Updates on the Novel Coronavirus (aka COVID-19): What You Need to Know
Information about the spread and about the safety concerns of the novel coronavirus (aka "SARS-Cov-2"), and the disease it causes, COVID-19, is evolving on an daily basis. It is also clear that politics has played a major role in the information that has been distributed and the recommendations made. So I wanted to try to bring you unbiased, non-political information about the of the virus in our community and in general. I will include some details on this topic from previous newsletters, as they remains important - new information will be in BOLD.
Excellent news about vaccine development continues. The FDA has scheduled a meeting of its "Vaccines and Related Biological Products Advisory Committee," a group of outside experts, for December 8 through 10. At the end of that meeting, it is hoped that an emergency use authorization for one or multiple vaccines could be declared.
The revised forecast for COVID-19 infections is, quite frankly, bleak. The CDC predicts a surge of infections and deaths from the disease in December. Yesterday, 3,100 people died in the U.S. of the disease - this is a much higher number than ever in the past. In the week of December 19, an estimated 1.1 to 2.5 million new cases and 10,600 to 21,400 deaths are predicted. The predictions for California don't look any better: without any changes in behavior, the number of Californians needing to be hospitalized due to the virus could double or triple in the next month, putting a strain on the health care system. I don't want to give such awful news, but I do want every one of you to please hunker down, stay indoors, don't socialize, and stay safe, please! Health care officials continue to implore Americans not to travel this holiday season.
I know all of these restrictions are stifling, especially after so many months. At this time, I would like to try to simplify things a bit (these ideas are based on the opinions of over 700 epidemiologists, not my own personal wisdom!):
One behavior that should be ELIMINATED: spending time in a confined space with people that are not wearing a mask and not part of your household. This means:
no eating at a restaurant or at a friend's house
no close conversations with people not wearing a mask (even if you are outside)
if you fly, try not to eat or drink on the plane
don't have lunch in the breakroom with your colleagues
MINIMIZE if you can't avoid altogether:
spending extended time in indoor spaces with people outside your household...even if everyone is wearing a mask
LESS RISKY activities include:
walking, biking, or jogging outside, even if you don't wear a mask
running errands (as long as you wear a mask, try to stay away from others, and wash your hands when you get home)
General Information:
Pandemics are not new to our civilization and each pandemic is unique. What makes SARS-Cov-2 different and more challenging is the high degree of infectiousness as well as transmission from people who have no symptoms at all or only mild symptoms.
As treatments have been improving, the mortality associated with COVID-19 has been steadily decreasing over the last few months. An article from the Journal of Hospital Medicine found a death rate of hospitalized patients of 25.6% from COVID-19 in New York in March. In August, the death rate had declined to 7.6%.
Another piece of good news came in a recent study in BioRxiv (which was NOT peer-reviewed): 185 people with past COVID-19 infection were studied and their memory B-cells (a type of white blood cell) analyzed. The result of the study suggested that an immune response to SARS-Cov-2 may last for many years. This would suggest that past infections as well as vaccinations will protect you for a long time indeed!
COVID-19 has had negative health impacts on many people who don't contract the virus: 40% of U.S. adults surveyed in late June reported at least one or behavioral health problem associated with the pandemic.
There has been a significant increase of Emergency Department visits of kids and teens for mental health reasons with the pandemic - increases of 24-37%.
Transmission:
The incubation period can be 14 days (or more), though most people develop symptoms within 5-10 days.
The CDC has reduced the duration of isolation of a person infected with SARS-Cov-2: previously, people were told to isolate for 10 days after onset of symptoms. However, since most of the viral shedding occurs 2 days before symptoms develop and end 5 days after, the CDC decreased the isolation period to 5 days after onset of symptoms.
For people who have been exposed to the virus, the CDC has shortened the minimum amount of time they need to quarantine as well. The quarantine can end 7 days after exposure if such people have no symptoms and have had a negative COVID-19 test (done 5 days after exposure). Without the test, the quarantine can end at 10 days. Note that these new recommendations were made in hopes that people would be more compliant with the restrictions. For travelers, the CDC recommended that people be tested 1-3 days prior to travel and again 3-5 days after return. They should also limit non-essential activities for 7 days after travel, even if they test negative.
