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. I will include some details on this topic from previous newsletters, as they remains important - new information will be in BOLD.
But, before we discuss all-things-COVID, I wanted to mention a few other things in the news:
The FDA recently approved a new medication for the treatment of Alzheimer's patients. This is exciting news indeed, as the current medications are not fabulous. Sadly, this medication may not be as promising as it first seems:
The medication is called "aducanumab" (or the brand name is Aduhelm). It is given as a once-monthly intravenous infusion and costs $56,000 per year.
The FDA approved the drug even though none of the 11 members of the independent advisory committee considered the medication ready for approval, as they were not sure it worked very well and was associated with some serious side effects (brain swelling and bleeding). In fact, at least 3 of the members of this committee resigned in protest when Aduhelm was approved anyway by the FDA.
Also, the medication was approved for all people with Alzheimer's, even though the studies were done on people with very early stage disease only.
Meanwhile, Eli Lilly announced on 6/24/21 that its new Alzheimer's drug ("donanemab") is receiving accelerated review by the FDA. This medication seems to perform better than its rivals. It is indicated for people with early Alzheimer's Disease. More details are pending.
General Information:
In the United States, more than 600,000 people have now died of COVID-19. This is more than the population of Baltimore. This number is comparable to all Americans who died of in 2019. Even if death rates are plummeting in the U.S., the rest of the world is not so lucky. At this time, the number of people who die of COVID-19 each day in the U.S. is less than 300 - this number is comparable to the death count in March, 2020, when the pandemic was just gaining speed.
The NIH now believes that the earliest cases of COVID-19 in the United States date back to December, 2019. This conclusion is based on new analysis of blood taken from patients at that time. 7 people in 5 states were found to have antibodies to the virus in early 2020.
Overall, the U.S. is doing quite well in most-things-covid-19. However, the number of new infections is no longer going down and the pace of vaccination has slowed. This is particularly concerning as the new variant out of India (aka the Delta variant) is becoming more dominant: this variant is both more contagious and more severe than earlier variants of the virus and now makes up the dominant variant in places like the United Kingdom. In the U.S., 10% of new infections are due to the Delta variant. Luckily, existing vaccines are very effective in preventing hospitalizations due to the Delta variant! But unvaccinated people remain vulnerable...
A recent study put forth by the CDC shows that COVID-19 hospitalizations of senior citizens have dropped precipitously since the vaccine rollout. Also, we are seeing fewer emergency department visits, hospital admissions, and deaths. As younger people are less widely vaccinated, they now make up a much larger percentage of people who get sick with the disease. At this time, half of the deaths due to COVID-19 are occurring in people aged 50-74.
About 80% of people older than 65 have been vaccinated against SARS-Cov2, but only 38% of people aged 18 to 29 are vaccinated. "What is the big deal?", you may ask, as these younger age groups don't tend to get very ill with the virus. "That is true," I will answer. However, even if the younger people don't get too sick with the disease, they can act as a reservoir for infection that allows the virus to mutate and get us older folks ill down the road, as future variants may elude our current vaccines.
Yet another study showed a marked increase of people who died of heart disease, diabetes, and other common diseases in 2020. This increase is attributed to people avoiding necessary hospitalizations due to the pandemic.
To incentivize people to get the COVID-19 vaccine, Washington state is offering a free marijuana joint to anyone who gets vaccinated. Yes, I know, this is hardly "news," but it did make me shake my head...
The American Medical Association just published a survey that shows that 96% of practicing physicians have been fully vaccinated against COVID-19...so if doctors are eager to get vaccinated, perhaps that should tell you something...
Experts now say that between 70% and 85% of the total population (not just the adults!) must be fully vaccinated in reach large-scale protection against the virus; we are doing great in our neck of the country, by and large (Marin County has 75% vaccinated population older than 12; Lassen County has 22% of that age group vaccinated. The top six counties with the highest percentage of vaccinated population are in the Bay Area.
One COVID-19 monitoring program that was employed by the NFL (National Football League) turns out to have been very effective: they used PCR-based daily testing and this was great at picking up early infections and isolating the affected individuals. A strategy that used antigen-based testing was not as effective.
The U.S. government is allocating $3.2 billion in funding to find treatments for viral disease (like COVID-19) that will help patients early in the course of infection and hopefully keep them out of the hospital...
A real-world example coming out of Israel (and published in Nature Medicine) showed that widespread vaccination also protects unvaccinated individuals: If the number of vaccinated people between the ages of 15 and 50 increases by 20%, then the number of kids under 16 who test positive for the virus drops in half.
The mRNA technology that was used so successfully in the Moderna and BioNTech vaccines is now being used to look at developing new anti-cancer treatments.
