The case rate and percent positivity declined substantially again this week in Easthampton (and Hampshire and surrounding counties, and nationally). This is what we expected to see, and so we'll celebrate the positives of continuing to head in the right direction. However, the current case rate is still at a level that was nearly unimaginable just two months ago. We'll try to stay both optimistic and realistic about where we are and what might be coming next. We need to continue to see a steady decline in case rate to reach a point where the healthcare system can manage the number of seriously ill patients in the system. Patients who are seriously ill with COVID-19 tend to have long hospital stays, adding additional strain to the system.
Epidemiologists are continuing to track the BA.2 sub-lineage of the omicron variant. It is a sub-lineage of omicron, but it does have a substantial set of unique mutations. So far we have seen it gain dominance over the BA.1 sub-lineage (what we just call "omicron"), but we are not seeing massive surges associated. Most experts continue to believe that while BA.2 does likely have some transmission advantage over BA.1 (meaning, it's more infectious or evades immunity more), it isn't enough of an advantage to cause a substantial shift in the trend. So far we expect to continue to see long slow declines, although perhaps with pockets of plateau or small increases. The good news is that there is no reason to suspect at this point that the severity of disease is any different between BA.1 and BA.2. We will keep our eye on this moving forward. We'll be watchful, but not panicked. Mutations will continue to occur, and the WHO will continue to categorize some as variants of interest or variants of concern. We will remember that we know what to do in the midst of a surge, and we know just how valuable vaccines are in preventing severe outcomes.
There is a lot of coverage of how this pandemic "ends." A recent Boston Globe article reported that 70% of respondents believe it's time to accept that COVID-19 is here to stay and "move on." Gosh, these headlines get me! I think that's meant to sound salacious, but.... is it actually salacious? I don't think there are many experts who disagree with that statement. Accepting a new normal with COVID-19 and continuing on with our lives does not mean throwing our hands up and throwing away all the strategies we know keep us protected from severe outcomes. It means that we lean into them: get vaccinated, test often, wear high-quality masks when needed, and use one of the excellent treatment options if infected. This requires individual action (get vaccinated and boosted, wear a mask) and governmental support (we need easy free access to PCR and rapid tests, masks as needed, and readily available treatment options). I believe we are moving closer to these goals every day.
The vaccine coverage in Easthampton is, on the whole, excellent. Nearly 80% of the community has been vaccinated and about 49% have a booster dose. Easthampton more closely resembles Denmark than other areas of the US! This is excellent news for our community - it will continue to both keep our surges controlled and it will continue to protect the community from the most severe outcomes associated with COVID-19. We do have low vaccination rates among our youngest children eligible, 5-11 years old. Only 56.2% of that age group is vaccinated. This is about two thirds of the vaccination rate of the 12-19 age group in our community. Vaccine rates in this group have not dramatically shifted in recent weeks. I will address some vaccine questions and especially pediatric vaccine questions below.
1) Do they work?
We've covered this extensively, so I won't belabor it much here. Those who are vaccinated are protected against infection and have substantial protection against severe outcomes. Those who are in hospitals and dying are largely unvaccinated individuals.
The Financial Times ran scenarios estimating the number of deaths in the US that could have occured, had our vaccination rates matched that of other countries. For example, in the visual provided, the red area describes the number of deaths in the US compared to Denmark that occurred as a result of the lower vaccination rates. Denmark has fully vaccinated 81% of their population, and 62% have a booster dose. The United States has fully vaccinated 64% of our population, and 27% have a booster dose.
Another way of analyzing the information is to consider how many deaths in the US could have been prevented if everyone was vaccinated. It is estimated that at least 200,000 deaths in the last half of 2021 were preventable. That estimate for the omicron surge in early 2022 will be substantial. This can be further seen by viewing a graph of COVID-19 daily deaths over time, with indications of when vaccines first became available and widely available. Surges in daily deaths after that point are largely preventable, had vaccination rates been higher. See visuals provided.
2) Are they safe?