People with a severely compromised immune system (like those receiving chemotherapy for cancers) may actually continue to shed the coronavirus for 2 months or longer after getting infected (New England Journal of Medicine). The current isolation precautions may therefore need to be adjusted for such people.
Transmission occurs predominantly via respiratory droplets. Transmission is more likely the longer you are close to an infected person, the closer you are, and the worse the air ventilation is. Transmission via touch (touching a surface with the virus on it and then touching your nose, eyes, and mouth) is quite unusual.
It is estimated that over 50% of people get infected with SARS-Cov-2 by patients who do not have any symptoms.
As many of you will know, Europe has been in a lockdown patter for the last 5 weeks. The good news is that it is working and the number of cases is coming down. The other part of the good news is that many European schools had stayed open during the lockdown, suggesting that we can get control of the the virus even if schools stay open.
A recent study found that SARS-Cov-2 can stay alive on human skin for up to 9 hours! So wash your hands frequently and use hand sanitizer often!
We need to all recognize that face masks are extremely important and effective in protecting the wearer as well as the people around them
The CDC estimated that if the number of people who wear masks increased by 15%, we could prevent lockdowns and decrease economic losses by up to $1 trillion.
Indeed, experts estimate that the pandemic could be eradicated if at least 70% of the population used surgical face masks consistently and correctly.
One article published in MMWR looked at the example of Kansas: those counties with mask mandates saw a 6% decrease in COVID-19 cases , while those without mandates saw an 100% increase.
Symptoms and Risk Factors:
People with COVID-19 usually develop achy muscles and a fever, as well as shortness of breath. A small number are also nauseated and have diarrhea. Loss of taste and smell is common. Severe cases usually involve a pneumonia that may lead to hospitalization and the use of a ventilator to allow the lungs to adequately transfer oxygen into the blood.
About half the patients with COVID-19 have neurologic symptoms.
In some patients with COVID-19, the "fundamental framework" of the lungs can be destroyed and people require a lung transplant.
Most children who get infected do not exhibit any symptoms. However, a small percentage who end up in the hospital have symptoms of "vasculitis," which is an inflammation of the blood vessels. This syndrome, called "pediatric multisystem inflammatory syndrome (MIS-C)" is still rare, but can be very serious.
JAMA Network Open reported on 11/19/2020 that many patients with COVID-19 - especially if they were older than 65 - presented with delirium (severe confusion). Indeed, more than 25% of older patients presented at the emergency department with delirium and 37% didn't have any of the more typical signs such as fever or shortness of breath.
An increasing number of COVID-19 patients seem to have long-standing sequelae of their infection:
A study out of Michigan looked at patients who had been hospitalized for COVID-19 and recovered: two months after discharge, one third of people still had ongoing health issues such as a cough, loss of taste and smell, or shortness of breath.
The CDC announced in mid October that people who are overweight have an increased risk of severe illness with COVID-19. This means that 75% of the U.S. population is at heightened risk.
Incidence/ Prevalence:
To the best of our knowledge, only a handful of people world-wide have become re-infected with SARS-Cov-2, a tiny number given the prevalence of the disease. This is great news!
An article published in the journal Clinical Infectious Diseases looked at blood donations collected by the Red Cross between December 13, 2019 and January 17, 2020: 106 of the 7,389 samples studied showed antibodies to SARS-Cov-2. This strongly suggests that people were getting infected with COVID-19 as early as December, a month before the first person known to have been infected with coronavirus arrived in the U.S. from China on January 15.
New calculations by the CDC suggest that the actual number of people infected with SARS-Cov-2 is eight times higher than we realize...in part because previous estimates relied on those that had laboratory-confirmed disease and didn't include those that were not ill enough to seek medical care.
Even so, a recent study from Jama Internal Medicine suggests that, in most communities, less than 10% of the population has evidence of past SARS-COV-2 infections as of late September.
Across the U.S., hospitals are teeming with with record number of COVID-19 patients. At this time, the U.S. has more hospitalizations due to the virus than ever before - 80,000 to over 91,000 per day in the last 2 weeks. Many states have insufficient number of beds. There is also an increasing number of shortages of doctors and nurses due to front line workers falling ill.
