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COVID Vaccines for Young Children, Ages 6 Months to 4 Years, Postponed

COVID-19 Virus
Update on Omicron Variant

February 11, 2022 — The Pfizer-BioNTech COVID-19 vaccine for children ages 6 months to 4 years old is delayed by at least 2 months in the United States. In a joint press release, the firms said they were postponing their request for Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA), pending more data on the effectiveness of a third dose for this age group. Data on the third dose is expected in early April, the companies stated.

In a December news release, the firms shared that two doses didn’t generate a strong enough immune response in its trial of children ages 2 to 4. Still, the companies asked the FDA earlier this month to authorize these first two doses, with a plan to submit additional data in the coming weeks on a third dose. The full vaccination series would be three doses for children 6 months to 4 years old.

As such, the FDA was expected to publish an analysis of the Pfizer data on February 11, ahead of an advisory committee meeting scheduled for February 15. The FDA instead postponed the meeting and, in a written statement, concurred that “additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.”

The US Centers for Disease Control and Prevention (CDC) tentatively plans to roll out 10 million doses in three phases as soon as the FDA authorizes the lower-dose, 3-microgram Pfizer-BioNTech shot for children 6 months to 4 years old, according to a CDC planning document posted on-line

Some 25 million children under age 5 are the only group not yet eligible for vaccination against the coronavirus in the United States.

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

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Highest-Risk COVID Patients Least Likely To Get Monoclonal Antibodies, Researchers Say

COVID-19 Virus
Update on Omicron Variant

February 9, 2022 — People who would benefit the most from receiving monoclonal antibody (mAb) treatment to fight a COVID infection — older Americans with chronic health conditions — have been the least likely to receive it, according to a new study co-authored by Harvard researchers.

The likelihood of receiving the antibodies was higher among those with fewer chronic conditions — 23.2% of those with no chronic conditions received the therapy, versus 6.3% with one to three chronic conditions, 6.0% with four to five chronic conditions and 4.7% with six or more chronic conditions.

Moreover, there were substantial variations among states when it came to rates of mAb treatment. Rhode Island and Louisiana, for example, administered the mAb therapy to the highest proportion of non-hospitalized individuals with COVID-19 at 24.9% and 21.2% respectively. Conversely, Alaska and Washington had the lowest proportion of mAb administrations at 1.1% and 0.7%.

Monoclonal antibodies have been touted as a highly effective way to keep a mild to moderate case of COVID-19 from progressing into something more severe. They “should first go to patients at the highest risk of death from COVID-19, but the opposite happened — the healthiest patients were the most likely to get treatment. Unfortunately, our federal and state system for distributing these drugs has failed our most vulnerable patients,” said Michael Barnett, lead author of the study, in a press release announcing the findings.

As of the February 9, 2022, about 74 percent of the roughly 900,000 U.S. deaths caused by COVID-19 since the start of the pandemic occurred in adults 65 and older, according to a statista review of National Center for Health Statistics (NCHS) data. Furthermore to age, which by itself is a risk factor for severe COVID-19 disease, the 2018 National Health Interview Survey (NHIS) estimates about 88 percent of adults 65 and older have at least one chronic health condition that can worsen a SARS-CoV-2 infection.

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

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N95 Masks Offer Better Protection Against COVID Omicron Variant Than Cloth Face Coverings, CDC Says

COVID-19 Virus
Update on Omicron Variant

February 4, 2022 — N95 and KN95 masks, also known as a respirators, apparently offer the best protection against COVID-19, including the Omicron variant, according to the newly updated Centers for Disease Control and Prevention (CDC) consumer mask website. People at higher risk for severe illness from COVID-19, including older adults and individuals with certain underlying medical conditions, may want to consider ditching their cloth mask for an N95 mask. The same may be true for people who are taking care of someone who is sick with COVID, retail workers, bus, taxi, and uber drivers, along with other individuals whose jobs require them to interact with the public at large. A long train or plane trip may also merit a switch to the best protective N95 mask. But the agency stopped short of saying that people should opt for certain masks over others.

