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 continuing to drop: new daily cases are down by 57% compared to early September. Even better, this decrease is widespread throughout much of the United States! At this time, there is no regional surge of cases, though some hot spots remain (think Alaska, Idaho, Montana, North Dakota and a few counties in northern New Hampshire and Vermont).
The CDC forecasting model predicts that U.S. cases will to fall 20% in the next 3 weeks.
On October 20, the FDA and CDC officially authorized booster shots for recipients of the Moderna and J&J vaccines: as expected, the Moderna vaccine is recommended for people older than 65 or with underlying medical conditions (or who work or live in high-risk settings). Boosters are recommended for all J&J vaccine recipients older than 18. Booster shots for Pfizer/ BioNTech vaccines were previously approved in September.
The CDC has also authorized recipients of all vaccines to receive booster shots from a different manufacturer, in hopes that this will facilitate vaccination logistics and boost vaccination overall. This strategy is known as "mix and match."
We likely will soon have approval for the Pfizer/ BioNTech vaccine for kids aged 5 to 11. An FDA review found "the benefits of the shot outweigh the risks in most scenarios." And an FDA Administration advisory panel did recommend emergency use authorization of the pediatric Pfizer/ BioNTech vaccine on October 26. The CDC advisory panel meets on November 2 and 3. The hope is that they will approve of vaccinations in this age group and vaccinations will be able to start in short order.
The pediatric dose is one third of the adult dose.
There is no suggestion that the pediatric vaccine will be in low supply.
Side effects of the pediatric vaccines seem to be quite mild, but could include pain at the site of injection, occasional headaches, and mild achiness and fever.
Of note, this younger age group has many more members than the teenage cohort, so that logistics will need to be prepared to allow for speedy and efficient vaccinations of the younger kids.
A recent study including research teams over seven states found that COVID-19 vaccination not only prevented death from COVID-19, but was also associated with death from ANY cause in the months following vaccination (Morbidity and Mortality Weekly). These results remained robust even after cofounders such as age, race, ethnicity, sex, and geographic location were taken into account.
More recent studies suggest that we should NOT yet be using COVID-19 antibody levels to assess immunity to the virus. The various antibody tests are not standardized and calibrated and are hard to compare one-to-the-other. Moreover, although all antibodies may bind to the virus, not all will neutralize (and kill!) the virus, so it is not clear how antibody levels translate into disease protection. Finally, some antibody tests only detect antibodies produced by prior infection, while others can detect prior vaccination, making interpretation of the tests tricky. Finally, scientists have not yet worked out what level of antibodies can predict a person's resistance to infection - an important piece of information!!
A letter published in the New England Journal of Medicine on October 20, 2021 again showed that the COVID-19 vaccines were safe during pregnancy: in a Norwegian study of of about 18,000 women, there was no increased risk of miscarriage in three to five weeks after vaccination.
As you well know, people who are severely immunocompromised (blood cancers, chemotherapy recipients, AIDS patients) already need 3 (not 2) initial vaccines to build up an immune response. In such people, the third vaccine is given two months after the second. Now the CDC is recommending that such people receive a 4th dose of vaccine, 6 months after the last - much like older and mild-to-moderately immunocompromised people need a third booster after 6 months.
The Biden administration MAY mandate private companies with more than 100 employees to require their employees to be vaccinated or undergo regular testing. Stay tuned: I expect we will hear more about this in the coming weeks.
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.
A recent article in Lancet Infectious Disease unfortunately found that vaccinated people could still spread the delta variant. So it is NOT appropriate to decline vaccination just because you feel protected by the vaccinated people around you!
Symptoms and Risk Factors:
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.
We have all heard of the brain fog associated with Long Haul COVID. A study published in JAMA Network Open found that this mental clouding could last months after infection and affect patients who were not severely symptomatic initially.
The CDC has now included mental health conditions such as depression and schizophrenia to the list of conditions that increase the likelihood of a patient requiring hospitalization for COVID-19. Other such conditions include cancer, diabetes, and obesity. The inclusion of mental health conditions to the list of high-risk conditions is based on a study published in JAMA Psychiatry.
Incidence/ Prevalence:
As of yesterday, more than 5 million people in the world have died due to COVID-19. Actually, many experts believe that the number is likely twice as high, but poor diagnosis and reporting on the part of various countries have led to an undercount.
The United States currently leads the world in COVID-19 deaths at 740,000. The country with the next most deaths is Brazil, then India, Mexico, and Russia.
Testing
By December, 200 million rapid tests will be available in the U.S. every month.
The hope is that some of these rapid tests will be available for free, as they are in Europe.
On October 25, the federal administration announced more measures to increase availability of rapid at-home COVID-19 tests and reduce their costs with a $70 million NIH investment. Also, the FDA plans to streamline its regulatory pathways for at-home tests approval to make the process faster and easier.