The vaccines approved for use in the US underwent rigorous testing, held to the same standard as any other drug or vaccine approved by the US. The vaccine technology was not rushed, nor were the studies testing safety or efficacy. The total time from phase 1 clinical trials to approval was faster than we're used to because of 2 main reasons: 1) there were a lot of people exposed to COVID-19 with no prior exposure, so the ability to test if the vaccine provided protection was widespread and relatively easy. If you're testing a vaccine for something like, Ebola, it's difficult to have enough people who are exposed to Ebola, to see if they are protected. Higher exposure = more available data = faster trials. 2) The federal government funded vaccine development (this was called "Operation Warp Speed", allowing for companies to be preparing for the next phase of trials while still in the midst of the current trial phase, and even overlap them slightly. They also funded the development of manufacturing, so doses were ready to ship out when the trials were finished and the FDA gave their approval. Without government funding, this isn't wise for companies - if the current phase fails, they've spent a whole bunch of money, and they can't move forward. Operation Warp Speed allowed them to move from one phase into the next phase quickly, eliminating months - years of downtime. This was not a rush of the trials, this was funding that allowed them to close the gap between trials. See the attached visual for an outline of how the phases progress.
More than 4.84 billion people worldwide have been vaccinated against COVID-19 vaccine, with a variety of different vaccine manufacturers. 543 million doses of Moderna, Pfizer, or J&J have been delivered into arms in the United States. This is enough data for us to get a very accurate understanding of potential adverse reactions.
Suspected or potential adverse reactions to any vaccine are reported to the Vaccine Adverse Event Reporting System (VAERS). Scientists and the CDC watch VAERS extremely closely for patterns of adverse reactions to vaccines. All concerning patterns are investigated, and in some cases, FDA approval can be paused or reversed, pending results of the investigation. The list below is the full extent of adverse reactions to the COVID-19 vaccine:
- Anaphylaxis, a severe allergic reaction, after a COVID-19 vaccine is rare, reportedly occurring in about 5 out of every 1 million vaccine doses administered (~0.000005%) than
- Thrombosis with Thrombocytopenia Syndrome (TTS) is blood clots in large blood vessels and low platelets. A pattern has been detected after the J&J vaccine, particularly among women ages 30-49. More than 18 million doses of J&J have been administered in the US and there are 57 confirmed resulting cases of TTS (~0.0000006% of J&J doses administered), 9 of whom died. The use of J&J was temporarily paused during the investigation, but the pause was lifted and the vaccine is still in use (because the risk is so low compared to the consequences of COVID-19 infection).
- Myocarditis (inflammation of heart muscle) and pericarditis (inflammation of the outer lining of the heart) occurs primarily after viral infection. A pattern has been detected after mRNA vaccines, particularly among adolescent men and young adults. More than 524 million doses of an mRNA vaccine have been administered in the US and there are 1,277 confirmed reports of resulting myocarditis / pericarditis (~0.000002% of vaccine doses administered). Most cases are mild. There are no associated deaths. I know this potential adverse reaction is a concern among parents deciding if they should get their child vaccinated. Looking at comparative risks is helpful. The "baseline" risk of myocarditis / pericarditus in children ages 0-18 is very low - about 9 cases for every 100,000 children. The risk of myocardititus / pericarditus after recieving an mRNA vaccine is about 1.5x - 2x higher than the baseline risk. The risk of mycarditus / pericarditus associated with a COVID-19 infection is 16x higher than the baseline risk.
- Guillain-Barré Syndrome (GBS) is a disorder in which the immune system overreacts and damages one's own nerve cells, causing weakness and rarely paralysis. More than 18 million doses of J&J have been administered in the US and there are 307 confirmed resulting cases of GBS (~0.000002% of J&J doses administered). There are no associated deaths. No risk of GBS has been detected after the use of mRNA vaccines.
- A total of 9 deaths have been confirmed to be associated with the COVID-19 vaccine, all as a result of TTS after a J&J vaccine (as outlined above).
3) Does everyone, including children and young adults, really need a booster dose?