The update clarifies that people no longer need be concerned related to supply shortages for N95s. Previously, the CDC did not recommend for the general population to wear N95 respirators or KN95s, a similar type of mask made in China. The government officials feared that a run on those higher-quality masks would impact the supply in healthcare settings. 

A new “real world” study in Morbidity and Mortality Weekly Report (MMWR) seemed to validate the efficacy of respirators, finding people who reported always wearing a N95 or KN95 mask in indoor public settings were 83% less likely to test positive for COVID-19 than people who didn’t.

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

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BA.2 Subvariant More Contagious Than Original Omicron Variant, Denmark Study Finds

COVID-19 Virus
Update on Omicron Variant

January 31, 2022 — The BA.2 subvariant of Omicron appears 33% more transmissible than the more common BA.1 Omicron coronavirus variant, according to preprint findings published in a Danish study. Researchers calculated the probability for spreading an infection within a household was 39% for BA.2 versus 29% for BA.1.

Not only was BA.2 more contagious than the original BA.1 strain among both vaccinated and unvaccinated individuals, but the relative rise in susceptibility to infection was considerably greater in vaxxed people than unvaxxed people, according to the study. That suggests the subvariant BA.2 is even better at escaping vaccine protection than BA.1, which was already significantly more contagious than any other Covid variant.

“We conclude that Omicron BA.2 is inherently substantially more transmissible than BA.1, and that it also possesses immune-evasive properties that further reduce the protective effect of vaccination against infection,” the study’s researchers told Reuters.

In Denmark, BA.1 has been pushed aside by BA.2, which became the dominant strain in the second week of January 2022. Now South Africa, which first discovered the original BA.1 Omicron variant, reported BA.2 levels are increasing, but against the backdrop of decreasing total infections. This somewhat alleviates US concerns BA.2 could stall a swift exit from the Omicron wave. 

For the week ending January 29, 2022, the BA.2 Omicron lineage accounted for less than 1% of cases in the United States. Outside the US, BA.2 has overtaken BA.1 in Denmark, Nepal, and the Philippines as the most frequently detected coronavirus variant, and has growing presence in India, the United Kingdom, South  Africa and several other countries.

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

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Omicron Evades Some, but Not All, Monoclonal Antibody Treatments, Study and FDA Say

COVID-19 Virus
Update on Omicron Variant

January 24, 2022 — Some of the human monoclonal antibodies (used clinically to prevent patients from becoming severely ill from COVID-19 disease) may not be protective against the Omicron variant of SARS-CoV-2 now spreading across the United States, researchers reported January 19, 2022 in the journal Nature Medicine.

Monoclonal antibodies are laboratory-made proteins that are administered to patients to fight off harmful pathogens such as viruses, like SARS-CoV-2.

Led by researchers at Washington University School of Medicine in St. Louis, Missouri, the laboratory study tested five antibody combinations against the SARS-CoV-2 B.1.1.529 Omicron virus. The authors report numerous antibodies, including those in clinical use by Regeneron and Eli Lilly, completely lost the ability to neutralize the omicron variant in cell culture. The authors concluded the loss of neutralizing ability of the monoclonal antibodies is due to the more than 30 mutations in the omicron “spike” protein, the antibody target, on the surface of the virus.

The NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, recently recommended against the use of Lilly’s bamlanivimab and etesevimab along with Regeneron’s REGEN-COV (casirivimab and imdevimab) because of markedly reduced activity against the omicron variant.

The FDA today announced the revisions of two emergency use authorizations (EUAs) for currently used monoclonal antibody treatments — bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab). With this EUA revision, then Lilly and Regeneron combo drugs are no longer authorized for use in any U.S. states, territories or jurisdictions, since Omicron is currently the dominant variant across the United States. As of Jan. 15, 2022, the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States, based on Centers for Disease Control and Prevention data.

“Importantly, there are several other therapies – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to work against the omicron variant, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death”, reaffirmed the FDA statement.

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

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Omicron Generally Causes Less Severe COVID-19 Disease, Multiple Studies Show

COVID-19 Virus
Update on Omicron Variant

January 21, 2022 — Several sources of real-world data from across the globe indicate the Omicron coronavirus variant produces a less severe form of COVID-19 disease. In South Africa, where Omicron was identified in November 2021, a private health insurance administrator reported in mid-December of 2021 that adults with Omicron were 29 percent less prone to be hospitalized, as compared to adults infected with the D614G strain of coronavirus that caused the first wave of COVID-19 infections in the country.

