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:
In August, the Biden administration had recommended that everyone get a booster vaccine 8 months after the last COVID-19 vaccine. However, this announcement came with a backlash from many experts and agencies who didn't believe this recommendation was needed or helpful. Then, just yesterday, a key advisory committee to the FDA recommended that booster shots be given only to Pfizer patients aged 65 or older OR people with weakened immune system OR health care professionals six months after their last dose. NO recommendations were made for those who have received Moderna or J&J shots. The CDC will review this recommendation next week and then hopefully an official recommendation will be made soon.
Here is some of the background leading up to the change of course in recommendations:
Top federal officials had told the Biden administration to scale back plans for third booster shots, as they need more time to collect and review necessary data.
Two scientists who led the FDA's vaccine division plan to leave the agency this fall. This decision is due in part to the scientists' discontent over the administration's decision to recommend this third booster shots before federal researchers could adequately review all of the evidence.
A recent review published in the journal Lancet stated that none of the data on coronavirus vaccines so far provides credible evidence in support of booster shots for the general population. This review was written by a group of international scientists, including some FDA and WHO members. This review stated that boosters may be appropriate for people with weakened immune systems or for older patients, but not for the general population.
Many people who have received the J&J vaccine are confused, as no recommendations have been given for them. Here is what we do know:
Federal officials have suggested that a booster for the J&J vaccine may be approved in the coming weeks or months.
Some scientists are recommending that the J&J recipients may get a better immunity if they follow up their vaccine with a booster from Pfizer/ BioNTech or Moderna. That may be in the future also. Stay tuned! There don't seem to be any side effects to such a "mix and match" approach.
Serious breakthrough infections (COVID-19 infections in people who have been fully vaccinated) continue to be rare. A recent study done in England in the first six months of 2021 showed that only 0.5% of fatalities were in vaccinated individuals. Some of these fatalities were in people who had not yet received their second shot.
All of us have heard of the breakthrough infections of COVID-19: the infections that occur in people who have been fully vaccinated - a scary idea, for sure. The good news is that such infections, when they occur, seem to be uncommon. In addition, the amount of time that such an infected individual can spread the virus to others is lower than in unvaccinated individuals. And finally, the duration of symptoms and the severity of disease is significantly better than in unvaccinated individuals.
Vaccination for kids younger than 12 were also delayed until the winter, as scientists and regulators want to better confirm the vaccines'
Hospitalizations of kids with COVID-19 have sky-rocketed since the beginning of the summer, increasing about fivefold from June to mid-August. Vaccinations have helped, however: hospitalization rates in teen who had NOT been vaccinated was about 10-times higher than those who were vaccinated. Similarly, if the community was poorly vaccinated (i.e. the adults surrounding the kids) then kids were four-times more likely to end up in the hospital themselves. So let's get vaccinated for the kids, folks!
New data shows that unvaccinated Americans are 11-times more likely to die of COVID-19 as unvaccinated Americans. The rate of hospitalization in vaccinated Americans is 1:100,000. The rate of hospitalization for unvaccinated Americans is 29.4:100,000.
Those states with the highest vaccination rates have among the lowest number of COVID-19 cases.
On September 9, President Biden mandated that all companies with more than 100 workers need to require their employees to be vaccinated or to undergo COVID-19 testing every week. In addition, all workers, federal contractors, and most federal workers will be required to get vaccinated by November 22. When enacted, these orders will result in two thirds of the American workforce getting vaccinated. Paid time off will be given to workers so that they can get vaccinated. Also, immunization requirements will also apply to workforces in facilities that receive Medicare or Medicaid funding.
Since the Pentagon announced in August that all active duty military would be required to get vaccinated, the vaccination rate in service members has gone up from 76% to 83%. Similarly, at the Department of Veterans Affairs, the vaccination rate has gone up to 82% from 77%
A study (JAMA Network Open) showed that if people checked for COVID-19 infections with rapid tests at home twice a week were very likely to pick up on the infection. Such testing may be a good way to prevent spread of infections in schools or in the work-place.
A senior U.S. health official reported that the United States plans to "invest $3 billion in the vaccine supply chain as it continues to position itself as a leading supplier of vaccines for the world." The money would be used to implement new production lines and facilities.
New COVID-19 variants
SARS-COv-2 variants:
(Alpha Strain)
Scientists estimate that this variant spread about 1.55 times faster than the previous variant.
Beta Strain
This strain is also more contagious than the original virus and it is more resistant to some of the antibody treatments we use on other strains.
Gamma Strain
Epsilon Strain
Delta Strain
This variant is significantly more contagious than prior versions of the virus.
A recent article in the New England Journal of Medicine showed only minor differences of the Moderna or Pfizer/ BioNTech vaccines in combatting the delta variant - as opposed to the alpha variant.
