There are four anti-SARS mAbs products Authorized but not Approved by the U.S. FDA to treat certain patients.
Since September 13, 2021, the U.S. government has distributed about 2.9 million mAbs.
The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.
There are four anti-SARS mAbs products Authorized but not Approved by the U.S. FDA to treat certain patients.
Since September 13, 2021, the U.S. government has distributed about 2.9 million mAbs.
Beginning December 7, 2021, coronavirus breaking news has been integrated into the Precision Vaccinations break news feed. Please visit www.PrecisionVaccinations.com.
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Karen McClorey Hackett, CEO
People everywhere want protection from the current Delta virus surge and future safeguards against the approaching Omicron variant.
Most public health experts agree on one thing: now is the time to get a COVID-19 vaccine booster.
A global leader in COVID-19 vaccines offers free webinars for professionals and publishes patient-facing information that people can understand.
Moderna Inc. is digitally hosting a series of webinars this week for vaccination providers to learn more about the Moderna COVID-19 Vaccine booster dose.
By clicking on this free webinar registration link, vaccine providers can easily enroll in one of the Dec 7th thru the 10th digital sessions.
And for patients with questions about primary, booster, dosage, and mixing-matching, Moderna has published the following information.
After attending a Moderna webinar, or reading through the new information, if you have further questions, the Moderna Call Center can be reached at 1-866-MODERNA (1-866-663-3762).
The European Medicine Agency safety committee (PRAC) reviewed new data on the known risk of myocarditis and pericarditis following vaccination with the Comirnaty and Spikevax vaccines.
These heart conditions can develop within just a few days after mRNA vaccination and have primarily occurred within 14 days. And they have more often been observed after the second vaccination in young men.
This PRAC review included two extensive European epidemiological studies.
One study was conducted using data from the French national health system, and the other was based on Nordic registry data.
Based on the reviewed data, the PRAC has determined that the risk for both conditions is overall “very rare.”
This finding means that up to one in 10,000 vaccinated people may be affected.
The EMA reconfirmed on December 3, 2021, that the benefits of all authorized COVID-19 vaccines continue to outweigh their risks, given the chance of COVID-19 illness and related complications, and as scientific evidence shows, that they reduce deaths and hospitalizations due to COVID-19.
The EMA is a decentralized agency of the European Union (EU) based in The Netherlands governed by an independent Management Board responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU.
A new peer-reviewed study published in Frontiers in Medicine by researchers from the University of Florida found people who survived severe cases of COVID-19 had more than twice the risk of dying in the year after recovery compared to people who had a mild or moderate disease or who never had COVID-19.
Additionally, the risk of dying from COVID-19 effects appears more significant for people under 65 years of age.
In fact, the risk of 12-month mortality among adults under 65 hospitalized with COVID-19 is increased by 233% over those who are COVID-19 negative.
Nearly 80% of the downstream deaths among patients with COVID-19 were for causes other than respiratory or cardiovascular.
In fact, 80% of such deaths occurred for various reasons that are not typically associated with Covid-19. This suggests that the patients experienced an overall decline in their health, which left them vulnerable to various ailments.
When nearly all COVID-19 hospitalizations are preventable, this study points to an under-investigated sequela of COVID-19 and the corresponding need for prevention.
"Taking your chances and hoping for successful treatment in the hospital doesn't convey the full picture of the impact of Covid-19. Therefore, our recommendation at this point is to use preventive measures, such as vaccination, to prevent severe episodes of Covid-19," stated these researchers in a press release.
The researchers tracked electronic health records of 13,638 patients who underwent a PCR test for Covid-19 within the University of Florida health system, with 178 patients experiencing severe Covid-19, 246 mild or moderate Covid-19, and the rest testing negative. All patients included in the study recovered from the disease, and the researchers tracked their outcomes over the next 12 months.
No conflicts of interest were disclosed.
Although children and adolescents have a lower burden of SARS-CoV-2-associated disease than adults, assessing absolute risk among children remains difficult due to a high rate of undetected cases.
A non-peer-reviewed study published on November 30, 2021, reported SARS-CoV-2-associated burden of a severe disease course or death in children and adolescents is low in Germany.