Similarly in the United Kingdom, the hospital admission rate among people who went to the emergency room with Omicron was about a third of what it was for Delta, per a technical briefing issued by the U.K. Health Security Agency in late-December of 2021.

As of early January 2022, U.S. adults with Omicron appear less than half as likely to visit the emergency department, be hospitalized, or put on a ventilator, according to a non-peer-reviewed study published by researchers from Case Western Reserve University School of Medicine.

Moreover, Omicron patients at Kaiser Permanente Southern California were 74% less likely to end up in ICUs and 91% less likely to die than Delta patients, a pre-print study found. “Reductions in disease severity associated with Omicron variant infections were evident among both vaccinated and unvaccinated patients, and among those with or without documented prior SARS-CoV-2 infection,” the team of researchers found.

Howbeit, up until recently, the reasons for Omicron to cause less severe COVID-19 disease than Delta and other earlier coronavirus mutations has remained elusive. An article published in Nature today now shows that the Omicron variant is especially susceptible to inhibition by the interferon response, an unspecific immune response that is present in all body cells. The study, led by researchers from the University of Kent and the Goethe-University Frankfurt, offers the first description of why Covid-19 patients afflicted with the Omicron variant are less likely to experience severe COVID-19 disease.

Although the Omicron variant likely causes less severe COVID-19 disease, it still brings about severe disease, and kills people. When you have large amounts of individuals getting sick simultaneously, even when only a small percentage get markedly ill, it can still overwhelm the health-care system and society. Now add in the fact that many of our monoclonal antibody therapies are thought to have lost effectiveness, and you get the crisis we’ve seen over the start to the new year. The 7 day trailing average of daily COVID-19 deaths in the United States stands at 2,076 people per day, per CDC data as of January 20, 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

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Saliva Covid Test Better Than Nasal Swabs To Detect Omicron, Study Says

COVID-19 Virus
Update on Omicron Coronavirus Variant

January 11, 2022 — COVID-19 saliva tests appear more effective at detecting the Omicron variant, a recently posted pre-print paper says.

Researchers in South Africa tested 382 people who were not sick enough to be hospitalized but still had COVID-19 symptoms. They found that in those affected with Omicron, saliva tests worked best. The positive percent agreement of saliva and mid-turbinate swabs to the composite standard was estimated to be 100% and 86% for Omicron infections, respectively. Moreover, the study observed the saliva samples contained more viral RNA than nasal samples.

The improved sensitivity of saliva over nasal samples appears to be a function of altered viral shedding patterns during an Omicron infection. Evidence suggests the replication rate of the Omicron variant is considerably greater in the upper respiratory tract than that of the Delta variant. Howbeit, in the lower respiratory tract, Omicron replicates substantially slower than the precursor wildtype SARS-CoV-2 Wuhan strain. 

Researchers have also shown that some people are testing negative for COVID-19 with over-the-counter rapid tests while sometimes having the Omicron variant. Rapid antigen tests that rely on nasal swabs might be especially slow to identify infections with Omicron. In a non-peer reviewed study posted last week on medRxiv, researchers looked at samples from 30 people who tested positive for COVID-19 around the United States during outbreaks in early December 2021. For most cases of Omicron, PCR tests showed positive days before a rapid test did. Those results echo what people have been reporting on social media, says study coauthor Anne Wyllie, a medical microbiologist at the Yale School of Public Health in New Haven, Connecticut.

The highly contagious Omicron variant is the most prevalent SARS-CoV-2 strain in the United States, and according to CDC estimates is responsible for approximately 95% of all new cases for the week ending January 8, 2022. The Delta variant, once dominant, only accounts for less than 5% of all new covid-19 infections in the U.S.

Here is a hospital grade At-Home Saliva PCR Covid-19 Test useful for diagnosing or ruling out an active SARS-CoV-2 infection, including the Omicron variant. This test is great for school, work or travel clearance as it comes with a physician order, pre-paid overnight shipping to the lab, and an actionable official CLIA approved laboratory result. Positive results receive care coordination from a telehealth physician group licensed in your state. And the best part is a saliva PCR test is not on highly accurate, it’s pain free. Recommended for individuals 5-years-old and over.

