I have a lot of ground to cover since my last post in February. At that optimistic point it appeared we might get everyone immunized by summer and beat the pandemic if we could move quickly enough. That has not happened nor is it likely to happen.
Let me summarize accurately for you in three major sections what I consider most important:
- Good vaccine news.
- Worrisome virus news.
- Practical advice on protecting yourself and others.
GOOD VACCINE NEWS
All the vaccines (Pfizer, Moderna, Johnson & Johnson) robustly work to protect you from hospitalization or death from Covid-19, and almost but not completely protect you from symptomatic Covid-19 illness. These vie for the most effective vaccines our scientists have ever produced. Current data show that in the U.S. essentially all deaths and hospitalizations (over 99%) now occur in the unvaccinated.
The mRNA technology (in Pfizer and Moderna) has been under development for well over a decade. Hundreds of millions of shots have been administered. Serious side effects (which dissipate uneventfully or are treatable) are truly rare and deaths vanishingly so — the vaccine safety record is extraordinary. Pfizer has already provided the long-term safety data that is required for full licensing. Formal licensing from the FDA is now expected tomorrow (8/23). Moderna’s vaccine will likely follow shortly. There are no safety or efficacy concerns about the vaccines that rationally could support a decision to risk getting the disease rather than the vaccine, regardless of age or health status (except in certain rare medical situations).
OHC will obtain vaccine to administer to members
After months of frustration about not being offered vaccine to administer (not to mention purchasing a special low-temperature freezer to handle the Pfizer vaccine), the Mass DPH will finally send Orchard Health Care appropriate smaller quantities of either Moderna or Pfizer vaccine to administer within a thirty-day window. We are applying to get vaccine to give to our members in accordance with evolving state and federal guidelines for primary vaccination or boosters. We obviously will keep everyone closely informed.
Boosters very soon for immunocompromised
Approval is imminent (and de facto given) for booster shots for people who are immunosuppressed (immunocompromised) and whose vaccination may not have provided adequate immune response. These include members with various inflammatory disorders taking immunosuppressive drugs (e.g., rheumatoid arthritis, Crohn’s disease, temporal arteritis) as well as solid organ transplants or multiple sclerosis. However, crucial details remain unclear. The final CDC recommendation will likely be to get a third dose of your original mRNA vaccine, but there was until recently unsettled discussion about choosing a different vaccine. (Johnson & Johnson vaccine was less commonly offered to immunosuppressed patients.) Everyone will follow federal guidelines on these boosters when they are finalized, which should be quite shortly.
For immunocompromised members, the route to the proper booster will be one of the medical centers that likely gave you your initial vaccine series or a local pharmacy (e.g., CVS or Walgreens), all of whom have both vaccines readily available now. Mass General Brigham and Beth Israel Lahey probably will contact you within weeks to get the third shot. Or you can simply call a local pharmacy chain. It appears you can self-certify that you are immunocompromised (as described above; ask us if needed). Get your booster by the end of September where possible. We are not likely to be operational to administer boosters until early October when the general population will be eligible. Our admin staff will help you to arrange the booster if you do not hear from your original vaccine provider by early September or have difficulty scheduling a pharmacy appointment. Please let us know when you get your booster shot.
Boosters for everyone else this fall
Our three vaccines in the U.S. are all efficacious against the current delta variant of Covid-19 and continue to effectively protect against hospitalization and death. However, there are more breakthrough infections being documented in the last two months. These are mostly asymptomatic or mild, with only a small number of vaccinated people hospitalized and rare deaths. But vaccinated people with asymptomatic infection can pass it on, which is one reason the delta variant is so dangerous.
Word spread this week that the Biden administration will shortly authorize boosters for everyone already vaccinated, likely targeted to be given 8 months after the initial shots. That would generally mean November or after since initial immunizations in Massachusetts began the second week in February. However, health care workers and nursing home residents will get the first boosters, so the start date for general public boosters, and many other details, remains unclear. These include whether the booster would be an additional shot of the first vaccine, or whether changing vaccines would be allowed or even encouraged. There are various efficacy studies underway on these different strategies. And there is as yet no guidance on Johnson & Johnson, where a booster study is underway that will eventually give us specific guidelines this fall. We will follow the public health guidance and inform you how to schedule a booster with us when available also later this fall.
