Posted on

Natural Immunity for the Win! At-Home COVID Antibody Test Gets FDA EUA

COVID-19 Virus
Update on COVID Antibodies Testing

March 5, 2022 — Symbiotica, Inc. received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for its Self-Collected COVID-19 Antibody Test Kit System, the first antibody test authorized for use with a simple home collected dried blood spot sample.

The COVID-19 Self-Collection Antibody Test System is intended for use as an aid to inform individuals over 5-years-old whether their body has made an adaptive immune response to SARS-CoV-2, the virus that causes COVID-19 disease. When someone is exposed to COVID-19 or vaccinated, their body usually produces antibodies as part of its immune reaction. This self-collect serology (antibody) test accurately tells the test taker whether they have antibodies to COVID-19. The test has a documented clinical sensitivity of 100% and a specificity of 98.04%.

The collection kit is not only accurate, but easy to use. The EUA allows for fingerstick dried blood samples to be self-collected at home by an individual over 18-years-old or collected by an adult from an individual over 5-years-old. The collected samples are then sent to California where a Symbiotica CLIA certified laboratory performs the analysis.

The test is available by prescription and offered online by 4UHealth.com. 4U Health is a wellness company that provides at-home lab testing kits and digital results for consumers. Instead of going to the doctor or health care provider to administer a test, individuals can now order a Covid Antibody Test kit online, perform the test collection in-home and send it to the lab for results.

“The authorization of the first prescription use, home collection antibody test will play an important role in helping health care professionals identify individuals who have developed an adaptive immune response from a recent or prior COVID-19 infection,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. 

Some antibodies made for the virus that causes COVID-19 provide protection from getting infected. CDC is evaluating what degree of safety COVID antibodies provide and how long protection from antibodies might last. Although infection is possible after having produced antibodies from vaccination or prior infection, having antibodies plays an important role in helping prevent severe COVID-19 disease.

The COVID-19 antibody test is authorized for at-home collection in all states, except for MD, NY and PA.

About FDA Emergency Use Authorization

The emergency use of this at home self-collection serology test system is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

Younger Males Should Wait Longer Between COVID-19 Vaccines Over Myocarditis Risk, CDC Advises. 4U Health. Updated February 28, 2022.

Omicron Name Used for Several Lineages of Coronavirus. 4U Health. Updated February 25, 2022.

N95 Masks Offer Better Protection Against COVID Omicron Variant Than Cloth Face Coverings, CDC Says. 4U Health. Updated February 24, 2022.

Saliva COVID Test Better Than Nasal Swabs To Detect Omicron, Study Says. 4U Health. Updated February 24, 2022.

About 4U Health

4U Health offers at-home lab testing to help you feel like your best self. Visit us at 4uHealth.com to learn about our COVID-19 Antibody Self-Collection At Home Test Kit, explore healthy living and wellness topics, and view our full at-home lab testing menu.

Updated: March 5, 2022

Posted on

Free Antiviral Pills for COVID-19 Positive People, President Biden Says

COVID-19 Virus
Update on COVID-19 Antiviral Treatments

March 2, 2022 — The United States government is apparently launching a program dubbed ‘test to treat’, a plan aiming to provide free antiviral pills at pharmacies for people who test positive for COVID-19, according to President Biden’s remarks during his State of the Union Address.

Gilead Science’s Remdesivir is the only antiviral drug approved by the Food and Drug Administration (FDA) for the treatment of COVID-19. Known commercially as Veklury, as of Jan. 21 the FDA has expanded its emergency use authorization (EUA) to include treatment in non-hospitalized patients with mild to moderate COVID-19 who have a high risk of their case becoming severe. Prior to the agency’s announcement via news release, the drug had been limited exclusively to hospitalized COVID-19 patients. Remdesivir is administered via an intravenous (IV) treatment. So it, along with another IV administered drug, Sotrovimab, may likely be excluded from the new pharmacy based program.

