Coronavirus Breaking News

The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.

Nov 30, 2021 • 2:38 pm CST

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.

Nov 30, 2021 • 10:01 am CST

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.

Nov 30, 2021 • 8:33 am CST

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.

Nov 29, 2021 • 8:00 pm CST

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.'

Nov 29, 2021 • 8:39 am CST

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.'

Nov 29, 2021 • 6:35 am CST

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.  

Nov 28, 2021 • 7:56 am CST

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.

 

Nov 27, 2021 • 8:37 am CST

Kathy Hochul, the Governor of the State of New York, declared on November 26, 2021, a disaster has occurred, for which the affected local governments are unable to respond adequately, and I do hereby declare a State disaster emergency for the entire State of New York through January 15, 2022.

'While the new Omicron variant has yet to be detected in New York State, it's coming,' Tweeted Gov. Hochul.

As of November 27, about 90% of adult New Yorkers have at least one dose of a COVID-19 vaccine dose.

Additionally, Hochul's executive order empowers the Department of Health to limit non-essential, non-urgent scheduled hospital procedures, if necessary, to ensure capacity and protect access to critical care services.

The new medical limitation protocols will begin on December 3 and will be re-assessed on January 15, 2022.

Previously, the local nursing shortage caused changes in health care delivery.

For example, the Emergency Department in Long Beach, operated by Mount Sinai South Nassau, closed temporarily due to nursing staff shortages resulting from the state vaccine mandate.

Nov 26, 2021 • 4:46 pm CST

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.

Nov 26, 2021 • 12:09 pm CST

The AP reported today South African scientists stated it is 'unclear where the new SARS-CoV-2 coronavirus variant arose. It was first identified in Botswana earlier in November 2021.'

The variant harbors a large number of the virus mutations, and it seems to be spreading quickly across South Africa.

"There's a lot we don't understand about this variant," Richard Lessells, an infectious-diseases physician at the University of KwaZulu-Natal in Durban, South Africa, said at a press briefing on November 25th, reported Nature.

"The mutation profile gives us concern, but now we need to do the work to understand the significance of this variant and what it means for the response to the pandemic."

The variant harbors a spike mutation that allows it to be detected by genotyping tests that deliver results much more rapidly than genome sequencing does, Lessells commented.

It has been defined as variant B.1.1.529 by the UK Health Security Agency.

B.1.1.529 was first detected by scientists in South Africa and has now been seen in travelers to Botswana, Hong Kong, and Israel.

The Times of Israel reported today the first case was detected in Israel today. The person is an Israeli who had returned from Malawi.

Israel's health ministry confirmed two other travelers were suspected of also being infected with the new strain and were awaiting final test results.

Nov 26, 2021 • 11:33 am CST

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. 

Nov 26, 2021 • 9:51 am CST

The U.K. Health Security Agency (UKHSA) announced today the new SARS-CoV-2 coronavirus variant B.1.1.529 was declared a variant under investigation (VUL).

The UKHSA stated in a media release that the variant includes many spike protein mutations and mutations in other parts of the viral genome.

These are potentially biologically significant mutations that may change the behavior of the coronavirus with regards to COVID-19 vaccines, antibody and/or antiviral treatments, and transmissibility.

More investigation is currently underway by the WHO and other organizations.

Separately, the WHO announced B.1.1.529 was designated a VOC named Omicron.

As of 9 am CT on November 25, 2021, no B.1.1.529 cases have been identified in the U.K. or U.S.

Nov 25, 2021 • 8:01 am CST

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.

Nov 24, 2021 • 3:22 pm CST

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada had approved its single-shot COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.

This decision was based on scientific evidence, including initial data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85% effective in preventing severe disease.

And the Janssen vaccine showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.  

“We are delighted by Health Canada’s decision to approve the Johnson & Johnson COVID-19 vaccine based on Phase 3 clinical data that proves the vaccine’s robust safety and efficacy,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson, in a press statement.

“As vaccination rates continue to climb, a vaccine that prevents severe disease and protects against COVID-related hospitalization and death will help ease the strain on healthcare systems and is an important option for people in Canada and around the world.”

The Janssen COVID-19 Vaccine (Ad26.COV2.S, recombinant) is indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 coronavirus in individuals 18 years of age and older.

The Janssen COVID-19 vaccine was authorized for use in Canada under the Interim Order respecting the importation, sale, and advertising of drugs for use in relation to COVID-19.

On November 23, 2021, the Janssen COVID-19 vaccine transitioned to an authorization under the Food and Drug Regulations.

Learn more at www.janssen.com/canada. 

Nov 23, 2021 • 5:29 pm CST

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.