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FDA Authorizes Two Antiviral Pills to Treat Some COVID-19 Cases
FDA Authorizes Two Antiviral Pills to Treat Some COVID-19 Cases
Earlier this week, the FDA approved two antiviral pills for emergency use to treat mild-to-moderate COVID-19 cases when there is a high risk of severe disease that would lead to hospitalization or death. Pfizer's Paxlovid has been authorized for certain people ages 12 and up, while Merck's molnupiravir has been authorized for adults only. The pills do not prevent COVID-19 and are not a substitute for vaccination. They are an option for people who have gotten sick and are at high risk of hospitalization or death, and are intended to be used within 5 days of symptom onset. While the drugs have the potential to dramatically reduce severe COVID-19 cases and deaths, it will be months before they are widely available, as production and distribution will take time. Even when they are widely available, people should still get vaccinated and get booster shots - preventing the disease is the first and most important step, and the pills are best used as a way to help in breakthrough cases.
In trials, Paxlovid was found to reduce the proportion of people with COVID-19 who were hospitalized or died by 88%, while molnupiravir reduced hospitalizations and deaths by 30%. Combined with vaccination, which dramatically reduces the chances of getting sick in the first place, the chances of getting severely sick or dying of COVID-19 become much lower. The pills are not intended to be used by everyone, being limited to those with risk factors that make progression to severe disease more likely, as well as being limited by age and other factors. Among the restrictions, Molnupiravir is not recommended for pregnant people and Paxlovid cannot be used by people who are taking or have recently taken certain types of medications. Paxlovid's side effects include impaired sense of taste, diarrhea, high blood pressure, and muscle aches, while molnupiravir's side effects include diarrhea, nausea, and dizzines
More information:
"Newly authorized Covid pills won't change course of pandemic right away"
https://www.nbcnews.com/health/health-news/newly-authorized-covid-pills-wont-change-course-pandemic-right-away-rcna9808"FDA authorizes emergency use of two COVID-19 pills to treat mild to moderate COVID-19"
https://www.mlive.com/public-interest/2021/12/fda-authorizes-emergency-use-of-two-covid-19-pills-to-treat-mild-to-moderate-covid-19.html"Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19"
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19"Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults"
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain
Two Monoclonal Antibody Found Not to Help Against Omicron
Two Monoclonal Antibody Found Not to Help Against Omicron
In addition, the United States Department of Health and Human Services issued and public health emergency announcement stating that it would pause the allocation of two monoclonal antibody treatments made by the pharmaceutical companies Eli Lilly and Regeneron, which had been used to treat mild to moderate cases of COVID-19, stating that current evidence suggests these two treatments do not help with COVID-19 cases that are due to the Omicron variant. The only monoclonal antibody treatment that still seems to work for COVID-19 due to the Omicron variant is sotrovimab, made by GlaxoSmithKline and Vir Biotechnology. This has caused a severe shortage of this treatment, meaning that a key component of treating mild to moderate COVID-19 cases is severely lacking.
More information:
Replace Your Cloth Masks with N95, KN95, or KF94 Masks
Replace Your Cloth Masks with N95, KN95, or KF94 Masks
Masks are a critical part of COVID-19 prevention, but not all masks are equally effective. While cloth masks were recommended early in the pandemic, they are not nearly as effective as other types of masks. Cloth masks were a temporary measure while manufacturers increased production of other types of masks (because there weren’t nearly enough - which is why N95 respirators were initially restricted to health care workers), but it's now time to switch to N95, KN95, or KF94 masks. Better masks are more important than ever, as there is evidence that the Omicron variant can cause infections after fewer particles are inhaled. While wearing a cloth mask is better than not wearing a mask at all, it doesn’t provide as much protection as you may think. N95, KN95, and KF94 masks are electrostatically charged, which keeps viral particles from passing through the mask, which cloth masks cannot do. Importantly, while these types of masks provide greater protection than cloth masks, they aren't harder to breathe through. Don’t just search on Google and buy the first N95, KN95, or KF94 mask you see - the prevalence of counterfeit masks means that it's necessary to find a trustworthy seller. Amazon, for example, is full of fake masks. Unfortunately, counterfeit masks aren’t just a matter of having a fake brand name on a mask - the fake masks don’t actually provide real protection (for example, they usually lack the electrostatic charge that makes real masks effective).