This finding seems particularly the case for 5-11-year-old children without comorbidities.
By contrast, Paediatric inflammatory, multisystem syndrome temporally associated with SARS-CoV-2 plays a significant role in overall disease burden among all pediatric age groups.
These researchers combine data from three sources — a national seroprevalence study (the SARS-CoV-2 KIDS study), the German statutory notification system, and a nationwide registry on children and adolescents hospitalized with either SARS-CoV-2 or Pediatric Inflammatory Multisystem Syndrome (PIMS-TS), to provide reliable estimates on children's hospitalization, intensive care admission and death due to COVID-19 and PIMS-TS.
The overall PIMS-TS rate was 1 per 4,000 SARS-CoV-2 infections, mostly children without comorbidities.
While the overall hospitalization rate associated with SARS-CoV-2 infection was 35.9 per 10,000 children, ICU admission rate was 1.7 per 10,000, and case fatality was 0.09 per 10,000.
Children without comorbidities were found to be significantly less likely to suffer from a severe or fatal disease course. The lowest risk was observed in children aged 5-11 without comorbidities.
In this group, the ICU admission rate was 0.2 per 10,000, and case fatality could not be calculated due to an absence of cases.
In the U.S., which is about four times more populated than Germany, the CDC reported 630 deaths attributed to COVID-19 (vaccination and comorbidity status undisclosed) in people under 18 since January 2020.
Additionally, the CDC reported 173 deaths involving both COVID-19 and pneumonia as of December 1, 2021.
The CDC publishes current 'COVID-19 Weekly Deaths by Age, Race/Ethnicity, and Sex' trends on this webpage.
Another COVID-19 antibody treatment, Xevudy (sotrovimab), has today been approved by the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to be safe and effective at reducing the risk of hospitalization and death in people with mild to moderate COVID-19 infection who are at an increased risk of developing severe disease.
It is approved for individuals aged 12 and above who weigh more than 40kg.
Developed by GSK and Vir Biotechnology, sotrovimab is a single monoclonal antibody that works by binding to the spike protein outside the COVID-19 virus. This, in turn, prevents the virus from attaching to and entering human cells so that it cannot replicate in the body.
In a clinical trial, a single dose of the monoclonal antibody was found to reduce the risk of hospitalization and death by 79% in high-risk adults with symptomatic COVID-19 infection.
Based on the clinical trial data, sotrovimab is most effective when taken during the early stages of infection. So the MHRA recommends its use as soon as possible and within five days of symptom onset.
Xevudy (sotrovimab) is the second monoclonal antibody therapeutic approved by the MHRA following Ronapreve (REGEN-COV).
REGEN-COV is delivered via injection or IV, providing 'passive immunity and immediately protecting people from COVID-19. However, it must be re-administered to remain effective over time.
Sotrovimab is administered by intravenous infusion over 30 minutes.
Moreover, it is too early to know whether the Omicron virus variant impacts sotrovimab's effectiveness, but the MHRA is working with the company to clarify this new threat.
Additional antibody treatment news is published on this webpage.
Mexico's Federal Commission for the Protection Against Sanitary Risks (Cofepris) authorized on December 1, 2021, for emergency use the combination of bamlanivimab and etesevimab in care actions for patients with COVID-19 during the pandemic.
Cofepris licensed the combination under the therapeutic indication for treating mild to moderate coronavirus disease in adults and pediatric patients (12 years and older weighing at least 40 kilograms), with positive direct diagnostic test results for the SARS-CoV-2 virus, and who present very high-risk comorbidities that are not controlled.
As part of the approval process, experts from the New Molecules Committee held an extraordinary session. They issued a non-binding unanimous favorable opinion on the combination of drugs, which was integrated into the file submitted by Indiana-based Eli Lilly and Company.
Bamlanivimab was designed by Lilly to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19 patients.
The U.S. NIH recently published Anti-SARS-CoV-2 Monoclonal Antibodies for the Treatment of COVID-19.
And as of December 1, bamlanivimab and etesevimab are authorized in all U.S. states, territories, and jurisdictions.
