Coronavirus Breaking News

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.'

BNO News reported today the SARS-CoV-2 virus Omicron variant (B.1.1.529) had reached thirteen countries. The online tracker indicates the number of confirmed (131) and suspected cases (1.057) reported as of 7 AM CT in the U.S.

No Omicron-related deaths have been confirmed.

The World Health Organization and most countries are issuing alerts highlighting significant travel restrictions.

For example, on November 27, 2021, Israel announced that the Ministry of Health identified 50 destinations in the African continent classified as Red Destination, which restricts various freedoms.

All returnees to Israel from a Red destination, including vaccinated and recovered travelers, must go into complete isolation.

The Israeli government also approved the obligation to isolate in a government-run isolation facility until a negative result is obtained in a PCR test performed at the entrance to Israel. This obligation applies at midnight November 29, 2021, for various travelers.

Additionally, anyone who is positive in the PCR test will stay in isolation in the government-run isolation facility until the end of the isolation days required by the guidelines.

The WHO issued an interim statement on COVID-19 vaccination for children and adolescents on November 24, 2021 that says 'Safety signals identified after widespread roll-outs of COVID-19 vaccines, such as myocarditis, albeit rare, are reported more frequently in young persons aged 16-24 years, particularly males.'

'And the risk of myocarditis in adolescents and/or children has not yet been determined.'

'Countries should consider the individual and population benefits of immunizing children and adolescents in their specific epidemiological and social context when developing their COVID-19 immunization policies and programs.'

'As children and adolescents tend to have the milder disease compared to adults unless they are in a group at higher risk of severe COVID-19, it is less urgent to vaccinate them than older people, those with chronic health conditions, and health workers.'

'As a matter of global equity, as long as many parts of the world are facing extreme vaccine shortages, countries that have achieved high vaccine coverage in their high-risk populations should prioritize global sharing of COVID-19 vaccines through the COVAX facility before proceeding to vaccination of children and adolescents who are at low risk for severe disease.'

Additional COVID-19 vaccine information for young people is found on this webpage.

The Maryland-based Center for Drug Evaluation and Research Antimicrobial Drugs Advisory Committee announced today the meeting briefing document was published for Merck's Molnupiravir, an oral antiviral treatment.

This U.S. FDA committee is scheduled to digital meet on November 30, 2021.

Led by Lindsey R. Baden, M.D., Chairperson, the committee will discuss Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules to treat mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.

According to the company, Molnupiravir inhibits the replication of the SARS-CoV-2 betacoronavirus, with similar activity across variants of concern.

Furthermore, it has a high barrier to resistance, with no evidence of resistance development to Molnupiravir in nonclinical or clinical studies to date.

Merck's proposed dosing regimen is 800 mg (administered as four 200 mg capsules) taken every 12 hours with or without food for five days.

And, the treatment should be started as soon as possible after a diagnosis of COVID-19 and within five days of symptom onset.

Initially developed at Emory University, then by Ridgeback Biotherapeutics L.P., molnupiravir is classified as a mutagenic nucleotide analogue, the underlying biochemical mechanisms with the purified RdRp complex of SARS-CoV-2.

On November 4, 2021, the U.K. Medicines and Healthcare products Regulatory Agency granted authorization for molnupiravir, known locally as Lagevrio.

The Deputy Director-General of the Gamaleya Research Institute of Epidemiology and Microbiology Denis Logunov stated at a press conference in Moscow, Russia, on November 24, 2021, "The use of the Sputnik M vaccine by people twelve to 17 years was authorized today.'

Sputnik M is a recombinant human adenoviral-based, two-part, reduced dosage COVID-19 vaccine created for adolescents. This vaccine could be available in late 2021.

Gamaleya developed the original two-dose Sputnik V vaccine that was registered in Russia on August 11, 2020, and is currently available in 71 countries.

Then the single-dose Sputnik Light vaccine was registered on May 6, 2021.

The World Health Organization and the U.S. FDA have yet to authorize any Sputnik vaccine.