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 24, 2022

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FDA Authorizes & CDC Recommends Booster Shots for Older Teens

Update on Covid boosters for older teens. Covid-19 picture of new omicron variant.
Update on Booster Shots for SARS-CoV-2 Virus

Updated Booster Guidance for 16-and-17-year-olds

On December 9, the Food and Drug Administration authorized third booster shots of the Pfizer-BioNTech Covid-19 vaccine for 16-and-17-year-olds. Hours later CDC Director Walensky signed off on third shots for the age group and issued updated booster guidance. Walensky said in a statement that initial data suggest a third shot may help with strengthening protection against Omicron and other variants. “We know that COVID-19 vaccines are safe and effective,” she said, urging 16-and-17-year-olds to get the booster. The prompt action taken by the CDC means teens in this age group can immediately make their appointments.

On Tuesday a first study on Omicron was posted online showing the new variant has extensive escape of the Pfizer vaccine. The South African study found antibodies from people having received the Pfizer jab were 41 times less effective at neutralizing the Omicron variant compared with the original virus.

On Wednesday, Pfizer and BioNTech issued a joint statement that seemed to reaffirm the South African study, saying its two-dose vaccine does not provide sufficient protection against infection with the Omicron coronavirus variant. Although the companies studies showed a significant 25-fold reduction in neutralization titers against Omicron as compared to the origin wild-type virus, they did reaffirm however that the two-dose vaccine regimen would still protect against severe COVID-19 disease. The companies said their preliminary data showed a booster dose increased protection back up 25-fold to nearly the same levels that its two-dose vaccines provide against the earlier strain of the virus.

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 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 results are typically within 24 hours of receipt by the lab.

Resources

Sigal, A et.al. SARS-CoV-2 Omicron has extensive but incomplete escape of Pfizer BNT162b2 elicited neutralization and requires ACE2 for infection. URL. Posted December 7, 2021. Accessed December 8, 2021.

Updated: December 9, 2021

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Omicron Has Extensive Escape of Pfizer Vaccine Protection, First Study of New Covid Variant Suggests

Omicron vaccine escape. Pfizer vaccine Escape. Covid-19 picture of New Omicron Variant.
Update on Omicron SARS-CoV-2 Virus Variant

Study Findings

A small study out of South Africa published online on December 7th offered a first look at how well people immunized with Pfizer and BioNTech’s vaccine might fare against the new Covid variant, Omicron. After testing Omicron against blood samples from 12 people – 6 individuals previously infected and vaccinated – and 6 individuals only vaccinated – the study found antibodies from people only having received the Pfizer jab were 41 times less effective at neutralizing the Omicron variant compared with the original virus.

For context previous variants of concern including the B.1.351 (Beta), P.1 (Gamma), and B.1.617.2 (Delta) showed substantial, but far less reductions in vaccine-induced antibodies ranging from 2.1-fold to 8.4-fold. The study findings are highly suggestive that Omicron is much better at evading vaccine protection than any variant to date, including Delta that is causing the propensity of infections in the United States.

In the study, researchers say “the results we present here with Omicron show much more extensive escape.” But, “previous infection, followed by vaccination or booster is likely to increase the neutralization level and likely confer protection from severe disease in Omicron infection”, they added. The study showed 5 of the 6 participants, all previously infected then subsequently vaccinated, had relatively high neutralization titers with Omicron.

Implications

The study suggests individuals previously infected with Covid-19 and who are subsequently vaccinated have a likelihood of demonstrating sustained protection against Omicron.

Otherwise, it can be dangerous to construct too much else from this small sample size non-peer-reviewed study. Although it’s nice to have real data with regards to Omicron and the Pfizer vaccine, the study notably omits specimens from fully vaccinated individuals with boosters and a control group of previously infected individuals that were not subsequently vaccinated. Further study is also needed on other approved vaccines, like the Johnson & Johnson and Moderna immunizations.