We do not recommend independently seeking out a third shot now for anyone with presumed normal immunity, since it is not yet approved and since multiple studies showed the vaccines to be highly effective at least for 6-8 months and still very effective for at least months longer, which covers almost everyone except early vaccinated health workers until the late fall or early new year. Self-protection with a good mask is and will still be important. We also do not plan to routinely do spike protein antibody tests on patients who are not immunocompromised, since it is unnecessary (given known normal robust immune response) and because there is no definite level of antibody that proves protection and would reliably indicate a third shot were not needed.
Booster vaccine summary
Covid-19 vaccine boosters are coming this fall, likely now into September for immunocompromised and health care workers and nursing homes, and starting in October or November to be available for everyone else 8 months or more after their second mRNA immunization. Boosters for J&J patients will be clarified likely sometime in September. Immunocompromised patients should get their boosters from the hospitals or pharmacies as soon as practical. OHC will be able to give everyone else their booster likely starting in October; we will inform you how to schedule an appointment before then. But you are safe now and for many months forward if you were immunized and continue to practice regular indoor use of an effective mask, frequent hand washing, social distancing and general avoidance of any prolonged indoor public gatherings.
Influenza vaccines this fall
We will start up our influenza clinics again in October. They ran quite well last year, with a calendar signup on our website. Everyone should get the flu vaccine! Influenza and Covid-19 can occur together. (I saw that in one very sick patient last year!) We do not recommend getting flu vaccine in August and September; that immunity may well wane by the next spring, when influenza is very much still present. October and early November are better months to immunize. Influenza virtually never shows up in the community until after Thanksgiving. If it is safe to administer the Covid-19 booster and influenza vaccine simultaneously, we will do that. However, we do not yet have CDC guidance on coadministration.
Our boosters v. world need
A final note. Most of the world has not had a first dose of any Covid-19 vaccine. Every American who had a full series of any of our vaccines is highly protected against what matters, hospitalization and death from Covid-19, and should be so protected well into next year without a booster. Public health analyses continue to point out our actual risk from unvaccinated world populations (as well as our own unvaccinated populations) where rampant virus infection promotes the emergence of viral variants that can be more infectious and more dangerous. The delta variant is one. Others are on the way. I hope our government will push out hundreds of millions of shots to the world in excess of the inventory we need for our boosters to help the world population and ourselves at the same time. (The cost is trivia: 300 million shots @ $15 is just $4.5 billion.) I just am not confident that is the path we are on.
WORRISOME VIRUS NEWS
Covid-19 is a potentially deadly and disabling infection
Why am I, as a physician, awed by and frightened of Covid-19? Not in our lifetimes has there been a community-acquirable infectious disease that regularly causes death and long-term disability among all age groups. While the likelihood of death has dramatically lessened mainly because of vaccination, but also because of better treatments (especially the Regeneron monoclonal antibody infusions early in the infection), people of all ages still are hospitalized and die from this infection and a sizeable minority have long-term adverse symptoms (nicknamed “long Covid”).
Young and midlife infections and hospitalizations common
For example, here is the most recent available Mass.gov data on age distribution of Covid-19 infections (percentages calculated) from the last two weeks of April 2021. This was shortly after most everyone became eligible to get the vaccine. It was also well before the advent of the delta variant, which recently has dramatically increased the cases and the hospitalizations in all ages:
- Ages 0-19 had 28% of infections, 4% of hospitalizations, and 1% of deaths
- Ages 20-39 had 38% of infections, 10% of hospitalizations, and 7.6% of deaths
- Ages 40-69 had 31% of infections, 48% of hospitalizations, and 40.5% of deaths
- Ages 70 to 80+ had 3% of infections, 37.5% of hospitalizations, and 51% of deaths
- Totals were 22,233 infections, 120 hospitalizations, and 131 deaths in that period.
Note the prevalence of infections, hospitalizations and deaths in younger and middle-aged patients (ages 20-69). Covid-19 is not a threat just to the elderly. National reports have recently indicated even more younger patients.
How high is mortality from Covid-19?