The U.S. has more than 14 million cases at this time, distributed all across the country. The state with the most cases is Texas, with 1,267,486 cases. Sadly, California is #2 with 1,238,379 cases. The bronze medalist is Florida, while Illinois and New York come next.
Due to this shortage of hospital staff and space, Medicare is now allowing hospitals to care for patients in their own homes. Such programs will offer around-the-clock electronic monitoring for Medicare patients who are sick enough to be hospitalized but don't need to be in an ICU.
At this time, over 65.4 million people in the world have contracted the novel coronavirus. 1.51 million people have died worldwide (compared to 1.34 million two weeks ago).
In the United States, more than 14.2 million people have now contracted SARS-Cov-2 (11.8 two weeks ago). The U.S. has the highest number of deaths in the world at 276,000 (236,000 two weeks ago)
California is reporting that it now has more than 1.29 million people infected with SARS-Cov-2 (compared to 1.08 million two weeks ago). 19,586 people have died.
As of December 3, 2020, there have been 15,040 people in San Mateo County who have tested positive with the SARS-CoV-2 virus (compared to 12,878 people two weeks ago). 170 people in San Mateo County have died from the disease (compared to 168 people two weeks ago). Currently, there are 80 people in the county who are in the hospital with the disease. Peninsula Hospital is NOT at capacity.
Over 1 million children in the U.S. have now been diagnosed with COVID-19 - 11.5% of all cases.
The CDC announced this week that Black, Hispanic, and Native American people with COVID-19 are four times more likely to require hospitalization compared to others.
Another study came out on November 24 and looked again at the correlation between blood type and risk of developing COVID-19. You may recall that previous studies had flipped back and forth about the influence of blood type on disease. This study again confirmed that patients with the "O" and "Rh-" blood groups may be at slightly lower risk of infection and severe disease....but there is certainly not a large discrepancy of risk.
Testing
On November 18, the FDA granted an emergency use authorization for the first rapid at-home test for COVID-19. This test is made by Lampira and uses a technology similar to the PCR tests available. This test can supply results within 30 minutes. Accuracy of positive and negative tests seems to be quite high (above 94%). The cost is projected to be about $50 and a doctor's prescription is still needed.
See also the notes (below)about what testing options are available through out office.
Treatment
On October 22, the FDA approved remdesivir as a treatment for COVID-19 and therefore took it out of the "experimental/ emergency use" category. It is the only medication COVID-19 treatment in the United States. At the same time, the WHO just recommended AGAINST using remdesivir for hospitalized patients, due to lack of evidence that the drug reduces risk of death or need for a ventilator....I know, it's confusing!
On 11/19/2020, the FDA granted emergency use authorization of the combination of remdesivir and the monoclonal antibody baricitinib.
A very small trial (published in Jama Network on November 12) included 152 adult outpatients infected with COVID-19. They were treated with fluvoxamine, an anti-depressant closely related to prozac. It seems that this medication not only affects the serotonin system, but can also have some anti-viral effects. At any rate, none of the patients treated with fluvoxamine got worse, while 6 patients (8.3%) of the placebo patients deteriorated. These are interesting results, though they need to be validated in larger trials.
An inhaled medication that stimulates the immune system (interferon beta-1) helped hospitalized patients with COVID-19. Those patients who were given the inhaled medications were two to three times as likely to get better; The treatment group had a 79% lower risk of developing severe disease or dying. This was just a phase 2 trial, so phase 3 trials are still needed until such a treatment could be considered.
Vaccine development is ongoing and very encouraging:
In a 31-1 vote, the CDC Advisory Committee on Immunization Practices recommended on December 1 that health care personnel and residents of long-term care facilities should be the first to receive the upcoming vaccines (phase 1a). Phase 2 will likely include people with significant illness, "essential workers" who can't telework, teachers/ school staff, older adults, people in homeless shelters. Individual states will have the final say on allocation of vaccines and will tailor recommendations to the needs of their populations.
