Dr. O'Hora, and all of PRC staff:

"Should I take the COVID-19 vaccine, when it's offered to me ?"

What vaccine?

At least 5 vaccines, different makers, different stages of development

2 were just FDA-approved for use in US (that is, they both completed Phase 3 trials and are in Phase 4 at least), in adults>16 yo.

Companies (at this time especially, the first two)

1. Pfizer/BioNTech--an mRNA vaccine

2. Moderna--an mRNA vaccine

3. Janssen (a division of Johnson & Johnson)--a vector vaccine. More on this below

Note: We will probably not have a choice as to which we are offered. The state of MD apparently plans to allocate some to immunize the staff at PRC; however, at last, recent report there are no details available yet, as to which vaccine, how many, when will it arrive allowing vaccinations to begin, etc.

The first 2 vaccines listed above have completed Phase 3 trials. What does Phase 3 mean?

The Phases of Vaccine Development

Preclinical phase--eligible companies begin here, gathering ideas and research that they or others have already done, to decide how they think their best vaccine should be "designed". Which would optimally stimulate our immune system, therefore protecting us best? How would this vaccine work? In the past this part itself has taken years--this has been sped up greatly by companies being able to use research they have been doing on vaccines for other organisms. Those technologies can be advanced; and they can be redirected to research for a different organism.

After deciding, they start Clinical Phases.

Interestingly, in Janssen's case, they had already been working with a design using "AdVac", a tested vaccine technology platform. It uses an entirely different virus, called the Adenovirus 26 (or Ad26) as a type of "decoy", or Trojan horse. ("Vector" means in biology, an insect, animal, etc, that carries germs that cause disease, like say a tick carrying Lyme disease from a deer to you is acting as a "vector"). The adenovirus 26 has been disabled so it can't make you sick with it's usual symptoms (a common cold-like illness). The Trojan horse applies, as AdVac transports PART of COVID's genetic code into the body. This part of the virus stimulates the immune system to fight the disease process caused by COVID, so you develop immunity to the disease without developing the disease itself. (so you are NOT given a weaker form of either virus, you are given an inactive genetic code sequence of COVID. And a totally inactivated adenovirus as a carrier.)

1. Phase 1- This marks the first time the vaccine is tested in human volunteers, ie small groups from 20-80 people. Here they check especially for any adverse effects. and measure the immune response the vaccine generates. (Some volunteers are compensated for their time and/or travel.)

2. Phase 2--Two parts of this phase.

2a--they focus in on the most effective dose, and expand the data collected about safety.

2b--the vaccine is given to increasing numbers of volunteers.

Janssen saved time in these phases as they had a design in mind they had already researched, when they started. They also managed to run some steps in the Phases in parallel, instead of sequentially. These were timesavers.

3. Phase 3-The vaccine is given to even larger numbers of volunteers, guided by what has been found in the previous phases. The Pfizer study had 44,000 pts in it. Janssen is shooting for 60,000, across 3 continents.

The volunteers are tested to make sure they don't already have the COVID-19 virus. Then the group is divided in half, with one half receiving the vaccine and one half receiving a placebo. Then both groups are followed for up to 2 yrs to see what COVID type and non COVID type symptoms they develop. Feedback about the vaccine will come faster and more persuasive in this phase, because it is being tried in so much larger of a group. After a successful Phase 3 trial:

The company/scientists must submit their data to regulatory scientists, like in the US (the FDA), whose greatest concern is that they demonstrate safety for the public, and efficacy of the vaccine at protecting the individuals from infection. Thus, FDA hearings are called, and after they analyze the data provided by the company--if acceptable to these experts (who have no financial investment in any particular vaccine's approval) they approve the vaccine for use with the general population, or in specified populations.

4 and 5. Phases 4 and 5--production is ramped up for distribution to the country of origin as well as other countries around the world in pursuit of strategic goals. All continue to collect data on any problems that surface in the immunized patients--either soon after immunization, or after longer periods of time like days, weeks, months, years.

Thought Process - whether to take the vaccine--a bottom line for most:

With 2300 Americans dying/day, on a Tuesday two weeks ago, and that death count now on Thursday of the same week being greater than 3000 Americans/day; one would say: 'WHY WOULDN'T EVERYONE JUMP AT THE CHANCE TO GET THE VACCINE?"

Most people do feel this way and will eagerly get their dose ASAP.

But not everyone thinks or feels the same.

