End of November Covid Update

Greetings all. I’ve waited a week or so to put this out because it seems the news keeps coming out pretty rapidly. I’ll do my best to summarize and give our perspective. Since there is a lot of news, I’ll focus on two of the most important issues.

The foremost issue on many folks’ mind these days is the vaccine. You can refer to a couple of prior posts for details on the different vaccines.

The first point to be made is this: the vaccine will not be available for most if not all of our patients until at least March or April of 2021. There are going to be supply and distribution issues as well as a tiered approach to who gets the vaccine when.

Here are some other questions that have come up:

Do you recommend these vaccines?
One of our concerns from the start has been safety because these vaccines have been developed extraordinarily fast. Vaccine, drug, test and device manufacturers can apply for Emergency Use Authorization (EUA) as long as the Federal government has declared an emergency. The COVID-19 pandemic was declared an emergency at the beginning of the year. Pfizer-BioNTech (Pfizer) and Moderna have presented two months of safety data in their applications for EUA for their vaccines. According to a publication released by the FDA in June of this year, vaccines need to have six months of safety data in order to get full FDA approval for use. This is why their requests are only for EUA, not for full approval. Only after the vaccines have been proven safe for six months can manufacturers apply for full FDA approval. Practically speaking, once manufacturers get EUA, they don't typically apply for full approval until the emergency is over.

The Harper Health clinical team will receive the vaccine when we are given the option. It is important to us that we help demonstrate vaccine safety. While we would prefer that the FDA fully approve the vaccine, we will recommend it to you under EUA if no significant adverse events are seen between its release and when the vaccine comes available to the general public (likely after March/April). Tens of millions of doses will have been given and we will have six months of follow-up on the study participants.

Again, it will be months before it becomes available to you. The first wave of vaccines will be appropriated to those at highest risk (nursing home residents (NH) and front-line healthcare workers (HCW)). However, given supply chain issues, it will likely be MONTHS before even the FIRST phase to NH and HCW is completed.

All of that being said, when your turn to get the vaccine comes up it will be your decision if and when you want to take it. For those comfortable with staying sheltered for a few more months as the dust settles, you don't need to take it right away. As 2021 moves on, more and more vaccines will become available. It is my anticipation that by the end of next year anyone who wants a vaccine will be able to get one.

And if given a choice, which vaccine do you recommend?
The Pfizer and Moderna vaccines have been demonstrated to be very effective. Overall, only one out of 20 people who get the vaccine doesn’t mount an immune response if given one of these two. This is an excellent success rate. We’ll learn more about different sub-groups (age, race and ethnicity, chronic illness, etc.) as the raw data from the clinical trials gets released by the FDA.

If you’re concerned about feeling pretty sick with a flu-like illness for a day after administration, the Pfizer vaccine would be preferred; it seems there are fewer side effects to that one. Otherwise the vaccines are similar. It seems both are better than the Astra Zeneca/Oxford (AZ) vaccine. More details around the AZ vaccine and others will be discussed later.

Who would get the vaccine first?
As mentioned above. the Advisory Council on Immunization Practices (ACIP) has recently met and created an initial allocation protocol that puts HCW and NH residents at the front of the line. Nothing has been confirmed with regard to the next groups. If Harper Health gets allocated vaccines we will follow the ACIP protocols as best possible, so we have begun to stratify patients in our practice based on age, employment status (HCW or NH) and chronic illnesses.

Will you be distributing the vaccine?
The details of vaccine distribution are still unclear. As you may know, the Pfizer vaccine needs to be delivered and stored at -90 degrees F and the Moderna just frozen at typical temperatures. We do not have the capability for deep freeze, but do have a regular freezer. We can still get the Pfizer vaccine because practices without a deep freezer have a few days at lower temperature to distribute it, which is completely reasonable for a practice of our size.

We are in the queue with the IDPH/Chicago Department of Health to be a distribution point. It is unclear if or when we will get vaccines at any supply. It could be that smaller practices will be lower on the list. I hope not.