Many immunologists and epidemiologists are encouraging the CDC to move away from calling a 3rd dose after the mRNA vaccine series (and a 2nd dose after the J&J vaccine) a "booster" dose, because it's very likely a 3rd (2nd) dose needed in the series to actually be fully vaccinated. The increased level of protection is substantial on an antibody level and on a real-world infection and severe outcome level. There are no safety concerns for an additional dose, above and beyond what I discuss above for vaccine safety. In fact, studies that separate vaccine reactions by dose find that the 3rd (2nd) dose has the fewest reported reactions. If you have not been boosted yet, please schedule a booster dose. I want you to have as much protection as you can. Research indicates that an mRNA booster dose provides the highest level of additional protection, regardless of if your initial vaccine was an mRNA vaccine or J&J. If you are immunocompromised, the research is clear that you should have a second booster dose, for a total of 4 (or 3) doses (depending on your original vaccine type). Immunocompromised folks with 2 booster doses are about as well protected as non-immunocompromised folks with one booster dose. This is true at every age range - yes, including children over age 12 and young adults. There is no scientific reason to believe that the immune response would be different in this age group in regards to waning immunity or immune memory.
4) Will we all need a booster dose every 6 months?
No. That's not a reasonable approach to lasting immunity on the immunologic side, nor is it a reasonable economic or social approach. Scientists are working on a universal COVID-19 vaccine that will provide protection against all variants. That version of a vaccine is likely years away, but hopefully that's where we'll end up. In all likelihood, one day the COVID-19 vaccine series will be part of the regular childhood vaccine series, subject to the same exceptions and considerations as other childhood vaccines. We're not there yet, but that may be where we're heading. By the way - we're hopefully also heading for a universal influenza vaccine, also. We're used to a yearly dose, but the reality is that preparing a flu vaccine that's specific for each year is inefficient and will be too slow in the case of a flu pandemic. I know, you're covering your ears (eyes?)! I promise to never say "flu pandemic" in these updates again, but I wanted to normalize the universal vaccine approach.
5) Is a vaccine coming for kids under 5 years old?
Many of us with children under 5 have been frazzled and anxiously awaiting a vaccine option for this age group. We initially hoped for a December or January approval, but our hopes were dashed when Pfizer announced that the 2 dose series was not going to be submitted for approval. The nitty-gritty is that they actually said that the 2 dose series was not "non-inferior" to the 2 dose series for adults. A quirk of vaccine clinical trials is they "step down" to younger age groups, testing if the vaccine is safe and as effective in younger age as it was in older age groups. The vaccine was incredibly safe in the 6 month to 4 year age group - no concerns there. But, the 2 dose series provided some immune protection but not as much immune protection as a 2 dose series for those 5+ years old. And actually, that was only really true among 2-4 year olds. The 6 month - 2 year olds were not "non-inferior". However, the fact that the 2-4 year old protection fell short of the 5+ level of protection was enough to "fail" a non-inferiority trial. (I know. I'm shaking the cobwebs out of my head about those sentences, too. I hope if nothing else, this stresses how incredibly careful and strict the clinical trial process is.)
At the time that the decision was made, the omicron surge wasn't in full swing. In the past few weeks, the pediatric case rate and rate of hospitalization for COVID-19 has reached new highs. See the visual in the center of the dashboard this week. This is a totally different situation, and the need for the vaccine for children of all ages is more urgent than ever. In fact, the situation is urgent enough that this "inferior" protection I described above is actually not at all "inferior" to no protection, and therefore incredibly valuable. Pfizer is in the process of testing if a 3 dose series passes the "non-inferiority" mark... but given that children will need the first 2 doses before they can get that 3rd dose, it makes sense for the FDA to provide emergency use authorization on those first 2 doses. The situation is actually quite parallel to the distinction in immune protection between those 12+ years old who have 2 doses of an mRNA vaccine now, compared to those who have 2 doses and a booster dose. Let's get the 3 dose series started as soon as we can! The FDA will meet to review the Pfizer data on Monday, February 14th. I cannot wait to see the Pfizer data and to hear the results of that meeting.
Take good care of yourself and each other.