The FDA has issued emergency use approval for a new rapid antigen test developed by Celltrion Diatrust. At this time, there are ten different rapid at-home tests that have been given emergency use authorization.
Treatment
Vaccines:
A new study done by the Center for Disease Control and Prevention indicates that vaccines are better at protecting against the coronavirus compared to prior COVID-19 infection itself: unvaccinated people who had had COVID-19 in the past were five-times more likely to get COVID-19 again compared to people who had received the vaccine.
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 article (European Surveillance) studied 17 prior studies to see how effective our current vaccines were against the delta variant. Although vaccination protected people only 63% against asymptomatic infections, the vaccines were 76% against symptomatic infections, and 91% against hospitalization.
More good news for people who consider themselves at high risk for allergic reactions and may therefore be more hesitant to receive the COVID-19 vaccine: in a study published in Jama Network Open, over 52,000 such high risk people were studied after receiving one of the mRNA vaccines: although such people did have a higher incidence of adverse events, most of them had mild reactions and were able to complete the two-dose vaccine series.
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 and the complication occurred almost exclusively in men around the age of 25 (JAMA Internal Medicine). Also, all cases improved/ resolved on their own. In a study in Israel, 2.6 million people were surveyed after receiving the Pfizer/ BioNTech vaccine: 54 cases of myocarditis were reported. Of these cases, 41 were mild. The medial age of was 27 and 94% were male.
Pfizer/ BioNTech:
Data from the CDC and published in the Morbidity and Mortality Weekly Report showed that the Pfizer/ BioNTech vaccine was 93% effective in preventing hospitalizations in kids aged 12 to 18. Those who were hospitalized tended to have at least one underlying health condition such as diabetes, asthma, or lung diseases. Indeed, of the kids studied who were hospitalized for COVID-19, 97% were unvaccinated. 16% of patients were sick enough to require life support.
A separate -as yet unpublished- study shows that a third booster shot of the Pfizer significantly decreased symptomatic infections: of the 5,000 people who received the 3rd booster shot, only five later developed symptoms of COVID-19. Of those who did not receive the third booster, 109 developed symptoms.
Moderna:
A recent trial done by Moderna show that its vaccine was able to produce a strong immune response in kids aged six to 11.
There does seem to be a link of heart inflammation and the vaccine in younger kids and adolescents - the Pfizer/ BioNTech vaccine seems to be associated with a similar risk. Nonetheless, this risk is extremely low and most kids with heart inflammation have few or no symptoms. At the same time, heart inflammation is more common in kids who actually come down with COVID-19.
The FDA has yet to approve use of the Moderna vaccine for adolescents aged 12 to 17.
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.
A recent study (JAMA Internal Medicine) showed that the incident of "cerebral venous sinus thrombosis" (blood clots in the veins of the brain) occurred at a rate of 13 per 100,000 patients. The incidence was most commonly seen in women between the ages of 30 to 49.
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. Instead, it medication causes errors in the virus's genetic code as it replicates. 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). Merck has announced that the company will share their license for molnupiravir with a nonprofit organization (called Patent Pool) so that it can be manufactured widely globally - and be available in low income countries also.
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%.
A recent article in the journal Lancet Global Health found that the common antidepressant called "fluvoxamine" can decrease the risks of severe disease in high risk patients with COVID-19. Although more studies need to be done to confirm this, this may be a great way for people to be able to be treated as outpatients in the future. Stay tuned!
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.
Due to dropping COVID-19 case rates, San Mateo has now met one of the above three requirements to get rid of the indoor masks.
San Francisco Intl. Airport is partnering with the CDC in a program aimed at identifying new COVID-19 variants: passengers arriving at the airport will be invited to take both a pooled PCR test as well as a test taken at home and mailed in. Similar programs will be launched at JFK and Newark airports. This program is not related to existing programs that involve travel restrictions.
In early October, California started off in the yellow tier. Shortly thereafter, rising COVID-19 rates dropped us down to the orange tier but -good news!- we are back in yellow again now.
There are three Bay Area counties in the yellow tier also: Alameda, Marin, and our own San Mateo!!
Oakland school district has joined three other Bay Area school districts in mandating vaccines for kinds 12 and older by January 1. Most other school districts will mandate this by the summer of 2022.
New York City is requiring its entire municipal workforce (including police officers and firefighters) to be vaccination against COVID-19.
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
Sorry, but I didn't find any other medical news worth sharing this time!
About Dr. Sujansky's Life in These Times
Well, one good sign of the times is that Halloween is back!
We welcomed 285 trick-or-treaters this year - our house is on our town's Halloween loop, as you can likely guess. Nonetheless, this was about half as much as pre-pandemic.