Moreover, the study does not reflect actual infection with the virus. It was performed on lab specimens and not in the context of a human trial. A drop in neutralizing antibodies found in blood samples may not reflect in the real world how the variant may behave and interact with the entire immune system in the human body. Neutralizing antibodies are just a single part of protection, and do not necessarily correspond in and of themselves to vaccine effectiveness.

“The clinical implications of these important laboratory data need to be determined. It is likely that lesser vaccine-induced protection against infection and disease would be the result,” said Africa Health Research Institute Executive Director Willem Hanekom in a statement. But “Importantly, most vaccinologists agree that the current vaccines will still protect against severe disease and death in the face of omicron infection. It is therefore critical that everyone should be vaccinated,” Hanekom said.

Pfizer Issues Press Release on 12/08/2021 Saying Its Third Booster Shot Blocks Omicron

  • Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant (B.1.1.529 lineage) while two doses show significantly reduced neutralization titers [more than a 25-fold reduction]
  • Data indicate that a third dose of BNT162b2 increases the neutralizing antibody titers by 25-fold compared to two doses against the Omicron variant; titers after the booster dose are comparable to titers observed after two doses against the wild-type virus which are associated with high levels of protection
  • As 80% of epitopes in the spike protein recognized by CD8+ T cells are not affected by the mutations in the Omicron variant, two doses may still induce protection against severe disease
  • The companies continue to advance the development of a variant-specific vaccine for Omicron and expect to have it available by March in the event that an adaption is needed to further increase the level and duration of protection – with no change expected to the companies’ four billion dose capacity for 2022

NEW YORK & MAINZ, Germany–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from an initial laboratory study demonstrating that serum antibodies induced by the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) neutralize the SARS-CoV-2 Omicron variant after three doses. Sera obtained from vaccines one month after receiving the booster vaccination (third dose of BNT162b2 vaccine) neutralized the Omicron variant to levels that are comparable to those observed for the wild-type SARS-CoV-2 spike protein after two doses.” You can see the full press release here.

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 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 results are typically within 24 hours of receipt by the lab.

Resources

Sigal, A et.al. SARS-CoV-2 Omicron has extensive but incomplete escape of Pfizer BNT162b2 elicited neutralization and requires ACE2 for infection. URL. Posted December 7, 2021. Accessed December 8, 2021.

Updated: December 8, 2021

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5 Reasons To Keep PCR Home COVID Test Kits on Hand

Saliva Covid Test Collection Device for a PCR Covid Test. This is a home covid test picture.
At Home COVID Test Includes the OMNIgene DNA Spit Test Kit

With the arrival of the Delta and Omicron variants, we are not just yet finished with the COVID-19 pandemic. Sure, the wide distribution of vaccines has greatly helped in our fight to slow the spread of SARS-CoV-2, the virus that causes COVID-19 disease. But as breakthrough cases emerge and the virus continues to spread in non-vaccinated individuals who don’t yet have protective natural immunity, there is a need for easy access to PCR covid tests. Now there is an FDA EUA authorized saliva covid test collection device that allows for easy at-home testing. And the best part is, the covid spit test device is for a PCR covid test; the most sensitive and accurate of all covid test methods. Here are the top 5 reasons why you should keep a PCR at home covid test kit [1] in your medicine cabinet.

1. Peace-of-Mind

Get a PCR home covid test and feel the freedom of knowing you are prepared for whatever life may throw your way. The OMNIgene saliva collection device included with the Covid test has a shelf life of at least one year, giving you the confidence to confirm any family member’s COVID infection status whenever, wherever, and for whatever your need is.

2. Easy and Painless

Tired of scrambling last minute to make an appointment at an urgent care center, doctor’s office, or hospital to get a covid test. Say goodbye to these frantic phone calls with a Self-Collection PCR Test. Simply stock a test at home so you can obtain a covid sample, whenever the need arrives, on your own schedule. And the best part is the PCR home covid test kit is a saliva sampling device, which involves less discomfort than swabbing your nose.

