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:
The big news in recent past is about the new coronavirus variant, called "omicron" (which is a Greek letter - who knew?!) that was initially found in various southern African countries, but now has spread across the world. The reason that this variant has received such publicity and is designated a "variant of concern" has to do with the enormous number of mutations that have been found in its genes that POTENTIALLY make it more resistant to current vaccines, though this has NOT been shown yet. Studies are underway and we should know a lot more in the next few weeks. Here are some of the things we do know:
The Omicron variant was first reported to the WHO on 11/24/21.
Omicron has about 50 mew mutations, 32 of which affect the spike protein. This is concerning, as our current vaccines target the spike protein. Nonetheless, the mutations would have to nullify a whole lot of the spike-protein targets or our current vaccines. In addition, vaccination also produces a response in the T-cells, which are different immune cells of the human body that are less affected by the mutations. Luckily, we now know that booster doses can produce super-high doses of antibodies, which should continue to be effective in combatting the virus, even if mutations exist. It seems that the quantity of antibodies can compensate for the suboptimal quality of the match.
South African doctors are seeing Omicron infections in people who had come down with COVID-19 in the past, indicating that the new variant is able to overcome our body's natural immunity.
Unfortunately, the many new mutations may also make the monoclonal antibody therapies we have less effective in preventing severe disease.
Evidence suggests that Omicron has a higher risk of infecting people who have had COVID-19 previously: South Africa, where omicron has been found, has seen an increase in COVID-19 infections in recent weeks. Of note, only 35% of adults in South Africa are fully vaccinated for COVID-19. In South Africa, Omicron is spreading faster than the Delta variant.
The COVID-19 cases in South Africa are rising faster than any time since the start of the pandemic and Omicron is now the dominant strain in some of the regions.
Omicron has since been found in over two dozen countries since. The first case in the U.S. was identified on December 1 in a man from San Francisco, who had traveled to South Africa. This man, who had been fully vaccinated (but had not received his third booster shot) was only mildly ill with the disease. His family and close contacts have tested negative for the virus so far. Since then, Omicron has been identified in many other U.S. states. However, most of the new infections in the U.S. are from the DELTA variant.
Luckily, the U.S. has much improved its surveillance of new variants since the beginning of the year. Earlier this year, only 1% of viral samples were screened for new mutations. Now 5 to 10% of virus cultures are screened.
Various countries (including the United States) have implemented travel bans from South Africa as well as seven other countries (all in Africa). This travel ban will NOT prevent the new mutation from moving in to the U.S., but will hopefully slow its migration here so that the U.S. can better prepare its testing and treatment facilities.
We do not know if Omicron is more deadly than the delta variant. Preliminary evidence suggests that Omicron is NOT causing more severe illness and, indeed, it seems to cause milder cases than the Delta variant: cases in South African have tended to be mild to moderate in severity. Severe cases were seen largely in unvaccinated populations. Israeli officials have also found that vaccinated people in Israel have not gotten severely ill.
We do not know how well people vaccinated for COVID-19 are protected from the omicron variant. However, it seems that vaccinated people - as well as people show were infected with the COVID-19 virus previously- only develop mild symptoms. Due to the waning immunity with past vaccinations, this new variant is one more reason to get the booster shot!
Vaccine makers are already researching if higher doses of their current vaccines would be effective in combatting the new variant or if they need to re-engineer their current vaccines to reflect the new mutations.
Moderna and Pfizer/ BioNTech are already looking into new booster shots for the Omicron variant.
Some estimates suggest that a new vaccines reflecting the new mutations could be available in as little as 4 months.
The current tests (both the PCR-based tests as well as those available from the drug store) seem to be able to diagnose the Omicron variant
The CDC now recommends COVID-19 booster shots for all adults over the age of 18. The booster shots are recommended to be given six months after the initial vaccination series (of any COVID-19 vaccine) had been completed.
The COVID-19 death rate of vaccinated adults under 50 is pretty much zero. In this age group, the hospitalization rate is similar to that associated with influenza.
According to the CDC, COVID-19 vaccine demand has increased by about 50% sine October.
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.
Symptoms and Risk Factors:
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.
Initial concerns about inflammation of the heart ("myocarditis") in athletes and young adults after COVID-19 infections were recently downgraded: a study showed that the risk of heart injury is extremely low. A study looked at over 3000 college athletes diagnosed with the coronavirus and found that 0.7% had hear injury. During subsequent surveillance, only one athlete had any heart issues, and even this was not thought to be related to COVID-19.
Pregnant women who contract COVID-19 are at increased risks of stillbirths (which are up to 4-times more common) compared to uninfected women.