Ritonavir-boosted nirmatrelvir (Paxlovid) and molnupiravir have recently received emergency use authorizations from the FDA for the treatment of COVID-19. Both are orally administered drugs and may likely play a part in the president’s ‘test to treat’ initiative.

Paxlovid — a five-day oral Covid treatment that can reduce the risk of hospitalizations by nearly 90 percent — has remained in critically short supply since its Dec. 22 emergency authorization. The Biden administration has purchased 20 million Paxlovid courses, half of which Pfizer said it expects to deliver by the end of June and the remainder by Sept. 30. A robust supply of the treatment is not expected until April of this year.

While the emergency use authorized antiviral, molnupiravir — co-developed by Merck and Ridgeback Biotherapeutics — is not the recommended treatment for Covid-19 infected people except when a patient has a contraindication to other therapeutics. A lower efficacy, inherent safety concerns, and a divided FDA Advisory Committee meeting meant that molnupiravir moved down the treatment schematic for Covid-19. However, in times of shortage, it remains the least supply constrained therapeutic treatment option for several states. The federal government has purchased more than 3 million treatment courses of molnupiravir.

And like most medications, Paxlovid and molnupiravir aren’t for everyone. Paxlovid isn’t recommended for people with severe kidney problems, for example, and molnupiravir should not be taken during pregnancy.

The National Institutes of Health (NIH) has its COVID-19 Treatment Guidelines that includes recommendations for caring for non-hospitalized COVID-19 patients who are at high-risk for progressing to severe COVID-19 disease. The Panel recommends the use of the following anti-SARS-CoV-2 therapies for the treatment of COVID-19 listed in order of preference based on efficacy and convenience of use:

  • Ritonavir-boosted nirmatrelvir (Paxlovid) (Oral)
  • Sotrovimab (IV Therapy)
  • Remdesivir (IV Therapy)
  • Molnupiravir (Oral)

Regardless of which oral therapeutic drugs may ultimately be included in project ‘test to treat’, only individuals at high risk for COVID-19 complications due to older age, obesity, or ongoing medical conditions such as lung, kidney, heart disease, or diabetes will most likely be eligible to participate in the program.

Younger Males Should Wait Longer Between COVID-19 Vaccines Over Myocarditis Risk, CDC Advises. 4U Health. Updated February 28, 2022.

Omicron Name Used for Several Lineages of Coronavirus. 4U Health. Updated February 25, 2022.

N95 Masks Offer Better Protection Against COVID Omicron Variant Than Cloth Face Coverings, CDC Says. 4U Health. Updated February 24, 2022.

Saliva COVID Test Better Than Nasal Swabs To Detect Omicron, Study Says. 4U Health. Updated February 24, 2022.

About 4U Health

4U Health offers at-home lab testing to help you feel like your best self. Visit us at 4uHealth.com to learn about our COVID-19 Antibody Self-Collection At Home Test Kit, explore healthy living and wellness topics, and view our full at-home lab testing menu.

If you’re interested in hospital grade home PCR COVID test kits to detect COVID-19 (including Omicron and its other variants), check out 4U Health’s COVID-19 Active Infection Self-Collection Test. It’s approved for children 5+ and adults alike. For the timeliest results, we recommend having our “just-in-case” saliva kit stocked in your medicine cabinet so you can test on your terms. Overnight shipping is included and official digital results are typically within 24 hours of receipt by the lab.

Updated: March 2, 2022

Posted on

Younger Males Should Wait Longer Between COVID-19 Vaccines Over Myocarditis Risk, CDC Advises

COVID-19 Virus
Update on COVID-19 Vaccines

February 28, 2022 — The Centers for Disease Control and Prevention (CDC) updated its vaccine recommendations on February 22 to say younger males age 12 to 39 should consider waiting longer between doses of the Pfizer-BioNTech and Moderna COVID-19 mRNA vaccines to reduce the risk of myocarditis — an inflammation of the heart muscle.