The three standards:
N95 respirators are approved by the United States National Institute for Occupational Safety and Health (NIOSH) to filter at least 95% of airborne particles.
KN95 is a standard from China. KN95 masks have been approved by regulators in China, but not the US, to filter at least 95% of airborne particles. KN95 masks are widely counterfeited, and the majority being sold in the U.S. have been found to be fakes that do not meet the filtering requirements.
KF94 is a standard from South Korea. KF94 masks have been approved by regulators in South Korea, but not the US, to filter at least 94% of airborne particles. Many KF94 masks for sale are also fake/counterfeit.
In all three cases, there are no higher standards to meet. For example, a mask that is consistently found to filter 99.9% of airborne particles would be classified as a KF94 in Korea, because their highest standard is for masks that filter at least 94% of particles, regardless of how much more they filter. That means that a KN95 mask isn’t necessarily any more effective than a KF94 mask.
No matter how effective a mask is supposed to be, the fit of the mask is absolutely critical - they must create a seal on your face and not let any air in around the edges of the mask to be effective. The CDC provides guidance on N95 fit and use and there are lots of articles and videos about making sure your N95, KN95, or KF94 mask fits properly. If you can afford it, buy a few different types of masks and try them out to determine which fit you best and are most comfortable. Some have loops that go around the ears, while others have bands that go around the entire head. Some have a very stiff metal piece for the nose that you can mold into shape, while others have a more flexible piece of metal. Some masks are larger and some are smaller (there are kid-sized masks, too!). Beards significantly reduce the effectiveness of all of these types of masks (because beards prevent the mask from getting a good seal on the face) - if you have a beard and cannot or will not shave your face, consider an under-mask beard cover.
Some experts have found that KN95 and KF94 masks can be reused multiple times before being replaced if they are properly stored, but unlike cloth masks, you should not attempt to clean them. Do not get them wet, do not leave them in direct sunlight, and do not leave them in excessive heat. After a few days of use, they should be thrown in the trash and replaced with a new one. People working in high-risk settings, including those in health care, should follow the guidelines from their employer or their profession, and may want to stick with N95s (rather than KN95s or KF94s) and may want to wear a new mask every day.
To find real (not counterfeit) N95 masks, try checking the CDC list of trusted N95 sellers or Project N95's N95 listings. Project N95 also has KN95 listings, if you’re looking for those types of masks. To find reviews of KN95 and KF94 masks, check Aaron Collins' YouTube channel (this video is a great place to start for reviews of many types of KN95 and KF94 masks and this one provides an overview of kids’ masks). Aaron's Mask Testing spreadsheet includes where he purchased each mask, and may be a helpful resource for finding reputable KF94, KN95, and N95 mask sellers. There are a variety of videos and articles online that will help you determine whether a mask you purchased is counterfeit. If you're having trouble figuring things out, please send us an email and we'll do our best to point you in the right direction!
