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 constantly evolving. I will include some details on this topic from previous newsletters, as they remain important - new information will be in BOLD.
General Information:
COVID-19 cases are going down, finally (!), and have dropped about 24% compared to previous weeks. These numbers are about 40% lower than they were in August.
The big news in this recent past is that of new booster recommendations. Please note, that these are (for now) just the recommendations from the advisory committee. The FDA will review the recommendations likely this week and then make the official recommendations. Only then will you be able to go to the pharmacy and get your booster.
As you may recall, a booster was previously recommended for recipients of the Pfizer/ BioNTech vaccines 6 months after the last dose. This recommendations was for people aged 65 and older OR for younger patients who had a disease that compromised their immune system OR have high risk of infection due to their jobs.
On October 15, the FDA Advisory Committee recommended that recipients of all ages of the J&J vaccines (regardless of age) receive a J&J booster 6 months after their shot. This recommendation is good, but also interesting: a recent NIH study suggested that following the initial J&J vaccine with Moderna or Pfizer may actually boost the immune system more effectively! The final recommendations by the CDC and FDA are likely to come out next week.
On October 14, the FDA Advisory Committee voted unanimously to recommend boosters (at half the dose of the initial vaccines!) for people aged 65 and older OR with underlying immune issues OR with high infection risk associated with their jobs. Like the Pfizer/ BioNTech booster recommendations, this booster should be given six months after the last dose. This recommendation will now be considered by the FDA itself, as well as the CDC.
As of today, the FDA "is planning to allow Americans to receive a different COVID-19 vaccine as a booster than the other they initially received," but that pronouncement is not yet official. I think that as soon as I hit "send" for this newsletter, the FDA will make it official, knowing how these things work!
Dr. Anthony Fauci, the U.S.'s top infectious disease doctor, has given his blessing to the upcoming trick-or-treating activity of Halloween!
Transmission:
A recent article in JAMA Internal Medicine showed that people with COVID-19 were most contagious 2 days before onset of symptoms to 3 days after onset of symptoms.
A recent study (Journal of Infectious Diseases) shows that kids (babies all the way through to young adults) can have large amounts of the SARS-Cov-2 virus in their bodies AND SPREAD THE VIRUS TO OTHERS, even if they have no symptoms.
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.
New research suggests that some of the symptoms of "long-COVID" are due to inflammatory molecules trapped inside tiny blood clots (Cardiovascular Diebetology).
And yet another study (JAMA Network Open) shows that about 50% of people with COVID-19 have symptoms that last at least 6 months after the initial acute disease.
Two new studies show that pregnant women infected with the SARS-Cov-2 virus risk significant emergency complications: they have a higher risk of cesarean sections as well as the need for supplemental oxygen. Babies born of mothers with COVID-19 were more likely to end up in the neonatal ICU (Journal of Maternal-Fetal &Neonatal Medicine AND presentation at the Anesthesiology 2021 Annual Meeting).
Incidence/ Prevalence:
More law enforcement officers have died of COVID-19 than of any other cause of duty-related deaths.
Unvaccinated pregnant women make up about 20% of the most critically ill COVID-19 patients in England. This fact confirms the high risk of severe COVID-19 in pregnant women.
As of October 18, 2021, in the U.S.
45.1 Million people have contracted COVID-19.
727,000 people have died.
The above numbers represent 122,000 new cases and 1,890 additional deaths in the prior 24 hours.
65.9% of people have received at least one dose of vaccine and 57% of people have been fully vaccinated.
The new "hot spot" of infection is Alaska, where hospitals and ICU's are full and doctors are put into the impossible position to decide who will get an available ICU bed who will not…
Testing
Rapid tests (such as the BINAX Now) test have been in scarce supply in the last month.
The FDA has tried to address the situation by allowing the U.S. sale of the Flowflex antigen test, which has only been available in Europe so far.
Other rapid tests may be approved in short order.
The government will purchase tests for $1 billion, with the goal of accelerating test production.
By December, 200 million rapid tests will be available in the U.S. every month.
The above measures should quadruple the number of rapid tests available within the next six weeks.
The hope is that some of these rapid tests will be available for free, as they are in Europe.
Treatment
Currently available vaccines are extremely good at reducing the severity of COVID-19 symptoms, but less good at preventing the spread of the disease. One reason for this seems to be that the virus sets up shop in the nose and can then be transmitted to others with a cough or a sneeze. Luckily, new vaccines are being developed that come in the form of a nasal spray and that may be able to prevent such transmission. Much work still needs to be done on such nasal spray vaccines to confirm that they are able to prevent severe symptoms as well, but initial research is promising!
A study published in JAMA Network Open looked at the safety of COVID-19 vaccines in pregnant women. The researchers looked at more than 100,000 pregnancies and did NOT find that there was an increased risk of miscarriage after vaccination.
A recent study confirmed initial reports that the Pfizer/ BioNTech and Moderna vaccines can cause myocarditis, an inflammation of the heart muscle. Nonetheless, this risk is still extremely low (5.8 cases per million) and the complication occurred almost exclusively in men around the age of 25 (JAMA Internal Medicine). Also, all cases improved/ resolved on their own. Nonetheless, Finland, Sweden, and Denmark are no longer administering the Moderna vaccine to men born later than 1991.