Hasn’t Covid-19 mortality improved in Massachusetts since early 2020 when it devastated the nursing homes? Yes it has. But the current 1.3% case mortality is still terrible. Remember, this is just a community-spread predominately respiratory disease. Deaths should be rare and mainly among elderly and frail, as is true for influenza. Yet, data derived from the state website (Archive of COVID-19 cases in Massachusetts | Mass.gov) show otherwise:
- From inception to May 31, 2020: 5.8% deaths (3,716 deaths, 64,311 cases)
- From June 1, 2020 to May 31, 2021: 2.3% deaths (13,550 deaths, 582,671 cases)
- And, now, from June 1, 2021 to August 12, 2021: 1.3% deaths (506 deaths, 39,036 cases)
We have good data that deaths among vaccinated people are rare. So the vast majority of those recent 506 deaths are people who were not vaccinated. What a waste. What an opportunity.
Current Covid-19 death risk is 15 times that of influenza
Think about it. If you are unvaccinated and get Covid-19, you currently have about a 1.3% or 1 chance in 77 of dying! I find those odds scary. And you need do nothing to get the disease except to spend time unmasked in an indoor crowd (say, a bar on Saturday). That’s quite a penalty. Open heart surgery is much safer. And a colonoscopy is much quicker and less unpleasant than the typical nonfatal Covid-19 infection.
Covid-19 is not influenza. CDC data for last year’s influenza season estimated median deaths of 43,000 out 47,000,000 cases. This is a death rate of 0.09% or 1 chance in 1100 of dying from influenza.
So death from contracting Covid-19 (unvaccinated) is 15 times more likely than from influenza. Does that concern you? It does me. Especially when our hospital treatments are really limited. And we have no curative drugs to administer to severe cases.
Delta variant even more infectious
The now-prevalent SARS-CoV-2 delta variant is by all reports much more contagious than the original infection. Last week the total Massachusetts daily cases averaged about 1500. Our low point had been two months ago in June when 60-70 cases a day were being recorded. That’s a 20-fold increase in cases in two months.
Our current vaccines (Pfizer and Moderna mRNA vaccines, and Johnson & Johnson virus vector vaccine) do protect well against the delta variant. Ideally they would protect against any symptomatic or asymptomatic infections. At first they appeared to do so. And they excelled in protecting against hospitalization and death, which ultimately is most important.
Breakthrough infections occur with delta
But with the delta variant, the vaccine protection is not so complete. It is still excellent against hospitalization and death, but “breakthrough” infections do produce mild-moderate symptoms in vaccinated people and also asymptomatic infections which can be passed on to others, including other vaccinated people. The method of transmission remains predominately aerosols and droplets.
At this point it is not known how much (or if at all) the expected booster shots for already vaccinated people will increase the effectiveness of the vaccines. Will the boosters restore more complete protection against even mildly symptomatic infections? Will they prevent asymptomatic infections of vaccinated people? We will have to find out by careful studies this fall.
Need to revise behavioral risk evaluation
In the meantime, the much higher infectivity of the Delta variant and its ability to be acquired and passed on by vaccinated people dramatically changes the risk evaluation for our behaviors. Unmasked gatherings indoors are much more worrisome. Indoor dining and theater are suspect again. Unvaccinated or immunocompromised people are not necessarily safe from vaccinated family. My suggestions for how to think through your risks are in the next section, Practical advice on protecting yourself and others.
Covid-19 is likely here to stay
We still have many Americans unvaccinated (the world is predominantly unvaccinated) and the virus has mutated and continues to mutate. SARS-CoV-2 delta or another evolved variant shows every likelihood that it will be with us for the duration, no longer pandemic but “endemic.” Many epidemiologists have written about this; I clearly see this as the outcome.
Endemic Covid-19 is not a tragedy, but it is a disappointment because early this year we appeared to have the means to constrain the virus and protect our population and prevent the evolution of more contagious or harmful variants. We have failed at that.
Our protective effort will have to include not just boosters later this fall but very likely annual updates to deal with the variants that will arise in the rest of the poorly vaccinated world, or even in our undervaccinated southern and central states. If Pfizer and Moderna and Beth Israel locally (who developed the Johnson & Johnson vaccine) do their jobs well, I’d fully expect that by next year we will see annual Covid-19 vaccines as we do the annual influenza shots. Conceivably in the same shots. We are lucky and privileged. Current biopharmacology is that good, despite the vaccine skeptics who are still asking for proof that the world isn’t flat.
PRACTICAL ADVICE ON PROTECTING YOURSELF AND OTHERS
More infections and higher infectivity change everyone’s risk
What should you do, in August 2021 and this fall, to protect yourself and others? The risk calculus has changed with the higher infectivity and severity of the delta variant and the greater and rising community caseload.