More information:
"With omicron, you need a mask that means business"
https://www.npr.org/sections/health-shots/2021/12/23/1066871176/mask-n95-omicron-contagiousProject N95:
https://www.projectn95.org/"Proper N95 Respirator Use for Respiratory Protection Preparedness"
https://blogs.cdc.gov/niosh-science-blog/2020/03/16/n95-preparedness/"Respirator Trusted-Source Information"
https://www.cdc.gov/niosh/npptl/topics/respirators/disp_part/respsource3surgicaln95.html"Assessing the effect of beard hair lengths on face masks used as personal protective equipment during the COVID-19 pandemic"
https://www.nature.com/articles/s41370-021-00337-1"Under-mask beard cover (Singh Thattha technique) for donning respirator masks in COVID-19 patient care"
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7532752/Aaron Collins' YouTube Channel:
https://www.youtube.com/channel/UC3fF_rzkmZD0ufN685YE7lgAaron Collins' Master Mask Testing Data Set:
https://docs.google.com/spreadsheets/d/1M0mdNLpTWEGcluK6hh5LjjcFixwmOG853Ff45d3O-L0/
Omicron Update
Omicron Update
Per the most recent CDC data, cases of COVID-19 due to the Omicron variant now account for 73.2% of all COVID-19 cases in the US. The Omicron variant is now the dominant variant, having overtaken the Delta variant, and this trend is expected to continue.
COVID-19 cases continue to surge and break records for the most number of daily cases, and most data thus far confirms that the Omicron variant is more transmissible. Early data from other countries, however, continues to show that COVID-19 due to the Omicron variant seems to be less likely to cause severe disease. Early data has also shown that those who have received their booster shot have significant increases in antibody levels, however this does not necessarily correlate to effectiveness of the vaccine. Currently, it looks like while vaccinations might not be very effective in preventing initial infection of COVID-19 from the Omicron variant, it does seem to provide protection against severe disease, hospitalization, and death, which is the primary goal of vaccines.
Unfortunately, hospitalizations were expected to increase due to the dramatic increase in the number of positive cases, and the data shows that hospitalizations have indeed been increasing. Of great concern has been the dramatic increase in the number of children that have been hospitalized in several states across the US, including New York, Pennsylvania, and Texas. The number of children who have been hospitalized since the beginning of December has dramatically increased, especially in younger children who have not yet been vaccinated. A large majority of hospitalized children so far have reportedly not been vaccinated. This trend is especially concerning for those with children under the age of 5, for which there is no approved COVID-19 vaccine yet.
Current available data is concerning, however we must do our best to protect ourselves and those around us, especially the most vulnerable in our communities. If you are eligible to get vaccinated or eligible for your booster, you should do so as soon as you can. In addition, continue to wear appropriate masks, socially distance, practice proper hand hygiene, and follow other public health guidelines, and as always, reach out with any questions if you have any!
More information:
https://covid.cdc.gov/covid-data-tracker/#variant-proportions
https://www.washingtonpost.com/health/2021/12/24/omicron-children-hospitalizations-us/
https://www.nytimes.com/2021/12/22/health/covid-omicron-delta-hospitalizations.html
https://www.sciencealert.com/moderna-confident-that-booster-works-against-omicron
https://www.nytimes.com/2021/12/19/health/omicron-vaccines-efficacy.html
https://www.washingtonpost.com/health/2021/12/24/omicron-children-hospitalizations-us/
Study Suggests Breakthrough Infections Improve Protection from Variants in Some Fully Vaccinated People
Study Suggests Breakthrough Infections Improve Protection from Variants in Some Fully Vaccinated People
A recent study from Oregon Health and Science University suggests that fully vaccinated individuals who experience a breakthrough infection of COVID-19 develop significantly more and different antibodies against the virus compared to the vaccination alone. The COVID-19 vaccine offers protection from severe symptoms and this higher level of more diverse antibodies may provide even broader protection from multiple virus variants. This is in stark contrast to unvaccinated individuals whose antibody levels do not increase after infection to the level required to provide such strong protection. However, understanding how infection can lead to these unique antibodies may help scientists develop ways to do so safely, without the risks an actual infection entails, which can include hospitalization and death. The evidence is still clear that being fully vaccinated provides much stronger protection than having recovered from being sick with COVID-19, so-called “natural immunity”. People should also not attempt to get sick in order to get stronger immunity - the goal of immunity is to reduce the chances of getting sick and potentially dying, and intentionally getting sick would totally undermine that. The vaccine is still the only known way to safely increase antibodies enough to provide protection from serious illness.