Pfizer and BioNTech asked federal regulators on 10/7/21 to authorize emergency use of their vaccines for kids aged 5 to 11. An FDA advisory committee plans to discuss this issue on October 26.
Pfizer/ BioNTech:
On September 20, Pfizer announced that vaccination of a lower dose of the vaccine (one third the amount given to adults and teens) was both safe and elicited a robust immune response in kids as young as 5 to 11 years old. Pfizer will present the information to the FDA in short order and they hope to get approval of the vaccine in kids older than 5 by early November.
Moderna:
According to an article in the New England Journal of Medicine, the Moderna vaccine continues to be effective in preventing COVID-19 and severe disease at more than 5 months after administration.
The FDA will delay its decision on approving the Moderna vaccine for adolescents, as they want to have more time to review the safety data.
Johnson & Johnson:
Recent studies show that a booster to the J&J vaccine prevented 94% of moderate to severe COVID-19 cases in the U.S. Also, the two-dose vaccine was 100% effective against severe disease. This information has now been submitted to the FDA on October 5 for review.
The Oxford/ AstraZenica vaccine:
This vaccine has NOT been approved for use in the United States yet.
Other treatments:
Merck has developed the first pill that seems to be effective in preventing severe disease from COVID-19. The medication is called "molnupavir" and likely will be effective for different variants of the virus, as it does NOT target the spike protein. This medication seems to decrease the risk of hospitalization from the virus by 50%! Merck has submitted an application for the FDA to authorize use of this pill (which would need to be taken as four capsules twice a day for five days) for use in high risk adults (people over 60 or younger folks with obesity, diabetes, and heart disease). The FDA is expected to make a decision within a few weeks. At this time, Merck has a U.S. government contract to supply 1.7 million courses at a price of $700 per course.
Pfizer has announced that they are in mid-to-late trials on an oral medication to PREVENT COVID-19 altogether.
AstraZenica is seeking emergency use authorization for a long-acting antibody treatment (called AZD7442" for now) to prevent COVID-19 in high risk groups. The treatment could reduce the risk of symptomatic disease by 77%.
Our Community and Beyond:
The counties of San Mateo (as well as San Francisco, Santa Clara, and most other Bay Area counties) plan to lift the indoor mask mandate for most public spaces if the following criteria are met:
COVID-19 transmissions are in the moderate (yellow) tier for at least three weeks.
80% of the jurisdiction's population is fully vaccinated.
COVID-19 hospitalizations are low and stable.
At this time, San Mateo, Santa Clara, and Contra Costa counties are still in the orange ("substantial") tier.
In early October, the public health departments of San Francisco and Marin counties announced changes to their face mask mandates: an exemption now allows small groups of people to remove their masks in some indoor settings where stable groups of vaccinated people gather. Such settings may include office settings or yoga classes, for instance.
The California Department of Public Health mandated on September 28 that all senior care facilities and in-home care workers be fully vaccinated for COVID-19.
Gov. Newsom has also mandated that all students aged 12 or older, as well as all school employees, be fully vaccinated (unless they have a medical exemption).
Stanford is now requiring all of his employees (working remotely or not!) to be fully vaccinated against COVID-19 by December 8, 2021, though medical and religious exemptions would be accepted.
San Mateo County is offering drive-through venues for people needing a COVID-19 booster shot (or the original series). Boosters are only available to people older than 18 and who have received 2 doses of the Pfizer vaccine. You can make an appointment through the state's website "Myturn."
Non-Covid Medical News
New recommendations have come out on the use of aspirin to prevent heart attacks and strokes. These changes reflect recent studies that question how effective and safe low dose aspirin is in preventing heart attacks for people who have not had heart disease in the past. Now the U.S. Preventative Services Task Force states that people older than 60 should not take an aspirin UNLESS THEY HAVE HAD HEART ATTACKS IN THE PAST. People younger than 60 are encouraged to discuss aspirin use with their doctors and then come to a decision on whether to take it. These recommendations reflect the increased risk of bleeding of the intestines or in the brain with which aspirin use has been associated. Please note that people who have had heart attacks still benefit from taking low dose aspirin daily.
Remember my last two newsletters where I was entreating all of you to get a flu shot? Well, at this time, the U.S. is experiencing 23% more flu cases compared to last year...though this is still less than in non-pandemic years. This is likely due to more face-to-face interactions.
About Dr. Sujansky's Life in These Times
I recently celebrated a birthday (I'm 29 again, it seems!) and we spent the weekend up at our place in Kirkwood. The weather has certainly turned colder there, but it was beautiful: the trees were all sorts of shades of yellow and red and animal tracks were visible in the thin layer of snow that had fallen. Luckily, the recent wild fires -while coming close to Kirkwood- had largely spared the area. Hiking was a bit more difficult, as all of the surrounding National Forrest land was closed off, due to some smoldering fire activity. We still found a few trails that were open and it was BEAUTIFUL!