Incidence/ Prevalence:
A fourth wave of COVID-19 infections has started to grip some European countries, including Germany and the Netherlands. Almost all of the patients hospitalized with the virus had not been vaccinated. As a corollary observation, those countries with low vaccination rates (largely in eastern Europe) are seeing a spike in their death rates from the virus, while western European countries, with higher vaccination rates, are seeing increased rates without increased deaths. Lockdowns have been imposed in Austria and Slovakia, where bars, restaurants, and non-essential stores have closed. Austria has also become the first Western democracy to mandated COVID-19 vaccination for all adults.
The U.S. COVID-19 cases continue to be very high in Minnesota and most cases are caused by the Delta variant.
Testing
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.
Treatment
Vaccines:
An article published in the New England Journal of Medicine in December looked at the how effective the three vaccines are in preventing disease in the U.S.: although the J&J vaccine had a lower effectiveness than Moderna or Pfizer/ BioNTech, the immunity from the J&J vaccine did not wane with time, unlike the other two vaccines. An accompanying editorial also showed that the death rate in people who had received either Pfizer/ BioNTech or Moderna is very very small.
An article in BMJ found that people became more likely to contract the coronavirus three months after receiving the second Pfizer/ BioNTech vaccine. This study raises the question as to whether a third routine vaccination dose for such vaccines would be appropriate. This observation was confirmed in a study out of Israel that showed that people who had received a third booster shot had a likelihood of infection of 14% of those who had only received two shots.
Pfizer/ BioNTech:
A recent study done in Israel (and published in Lancet) looked at the effectiveness of booster shots for the Pfizer/ BioNTech vaccine: after the booster, the vaccines were 93% effective in preventing hospital admissions and 81% in preventing death.
A recent study (JAMA) showed that COVID-19 vaccines were NOT associated with a higher risk of heart attacks or heart failure in adults aged 75 or older.
An article in Circulation showed that most young people who develop heart inflammation after COVID-19 vaccination had mild symptoms that resolved quickly. Symptoms usually occurred within two days of vaccination and included chest pain, fever, and shortness of breath.
Previous studies have suggested that the Pfizer/ BioNTech vaccine looses efficacy over time. A recent study (JAMA Internal Medicine) showed that a third booster shot helped prevent this and reduced the incidence of COVID-19 by 86% compared to those who had received the initial two-dose series by had not received the third booster.
Pfizer announced that its vaccine is 100% effective in adolescents aged 12 to 15.
A recent study published in Lancet suggests that the "mix-and-match" approach in vaccination (when an initial Pfizer/ BioNTech vaccine is followed by a Moderna booster, for instance) may produce a better immune response than two Pfizer shots.
Moderna:
The FDA has yet to approve use of the Moderna vaccine for adolescents aged 12 to 17.
Johnson & Johnson:
A study involving 9,000 real-life people assessed the effectiveness of the J&J vaccine and found it 73.6% effective. (JAMA Network Open)
Covaxin: the COVID-19 vaccine "covaxin" made in India has received emergency use authorization by the WHO. The vaccine is administered in two doses and has an efficacy rate of 78% against the disease
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. Unfortunately, MERCK recently announced that the medication was only 30% effective in preventing hospitalization from COVID-19, not 50% as was initially thought. Nonetheless, the FDA's Advisory committee has recommended to authorize the pill at this time. It could be available within weeks for people who are infected with the coronavirus and are at high risk of becoming severely ill. Merck plans on producing more than 10 million courses of this medication by the end of this year.
Pfizer has announced that their new pill to treat COVID-19 is highly effective in preventing severe disease among high-risk people who started the medication soon after developing symptoms. Indeed, the pill seems to cut the likelihood of hospitalization by 89%. Pfizer is planning to produce enough medication to treat 20 million people in the first six months of 2022. another 60 million people could be treated in the second half of 2022.
It is likely that both the Pfizer and the Merck COVID-19 pills will be available only for people who have tested positive for the virus and receive a doctor's prescription. Also, initially only vulnerable people (older patients or those with severe underlying conditions) would be eligible.
Our Community and Beyond:
16.4% of kids aged 5- to 11 in California have been vaccinated for COVID-19. This number is similar to the national average, but belies the huge discrepancy in vaccination rates among the various California counties: for instance, in Marin county, about 58 of the kids are vaccinated, while in Kings County (San Joaquin Valley) the vaccination rate for that age group is at less than 5%.
New York City will require on-site employees of all private businesses to get vaccinated.
Germany plans on excluding unvaccinated people from going to restaurants, bars, most stores, and other venues.
Non-COVID-19 News
Remember the new Alzheimers medications "aducanumab" (aka Aduhelm) that was recently approved? New safety concerns have now emerged after the death of a 75-year-old woman who experienced brain swelling after receiving the drug. In addition, three other such cases were reported earlier in the summer. Indeed, it seems that 35% of patients who receive the medications have some degree of brain swelling, though most don't have any symptoms or bad outcomes from this (JAMA Neurology).
The pandemic has not been good for blood pressure: blood pressure measurements rose significantly in the last year (Circulation) compared to the previous year. Women seemed to be most vulnerable to blood pressure increases.