Your response to the situations where you might be susceptible to becoming infected is, ultimately, your choice. I give what I think is realistic, conservative advice for you to evaluate that risk.
But any personal behavior that puts other people at risk is, I believe, not really your choice alone. Many of the behaviors we need to abide by are critical to protecting others, especially the immunocompromised and elderly. I will be clear about what I think those behaviors are.
Get immunized and boosted
Everyone should be or get immunized. This protects you and others. If you are immunocompromised, get your third shot. It may well work, perhaps not (we will be able to test antibody levels a month afterward). Preliminary studies have been partially successful. If you are already immunized, you are already well-protected, but get your booster when available later in the fall. It should offer you and others better protection. We’ll find out how much, but there is hope it will make a substantial difference in stemming transmission and asymptomatic infections of already vaccinated people.
If you are not immunized, you have made a bad decision. You are at dramatically more risk of serious illness and death (as illustrated earlier), and you present a threat to others when you unknowingly become even an asymptomatic carrier of the highly contagious delta variant. You are a particular threat to immunocompromised friends and strangers. Get immunized. We are a community.
More governments and businesses are requiring immunizations. I think it is the correct public policy in this pandemic, as do many others. Universal immunization is the surest way and the only way really to stem this contagion.
Wear an effective mask indoors in any public setting
Indoor venues, especially smaller rooms with many people and not necessarily robust air circulation, are the perfect medium for aerosol spread of Covid-19. This has been exhaustively documented. We need to resume masks whenever we are indoors with strangers, even if only brief encounters.
But it also time to routinely use better masks. Cloth masks are only partially effective. Public health authorities promoted cloth masks in 2020 because much more effective masks were not readily available. Now they are, and not particularly expensive.
The consideration with masks is how well they conform to the face to assure airflow goes through and not around the mask, and how well the mask material filters the air. Consider:
- Cloth masks are convenient and should conform well to the face, though many clearly do not and hang loosely. Regardless, cloth masks, whether commercial or homemade, generally do not effectively filter the air nor have they been laboratory tested for effectiveness. Consequently your level of protection is unknown. I am aware some patients have made their own cloth masks with N95 inserts, for example, but that is not the typical cloth mask. I think plain cloth masks are inadequate to protect you or others from the delta variant.
- Surgical masks are meant for surgery and stopping exhaled droplets. They best protect the people who are around you, because your own exhalations largely go through the mask, which is pretty effective droplet and reasonable aerosol filtration. However, surgical masks do not fit snugly, so inhalations allow aerosols to readily enter your lungs. Adding a cloth mask over a surgical mask can improve the fit and reduce leaks, but breathability may be a problem.
- N95 respirator masks (without valves) are the highest level of filtration. They are meant to tightly conform to your face to avoid leaks. They have two elastics around the back of your head that pull the mask in firmly. The breathability (effort of breathing) may be an issue, especially for prolonged periods. They provide the highest level of protection for you against inhaled aerosols, but really were not intended for many hours of use. Many people find them uncomfortable. Also, while they are more available now, they still tend to be expensive, perhaps $2 or more each.
- KN95 masks conform easily to the face, have ear loops not head bands, and have a high level of filtration less than but next in effectiveness to the N95. They usually are reasonably comfortable to wear, even for several hours. They can protect you as well as your neighbor. Prices are substantially down and they can now be purchased for well under $1 each. I think the KN95 masks (a Chinese standard) are the best choice now for a protective mask.
Distancing and cleanliness
Please don’t forget social distancing. That still matters and still protects you and others. And frequent hand washing is basic. You need not wash your mail or packages — environmental surfaces have been shown not to be significant sources of Covid-19 transmission. But cleaning your hands frequently does protect you. And face washing on return from a store is simple and may be useful. It also feels good.
Outdoors is safe
It is still summer. Enjoy it. Enjoy the fall as long as we can. There is no meaningful risk of Covid-19 infection outside unless one sits up close and personal and talks directly at the other person. Give a little space. Don’t worry. No masks outdoors.