Furthermore, healthcare providers should refer to Section 15 of the Fact Sheet for Health Care Providers for further details regarding specific variants and resistance.
Additional SARS-CoV-2 antibody treatments and news is published on this webpage.
U.S. health officials confirmed today that the first case of the Omicron SARS-CoV-2 virus variant had been identified in a person currently in California.
During today's press conference, the Centers for Disease Control and Prevention revealed the individual returned from South Africa on November 22, 2021.
"The individual, who was fully vaccinated and had mild symptoms that are improving, and is self-quarantining. All close contacts have tested negative."
The new variant Omicron has been found in countries from Europe to the Middle East.
The ECDC reported as of December 1, 2021, a total of 59 cases have been reported by 11 European Union and European Economic Area countries: Austria (3), Belgium (2), Czechia (1), Denmark (4), France (1, in Réunion), Germany (9), Italy (4), the Netherlands (16), Portugal (14), Spain (2), and Sweden (3).
Cases have been reported in 12 countries and territories outside the EU/EEA - Australia, Botswana, Brazil, Canada, Hong Kong Special Administrative Region, Israel, Japan, Nigeria, Saudi Arabia, South Africa, Switzerland, and the United Kingdom.
The World Health Organization (WHO) confirmed today the SARS-CoV-2 virus variant Omicron had been designated a Variant of Concern, and several countries are introducing temporary travel measures.
As of November 28, 2021, the WHO reported 56 countries were reportedly implementing travel measures to potentially delay the importation of Omicron.
National authorities may apply a multi-layered risk mitigation approach to potentially delay and/or reduce the exportation or importation of the new variant.
Such measures may include screening passengers before traveling and/or upon arrival, including via SARS-CoV-2 virus testing or the application of quarantine to international travelers.
These measures, nonetheless, need to be defined following a thorough risk assessment process informed by the local epidemiology.
The WHO says 'blanket travel bans will not prevent the international spread, and they place a heavy burden on lives and livelihoods.'
In addition, 'they can adversely impact global health efforts during a pandemic by disincentivizing countries to report and share epidemiological and sequencing data.'
'All countries should ensure that the measures are regularly reviewed and updated when new evidence becomes available on the epidemiological and clinical characteristics of Omicron.'
Additional travel-vaccination news is published at Vax-Before-Travel.
The European CDC announced today 44 confirmed cases of SARS-CoV-2 Omicron have been reported by eleven European Union and European Economic Area (EU/EEA) countries (Austria, Belgium, Czechia, Denmark, France (Reunion), Germany, Italy, the Netherlands, Portugal, Spain, and Sweden.
Omicron variant cases have been reported in nine countries and territories outside of the EU/EEA: Australia, Botswana, Canada, Hong Kong Special Administrative Region, Israel, Japan, South Africa, Switzerland, and the UK.
As of November 30, 2021, the ECDC says 'the majority of confirmed cases have a history of travel to African countries, with some having taken connecting flights at other destinations between Africa and Europe.'
'All cases for which there is information available on severity were either asymptomatic or had mild symptoms.'
'So far, no severe cases or deaths have been reported among these cases.'
The U.S. CDC has not confirmed an Omicron case.
However, states have already taken action.
The Governor of the State of New York declared a disaster has occurred, for which the affected local governments are unable to respond adequately, and declare a disaster emergency for the entire State of New York through January 15, 2022.
New York-based Regeneron Inc. announced today there had been no direct data testing the Omicron variant's resistance to monoclonal antibody-conveyed immunity.
However, the company is currently evaluating REGEN-COV® (casirivimab and imdevimab) against the Omicron (B.1.1.529) variant.
The current U.S. Food and Drug Administration (FDA) Fact Sheet and multiple separate analyses, including a publication in Cell, affirm that REGEN-COV retains potency against the main variants of concern, including Delta, which remains the predominant strain in the U.S. today.
This information is integrated into the REGEN-COV overview.
'It is important that high-risk patients who are diagnosed with COVID-19 are aware of current authorized treatment options and seek out these therapies early in the course of their infection,' stated Regeneron's press statement issued on November 30, 2021.