California will receive its first batch of vaccines (263,600 doses) between December 12 and 15. This is far short of the 2.4 million of the most vulnerable Californians, so there will be priorities even within the "phase 1a" grouping.
You may have heard about the novel technology employed with the Moderna and Pfizer vaccines, the mRNA technology that is ground-breaking. I just wanted to take a minute to explain what all the hype is about: most prior vaccines were "protein-based." Such vaccines usually inject parts of a virus or an inactivated virus into the human body. The human body identifies these particulates as "foreign" and develops an immune response to this virus part. Then, when the body actually gets infected with the real virus, the immune system "armies" are already formed and can be deployed. The mRNA technology of Pfizer and Moderna approach the immune response very differently. Their vaccines inject the RNA (genetic material) of the spike protein of the SARS-Cov-2 virus into human beings. The viral mRNA then coaxes the human body to make the actual virus spike protein. This spike protein is then recognized as "foreign" and an immune response ensues. This process more closely resembles what happens in an actual infection. A bigger portion of the human immune system is mobilized (not just antibodies and CD4+helper cells, but also CD8+ cycotoxic T-cells - if you want to know the details!). Also, protein-based vaccines are sometimes less effective if there is a preexisting immune response present already. This problem does not occur with mRNA vaccines.
The Russian "Sputnik V" vaccine, which is in phase 3 trials, seems to be 92% effective with "no unexpected adverse events." Unfortunately, very little information has been made available to the public, so this success has been greeted with a dose of skepticism also. Russian president Putin announced this week that large scale administration of the vaccine to doctors and teachers will begin next week.
In November, the vaccine produced by Pfizer/ BioNTech was shown to be up to 95% effective. Also, both mild and severe disease seems to be prevented. Seniors as well as younger people respond well to the vaccine. There are some difficulties in administration of the vaccine, however: it has to be given in 2 doses, 3 weeks apart. More importantly, however, it has to be stored in -70 decrees C temperatures, which is much lower than most freezer can provide. So the logistics still need to be worked out... Pfizer has already filed for emergency use authorization and the FDA will meet on December 10 to come to a decision. Once approved by the FDA, doses of the vaccine will be ready "within hours" to ship and to be administered.
However, this last week Britain already authorized the Pfizer vaccine for use and distribution. Why, you ask, has Britain done this while the U.S. has not yet given their ok? The U.S. is actually more careful in their review process of medications and vaccines and carefully looks at the raw data to make sure all the results are as they should be. The United Kingdom, conversely, reviews the pharmaceutical companies conclusions and then comes to a decision. I understand all of our eagerness to get the vaccine to the population, but I am rather happy that the U.S. is more careful in their review process....I know a few examples where this extra care allowed for the U.S. to avoid some of the catastrophes associated with medications that were allowed in Europe more easily...
Moderna announced on 11/16/2020 that it's two-dose vaccine showed 94.5% efficacy. It is important to note that none of the people who received the actual vaccine became severely ill. Moderna's vaccine does not have the deep-freeze requirement of the Pfizer vaccine. Moderna will start testing its vaccine in adolescents soon. Moderna requested U.S. and European regulators for emergency use authorization for it's vaccine on Monday, November 30. The FDA vaccine advisory committee will meet on December 17 to review this application. If the vaccine is authorized, people could start receiving it as early as December 21.
The Oxford/ AstraZenica vaccine showed great efficacy in recent trial as well. Depending on the dosing of the two-part vaccine, either 62% of 90% of recipients were protected. This vaccine is supposed to be very inexpensive ($4 per shot) and can be stored at regular refrigerator temperatures. AstraZenica is working on emergency use authorization from multiple countries and the WHO. However, AstraZenica's CEO, Pascal Soriot, just announced that they will be testing the vaccine in a new global trial now, as there were some concerns about the adequacy of the testing environment previously. Specifically, there are concerns that the patients receiving the lower (and seemingly more effective) vaccine dose did not include anyone over the age of 55. The new global trial will be therefore giving the lower dose regiment to older populations. The full details of the recent trial will be published in the British medical journal Lancet in the coming days.