“While absolute risk remains small”, some studies show “the relative risk for myocarditis is higher for males ages 12-39 years, and this risk might be reduced by extending the interval between the first and second dose,” the agency said. The CDC cited studies further showed in adolescents and adults alike, peak antibody responses and mRNA vaccine effectiveness may be increased with an interval longer than four weeks between the first and second doses. 

Howbeit, the shorter interval (three weeks for Pfizer-BioNTech and four weeks for Moderna) between the first and second doses of the mRNA vaccines remains the recommended interval for adults 65 years and older, people who are immunocompromised, and others at high risk for severe COVID-19 disease.

The updated guidance most notably affects younger not fully vaccinated males, those who have received one or fewer jabs. The CDC estimates by age group the following percentages of American males not fully vaccinated: 12 to 17yrs (45%), 18-24yrs (42%), 25-39yrs (37.6%).

Omicron Name Used for Several Lineages of Coronavirus. 4U Health. Updated February 25, 2022.

N95 Masks Offer Better Protection Against COVID Omicron Variant Than Cloth Face Coverings, CDC Says. 4U Health. Updated February 24, 2022.

Saliva COVID Test Better Than Nasal Swabs To Detect Omicron, Study Says. 4U Health. Updated February 24, 2022.

About 4U Health

4U Health offers at-home lab testing to help you feel like your best self. Visit us at 4uHealth.com to learn about our COVID-19 Antibody Self-Collection At Home Test Kit, explore healthy living and wellness topics, and view our full at-home lab testing menu.

If you’re interested in hospital grade home PCR COVID test kits to detect COVID-19 (including Omicron and its other variants), check out 4U Health’s COVID-19 Active Infection Self-Collection Test. It’s approved for children 5+ and adults alike. For the timeliest results, we recommend having our “just-in-case” saliva kit stocked in your medicine cabinet so you can test on your terms. Overnight shipping is included and official digital results are typically within 24 hours of receipt by the lab.

Updated: February 28, 2022

Posted on

Majority of Healthy Americans Can Ditch Masks, per New CDC Guidelines

COVID-19 Virus
Update on Coronavirus

February 27, 2022 — In response to the growing consensus that the Omicron coronavirus variant is more transmissible but causes less severe disease, the Centers for Disease Control and Prevention (CDC) released on Friday a new framework for measuring community Covid-19 levels that focuses less on positive test results and more on hospital utilization rates.

The CDC will now report the amount of COVID-19 in a community at the county level as Low, Medium or High. The degree is determined on new COVID-19 hospital admissions per 100,000 population during the past 7 days, the percent of utilized inpatient beds occupied by COVID-19 patients along with total new COVID-19 infections per 100,000 people in the last 7 days.

The new framework significantly shifts the makeup of the CDC’s risk map. Now, according to the agency, more than 70 percent of Americans live in counties where SARS-CoV-2 poses a low or medium risk. Per the guidance, healthy individuals in low to medium risk counties do not need to wear a mask at indoor public settings.

People, including schoolchildren, are advised to wear masks where the risk level of COVID-19 is high. You can check out your local community COVID-19 Risk level here.

The updated CDC guidance does not change the rules requiring travelers to wear masks on public transportation and indoors at airports, bus stations and train stations.

Omicron Name Used for Several Lineages of Coronavirus. 4U Health. Updated February 25, 2022.

N95 Masks Offer Better Protection Against COVID Omicron Variant Than Cloth Face Coverings, CDC Says. 4U Health. Updated February 24, 2022.

Saliva COVID Test Better Than Nasal Swabs To Detect Omicron, Study Says. 4U Health. Updated February 24, 2022.

About 4U Health

4U Health offers at-home lab testing to help you feel like your best self. Visit us at 4uHealth.com to learn about our COVID-19 Antibody Self-Collection At Home Test Kit, explore healthy living and wellness topics, and view our full at-home lab testing menu.

