New Coronavirus News from 10 Dec 2021

Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 [FDA.gov, 10 Dec 2021]

COVID-19. We’ve been living with it for what sometimes seems like forever. Given the number of deaths that have occurred from the disease, it’s perhaps not surprising that some consumers are turning to drugs not approved or authorized by the Food and Drug Administration (FDA).

One of the FDA’s jobs is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use. In some instances, it can be highly dangerous to use a medicine for the prevention or treatment of COVID-19 that has not been approved by or has not received emergency use authorization from the FDA.

There seems to be a growing interest in a drug called ivermectin for the prevention or treatment of COVID-19 in humans. Certain animal formulations of ivermectin such as pour-on, injectable, paste, and "drench," are approved in the U.S. to treat or prevent parasites in animals. For humans, ivermectin tablets are approved at very specific doses to treat some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea.

However, the FDA has received multiple reports of patients who have required medical attention, including hospitalization, after self-medicating with ivermectin intended for livestock.

Here’s What You Need to Know about Ivermectin

• The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea.
• Currently available data do not show ivermectin is effective against COVID-19. Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing.
• Taking large doses of ivermectin is dangerous.
• If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed.
• Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous.

What is Ivermectin and How is it Used?
Ivermectin tablets are approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. In addition, some topical forms of ivermectin are approved to treat external parasites like head lice and for skin conditions such as rosacea.

Some forms of animal ivermectin are approved to prevent heartworm disease and treat certain internal and external parasites. It’s important to note that these products are different from the ones for people, and safe only when used in animals as prescribed.

When Can Taking Ivermectin Be Unsafe?
The FDA has not authorized or approved ivermectin for the treatment or prevention of COVID-19 in people or animals. Ivermectin has not been shown to be safe or effective for these indications.

There’s a lot of misinformation around, and you may have heard that it’s okay to take large doses of ivermectin. It is not okay.

Even the levels of ivermectin for approved human uses can interact with other medications, like blood-thinners. You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.

Ivermectin Products for Animals Are Different from Ivermectin Products for People
For one thing, animal drugs are often highly concentrated because they are used for large animals like horses and cows, which weigh a lot more than we do— up to a ton or more. Such high doses can be highly toxic in humans. Moreover, the FDA reviews drugs not just for safety and effectiveness of the active ingredients, but also for the inactive ingredients. Many inactive ingredients found in products for animals aren’t evaluated for use in people. Or they are included in much greater quantity than those used in people. In some cases, we don’t know how those inactive ingredients will affect how ivermectin is absorbed in the human body.
Options for Preventing and Treating COVID-19

The most effective ways to limit the spread of COVID-19 include getting a COVID-19 vaccine when it is available to you and following current CDC guidance.

Talk to your health care provider about available COVID-19 vaccines and treatment options. Your provider can help determine the best option for you, based on your health history.

Scientists Are Puzzling Over Omicron's Origins [Bloomberg, 10 Dec 2021]

By Janice Kew

Here’s the latest news from the pandemic:
• Covid crisis threatens holiday season as hospitals overflow
• Hong Kong to tighten quarantine for travelers from U.S.
• Omicron may be spreading faster in U.K. than in South Africa

Seeking answers on omicron

Omicron’s sheer number of mutations has raised many questions—including whether the variant will evade vaccines, spread more easily and lead to severe illness. The strain’s changes are also causing scientists to puzzle over its origins.

When the scientist who first detected the new variant in late November took samples from foreign diplomats who had traveled together to Botswana and sequenced them, the international database provided a surprise: The samples most closely resembled a strain first detected in early April 2020 and known as the U.A.E lineage.

After Sikhulile Moyo, director for the Botswana Harvard HIV Reference Laboratory and a research fellow at Harvard T.H. Chan School of Public Health, looked more closely, he saw the earlier variant had fewer mutations and ruled out what he was seeing as being the same.