Importantly, several limitations to the study mean more data is necessary before using these results for further investigation. The study had a low sample size and all participants were healthcare workers who had received the Pfizer vaccine. Also, the limitations of the study meant control participants had not been vaccinated for as long as those with breakthrough infections, and the length of time a person is fully vaccinated may influence protection from multiple variants.
More information:
“If you're vaccinated and get COVID-19, you could have 'super immunity'” | TheHill
https://thehill.com/changing-america/well-being/prevention-cures/586294-if-youre-vaccinated-and-get-covid-19-you-couldArticle from the Journal of the American Medical Association
http://jamanetwork.com/article.aspx?doi=10.1001/jama.2021.22898
Kim Potter Found Guilty of Manslaughter in Death of Daunte Wright
Kim Potter Found Guilty of Manslaughter in Death of Daunte Wright
Kim Potter, the Minneapolis police officer who killed Daunte Wright, was convicted of manslaughter on Thursday. Potter, who is White, pulled over Wright, a 20-year-old Black man on April 11, 2021, while she was training a new officer. She pulled over Wright for having an expired license tab and for having an air freshener hanging from his rearview mirror. After determining that Wright was wanted for failure to appear in court on a weapons charge, the trainee, Anthony Luckey, tried to handcuff and arrest Wright, who got away and returned to his car. Potter then said she was going to use her Taser on him, but instead pulled her gun and shot him, resulting in his death. Her attorneys argued that she made a mistake and had not intended to use her firearm, and also that the use of a firearm would have been appropriate in the situation. The jury found her guilty of first-degree manslaughter (by causing Wright's death while committing a misdemeanor - recklessly handling her firearm) and second-degree manslaughter (by causing his death through "culpable negligence").
More information:
"Kim Potter is found guilty of manslaughter in the death of Daunte Wright"
https://www.npr.org/2021/12/23/1066012247/kim-potter-trial-daunte-wright"Kim Potter guilty of manslaughter in Daunte Wright’s death"
https://apnews.com/article/kim-potter-guilty-manslaughter-death-of-daunte-wright-43e70645189bf61be64fc00534adf388
State of Michigan Sets New COVID-19 Booster Goal and Asks People to Take Precautions
State of Michigan Sets New COVID-19 Booster Goal and Asks People to Take Precautions
The State of Michigan announced a new goal for COVID-19 boosters: 1 million more Michigan residents and 95% of eligible nursing home residents in the state receiving a COVID-19 booster by the end of January. The announcement also included 3 "Actions for Michiganders to Take":
"Get your vaccine. Get your booster. Find an appointment at vaccines.gov"
"Mask up in public indoor settings and crowded outdoor settings. Upgrade your mask to something with additional layers such as a KN95 mask or wear two well-fitting face coverings."
"For holiday gatherings with friends or family, immunocompromised people should take all precautions of unvaccinated people, including wearing a well-fitted mask. If a member of your household has a weakened immune system, wear a mask. If you have symptoms consistent with for COVID-19 or if you may have been exposed to COVID-19, and before any unmasked gatherings, get tested."
More information:
"State of Michigan sets COVID-19 booster goal, outlines actions to protect yourself and family from Omicron variant"
https://www.michigan.gov/coronavirus/0,9753,7-406-98158-574364--,00.html
This Week's QM Round-Up Contributors (in alphabetical order):
This Week's QM Round-Up Contributors (in alphabetical order):
Wilfredo Flores (he/him/his), fifth-year PhD candidate in Writing and Rhetoric, M.A. Technical Communication
Daniel Pfau (they/them/theirs), Neuroscience PhD, Postdoctoral Researcher, Obstetrics & Gynecology/Biomedical Engineering, University of Michigan
Grey L. Pierce (they/them); M.A., Cognitive Psychology; Chair, Power of We Consortium
Francis Yang (he/him/his), M.S.-Global Medicine, Third-year medical student
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