If you’re interested in hospital grade home PCR COVID test kits to detect COVID-19 (including Omicron and its other variants), check out 4U Health’s COVID-19 Active Infection Self-Collection Test. It’s approved for children 5+ and adults alike. For the timeliest results, we recommend having our “just-in-case” saliva kit stocked in your medicine cabinet so you can test on your terms. Overnight shipping is included and official digital results are typically within 24 hours of receipt by the lab.

Updated: February 27, 2022

Posted on

BA.2 Omicron Subvariant Apparently Does Not Make People More Sick, South African Researchers Say

COVID-19 Virus
Update on BA.2 Lineage of Omicron Variant

February 25, 2022 —  Worries that the BA.2 Omicron subvariant may cause more severe COVID-19 disease than the original BA.1 Omicron variant have been promulgated by a recent laboratory hamster study, but real-world data suggest that BA.2 isn’t more dangerous.

Among 3,058 patients who required hospitalization in South Africa for COVID-19 from December 1, 2021 thru January 20, 2022, a recently posted study found the hospitalization rates were 3.4% for those infected with original-Omicron BA.1 lineage and 3.6% for individuals with BA.2 infections. Moreover, severe COVID-19 disease was diagnosed in 33.5% of original-Omicron BA.1 patients and 30.5% of BA.2 patients. After reviewing the data, the South African researchers found that while BA.2 may have a competitive transmission advantage over BA.1 in some settings, the clinical profile of illness between the two lineages remains similar.

“By the end of January 2022, most COVID-19 infections were due to BA.2,” said Dr. Nicole Wolter of South Africa’s National Institute for Communicable Diseases. “We found that individuals that were infected with BA.2 did not have a higher risk of being admitted to hospital,” she said.

It should be noted however that because many people in South Africa had been formerly sick with earlier variants of SARS-CoV-2, the virus that causes COVID-19 disease, these South African findings may not be standard or reproducible in other countries with less background natural infection.

Equally important, in the four weeks after the collection period of the study (Dec. 2021 thru Jan. 20, 2022), data on worldometer for South Africa reports cases have apparently reached a relatively low plateau over the past month, but daily death counts are seemingly continuing to rise. Although deaths are a lagging indicator, if BA.2 is not more severe than Original BA.1 lineage, daily deaths should also soon begin to fall. For now, we will just have to wait and see.

BA.2 Omicron Appears More Dangerous, Researchers Say. 4U Health. Updated February 19, 2022.

5 Reasons To Keep PCR Home COVID Test Kits on Hand. 4U Health. Updated December 6, 2021.

Ditch Nose Swabs for a Home Saliva PCR Covid Test Kit. 4U Health. Updated December 6, 2021.

About 4U Health

4U Health offers at-home lab testing to help you feel like your best self. Visit us at 4uHealth.com to learn about our COVID-19 Antibody Self-Collection At Home Test Kit, explore healthy living and wellness topics, and view our full at-home lab testing menu.

If you’re interested in hospital grade home PCR COVID test kits to detect COVID-19 (including Omicron and its other variants), check out 4U Health’s COVID-19 Active Infection Self-Collection Test. It’s approved for children 5+ and adults alike. For the timeliest results, we recommend having our “just-in-case” saliva kit stocked in your medicine cabinet so you can test on your terms. Overnight shipping is included and official digital results are typically within 24 hours of receipt by the lab.

Updated: February 25, 2022

Posted on

Omicron Name Used for Several Lineages of Coronavirus

COVID-19 Virus
Update on Omicron Variant

February 23, 2022 — Pittsburgh, PA

Meet the Omicron Family

Omicron, originally referred to as B.1.1.529, has four other main lineages, BA.1, BA.1.1, BA.2, and BA.3, according to the Centers for Disease Control and Prevention (CDC). As viruses replicate, they often experience mutations. Successful mutations lead to new variants. Sometimes these genetic variations cause the virus to split or branch off into sub-lineages. The Delta variant, for instance, consists of more than 200 different subvariants. Similarly, to date, the Omicron variant consists of B.1.1.529 – the first lineage discovered – along with four other lineages — BA.1, BA1.1, BA.2 and BA.3.