But the European Medicines Agency began its rolling-review process in March 2021.

Furthermore, the Sputnik vaccine team posted on Twitter 'Countering New Cases Surge in Europe' regarding the surge of COVID-19 related fatalities in Europe and Russia.

New York-based Pfizer Inc. and its co-development partner BioNTech SE announced on November 22, 2021, positive topline results from the safety and efficacy analysis of their Comirnaty COVID-19 vaccine when used in adolescents.

The updated findings from the companies’ pivotal Phase 3 trial show that a two-dose series of the Comirnaty Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose.

And the adverse event profile was generally consistent with other clinical safety data for the vaccine.

Furthermore, no serious safety concerns were observed in individuals with at least six months of safety follow-up after the second dose.

“These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 to 15 years of age,” said Ugur Sahin, CEO, and Co-founder of BioNTech.

These longer-term follow-up data will form the basis for a planned supplemental Biologics License Application to be submitted to the FDA to expand approval of the vaccine for use in individuals 12 years and older. The vaccine is currently available for individuals 12 to 15 years of age under emergency authorization.

In individuals 12 years of age and older, a third primary series dose may be administered at least four weeks after the second dose to individuals who are determined to have certain kinds of immunocompromise.

And a single booster dose of the vaccine may be administered at least six months after completion of a primary series to individuals 18 years of age and older.

Moreover, myocarditis and pericarditis have occurred in some people who have received the vaccine, more commonly in males under 40. In most of these people, symptoms began within a few days following receipt of the second dose of the Comirnaty vaccine. The chance of having this occur is very low, says Pfizer.

A new study was presented by Dr. Steven Grundy at the Scientific Sessions of the American Heart Association annual conference on November 8, 2021, and published in the Circulation scientific journal, found an increased heart health risk related to mRNA based COVID-19 vaccines.

These researchers conclude 'that the mRNA vaccine dramatically increases inflammation on the endothelium and T cell infiltration of cardiac muscle and may account for the observations of increased thrombosis, cardiomyopathy, and other vascular events following vaccination.'

This team used the PLUS Cardiac Test, a clinically validated measurement of multiple protein biomarkers which generates a score predicting the 5 yr risk (percentage chance) of a new Acute Coronary Syndrome (ACS).

The score is based on changes from the norm of multiple protein biomarkers, including IL-16, a proinflammatory cytokine, soluble Fas, an inducer of apoptosis, and Hepatocyte Growth Factor (HGF), which serves as a marker for chemotaxis of T-cells into the epithelium and cardiac tissue, among other markers.

Elevation above the norm increases the PULS score, while decreases below the norm lower the PULS score.

The score has been measured every 3-6 months in our patient population for eight years.

Recently, with the advent of the mRNA COVID 19 vaccines, dramatic changes in the PULS score became apparent in most patients.

This report summarizes those results.

A total of 566 adult patients seen in a preventive cardiology practice had a new PULS test drawn from 2 to 10 weeks following the 2nd COVID-19 dose and was compared to the previous PULS score drawn 3 to 5 months previously pre-shot.

• Baseline IL-16 increased from 35=/-20 above the norm to 82 =/- 75 above the norm post-vac.
• sFas increased from 22+/- 15 above the norm to 46=/-24 above the norm post-vac;
• HGF increased from 42+/-12 above the norm to 86+/-31 above the norm post-vac.

These changes increased the PULS score from 11% 5 yr ACS risk to 25% 5 yr ACS risk.

At the time of this report, these changes persist for at least 2.5 months post the second dose of mRNA vaccine.

Steven Gundry, MD, is a renowned cardiologist, New York Times best-selling author, and medical researcher. During his 40-year career in medicine, he has performed over 10,000 heart surgeries.

Note: Abstract 10712: mRNA COVID Vaccines Dramatically Increase Endothelial Inflammatory Markers and ACS Risk as Measured by the PULS Cardiac Test: a Warning.