What would be the possible reasons why anyone would fear taking it, or at least hesitate?

At least 3 possible sources of their concern:

1. Fears that the agencies involved, "rushed" this process too much, leaving important steps out, or especially not having had sufficient time pass after vaccination to observe what adverse effects might surface--either right away, or over a longer period of time. Dr. O's hesitation to take the vaccine, originally, was significantly related to this concern.

2. Our government has sent mixed messages about the science of COVID. It must be acknowledged that we do not have the usual 100% trustworthiness of our government agencies.

3. There has been a history, both in extreme isolated instances, and systemically, in our culture and in the medical field to an extent: anywhere from ignoring/neglecting/uncaring behavior about certain racial and/or minority groups, to exploitation of these--behavior that was deeply untrustworthy. It can be hard for some to forgive, forget, trust--understandably. But I hope those who feel/think this, will rethink this now, not be hurt by failing to trust at this time.

Dr. O' s thought process

I was particularly concerned about the possibility of over-rushing both the vaccine preparation, and the implication that it couldn't have any longer term side effects, when researchers really didn't have enough time yet to say definitively that patients DIDN'T develop these.

To assuage my concerns about this: It now appears that in vaccine development, some time was saved in several different ways along the process, some as reviewed above. Some time was saved in ways that appear safe but unprecedented--they had to be done given the urgency of the task. Also I have read that some time was collapsed (and saved) by eliminating some of the red tape and usual delays in the regulatory process, as well, leading to faster approval.

Further, it helped me greatly to hear Dr Fauci speak about this (and other concerns) on a recent CNN Town Hall re: COVID-19. Anderson Cooper and Dr. Sanjay Gupta interviewed Dr. Fauci, and I found this persuasive. I believe Dr. Fauci is trustworthy. He is arguably the leading virologist in the world--he spearheaded the work that gained us so much knowledge on HIV and ebola. Early in the pandemic he voiced we could NOT get a vaccine ready this quickly. But, he has from this summer on, been increasingly forceful that he DOES TRUST the safety and efficacy of the process that was followed as it unfolded. If you want to watch, here's the link: https://www.cnn.com/2020/12/05/app-news-section/full-coronavirus-town-hall-december-4/index.html

Another resource: National Vaccine Hotline (per Kaiser Permanente)

855-550-0951

A final important consideration in your and my decision: it IS true that the volunteers who were vaccinated could not be followed up for years before it was offered to the general public, the way it would normally be done. We need our vaccine sooner than that! But at least the research found, in the time since the first vaccine doses were given, that serious complications or side effects over days, weeks, months in some cases, appear to be rare. Less serious ones have included 3-4 cases of (potentially serious) allergic reactions, but these were quickly treated and the patient in each case recovered completely within hours. Sore arms are very common; bad headache happens occasionally but also clears up quickly.

It also appears that we will not be able to give up our mask and distancing for some months yet, in order to protect those around us who have not been vaccinated. That is a disappointment, but I would argue it is one we can live with having come this far, now having a real tool that can help stop the infections and deaths. Especially for those on the front lines.

This is the part where we each have to weigh the possibility that some long term effect could actually happen to us. This appears to be very rare and must be balanced against getting COVID and perhaps even dying from it--THAT IS NOT RARE. What also is not rare, is giving it to someone else who might die even if you don't. Think, if you wait to take the vaccine, waiting for longer safety data--COVID might kill you while you are waiting, or someone you love.

It is also concerning that increasingly people are coming down with COVID-19, who reportedly didn't "take chances" at all.

I would also advise each person, PRC Staff member, to make a phone appointment or a (masked) visit to see their doctor, to discuss whatever concerns you have about the vaccine. Ask them their honest opinion: are you (Doctor), going to take it? Would you take it IF YOU WERE ME? Since they know your history etc.

You also can send any question to the email address provided by Kim: ask@prcinc.org. Those questions come to me and I will do my best to get an answer, and share both Q and A during our weekly educational Zoom sessions. I have over the years always given out my cell phone in case someone feels they need to ask me something personally, and this is no exception. My cell phone is 443-223-6659. I also carry a PRC phone which is 443-695-5123.

I think I speak for PRC leadership as well as myself that I sincerely hope each and every staff person will decide to take the vaccine. I would be planning to take it last in line (depending on logistics) as I am nearly 100% virtual at PRC now, and I want all our front liners to have it first. Although I will definitely be taking it, especially being a high risk person myself.

-Dr. O'Hora