HHS Secretary Alex Azar has announced that the government has come to an agreement with various large pharmacy chains (Costco, CVS, Kroger, Walgreens, and Walmart) to help distribute the coronavirus vaccine, once it becomes available. There will be no cost associated for the public. Various other public health agencies are also ramping up their efforts now to be able to provide the vaccine to people as soon as it becomes available.
U.S. officials announced in late November that they plan on releasing 6.4 million doses of vaccine as part of their initial distribution. The individual states will decide on how best to distribute their allocated amount. The first vaccines should be available in mid to late December.
Lt. Gen Paul Ostrowski, an official in the White House's Operation "Warp Speed" announced on December 1 that all Americans who want to be vaccinated, can get a vaccine by June.
Children younger than 18 will likely have to wait longer for immunization, as the trials on vaccine efficacy and safety have largely excluded kids.
Antibody therapy:
The FDA has issued an emergency use authorization for the monoclonal antibody "bamlanivimab" produced by Eli Lilly. This treatment is indicated for people with mild to moderate COVID-19 not sick enough to be in the hospital or to require supplemental oxygen. Treatment consists of a one-hour intravenous infusion and should be given to outpatients as soon as possible after the diagnosis of COVID-19 is made. On November 18, the NIH noted that there was insufficient information to recommend for or against this medication for people with mild to moderate disease. It should not be considered the "standard of care" but be considered only for selected patients at high risk and preferably in the setting of a clinical trial. A similar recommendation came on from the November 18 guidelines of the Infectious Diseases Society of America.
In late November, the FDA granted emergency use authorization for two more monoclonal antibodies (casirivimab and imdevimab) that need to be administered together intravenously for the outpatient treatment of mild to moderate COVID-19. These too are recommended only for "high risk" individuals. This is the medication cocktail made by Regeneron that was administered to President Trump during his hospitalization.
A study published in late November in the New England Journal of Medicine found that blood plasma from COVID-19 survivors used to treat patients with severe pneumonia due to the virus showed little benefit.
Mills-Peninsula Hospital:
Peninsula Hospital continues not to be full and is managing its share of COVID-19 cases as well as could be hoped for. Plenty of beds are still available in case more people fall ill and all the treatment modalities we discussed above are available here.
Ryan Stice, who oversees pharmacy services at Sutter Health, has been preparing for the cooling requirements for the Pfizer COVID-19 vaccine (minus 94 degrees Fahrenheit!!) since the summer. Now Sutter, like other local health care providers and local health departments, is moving quickly to acquire about a dozen large and several smaller portable freezers for vaccine storage.
Our Community and Beyond:
The State of California has come out with a new color-coded system to guide reopening of different parts of the state: this system has 4 tiers: certain criteria such as each region's number of positive COVID-19 tests, hospitalizations, and Intensive Care Unit admissions will dictate what tier is appropriate for each region.
California has been divided in 5 regions: we are in the "Bay Area" region which includes the counties of Alameda, Contra Costa, Marin, Monterey, Napa, San Francisco, San Mateo, Santa Clara, Santa Cruz, Solano, and Sonoma). Each regions will be subject to additional restrictions if ICU availability falls below 15%. As of yesterday, none of the regions met that threshold yet, though all (other than the Bay Area) were expected to get there within a few days. The Bay Area is expected to reach this threshold in a matter of weeks. If this threshold is reached, the following restrictions will be instituted and supersede any rules based on the colored tiers:
personal care services (hair and nail salons), playgrounds, bars, wineries, movie theaters, museums, zoos will be closed.
retail and grocery stores as well as other businesses will operate at 20% capacity
restaurants will be able to offer only takeout or delivery. No outdoor or indoor dining will be allowed
all non-essential travel should be avoided
these orders will remain in effect for at least 3 weeks
As of November 30, 51 of the state's 58 counties were in the purple tier, accounting for 99.1% of the state's population.
On November 29, San Mateo County moved into the purple Tier 1, the most restrictive tier. In addition, a stay-at-home order has taken effect (see below).
Businesses and activities that may have been operating indoors (places of worship, movie theaters, gyms, and museums) must move outdoors or close.
Shopping malls and all retail must operate at no more than 25% capacity.