Omicron Variants Now Account for Virtually All Cases in the US

As of mid-February 2022, the predominant Omicron lineage in the United States is BA.1.1, which is descendent of the BA.1 lineage and characterized by an additional substitution (R346K) in the spike protein. In the United States, BA.1.1 has gained its prominence by outcompeting the B.1.1.529 and Delta variants. For the week ending February 19, 2022, CDC data shows BA1.1 accounted for approximately 76 percent of total reported COVID-19 infections in the United States, with B.1.1.529 accounting for about 21 percent of cases and BA.2 just under 4 percent. Delta accounted for approximately 0 percent of the total COVID-19 infections reported within the US for the week ending February 19, 2022.

BA.2 Omicron Subvariant Gaining Ground

BA.2 is less abundant globally than BA.1 lineages but gaining ground. “BA.2 now accounts for at least 21 percent of all sequenced omicron cases worldwide. It has overtaken BA.1 as the dominant virus in at least 10 countries, including Bangladesh, China, Denmark, India, Nepal, Pakistan, and the Philippines. Where it rises, it rises quickly. In South Africa, for instance, BA.2 jumped from 27 percent on February 4 to 86 percent by February 11. In the United Kingdom, BA.2 prevalence jumped sixfold from January 17 to January 31. And in the US, it has more than tripled from 1.2 percent in the week ending on January 29 to its most recent prevalence estimate of 3.9 percent as of February 12”, according to Ars Technica.

As for BA.3, it has not spread in any significant way to date. Thru the end of January 2022, Forbes reports only several hundred have been documented globally.

BA.2 Omicron Subvariant Likely More Transmissible and Pathogenic Than Omicron BA.1 Lineage

The Omicron subvariants BA.1.1, BA.1 and BA.1.1.529, are thought to be several times more transmissible but cause less severe COVID-19 disease than other prior coronavirus variants, including Delta.

BA.1.1 and BA.2 are some 20 mutations apart.  It is not clear where BA.2 originated, but it was first detected in the Philippines in November 2021. The “S gene target failure” in routine PCR COVID-19 tests made the BA.1.1.529 Omicron variant easy to detect. But this is not the case for BA.2. The inability to detect the BA.2 Omicron subvariant in regular PCR tests caused some to label it by the nickname “Stealth Omicron” or “Silent” subvariant. Although we are just learning about BA.2, lab studies show it may not only be more transmissible than Omicron BA.1.1, but cause more severe COVID-19 disease. The BA.2 “stealthy” lineage is genetically distinct, and so has the potential to behave differently from other Omicron lineages.

And now you know, Omicron is an umbrella term used by the CDC and WHO for several mutation lineages of the SARS-CoV-2 coronavirus: B.1.1.529, the first discovered lineage, along with four other lineages: BA.1, BA1.1, BA.2 and BA.3.

BA.2 Omicron Appears More Dangerous, Researchers Say. 4U Health. Updated February 19, 2022.

5 Reasons To Keep PCR Home COVID Test Kits on Hand. 4U Health. Updated December 6, 2021.

Ditch Nose Swabs for a Home Saliva PCR Covid Test Kit. 4U Health. Updated December 6, 2021.

About 4U Health

4U Health offers at-home lab testing to help you feel like your best self. Visit us at 4uHealth.com to learn about our COVID-19 Antibody Self-Collection At Home Test Kit, explore healthy living and wellness topics, and view our full at-home lab testing menu.

If you’re interested in hospital grade home PCR COVID test kits to detect COVID-19 (including Omicron and its other variants), check out 4U Health’s COVID-19 Active Infection Self-Collection Test. It’s approved for children 5+ and adults alike. For the timeliest results, we recommend having our “just-in-case” saliva kit stocked in your medicine cabinet so you can test on your terms. Overnight shipping is included and official digital results are typically within 24 hours of receipt by the lab.