Vaccine Administration and Availability:
Sutter has walk-in locations across the Bay Area: they offer the Moderna vaccine to anyone aged 18 or older. COVID-19 vaccination appointments can also still be made on line through the "my health online" website or by calling 844-987-6115.
Mass vaccination sites (like at SFO) are finishing up just as community clinics, pharmacies, and possible pop-up events will take on the heavy lifting for vaccine administration.
Please realize that your vaccination cards are NOT the only record of your vaccination status! All vaccine administrators have to document the vaccines they give in a central database. You can view your status at
https://cairforms.cairweb.org/AuthorizationToRelease/
If you have problems accessing this site, you can call 800-578-7889 or email CAIRHelpDesk@cdph.ca.gov
California recently launched a new way that residents can access their vaccine records: go to myvaccinerecord.cdph.ca.gov and input your name, date of birth, phone number/ email and four-digit PIN. Users will then receive a link to their digital record with their vaccination status. This may come in handy if businesses decide to require patrons to show proof of vaccination for entering without a mask. I'm thinking that entertainment and sports venues may likely do that. Another time this digital information may come in handy is if you are traveling.
Sadly, about 10% of the American population has missed one of the two COVID-19 shots and so continues at higher risk of the infection, especially with the Delta variant becoming more dominant in our country.
New COVID-19 Variants
A study published in early June in Nature provided some welcome results, indicating that our vaccines seem to be quite effective against the current variants. In particular, the J&J vaccine was tested on the South African variant ("Beta") and found a robust antibody and T-cell response. The T-cell response, in particular, doesn't seem to be any worse in the new COVID-19 variants - Alpha and Gamma as well as Beta. This would explain why the J&J vaccine is working so well in South Africa, where the three different variants are prevalent. Similar effects have also been observed with the Pfizer/ BioNTech and Moderna vaccines
SARS-COv-2 variants:
B.1.1.7
Scientists estimate that this variant spread about 1.55 times faster than the previous variant.
This variant is now the dominant virus an area the U.S. population.
This strain is now known as the Alpha strain.
South African strain (aka N501Y.V2 or B.1.351)
This strain is also more contagious than the original virus.
This strain is now known as the Beta strain.
Another highly-contagious variant has originated in Brazil. This variant is also known as P.1. This variant is now known as the Gamma variant.
California strain
Various new strains ( B.1.427 and B.1.429) have cropped up in California. This strain is now known as the Epsilon variant.
New York: strain B 1.526. Two independent studies indicate that both the Moderna and the Pfizer/ BioNTech vaccine effectively protect against this variant.
India: the strain that is ravaging India (B.1.617, aka Delta) has spread to dozens of other countries so far, including the United Kingdom.
This strain is now known as the Delta strain.
According to Dr. Anthony Fauci, the Delta variant "is the greatest threat to the United States' effort to eradicate COVID-19 in its borders."
This strain has been found in 80 countries and comprises 20% of the new infections in the United States. Cases of the Delta variant have double in the last two weeks alone (in the United States).
This variant is both significantly more contagious and also more deadly than prior versions of the virus. It is thought to be 60% more transmissible than the Alpha variant....and that one was more transmissible than the wild type variant!
A new analysis shows that the Pfizer/ BioNTech vaccine is 96% effective in preventing hospitalizations due to the Delta variant. The AstraZenica vaccine is 92% protective. So our vaccines work against this virus variant....get vaccinated!
Transmission:
The CDC also just updated their guidance on transmission of the novel coronavirus, emphasizing that the virus has airborne spread in addition to droplet spread.
A recent article in Clinical Infectious Diseases showed that 0.7% of patients who have recovered from severe COVID-19 infections contracted the disease a second time....so: not a lot, but it does happen!
Symptoms and Risk Factors:
Although COVID-19 is associated with a wide array of symptoms, 96% of infected people have either fever, cough, or shortness of breath.
The lingering effects of COVID-19 infection ("long-haul COVID") continues to be investigated. Prominent symptoms include brain fog, kidney damage, and lung problems. Long-haul COVID-19 is seen in 45% of people who were sick enough to require hospitalization for COVID-19.
Yet another study (Jama Open Network) shows evidence of the "long-haul" COVID syndrome: more than 70% of people who have recovered from the infection experience at least one symptom for at least 60 days.
Incidence/ Prevalence:
The incidence of new COVID-19 infections and deaths are highly variable throughout the world. The Bay Area has a very low incidence of new infections, but other areas of the state and the country have significantly lower immunity and are seeing much higher infection rates, especially as mask mandates are being rolled back in most places. Internationally, Brazil is a big hot spot: this country has had a particularly poorly organized and haphazard response to the pandemic and the results are devastating for the population: at this time, more than 500,000 people have officially died of the disease in Brazil alone, which is very likely an undercount. About 1 in 400 Brazilians has died of the virus.