Indoor gatherings among members of different households are banned and outdoor gatherings can include people from only 3 households.
There is now a curfew imposed on residents living in purple tier counties: residents are asked to stay indoors (except to buy essential foods and products or to walk their dogs) between 10 pm and 5 am. This curfew is expected to last until at least December 21.
Gov. Newsom has warned that a new targeted stay-at-home order could be issued in the future, if the hospitalization rates continue to surge. At this time, COVID-19 cases are on track to rise by up to 30% by Christmas Eve in much of the state. The Bay Area is doing slightly better compared with the rest of the state, as currently 58% of the hospital beds and 72% of the ICU beds are occupied.
As of November 30, all three of Santa Clara county's main hospitals canceled all adult elective surgeries.
San Mateo is still offering free PCR testing for COVID-19:
Scheduled testing occurs at the San Mateo County Event Center. Testing here can be scheduled Tuesdays through Saturdays from 8 am to 3 pm - all without a cost to the patients. Appointments are required and can be made at "projectbaseline.com/COVID19"
Our Office: What We Are Doing to Keep You Safe:
All patients seen in person will be screened for COVID-19 exposure and symptoms prior to coming into the building.
We disinfect all exam rooms and medical equipment as well as all door handles after EVERY patient visit, regardless of the medical issues involved.
We are also using tele-health options that allow you to have video as well as audio interactions with us as part of a "remote office visit." With the recent surge of cases, we are postponing most routine physical exams and minimizing most in-person visits. Patients who require physical evaluations to diagnose and treat their medical issues will always be seen in person.
For those patients seen in the office, we ask that friends and family members stay in the car (or elsewhere outside the office) during the visit. Of course we do welcome caregivers into the office with the patient if they are needed for improved safety or communication.
All of us in the office are healthy and doing well.
We have still are giving "regular" flu shots (i.e. NOT those for seniors). So if you are under 65 and have not yet received your flu shot, call our office and come on in!
In addition to the "regular" Covid-19 testing that we have had all along (nasal swab, PCR-based test with approx. 24-48 hour turn around) our office also has two other COVID-19 testing options available:
A saliva based PCR-test that can be done in a patient's home. It is then sent via Fed-Ex to a lab and usually gives results in 36 hours. This test is usually covered by insurances and is 100% sensitive and 100% specific. It is accepted as evidence of immunity for most travel (not including travel to Hawaii, which does not accept this test).
A rapid 10-minute test that is based on a nasal swab and performed in our office. This test is 85% sensitive and 100% specific. This test is perfect for people without symptoms or prolonged exposure to a COVID-10 patient who "just want to make sure" they are ok. This test is not covered by insurance and costs patients $30/ test.
We will try to keep you updated as the epidemic evolves. Feel free to call or email with questions or concerns.
About Dr. Sujansky's Life in These Times
On a more personal note, my family and I continue to do well
We spent Thanksgiving in Kirkwood, which was beautiful. The weather was cold but dry, so we were able to take some beautiful hikes...a necessity after consuming so much turkey. As mentioned in the last newsletter, there were three of us and a 16 pound turkey. Then there were leftovers, turkey fried rice, turkey tetrazzini...and it's still not quite gone.
My latest knitting project involved hot water bottle covers...for those of you who have not heard me rave about how water bottles, you have missed out. These old-fashioned things have kept me warm on many a cold winter night and have soothed sore muscles any time of year. At any rate, I can't show you a picture of these knitting masterpieces as one will go to my mother and she subscribes to this newsletter (Oh My!)
Finally, I wanted to remind you about the 20% discount on Obagi skin products through the rest of December. Many of you are already familiar with the wonderful products by Obagi that we carry at the office. Check out the "Holiday Hydrate Special" which includes the hydrate luxe, retinol, travel sizes of foaming gel and toner, as well as travel size facial elastiderm and hand sanitizer).
So treat yourself (and others in your family) for the holidays. I think we all deserve something special in these times.
I wish you all a wonderful weekend and coming week. I hope all of you stay safe and healthy. I am thinking of you often.
Sincerely,
Ulrike Sujansky, MD
