COVID-19 Update: Thursday, September 24th

Special Vaccine Edition. It's long and sciencey, so bring a snack.

As we near the time when a COVID vaccine may become available I thought I would provide some information about vaccines in general and then the 4 top runners for a COVID vaccine and a snapshot of where we are in the process.

Types of vaccines: There are currently 4 primary types of vaccines in use in the US

1. live-attenuated vaccines – these use a weakened form of the germ to make the vaccine. The germ is too weak to “win” giving your body a very unfair advantage and your immune response is very similar to a natural infection. These vaccines result in strong, long-lasting immunity. They can require 1 or 2 doses. Live attenuated vaccines are not recommended for people with compromised immune systems, some chronic conditions, and people who have had transplants. They don’t travel well and have very stringent temperature storage requirements. Examples include MMR, rotavirus, smallpox, chickenpox, and yellow fever.

2. Inactivated vaccines – These use a dead version of the germ so they aren’t quite as strong as live vaccines but still effective. These typically require booster shots to maintain immunity over time. Examples include polio, flu, rabies, and Hepatitis A.

3. Subunit, recombinant, polysaccharide, and conjugate vaccines – these vaccines only use a specific piece of the germ to create the immune response, such as a protein, sugar or casing. They provide a strong immune response and are typically safe for people who can’t take other vaccines. They commonly require a booster to maintain immunity. Examples include shingles, Hib, HPV, and whooping cough (pertussis).

4. Toxoid vaccines – these vaccines work based on providing immunity to the toxin produced by the germ and not the germ itself. Some of them require booster shots. Examples include diphtheria and tetanus.

Vaccines all need time to take effect, so you aren’t instantly immune when you get the shot. Your immune system needs time to do its job, fight off the invader, and develop immunity. How long that takes can vary but it can take weeks for a vaccine to provide immunity. During that time, it is not uncommon for people to feel a little “under the weather” or tired. This is because your body doesn’t realize the “fight” isn’t real and it is launching a full-scale attack on the germ. This requires energy and white cell production (white cells are your germ fighters).

White cells are mainly produced in your long bones (arms and legs) down in the bone marrow. You keep a few on hand all the time but when you encounter a germ invasion your body produces more – it’s like our military being on patrol, encountering an enemy, and calling for the rest of the team to join them. This takes a little time and a fair amount of energy, so it can leave you feeling a little run down or tired and some people experience achy arms or legs. This is not you being sick, it is your immune system doing its job.

Vaccines are also designed to do different things. Some are designed with the sole intent to prevent death from the germ, others to prevent death and or severe disease/hospitalization, still, others to prevent those things as well as mild or even moderate sickness. So a vaccine maybe 99% effective at preventing death or severe illness but only 80% effective at preventing mild illness. It is also worth noting that not all vaccines work 100% of the time in 100% of the people. Our bodies are all so different and react to different things differently. Occasionally someone will get vaccinated and for some reason, their body won’t develop immunity. It is unusual but it happens.

One final and important note, some people have adverse responses to some vaccines. There are of course people who shouldn’t take specific vaccines – but some people have no known reason they shouldn’t take a vaccine, but their body just responds negatively, and they experience negative side effects. Rarely these are pretty severe. Severe side effects are extremely rare, but they do happen and unfortunately, we have no way of predicting that although scientists are working on this and hope to one day have vaccines that are as individual as we are.

The COVID vaccine candidates: Currently there are 4 vaccine candidates in phase III trials in the United States. All four recently released their study protocols to the public in order to increase transparency, this is unprecedented. Scientists, medical professionals, and public health professionals all over the world are reviewing these protocols critically because we have worked really hard to make vaccines safe and earn public trust and no one wants to see that discarded over this. Additionally, the National Medical Association, which is a professional society for African American physicians is planning to specifically review all COVID vaccine data as it applies to African Americans as well as all CDC data and FDA information as well as distribution plans to assure the African American community is well represented.

Today the FDA is expected to release new guidelines for EUA approval. (remember this is emergency use authorization which is allowing the vaccines to be approved in an expedited way) the new guidelines are expected to make it harder to get EUA so that we can have more assurance of a safe vaccine. Current scientific estimates are that a COVID vaccine won’t be ready until at least mid-November.