Stores, large and small
If you wear a protective mask (KN95 or surgical/cloth combo) in a small store which is not crowded, and spend a modest amount of time there, you should be safe. Similarly, most of the large box stores have enormous volume and good ventilation. So you should be safe in a Costco or Home Depot or Market Basket with your mask if you socially distance in the aisles and the checkout lines.
Nuclear family situations
If you have maintained your nuclear family and close family as a “circle of safety” or “bubble” as it came to be more generally known, you should be safe without masks in the home, assuming everyone is vaccinated. However, I’d still check regularly with members about their exposures or risks during the week and about work contacts and so forth.
Children are more complex. I’d hope children 12 and over would be vaccinated by now so they can safely return to the home from school (having been masked in school) without important risk of bringing home a Covid-19 infection.
Children under 12 who are yet to be eligible for vaccination are a bigger problem. They will present an active risk if there is any infection at school. In Lincoln (where I am on Board of Health) we already saw a large cluster involving children several weeks ago where the specific source of infection was unknown. Certainly parents have to pay attention to the school situation.
The conundrum really is the grandparents and anyone in the family who is immunocompromised (or somehow not vaccinated). Then the children not vaccinated (or older vaccinated children who are in circulation in outside activities) really provide a palpably higher risk level to them. I think it prudent in this situation for these children’s contact with the grandparents or immunocompromised adults to take place outdoors for now. Or, if indoors in a home, children and adults should wear masks. You may choose not to do so, but I believe the risk now of asymptomatic carriage of infection is substantial and has to be considered.
Situations with friends
If your friends are vaccinated, you should be able to have dinner in your home without masks. Yet, it still will be prudent to check on their possible exposures through their children or grandchildren, etc. If there are any unknowns (e.g., someone in their nuclear family just returned by airplane from Chicago 2 days ago), I would be prudent and have the interaction outdoors or consider masking inside. This is your decision, but I’d carefully consider Rumsfeld’s “known unknowns” and factor that in. So long as the weather is good, there may be good alternatives. And there is certainly hope that by deep winter the booster vaccinations will again change the risk calculus.
Unscreened public indoor venues (no)
Restaurants and theaters — where anyone can be a patron and where you will spend substantial time in a relatively small space in close proximity to others — inherently present a high risk of prolonged exposure to infection from someone unvaccinated or even an asymptomatic vaccinated person. I would not go to such venues, particularly if you have in your own close circle any older grandparents or immunocompromised members. Although it is hard to calculate just how risky it is, because of the lack of accurate data about the prevalence of asymptomatic infections, it has to be substantial. You may decide to do so, but your risk tolerance must be much greater than mine.
Screened public indoor venues (maybe)
Some restaurants as well as theaters (such as Huntington Theatre) are now screening the patrons and insisting that only fully vaccinated people may enter (or possibly with a very current Covid-19 test). That changes the risk calculus substantially. Now, if you are personally healthy and wear your KN95 or surgical/cloth mask, your safety will be much higher and it could be reasonable to attend. This screening may be the savior of the restaurant and theater industry this winter. I’d note, however, that if you had an unvaccinated elder or immunocompromised person at home, I’d still think several times before attending.
Airplanes are both relatively safe and relatively dangerous. Air circulation and filtration in planes is pretty good and localized by small groups of seats. If you are immunized and wear a good KN95 mask and maybe even a face shield (and everyone else wears masks as they are supposed to), you are not likely to get a symptomatic Covid-19 infection. However, if the flight is long (transcontinental or across to Europe), then the duration may matter. You clearly are at some meaningful risk similar to being in the restaurant with unscreened patrons, not to mention the exposure risk in passing through crowded airports likely with many unmasked passengers.
If you are midlife and healthy, your risk of a bad outcome is low. However, the same risk to immunocompromised or elderly in your family will pertain when you return home. That needs to be considered, and whether you might isolate for 4 days upon return even when you feel fine. You certainly should get (and may be required to get) a PCR or antigen test 3-4 days after you return to check on asymptomatic infections.
I have tried to quickly but thoroughly and accurately give you the latest information on vaccines, the state and severity of the pandemic that engulfs us still, and practical approaches to behavioral risk management to protect you, your family, and others.
Undoubtedly members will have questions. I hope there are not many inaccuracies or substantive omissions. We welcome comments and questions. We will moderate the comments and publish them promptly, along with responses to questions. Members are welcome to respond to other comments.
We will be in this through the winter at least. I’ll do another update as we get further into the fall.