The other issue is the overall strategy for distribution to states, counties and distribution points. Who? How many? How? When? In addition, a new issue that has recently come to light is that Pfizer won’t be able to deliver more vaccines than the initial 100M doses to the US market until the summer of 2021. Moderna has a contract to deliver 100M doses to the US government, however it is unclear how fast those will be delivered. Moderna has committed to deliver 125M doses worldwide by end of Q1 2021.

What do I do if you aren't providing vaccines?
If we aren’t assigned any vaccines, we are working to determine what options are available. We are on staff at three different hospitals in the region and get regular updates from them.

At this time there is no “waiting list” for the vaccine. If you have a chronic illness that is followed by a specialist at one of the hospitals in the region, you potentially have dual access to the vaccine, through that doctor and through us. Again, we are working hard to be in front of this.

The other matter I want to discuss in this update are changes to the recommendations about quarantine from the CDC. Changes are usually made when science dictates. When the pandemic started, the public health recommendations were made based on what the safest approach could be. For example, at the beginning masks weren't pushed as much as handwashing and physical distancing. Now they are core to public health messaging.

Unfortunately, these days people are ignoring these public health guidelines. The mindset is often, “This is too much so I won't do anything. It will be okay.” We’ve seen this attitude in our own clinic: a group of boys were playing contact football outside, unmasked, and then came inside to one family’s kitchen where they spent unmasked time together, indoors, in a small room. The next day one of the boys got sick and was diagnosed with COVID-19. The mom of one of the boys who was exposed was told to quarantine the child. She refused to quarantine or even keep him out of school, “Fourteen days is just too much.”

So, the CDC made a change to the quarantine recommendation, not because of new science but because it wants to stem the tide of infections, and more people in at least a shorter quarantine will help. First, there is no change to the recommendation that you immediately quarantine after a person with whom you have had close contact tests positive for COVID-19. The change is this: anywhere from 5-7 days after the exposure, a person can get a molecular test (rtPCR), and if negative can be released from quarantine. If they don’t get tested, 10 days is now the recommended duration for quarantine, dropping from fourteen. So, contrary to our recommendations for the past nine months, testing CAN get you out of quarantine.

The timing is good, then for us to announce that Harper Health has finally gone live with its same-day COVID-19 molecular testing. We have secured a Cepheid rtPCR NAA analyzer for the office. This is the same machine, albeit on a much smaller scale, that is used in hospitals to do high-sensitivity COVID testing. We can do two samples at a time in a 36-minute cycle. Hospitals can probably do 100 at a time. It is rare for a primary care practice to invest the capital and the effort toward a resource like this. So, while we wish we could offer this test at no charge, the cost will be $250 per test with results as soon as 40 minutes.

If you want/need a same-day molecular test we can do that. Given the surge, the turnaround time on COVID testing at Quest, LabCorp, and local hospitals has grown significantly. We hope our in-house molecular testing will be a valuable resource for you. We have the capability right now to do as many tests as there is demand, up to about 20 per day. However, when our test kits run out, we will need to put a pause on molecular testing until supplies are replenished. We will continue to work hard to keep us stocked.

So, if you want/need a rapid test, please reach out to Priscilla or your provider to discuss why and when you need it.

We also have rapid antigen testing available. Rapid antigen testing is for symptomatic people with a high concern for COVID. This test costs $100 and results are available in 15 minutes. Rapid antigen tests are not recommended for asymptomatic people, as the sensitivity of this analyzer isn’t good enough to detect the virus at the low levels that are typical of asymptomatic people. If your provider recommends the rapid test, and it’s negative we can either do a same-day PCR test or send your sample to LabCorp which would be typically covered by insurance.

I know I covered a lot in this post. I hope that you see that we as a practice are doing our best to stay on top of everything and continue to provide access to resources to keep you healthy.