The 4 COVID vaccine Candidates in the US are:

1. AstraZeneca – AZ is working with Oxford University. This one has been in the news due to two female participants experiencing adverse effects that may or may not have been associated with the vaccine. That is currently being investigated. AstraZeneca is developing an mRNA vaccine and requires 2 intramuscular shots administered 4 weeks apart. They expect to test the vaccine on 30k participants around the world. They are conducting a randomized, double-blind, placebo-controlled study. Meaning people are randomly being assigned to either a test group (getting the vaccine) or a placebo group (getting a fake). Double-blind means that the participant does not know which group they are in nor does the person giving the immunization know if they are giving the actual vaccine or a fake. The primary objective in the study is to prevent COVID in adults. Their initial protocol included ages 18-65 but they revised it recently to include additional ages. The estimated completion date is December 2nd. You can read more here: https://clinicaltrials.gov/ct2/show/NCT04516746?term=AstraZeneca&cond=Covid19&draw=2&rank=2

2. Pfizer – Pfizer is working with BioNTech. They are also working on an mRNA vaccine. Pfizer plans to study different dosing and different age groups. They plan to include 30k study participants ages 18-85 from 120 locations globally. They include 20 safety objectives in their plan with safety being their primary objective and efficacy being secondary. They are doing a randomized, observer-blinded study. They too are giving 2 injections spaced 21 days apart. Their primary objective is to prevent COVID in adults. Pfizer gives special attention in their protocol to minorities and diversity. Their estimated end date is April 19, 2021. They expect to have efficacy data by the end of October. You can read more here: https://clinicaltrials.gov/ct2/show/NCT04368728?term=Pfizer&cond=Covid19&draw=2&rank=1

3. Moderna – Moderna is working with the National Institute of Allergies and Infectious Diseases (NIAD). The Moderna vaccine also consists of two doses via injection administered 28 days apart. They too call for about 30k participants. They are also proposing an mRNA vaccine. Their study design is a randomized, stratified, observer-blind, placebo-controlled study in those 18 and older. Randomized, stratified, means that the study participants will randomly be put into groups based on some particular shared characteristic – in this case, age and health risk. The estimated completion date is October 27th You can find overview information on this trial here: https://clinicaltrials.gov/ct2/show/NCT04470427?term=MODERNA&cond=Covid19&draw=2&rank=1

4. Johnson and Johnson – J&J is also working with the NIAID. They just entered phase III this week. Their vaccine is unique in that it is a single-dose vaccine instead of two doses and is not an mRNA vaccine but a live attenuated vaccine similar to the Ebola vaccine (genetically engineered). Their study is a Randomized, Double-blind, Placebo-controlled study in individuals 18 and up. They are looking to include 60k study participants in 180 locations. Their estimated completion date is March 10th, 2023. You can find more information here: https://clinicaltrials.gov/ct2/show/NCT04505722?term=Janssen&cond=Covid19&draw=2&rank=4 Interestingly they are also running a trial with a 2 dose option with the dosing 8 weeks apart and an earlier completion date. And, they are running a trial on the use of mouthwash to reduce viral load. All available to review at clinicaltrials.gov

A few notes and resources: mRNA vaccines are, to date, clinically unproven – meaning there are no commercially available vaccines using this platform and no large scale studies in human trials, however, they have been studied in smaller trials that simply didn’t go to market due to decreased need for the vaccine so they are not an entirely new thing.

You can read more about the different types of clinical trials here: https://www.scientific-european-federation-osteopaths.org/different-types-of-clinical-trials/

You can learn more about the ongoing COVID clinical trials here: https://clinicaltrials.gov/

You can learn more about vaccines in general here: https://www.vaccines.gov/basics/types

I, along with thousands of others, will continue to monitor all of this and keep you updated.

FINAL THOUGHTS: I believe we are all familiar with the saying that it is darkest just before the dawn. There is hope in that statement, but there is also a need for patience. Sitting in that darkness awaiting the light that you know is coming can be a true test of patience, endurance, and grit. It can drive you a little batty. But here we sit. Amid the darkness it can be difficult to see clearly, to recognize all those around you who also sit and wait with patience and endurance. It can be difficult to believe that the dawn is truly coming. But it is. This pandemic will not last forever, I know this because none ever has. History is on our side. Certainly, it can test our nerves, our endurance, our grit, and our unity – but the dawn will come, and the pandemic will end and when it does we will be able to see a little bit better. Hang in there and know that while it may be dark right now, you are surrounded by a host of witnesses, and joy comes in the morning.