Lambda strain: a new variant has just emerged, originally in Peru. It is spreading in South American countries.
Mu variant:
This variant was first detected in Columbia.
The WHO recently designated this strain as a "variant of interest" due to it possibly being more resistant to the human immune response.
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.
CAL/ OSHA now encourages indoor masking at jobs for all employees, regardless of vaccination status, to help stem transmission of the virus.
I know you have all heard me for years (literally!) now about the importance of masks. But there are still people doubting masks' ability to help stem the transmission of this virus. Well, we finally have some prospective data that should (hopefully) lay the issue to rest: in a recent study done in Bangladesh, some villagers were instructed to wear masks and some were not. Significantly more people in the villages without masks became sick with COVID-19 than in those where mask-wearing was encouraged. This study has not yet been published in a journal, but the data is pretty compelling.
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. Women and obese individuals were more likely to develop long-term COVID-19 symptoms (Clinical Infectious Diseases).
One year after hospital discharge for COVID-19, survivors had significantly more mental and physical impairments compared to uninfected people. A full 12% had not resumed their previous employment.
The above notwithstanding, if you develop COVID-19 even though you were previously vaccinated ("breakthrough infections"), you are 50% less likely to develop long COVID-19 (Lancet Infectious Disease).
The National Institutes of Health have put forth $470 million to investigate the long-term effects of COVID-19.
A study published in the Journal of the American Society of Nephrology found that people who recover from COVID-19 may continue to have kidney damage for months afterwards, and possibly for the rest of their lives. Those patients with more severe COVID-19 were more likely to have significant kidney impairment.
Incidence/ Prevalence:
According to Johns Hopkins University data, as of 9/14/21, one in 500 Americans have died of the coronavirus infection. At this time, the U.S. is seeing more than 152,300 new cases of COVID-19 every day and 1,805 new deaths daily.
A recent study done in Kenya found that antibodies to SARS-Cov-2 increased from 4.3% of the general population to 48.5% of the population over the course of one year. This study indicates how rapidly the disease spread.
An article (JAMA Netw Open) researched how many cases of COVID-19 and deaths of the disease in nursing homes residents occurred before the federal reporting mandate was implemented: about 44% of cases and 40% of deaths were NOT reported prior to May 24, 2020 - these numbers represent 11.6% of the overall nursing home COVID-19 cases for 2020 and 14% of the nursing home deaths.
Currently, in the United States, the COVID-19 incidence and death rates are highly variable. In southern states like Florida and Mississippi, hospitals are filled to capacity and patients are waiting in the emergency department for days waiting for beds. In Alabama, currently all ICU beds are occupied. In Texas, 169 hospitals that ICU that are more than 95% full. At the same time, states like California (with a high vaccination rate!) are doing extremely well. At this time, there are 0.2 deaths of COVID-19 per 100,000 population in California overall. In San Mateo, we are seeing 0.04 deaths per 100,000 population.
California has less COVID-19 transmission than any other state in the country! In California, 82% of people aged 12 and older have received at least one dose of a coronavirus vaccine.
Treatment
A recent article in BMJ looked at the increased risk of blood clots after receiving either the Astra-Zenica, or the Pfizer/ BioNTech vaccines. The study used the 30 million people vaccinated in the U.K. between December, 2020 and April, 2021. Though there was a mildly increased risk of blood clots for a short time after receiving the vaccines, the risk of blood clots associated with falling ill with COVID-19 was significantly higher and of longer duration.
Three studies have come out recently that again show that the COVID-19 vaccines are very effective at preventing infections and hospitalizations, even in the age of the Delta variant. Unfortunately, two of these studies show that the vaccines are slightly less effective in people aged 65 and older, though they are still powerful in preventing hospitalizations.
JAMA: After evaluating more than 11 million doses of the mRNA vaccines given to 6.2 million patients, researchers found no increase in serious adverse effects such as heart attacks, Bell's palsey, cerebral venous sinus thrombosis (blood clots in the brain), Guillan-Barre syndrome, stroke, inflammation of the heart muscle - though heart muscle inflammation was slightly more common when people aged 12 to 39 were vaccinated.
Pfizer/ BioNTech:
Pfizer/ BioNTech seems almost ready to seek approval for their vaccines for kids aged 5 and older. They are looking at producing smaller doses of the vaccines for the younger kids. Once the data is complete and the approval process started, the FDA has stated that it will work around-the-clock in reviewing the information so that younger kids can get vaccinated safely. Even so, it is likely to be some months before this age group receives approval for the vaccine.
Pfizer may have enough data for vaccinating kids aged 6 months to 2 years in just a another one to two months.