Some statistics:
San Mateo:
number of cases:42,756 (42,396 three weeks ago)
number of deaths: 576 (576 three weeks ago)
number of people in the hospital: 9 (10 two weeks ago).
85% of people aged 16 or older have received at least one COVID-19 vaccine and 80% of adult residents have detectable antibodies - up from 70% just one month ago.
California:
number of cases: 3.81 Million (3.79 Million three weeks ago)
number of deaths: 63,490 (63,392 three weeks ago)
U.S.:
number of cases: 33.6 Million (33.4 Million three weeks ago)
number of deaths: 602,917 (596,000 three weeks ago)
World:
number of cases 180 Million (172 Million 3 weeks ago)
number of deaths: 3.9 Million (3.70 Million 3 weeks ago)
Treatment
You may have heard various accounts of fully vaccinated people who still became ill with COVID-19 and may even have died. This should not be news, as we know that the vaccine are highly effective, but not 100%! But also note that over 25% of these breakthrough infections were NOT associated with any symptoms. 1.5% of those re-infected did die, but 18% of those deaths were due to causes not related to the virus. Overall this is all very promising. Indeed, at this time it seems that the vaccines protect against EVERY variant of SARS-COV-2.
Some people are hesitant to take the COVID-19 vaccines as they believe the vaccines are associated with a lower fertility rate. Well, an article in JAMA from 6/17/21 seems to dispute this concern: various sperm characteristics associated with fertility were measured in med before and after receiving the mRNA vaccines: there was no difference in sperm count or other parameters after the vaccination. Men can now take a deep sigh of relief.
Vaccine manufacturers say that the vaccines may be available for children as young as 6 months by the fall of 2021.
As you may have read, people who have a depressed immune system due to a prior organ transplantation may not produce an adequate immune response to the current coronavirus vaccines. However, a recent small study suggested that such patients do really well with a booster vaccine shot that allows them to produce a more robust immune response.
More evidence is emerging that people vaccinated with the Pfizer/ BioNTech or Moderna vaccine are at a mildly increased risk of myocarditis/ pericarditis, an inflammation of the heart muscle. These events are rare, but tend to occur in young men aged 12 to 24. In a recent statement, the CDC, the Department of Health and Human Services, as well as 15 of the country's leading public health and medical organizations (including the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Medical Association, and the American Nurses Associates) issues a joint statement that they "strongly encourage everyone 12 and older" to get vaccinated as the benefits outweigh the risks by far.
There are some interesting data that suggest that "mixing and matching" the two RNA vaccines (Pfizer/ BioNTech for one shot and Moderna for the other) may actually be beneficial and produce a better immune response. Studies are ongoing, but this may be an interesting recommendation for the future.
I am printing this part in RED because I think it is so noteworthy: only 150 of the 18,000 COVID-19 deaths in the U.S. in May, 2021 were in fully vaccinated people. Breakthrough infections in fully vaccinated people account for only 0.14% of hospitalizations for the disease. The Vaccines work and are safe.
Pfizer/ BioNTech:
Pfizer expects for apply for FDA emergency use authorization to use their vaccine in kids aged 2 to 11 by September.
Pfizer and BioNTech have asked the FDA for full approval for their vaccine. If this is granted, then the vaccine will be taken out of the "emergency use" category and could be given to patients even after the current public health crisis is over.
Moderna:
Moderna has applied to the FDA for use of its vaccine in kids aged 12 to 17. In a trial of 3,732 kids of that age, no cases of symptomatic infection were found in fully vaccinated teens, giving the vaccine an efficacy rate of 100% - the same as was found with the Pfizer vaccine. The FDA is expected to approve Moderna's request in July.
Moderna has joined Pfizer in applying to the U.S. Food and Drug Administration for full approval for it's vaccine - not just as an "emergency use authorization."
Johnson & Johnson:
The Vaccine is about 85% effective in preventing serious COVID-19 illness and 100% effective in preventing COVID-19 associated death.
On May 12, the CDC announced that their latest review found a total of 28 cases of blood clotting among the 8.7 million people who had received the vaccine. Three people of those 28 had died.
As noted above, a recent study found the J&J vaccine effective against the Alpha, Beta, Gamma, and Epsilon variants of the virus.
The Oxford/ AstraZenica vaccine:
This vaccine has NOT been approved for use in the United States yet.
The final efficacy reported by AstraZenica for its vaccine showed it to be 76% efficacious against any symptoms. The even better news is that the vaccine is 100% effective in preventing severe COVID-19 disease or hospitalizations.
This vaccine is associated with a slightly increased risk of a bleeding disorder known as ITP (Nature Medicine). The increased incidence stands at 1:100,000. No increased risk of blood clots in the brain were noted in this study.
Novavax:
This vaccine is produced my a company based in Maryland.