Not thrilled with the idea of the brain poke swab? Can you spit? I bet your child can! If so, then this test is for you. Just spend as little as 2 minutes spitting into the collection device. Saliva sample collection supplies are included in your test along with detailed instructions. You collect your non-invasive spit sample from the comfort of home and mail it to a certified lab with prepaid overnight shipping. Usually within 24 hours of your sample arriving at the lab, receive secure electronic results on your device of choice.

3. School, Work or Travel Clearance

Not your typical pharmacy or urgent care center rapid test. In addition to identifying COVID-19 in a patient that is presenting with symptoms, the Self-Collection At Home Covid PCR Test can be a helpful tool to track the progression of the disease and confirm when a patient is virus-free. Print our actionable CLIA certified lab report for return to school, work, or travel.

4. Accuracy

A PCR test is considered the most accurate test method for detecting the virus that causes COVID-19. This Covid PCR test looks for the SARS-CoV-2 RNA genetic material. It checks whether you have COVID-19 right now and can spread it to others. A positive PCR test result is considered a confirmed case of COVID-19 and is reported by the performing laboratory to your state reporting agency for public health purposes.

As for rapid antigen pharmacy tests vs laboratory performed PCR tests, The Cleveland Clinic notes “the antigen test is typically faster but is less sensitive than the PCR test. Because the antigen test is not as accurate as PCR, if an antigen test is negative, your healthcare provider could request a PCR test to confirm the negative antigen test result.”

Note, the PCR at home covid test discussed is this article is not an antibody test that looks for whether you have had an immune response to a prior COVID-19 infection or vaccination. If you are interested in checking for covid antibodies from the comfort of home, check out this COVID-19 Antibody Self-Collection Test.

5. Safety and Protection

Having a home covid test kit on hand means you don’t need to go to a medical facility and risk exposing yourself to other potentially infected individuals. Moreover, if you self-collect a saliva covid test sample at home and are infected with SARS-CoV-2, you won’t risk transmitting it to the staff and patients of the healthcare facility.

With quick access to results, someone who’s infected can easily isolate to prevent further spread. Having a “just-in-case” PCR at home covid test in your medicine cabinet means you can test on your terms as soon as the need arises. And thanks to the return overnight shipping included with the self-collection covid test kit, you can expect rapid accurate actionable results, typically within 24 hours of the lab receiving the specimen.

If you’re feeling sick now and don’t have a Covid PCR test on hand, don’t worry you’re covered. You may choose expedited next-day shipping to receive your at home Covid test.

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

Vitamin D & Coronavirus Prevention: Facts & Myths. 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 a PCR at home COVID test to detect COVID-19 (including Omicron and its other variants), check out 4U Health’s COVID-19 Active Infection Self-Collection Test. It’s recommended for children 5+ and adults alike. For the timeliest results, we advise having a “just-in-case” saliva kit stocked in your medicine cabinet so you can test on your terms. Overnight shipping is included and results are typically within 24 hours of receipt by the lab.

References

Centers for Disease Control and Prevention. Self-Testing. URL. Updated November 4, 2021. Accessed December 6, 2021.

Centers for Disease Control and Prevention. Test for Current Infection. URL. Updated October 27, 2021. Accessed December 6, 2021.

Cleveland Clinic. Here’s What to Know About New At-Home COVID-19 Tests. URL. March 25, 2021. Accessed December 6, 2021.

Cleveland Clinic Journal of Medicine. Procop, GW et. al. Home testing for COVID-19: Benefits and limitations. URL. March 1, 2021. Accessed December 6, 2021.

CNBC. Stieg, C. What you should do if you or someone you know is fully vaccinated but tests positive for Covid anyway. URL. Updated July 29, 2021. Accessed December 6, 2021.

U.S. Food and Drug Administration. Coronavirus Disease 2019 (COVID-19). URL. Updated December 3, 2021.Accessed December 6, 2021.

U.S. Food and Drug Administration. EMERGENCY USE AUTHORIZATION (EUA) SUMMARY OMNIGENE·ORAL OM-505 AND OME-505 SALIVA COLLECTION DEVICES. URL. Updated October 28, 2020. Accessed December 6, 2021.

Note(s)

[1] The term “kit” references the OMNIgene saliva collection device that is a part of the COVID-19 Active Infection Self-Collection Test.

Updated: December 6, 2021