Moderna:
An article published in JAMA recently showed that the Moderna vaccine produced twice as many antibodies as the Pfizer/ BioNTech vaccine. This does not necessarily mean that the immune response is better in the Moderna vaccine (as many different types of immune responses are involved in fighting off disease), but it is interesting!
Johnson & Johnson:
The Vaccine is about 85% effective in preventing serious COVID-19 illness and 100% effective in preventing COVID-19 associated death.
The Oxford/ AstraZenica vaccine:
This vaccine has NOT been approved for use in the United States yet.
Novavax:
This vaccine is produced by a company based in Maryland.
This is also a two-shot vaccine series.
The company plans to seek emergency use authorization from the FDA in September.
Novavax has started trials of a new vaccine that combines a flu and COVID-19 vaccine in Australia. Results from the study are expected in the first half of 2022.
Other treatments:
In early August, the FDA expanded an Emergency Use Authorization for an antibody combination (REGEN-COV): this injection medication may now be given to people at high risk for complications due to COVID-19 who were exposed to the virus or are in a setting that puts them at high risk of contracting it (e.g. nursing homes and prisons). High risk factors include age more than 65, obesity, diabetes, heart disease, lung disease, and an immunocompromised state). Non-vaccinated people as well as people with an compromised immune system (e.g. chemotherapy patients, HIV patients, blood cancer patients) are usually considered for this treatment. This EUA was based on a study in the New England Journal of Medicine: 4.8% of the people treated with REGEN-COV developed an infection, while 14.2% of the people not treated with REGEN-COV became infected.
The Biden administration has taken over the distribution of monoclonal antibody treatments, which have proven useful for people seen in the emergency department with COVID-19, but not ill enough to be admitted. The goal of this change of management is to allow a more equitable distribution of the medicines.
You may recall that - early in the pandemic - plasma treatments were "all the rage." Such plasma treatments involved giving sick COVID-19 patients the blood plasma from others who had already recovered from the disease. Recent research suggests now that plasma treatments actually cause more harm than good and should be avoided (Nature Medicine).
Our Community and Beyond:
California is now requiring proof of vaccination or a negative test result in the prior 72 hours for any large indoor event with more than 1,000 people.
California is requiring all public and private teachers and staff to be vaccinated or test weekly for COVID-19.
San Jose will require proof of full vaccination against COVID-19 for all events held at city-owned facilities (e.g. the SAP Center, Convention Center, Center for Performing Arts). Proof of negative COVID-19 testing would not be adequate.
San Francisco is barring unvaccinated people from indoor dining, bars, nightclubs, gyms, large concerts, and theaters. These rules took effect on August 20. A negative COVID-19 test would not be an acceptable substitute.
The Los Angeles Unified School District now requires vaccines for all eligible students, teachers, and school employees. The California Medical Association have been vocal in supporting this decision.
Starting next month, L.A. County will require proof of vaccination for people to enter indoor bars, clubs, and other drinking establishments.
Contra Costa County also now requires vaccination cards to be shown by people wanting to enter bars, restaurants, and gyms.
In the greater Bay Area, vaccination rates are higher than in the rest of California (except for one county)! and about 80% of Californians eligible for the vaccine have received at least one dose, while 65.4% of eligible Californians are fully vaccinated.
Officials in the Sequoia Union High School District are asking the state to require that students be vaccinated against the novel coronavirus in order to attend in-person instruction.
Non-Covid Medical News
If you know me, then you know I am usually on your back to exercise more. A recent study (JAMA Network Open) showed that people who walk more than 7000 steps per day had a 50% to 70% lower mortality of all causes. This applied to Black people as well as White, men as well as women. Maybe we should all wear a pedometer???
It's time again for flu shots! This flu season is supposed to be more severe than usual. Last year, due to the social-distancing measures in place, we had an unprecedented low-flu-year: in a atypical flu season, 75 to 150 children die of influenza in the U.S.; last years, one child died of the flu. In the 2019-2020 flu season, 22,000 people overall died of influenza; last year, the number was closer to 750. Who knows what this season will bring, so we are recommending shots for everyone. We have both the regular flu shots and those for "seniors" in our office. No appointment needed, but please let us know if you will be coming in for one, if you can. BTW, the CDC just recommended that flu shots can be given any time around the COVID-19 vaccinations - no need to wait for 2 weeks between shots!
About Dr. Sujansky's Life in These Times
On a more personal note, my family and I continue to do well.
I now live in a much emptier house, as both kids are off to college. It is much quieter and much cleaner, for sure. And making dinner is also much easier....but all of these things don't necessarily make my life nicer.
This last week, my husband visited his mother (who is ill) in Colorado - so I have been alone for the last 6 days. Now, that is weird! I don't think I have been alone in the house for 6 days for over 20 years! My only companions were the dog and cats. There were perks (eating cereal for dinner!) but I actually do look forward to my husband coming back and making more work and mess for me!