Regeneron has one of the largest collections of fully human monoclonal antibodies targeting the SARS-CoV-2 betacoronavirus.
The first of these additional investigational candidates have already entered into clinical trials, with others nearing clinic readiness.
Preliminary analyses suggest that several of these next-generation antibodies may have the potential to retain activity against the Omicron variant and the other existing variants of concern. Further in vitro data is expected over the next month.
Breaking antibody treatment news is published on this Coronavirus Today webpage.
This week's U.S. CDC's COVID Data Tracker shows that rates of COVID-19 related deaths continued to decrease.
Since the recent peak on September 21, 2021, the 7-day rate averaged deaths decreased from about 1,830 fatalities to about 1,000 on November 19, 2021.
Most importantly, the number of pediatric deaths related to COVID-19 has significantly diminished over the past two months.
According to the CDC, as of November 24, 2021, there have been 621 deaths attributed to COVID-19 (vaccination and comorbidity status undisclosed) in people under 18 since the pandemic began in January 2020.
Additionally, the CDC reported 170 deaths involving both COVID-19 and pneumonia during that period.
And there have been 1,132 deaths from pneumonia alone.
Recently, the emergence of the Omicron variant (B.1.1.529) further emphasizes the importance of vaccination, boosters, and prevention efforts needed to protect people against COVID-19.
In response to this unknown threat, the CDC announced it is strengthening its recommendation on booster doses for 18 years and older individuals.
Effective today, everyone ages 18 and older should get a booster shot either when they are six months after their initial Pfizer or Moderna series or two months after their initial J&J vaccine.
CDC Director Dr. Rochelle Walensky stated in a press statement issued on November 29, 2021, 'I strongly encourage the 47 million adults who are not yet vaccinated to get vaccinated as soon as possible.'
'And to vaccinate the children and teens in their families as well because strong immunity will likely prevent serious illness.'
'I also want to encourage people to get a COVID-19 test if they are sick. Increased testing will help us identify Omicron quickly.'
The South African doctor who initially identified the SARS-CoV-2 virus variant known as Omicron says her patients have had "extremely mild symptoms."
However, Dr. Angelique Coetzee said in an interview on November 28, 2021, 'more time is needed before we know the seriousness of this new virus variant.'
Watch Dr. Coetzee tell the BBC's Andrew Marr how patients in South Africa have told her they've been feeling.
And today, Public Health Scotland confirmed six cases of the Omicron variant had been identified; four cases in the Lanarkshire area and two in the Greater Glasgow and Clyde area.
Furthermore, some of those affected in Scotland have no travel history, indicating community transmission of the variant.
Health Secretary Humza Yousaf said in a press statement, "This will be a worrying time for the six people now identified as having the new variant."
"If you have symptoms, self-isolate and take a test, and if contacted by Test and Protect or public health teams, please co-operate and follow their advice."
"All close contacts of suspected Omicron cases will be advised to self-isolate for ten days, regardless of their vaccination status."
"This will help establish the origin of the virus and any further individuals they have come into contact with in recent weeks.'
Japan's Prime Minister Fumio Kishida announced today he intends to move quickly to "avoid the worst-case scenario" related to the coronavirus variant known as Omicron.
Extended travel bans and restrictions will become effective on November 30, 2021, and last for about one month.
PM Kishida said, "when dealing with an unknown risk, it's best to take every precaution."
Returning Japanese citizens and foreign residents will be required to isolate for two weeks, regardless of whether they are fully vaccinated.
Travelers who arrive in Japan without proper documentation of a negative COVID-19 test will be denied entry.
'Due to the regularly changing situation and the constant updating of information, it is essential that you always check for updates and follow the latest guidance from the relevant ministries and official bodies,' says Japan's travel information website.
Furthermore, Japan will also lower the number of people arriving from 5,000 down to 3,500.
The Japanese Ministry of Health, Labor, and Welfare also has a 24/7 hotline at +81-3-3595-2176 with English-speaking operators and has a Q&A on the new measures.
Visit the Embassy's COVID-19 webpage for more information on COVID-19 and related restrictions and conditions in Japan.