Period. Continual monitoring for effectiveness and safety has always been part of our successful vaccine strategies. There will be multiple agencies, in both the public and private sector, that will be watching every recipient of this vaccine for years to come. Lots of details about safety monitoring can be found in this report.
What about pregnant or breastfeeding people?
This is a tightrope walk. Pregnant people have not been included in trials. But, we have pregnant health care workers who are on the front lines of getting sick, and we know that pregnant individuals are at a greater risk of getting significantly ill with COVID-19. We should hear more from leading women’s health groups in the weeks to come.
Until then, here are two go-to videos from Ob/Gyn experts, Dr. Marta Perez and Dr. Danielle Jones. These should help start your discussion with your personal doctor.
What about all the people who already say they are not going to get it?
There will be people that don’t want it. That’s okay. We all carry our own set of risks and worries. I just hope all of us are able to keep an open mind about the process and not shame each other’s choices. When safety and efficacy data are increasingly sound, the choice to vaccinate will become more clear for everyone.
When will we know more?
The VRBPAC is the FDA advisory committee that will be meeting on Thursday, Dec. 12th. This is a group of independent, career experts who review the data as presented by Pfizer, then complete their own analysis of the results. (The VRBPAC’s independent analysis is an important procedural difference than the UK approval process.)
The comments of the VRBPAC will then be taken into consideration by the FDA who ultimately grant the EUA, or offer feedback to Pfizer for correction. The FDA’s meeting will be open to the public and live-streamed on all major social networks. Committee comments on the Moderna vaccine will be the following week.
What else can we expect?
Problems, delays, and rumors.
I think it’s really hard to wrap our heads around the level of logistics, education, and participation that will be necessary to get all humans on the planet access to vaccination. This process will be slow and happen over time.
The public health measure we all know (distancing, masking, avoiding crowds) will need to be continued through the first few rounds of vaccines. The lower the disease prevalence in our individual communities, the better the vaccine will be able to help decrease disease burden in our global community.
Don’t expect a pandemic-ending ticker tape parade. No firework celebration. No synchronous tossing of masks to the sky. The end of this Pandemic will not be a bang, but a whimper. Remain patient. Expect road bumps. Continue to be vigilant.
Meanwhile, those opposed to vaccination will intentionally amplify concerns, use crafty language to legitimize false data, and will want to sell you something. We will all have to continue to evaluate what we read with a critical eye, and ask questions of our experts if we hear something that makes us worry.
“Such [anti-vaccine] theories, which have rocketed around the internet all year, don’t just do damage to the terminally gullible: By turning the internet, the watering hole of the collective consciousness, into an unnavigable swamp of intermingled truths and lies, they help to breed a sort of numb helpless apathy in pretty much everybody.”
Are you going to recommend the vaccine for kids?
Although kids are transmitting the virus to others, they are not taking the direct burden of disease. Praise be. And because kids are rarely dying from COVID-19, we don’t have the urgency to provide direct protection. Currently, Pfizer has trials down to age 12 years, but that data will not be available for a while. Moderna is adding 12 yr + to their trials soon.
That being said, we have NO childhood data available to make any recommendation. Any speculation would be irresponsible. However, we do know the pandemic will not be over until the kids are vaccinated in some way.
But, Dr. Natasha, my kids NEED to go to school next fall.
I don’t think that taking time to get safety data will affect school openings. If we have learned nothing else in the past few months, it is that viral spread can be controlled with social distancing, basic hygiene and wearing masks. There is no better place consistently executing all these safety measures than our schools, daycares, and preschools.
Our current vaccination plan is like putting our own proverbial oxygen mask on first before we can help the kids. If we can vaccinate the adults around the kids, that will decrease the illness being brought into our schools. The kids will be okay while consenting adults can take a relatively higher risk as initial vaccine recipients.
As always, I will not recommend any medical intervention to my patients that I would not offer to my own children. I plan on being fully transparent when/if Dr. Kevin and I choose to vaccinate ourselves and our own kids. We should know more soon.
All this vaccine stuff is going to come fast and furious. Let’s all be cautious as we read, careful as we learn, and critical of what we share. We can get through this, together.
BONUS: Get ready for the #vaccine episode of “Masks Off Live” with my friend, Dr. Nicole Baldwin. We will be on Instagram Live on Wednesday, December 9th at 7 pm CST to discuss all things COVID-vaccine, prepare us for Thursday’s VBPAC/FDA meeting, and answer more of your questions.
Have something we can’t miss? Reply to this email or drop a comment.
I’ll see you on Insta tomorrow.
The answer to the question: Hib, pneumococcal, and HPV. Hit the heart if you got it right!
Laurie S4 min ago
I have several follow on questions:
1) It reduces the severity of the symptoms. Is there any data on how it affects transmission to others? For example, could you get it but have a very mild case of it after vaccination, not realize it, and still be infectious to others? I don't see this being talked about a lot. My concern is that it *is* still infectious and people who are vaccinated treat it like a Get Out of Jail Free card to go back to pre-pandemic behavior.
2) Is there any Covid-19 data on families with high-risk, cognitively, and behaviorally challenged children, in any direction? Some questions -
*How are these families faring overall? Is the infection rate for the children or adults in these families more or less when all factors are considered?
*Are they more isolated out of an abundance of precaution? How is that affecting the family dynamic differently than in families with more typical children? Is there guidance specifically for these families? Are there any supports for these families (increasing respite care availability, more family welfare checks, etc)?
*How much are the children regressing without the consistent therapeutic, educational and medical inputs they had daily or weekly prior to the pandemic? Is anyone talking about plans to address that going forward?
3) I spoke with Clay County Health Department to get clarification on where families of medically high-risk children placed on the tier system because I could not find any specific mention of these families anywhere in Missouri's guidance. They had not considered this, suggested I get a job in the essential worker population segment and referred me to get further clarification from the state.
Do you see Missouri eventually including families of pediatric (high-risk and special needs) population in their emergency planning?
Thank you for sharing your thoughts.
Laurie