Updated: February 25, 2022

Posted on

BA.2 Omicron Appears More Dangerous, Researchers Say

COVID-19 Virus
Update on BA.2 Omicron Subvariant

February 19, 2022 — According to a pre-print Japanese lab study posted this week on bioRxiv, the BA.2 Omicron subvariant is not only faster at spreading than the BA.1 Omicron variant, but may also cause more severe COVID-19 disease.

To place the study in context, during the two-week period from January 30, 2022 thru February 12, 2022, the incidence of BA.2 subvariant infections in the United States rose from less than 1% of all coronavirus cases to an estimated 4%.  

BA.2 Omicron Subvariant Shows Increased Spread

The study findings suggest BA.2 subvariant has considerable transmission improvement over the BA.1 Omicron Variant. A statistical analysis performed by The University of Tokyo researchers reveals the effective reproduction number of the BA.2 Omicron subvariant as 1.4-times higher on average than the BA.1 Omicron variant. In the rear world, the BA.2 subvariant follows the initial spread of BA.1 Omicron variant. Even so, the subvariant has been observed to start outcompeting BA.1 Omicron. The Japanese study authors note “the lineage frequency of BA.2 increased and exceeded that of BA.1 since January 2022 in multiple countries, such as Philippines, India, Denmark, Singapore, Austria, and South Africa.”

In the lab, researchers found the BA.2 subvariant could replicate itself in cells more rapidly than the BA.1 Omicron variant. BA.2 was also more proficient at making cells cling together. This characteristic enabled the virus to produce larger clusters of cells, called syncytia, than the BA.1 Omicron variant. That’s concerning not only as these bunches then become more proficient at producing additional copies of the virus (higher load levels), but because the creation of syncytia is also thought to be a reason why other strains of SARS-CoV-2, like Delta, were so destructive to the lungs.

BA.2 Omicron Subvariant May Cause More Severe Illness

Further infection experiments using hamsters showed the BA.2 subvariant was more pathogenic – capable of causing disease – than the BA.1 Omicron variant. When researchers infected hamsters with BA.2 subvariant and BA.1 Omicron variant, the animals with administered BA.2 virus exhibited more health disorders such as body weight loss than those infected with BA.1 virus. In tissues samples, the lungs of BA.2-infected hamsters had more damage than those infected by BA.1. The study also found that the amount of BA.2 virus was higher in the hamsters’ lungs than that of BA.1 virus.

BA.2 Omicron Subvariant Shows Significant Vaccine Escape

Like the BA.1 Omicron variant, researchers found the BA.2 subvariant of Omicron to largely escape the immunity induced by COVID-19 vaccines. BA.2 was also nearly entirely resistant to some monoclonal antibody treatments, study authors say, including sotrovimab ­ — a monoclonal antibody used against the BA.1 Omicron variant.

BA.2 More Resistant to Previous Omicron BA.1 Variant Infection

Researchers also observed the antigenicity of the BA.2 subvariant to differ from the BA.1 Omicron variant. The researchers infected hamsters with the BA.1 Omicron virus and then obtained convalescent sera (blood samples) after their bodies had produced antibodies. They then subjected the Omicron BA.1 antibodies to BA.1 and BA.2 viruses. The researchers observed the BA.2 strain was 2.9-times more resistant to the Omicron BA.1 antibodies than BA.1 strain. Next, they tested this finding in mice by injecting them with cells conveying the spike protein of the BA.1 Omicron variant and once again tested their antibodies against BA.1 and BA.2 viruses.  This time they noticed the BA.2 virus subvariant was 6.4 times more resistant than the BA.1 Omicron virus variant.

Conclusions

The study notes BA.2 is not only highly mutated as compared to the ancestral SARS-CoV-2 virus that emerged in 2019 in Wuhan, China, but also has dozens of gene alterations from the original Omicron strain — making it as distinct from the BA.1 variant as the Alpha, Beta, Gamma and Delta variants were from each other. Although BA.2 is currently considered an Omicron subvariant, the authors suggest with its genomic sequence being heavily different from BA.1 along with its increased transmissibility rate and pathogenicity over BA.1, the BA.2 subvariant should be recognized as a unique variant of concern and monitored separately from the Omicron BA.1 variant.