This is a protein-based vaccine (NOT a mRNA vaccine).
This is also a two-shot vaccine series.
On June 14, Novavax announced that trials showed that the vaccine is 90% effective in preventing any COVID-19 infection, and 100% effective in preventing severe infections.
The company plans to seek emergency use authorization from the FDA in September.
Sinopharm:
The WHO has declared the vaccine produced by the Chinese company "Sinopharm" as safe and effective. This vaccine is not yet approved for use in the United States.
Unfortunately, some countries that have given the Chinese vaccines (Sinopharm and Sinovac) to their populations are now seeing a resurgence of COVID-19, calling into question the efficacy of the vaccines donated to these countries. These countries include Bahrain, Mongolia, Chile, and the island nation of the Seychelles.
The Russian vaccine known as "Sputnik V" was reported in the medical journal Lancet to have a 92% efficacy in preventing symptomatic disease.
CureVac:
the German firm CureVac has developed a mRNA vaccine that is in late-stage trials.
Unfortunately, a recent trial showed that this vaccine was only 47% effective in preventing disease...so this vaccine doesn't seem to be a viable alternative at this time.
Antibody treatments:
The FDA as granted emergency use to a third COVID-19 antibody treatment for people at high risk of hospitalization. The new medication, "sotrovimab," is effective against the variants seen in India, U.K., South Africa, Brazil, California, and New York. Like previous antibody treatments, this medication requires intravenous administration and is usually available in the emergency departments of hospitals.
Combinations of two different antibody therapies are likely effective in treating some of the newer nastier SARS-COv-2 variants that are out there (Nature).
Our Community and Beyond:
It is not clear if California will create a statewide system to allow easy verification of vaccine status.
In early June, the Bay Area Health officers representing, among others, San Mateo, announced support for re-opening schools for all grades in the fall.
The California Division of Occupational Safety and Health announced last week that fully-vaccinated workers do not need to wear masks in their workplace, regardless of whether others at the job are vaccinated.
For those of you who are wondering: your job is legally allowed to require you to get the COVID-19 vaccine, as long as there are exemptions for health reasons or religious convictions.
On June 15, California reopened almost entirely:
Stores, gyms, restaurants, theaters, etc. will no longer have a maximum number of patrons that can be present at one time.
The color-coded system of restrictions has ended.
Social distancing guidelines will no longer apply.
Exceptions to the above new guidelines involve "mega events," in which more than 5,000 patrons (indoor events) or more than 10,000 patrons (outdoor events) will be present. Such events are more likely to spread the coronavirus. As a consequence, attendees of such mega events need to either show proof of vaccination or have a negative COVID-19 test at entry. Conventions, sporting events, business conferences, and concerts may often qualify as "mega events."
Masking will still be needed when riding public transit, being in a school/ child care setting or in medical clinics or nursing homes. Masks are also still needed in taxis and ride-sharing vehicles and in airports.
Individual businesses may still require patrons or employees to wear a mask.
On May 27, Governor Newsom announced a very lucrative lottery for people who have received the coronavirus vaccine. A total of $116.5 million will be distributed as follows:
$1.5 million will be given to each of 10 "grand prize" winners who will be picked randomly on June 15.
$50,000 will go to 30 people on June 4 and 11.
The remaining $100 million will be divided up in $50 retail gift cards for the next 2 million Californians to complete their vaccine.
If you have received your vaccine already, you will automatically be entered into the $1.5 million and the $50,000 contests.
On 6/14, California state officials announced another incentive program: six winners (selected from people who have been vaccinated) will win trips for four throughout our beautiful state. Each trip also comes with $2000 in cash prizes. Disneyland, here I come!
Santa Clara County and the city of San Jose are raffling away 100 tickets to upcoming concerts, events, and other prizes to anyone who gets the COVID-19 vaccine in the next few weeks at one of the county-run vaccination sites.
Our Office: What We Are Doing to Keep You Safe:
We disinfect all exam rooms and medical equipment as well as all door handles after EVERY patient visit.
All of us have been fully vaccinated.
Please note that the CDC continues to recommend face masks in medical settings. As a consequence, despite the recent loosening of mask mandates, we ask you to wear a mask when you come to our office.
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.
I love the summer! The weather is (usually) wonderful and we are spending much time sitting outside in the evenings.
My recent-high school graduateson has started work as a camp counselor for a local sports camp. He is loving the work and the camaraderie with the other counselors. And he is also "appreciating" how hard it is (sometimes) to deal with a bunch of 8-year-old boys...it seems they don't always listen... :)
I have purchased a hummingbird feeder and now can watch the tiny birds feed while I work in my home office. Do you know that hummingbirds have a heart rate ranging from 50-180 beats per minute (on a cold night) to 1,260 beats per minute? Amazing! I wouldn't want to interpret an EKG on those guys!