What it did show was that omicron has an unusually large number of mutations on the gene that helps the coronavirus spread. Since omicron’s discovery, others have checked samples sitting in freezers in their laboratories and found that the lineage was already circulating as early as October.

Viruses don’t accumulate mutations in a single step. So scientists are still trying to understand how so many mutations arose for omicron in an apparently short space of time.

One of the theories is that the strain developed in an immuno-compromised person who harbored the virus for much longer than normal, allowing it to go through many adaptations.
In southern Africa, the high rate of HIV infections means that millions of people have a weakened immune system. While most are on antiretroviral drugs that prevent the HIV virus from multiplying, many aren’t. That means that their ability to fight off and rid the body of pathogens is severely diminished. Advanced cancer sufferers have similar immune system problems.

Another hypothesis being looked into is whether the variant could have been transferred from people into an animal host, where it adapted to that host relatively quickly and then moved back into humans.

It could also be that there simply hasn’t been enough global testing of various Covid samples and that close relatives of omicron had already developed undetected.

Trying to figure out omicron’s origins is important as it gives insight into how it’s behaving and what SARS-CoV-2, the coronavirus that causes Covid-19, might do next.

Still, figuring out the origins of a virus is often tricky, and the contentious issue of how the virus that sparked the pandemic first appeared in people hasn’t yet been answered.—Janice Kew

Track the virus
How Does Omicron Challenge the Treatments for Covid?

A treatment Covid-19 patients could take by pill to avert life-threatening illness has been something of a holy grail for doctors and drugmakers. The earliest therapeutics shown to help have typically been administered to patients via a transfusion or once they have become sick enough to require hospitalization. Two years after the first Covid cases were reported in China, two pill-based treatments have emerged that even skeptical scientists are hailing as potential game-changers.

New CDC data shows first-known omicron Covid patient in U.S. had symptoms starting Nov. 15 [CNBC, 10 Dec 2021]

By Spencer Kimball

The Centers for Disease Control and Prevention on Friday said the first-known case of omicron Covid in the U.S. was found in a person who had traveled internationally and started presenting symptoms on Nov. 15.

The new infection timeline means omicron arrived in the U.S. earlier than first thought.

California had reported what was believed to be the first confirmed case on Dec. 1. An international traveler returned to San Francisco from South Africa on Nov. 22, developed symptoms three days later and tested positive on Nov. 29.

The CDC said 22 states have confirmed at least one omicron case, and some of those cases indicate community spread is underway. Among 43 omicron Covid patients, 33% reported international travel during the 14 days before symptom onset or testing positive, according to the CDC.

Case investigations have identified exposures associated with international and domestic travel, large public events and household transmission.

One vaccinated person was hospitalized for two days, but there haven't been any deaths reported to date among the patients who have been followed by health officials, according to the CDC.

Among the cases, 58% of the patients were between 18 and 39 years of age, and 79% were fully vaccinated at least 14 days before symptom onset or testing positive. Fourteen people had received booster doses and six had recovered from previous Covid infections, according to the CDC. Five received their booster dose less than 14 days before symptom onset.

The most common reported symptoms were cough, fatigue and congestion, or a runny nose.
"Many of the first reported cases of omicron variant infection appear to be mild, although as with all variants, a lag exists between infection and more severe outcomes, and symptoms would be expected to be milder in vaccinated persons and those with previous SARS-CoV-2 infection than in an unvaccinated person," the CDC said in its weekly Morbidity and Mortality report on Friday.

The World Health Organization has said the omicron variant appears to be more contagious than the predominant delta variant, though more data is needed for conclusive answers. White House chief medical advisor Dr. Anthony Fauci has said early reports of mild symptoms are encouraging, though more data is needed to determine the possible severity of health outcomes.

The U.K. Health Security Agency warned on Wednesday that the spread of the omicron variant is widening, eclipsing the previous delta one. Health Secretary Sajid Javid told British lawmakers that omicron infections in the U.K. could top 1 million by year-end.