Opposite to these findings, the World Health Organization (WHO) on Thursday noted that while the BA.2 subvariant is more infectious than the more common BA.1 Omicron variant, between the two strains there is no change in virulence (severity of disease). “Among all subvariants, BA.2 is more transmissible than BA.1. However, there is no difference in terms of severity,” Maria Van Kerkhova, COVID-19 Technical Lead at WHO said in a video.

According to a WHO update published this week, the BA. 2 subvariant now accounts for 21.1% of Omicron cases worldwide.

New COVID-19 Variant Facts: What We Know So Far. 4U Health. Updated December 7, 2021.

5 Reasons To Keep PCR Home COVID Test Kits on Hand. 4U Health. Updated December 6, 2021.

Ditch Nose Swabs for a Home Saliva PCR Covid Test Kit. 4U Health. Updated December 6, 2021.

About 4U Health

4U Health offers at-home lab testing to help you feel like your best self. Visit us at 4uHealth.com to learn about our COVID-19 Antibody Self-Collection At Home Test Kit, explore healthy living and wellness topics, and view our full at-home lab testing menu.

If you’re interested in hospital grade home PCR COVID test kits to detect COVID-19 (including Omicron and its other variants), check out 4U Health’s COVID-19 Active Infection Self-Collection Test. It’s approved for children 5+ and adults alike. For the timeliest results, we recommend having our “just-in-case” saliva kit stocked in your medicine cabinet so you can test on your terms. Overnight shipping is included and official digital results are typically within 24 hours of receipt by the lab.

Important notice

bioRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

Updated: February 19, 2022

Posted on

Coronavirus Cases Fall After Record Breaking Omicron Surge

COVID-19 Virus
Update on Omicron Variant

February 16, 2022 — The U.S. on Tuesday reported an average of about 136,000 new COVID cases per day over the last week, down 83% from the record high average of more than 800,000 cases per day set on Jan. 15, according to a CNBC analysis of data from Johns Hopkins University. Excluding Maine, new infections are declining in every state and Washington D.C., according to the data.

For the week of February 14, 2022, about 78,000 patients are in U.S. hospitals with COVID-19 disease, according to a seven-day average of data from the Department of Health and Human Services. That’s also down some 50% from a peak of nearly 158,000 for the week of January 17, 2022.

Saliva Covid Test Better Than Nasal Swabs To Detect Omicron. 4U Health. Updated February 24, 2022.

5 Reasons To Keep PCR Home COVID Test Kits on Hand. 4U Health. Updated December 6, 2021.

Ditch Nose Swabs for a Home Saliva PCR Covid Test Kit. 4U Health. Updated December 6, 2021.

About 4U Health

4U Health offers at-home lab testing to help you feel like your best self. Visit us at 4uHealth.com to learn about our COVID-19 Antibody Self-Collection At Home Test Kit, explore healthy living and wellness topics, and view our full at-home lab testing menu.

If you’re interested in hospital grade home PCR COVID test kits to detect COVID-19 (including Omicron and its other variants), check out 4U Health’s COVID-19 Active Infection Self-Collection Test. It’s approved for children 5+ and adults alike. For the timeliest results, we recommend having our “just-in-case” saliva kit stocked in your medicine cabinet so you can test on your terms. Overnight shipping is included and official digital results are typically within 24 hours of receipt by the lab.

Updated: February 24, 2022

Posted on

3rd Vaccine Booster Offers Strong Short-Term Protection Against Omicron, but Effectiveness Wanes, CDC Study Shows

COVID-19 Virus
Update on Omicron Variant

February 11, 2022 — Booster shots of the Pfizer-BioNTech and Moderna vaccines provided a high level of protection against COVID-19 hospitalizations, but experienced considerable decline in effectiveness after about four months, according to a study published by the Centers for Disease Control and Prevention (CDC). The multistate analysis was the first real-world data in the United States on the durability of vaccine protection during the Delta and Omicron surges. Vaccine effectiveness was 91 percent in preventing COVID-19-related hospitalizations during the first two months after receiving a third mRNA booster shot, the researchers found. After four months, protection fell to 78 percent, and more than five months later waned considerably to only 31 percent effectiveness against preventing hospitalizations.

Declining protection after a third vaccine dose “reinforces the importance of further consideration of additional doses to sustain or improve protection against COVID-19-associated” emergency department/urgent care visits and hospitalizations, the study’s authors wrote. Doctor Anthony S. Fauci, President Biden’s chief medical adviser on the pandemic response, echoed similar sentiments saying “there may be the need for yet again another boost — in this case, a fourth-dose boost for an individual receiving the mRNA — that could be based on age, as well as underlying conditions.”

Saliva Covid Test Better Than Nasal Swabs To Detect Omicron. 4U Health. Updated February 24, 2022.

5 Reasons To Keep PCR Home COVID Test Kits on Hand. 4U Health. Updated December 6, 2021.

Ditch Nose Swabs for a Home Saliva PCR Covid Test Kit. 4U Health. Updated December 6, 2021.

About 4U Health

4U Health offers at-home lab testing to help you feel like your best self. Visit us at 4uHealth.com to learn about our COVID-19 Antibody Self-Collection At Home Test Kit, explore healthy living and wellness topics, and view our full at-home lab testing menu.

If you’re interested in hospital grade home PCR COVID test kits to detect COVID-19 (including Omicron and its other variants), check out 4U Health’s COVID-19 Active Infection Self-Collection Test. It’s approved for children 5+ and adults alike. For the timeliest results, we recommend having our “just-in-case” saliva kit stocked in your medicine cabinet so you can test on your terms. Overnight shipping is included and official digital results are typically within 24 hours of receipt by the lab.

Updated: February 24, 2022

Posted on

New COVID-19 Monoclonal Antibody Treatment for Omicron Authorized by FDA

COVID-19 Virus
Update on Omicron Variant

February 11, 2022 — The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bebtelovimab, a new monoclonal antibody treatment that shows efficacy against the Omicron variant. The single-dose IV infused drug by Lilly, available only by prescription, is for individuals 12-years-old and over with mild to moderate cases of COVID-19 who are at high risk for severe illness. In a phase 1/2 human trial, laboratory testing showed the monoclonal antibody works against both the Omicron variant and the BA.2 Omicron subvariant. The trial showed some participants who received bebtelovimab recovered faster and saw a reduced viral load after five days, compared to those who had the placebo. Earlier this year, the FDA limited the use of two other monoclonal antibody therapies that worked against the Delta variant but proved to be ineffective against Omicron. “Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.”

For more information about using bebtelovimab to treat COVID-19 including its potential side effects, visit the FDA Fact Sheet for Healthcare Providers and FDA Fact Sheet for Patients, Parents and Caregivers.

Saliva Covid Test Better Than Nasal Swabs To Detect Omicron. 4U Health. Updated February 24, 2022.

5 Reasons To Keep PCR Home COVID Test Kits on Hand. 4U Health. Updated December 6, 2021.

Ditch Nose Swabs for a Home Saliva PCR Covid Test Kit. 4U Health. Updated December 6, 2021.

About 4U Health

4U Health offers at-home lab testing to help you feel like your best self. Visit us at 4uHealth.com to learn about our COVID-19 Antibody Self-Collection At Home Test Kit, explore healthy living and wellness topics, and view our full at-home lab testing menu.

If you’re interested in hospital grade home PCR COVID test kits to detect COVID-19 (including Omicron and its other variants), check out 4U Health’s COVID-19 Active Infection Self-Collection Test. It’s approved for children 5+ and adults alike. For the timeliest results, we recommend having our “just-in-case” saliva kit stocked in your medicine cabinet so you can test on your terms. Overnight shipping is included and official digital results are typically within 24 hours of receipt by the lab.

Updated: February 24, 2022