Coronavirus Breaking News

Oct 27, 2021 • 9:39 am CDT

What Do These New Vaccination Terms Mean?

The US Centers for Disease Control and Prevention (CDC) published updated terminology for COVID-19 vaccine dosing schedules on October 25, 2021.

These new CDC terms are as follows:

Primary series: 2-dose series of an mRNA COVID-19 vaccine (Pfizer-BioNTech and Moderna) or a single dose of Janssen vaccine
Additional dose after an initial primary series: a subsequent dose of vaccine administered to people who likely did not mount a protective immune response after primary vaccination in order to optimize vaccine-induced protection. An additional mRNA COVID-19 vaccine dose is recommended for moderately to severely immunocompromised people who received an mRNA vaccine primary series.
Booster dose: a subsequent dose of vaccine administered to people with protection from primary vaccination is likely to have waned over time.
Homologous booster dose: a subsequent dose of vaccine that is the same product as the primary series
Heterologous booster dose (mix-and-match booster): a subsequent dose of vaccine that is a different product than the primary series

The CDC stated these terms could be updated when additional information becomes available or if different vaccine products are approved or authorized.

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Oct 26, 2021 • 12:14 pm CDT

Are Companies Requiring COVID-19 Testing and Vaccination?

In September 2021, the U.S. government directed the Occupational Safety and Health Administration (OSHA) to draft rules requiring private companies with 100 or more employees to ensure their staff are vaccinated against COVID-19 or test those who aren’t at least once a week.

On October 12, 2021, OSHA submitted its proposal to the Office of Management and Budget, which revealed the following data points:

41% of employers have enacted a vaccine mandate. Amongst employers who haven’t passed a vaccine mandate, 40% are still unsure if they will,
38% of employers have enacted a testing program. Of those who haven’t, 49% say they won’t. Almost as many, 47%, are still unsure if they will.

BioSpace published an insightful review of this new OSHA data on October 26, 2021. Click here to access their pdf.

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Oct 26, 2021 • 11:42 am CDT

U.S. Begins Investing $3 Billion into COVID-19 Testing

The U.S. Department of Health and Human Services (HHS) recently invested more than half a billion dollars in increasing domestic COVID-19 test-related supplies.

These HHS investments are an integral part of the U.S. Administration's strategy to expand COVID-19 testing and make tests more widely available for Americans and protect public health.

As of October 25, 2021, over 607 million RT-PCR diagnostic tests had been performed to confirm SARS-CoV-2 coronavirus infections since the COVID-19 pandemic began in late 2019.

In recent weeks, HHS, in partnership with the Department of Defense, has awarded over $562 million to a dozen U.S. companies to support manufacturing supplies like pipette tips, protective packaging, swabs, and reagents used to detect the evolving coronavirus in samples.

A list of companies receiving the HHS investments is available on this webpage.

In September 2021, the Administration confirmed it would invest a total of $3 billion in rapid testing to quadruple the supply of at-home tests by December 2021 and increase the number of no-cost testing sites, including up to 30,000 pharmacies.

Recently, the National Institutes of Health (NIH) announced it is investing $70 million of that amount to help bring additional high-quality, at-home tests onto the U.S. market.

The NIH's Independent Test Assessment Program will establish an accelerated pathway to support U.S. FDA evaluation of tests with potential for large-scale manufacturing. This new program is an extension of the NIH Rapid Acceleration of Diagnostics initiative.

The latest SARS-CoV-2 virus testing news is available on this Coronavirus Today webpage.

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Oct 26, 2021 • 7:32 am CDT

South Korea Authorized to Produce Russian COVID-19 Vaccines

The Russian Direct Investment Fund (RDIF) and South Korea-based GL Rapha (Hankook Korus Pharm Co., Ltd) announced the issuance of a GMP certificate by the Ministry of Industry and Trade of Russia to produce Sputnik vaccines in Korea.

This is the first time a foreign production partner of RDIF obtained a Russian GMP certificate.

In a press release, Whang Jae Gan, CEO of Hankook Korus Pharm Co, commented, "It is our honor to be the first partner outside Russia to obtain the Russian GMP certificate for production Sputnik Vaccines."

"From the humanitarian perspective, our greatest goal is mass production and widespread use of Sputnik Vaccines in many countries."

"Hankook Korus Pharm Co., Ltd. has already finished preparing commercial amounts of Sputnik Vaccines for the shipment."

The RDIF and GL Rapha have agreed to produce over 150 million Sputnik V vaccines per year.

Sputnik V is a vector vaccine based on adenovirus DNA, in which the SARS-CoV-2 coronavirus gene is integrated.

Adenovirus is used as a "container" to deliver the coronavirus gene to cells and start synthesizing the new coronavirus's envelope proteins, "introducing" the immune system to a potential enemy.

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Oct 26, 2021 • 6:07 am CDT

The African Union Purchases Millions of Moderna's mRNA COVID-19 Vaccines

Massachusetts-based Moderna, Inc. today announced a Memorandum of Understanding to make up to 110 million doses of the Company's COVID-19 vaccine (SpikeVax) available to the African Union.

The vaccine delivery schedule indicates the first 15 million doses in the fourth quarter of 2021, 35 million doses in the first quarter of 2022, and up to 60 million doses in the second quarter of 2022.

Moderna is also working on plans to fill doses of its COVID-19 vaccine in Africa as early as 2023, in parallel to building an mRNA vaccine manufacturing facility in Africa.

Furthermore, the Company recently announced an investment of up to $500 million to plan to build a state-of-the-art mRNA facility in Africa to produce up to 500 million doses of vaccines at the 50 µg dose level each year.

Stéphane Bancel, Moderna's CEO, stated in a press release, "We believe our vaccine can play an important role in addressing the needs of low-income countries given its combination of high Phase 3 efficacy against COVID-19, strong durability in the real-world evidence, and superior storage and handling conditions."

"We recognize that access to COVID-19 vaccines continues to be a challenge in many parts of the world, and we remain committed to helping to protect as many people as possible around the globe."

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Oct 25, 2021 • 3:51 pm CDT

As COVID-19 Testing Slows, So Does the Infection Rate

The percent of positive tests for the SARS-CoV-2 betacoronavirus that causes COVID-19 continues to decrease in the U.S.

On October 23, 2021, the U.S. CDC reported COVID-19 NAATs (nucleic acid amplification tests) that are positive (percent positivity) results decreased from the previous week. The 7-day average of percent positivity from NAATs is now 5.2%.

And the 7-day average number of tests reported for October 8–October 14, 2021, was 1,416,658, a decrease of 7.4% from the previous seven days.

Since the COVID-19 pandemic began in early 2020, the CDC's Data Tracker has reported over 607 million RT-PCR diagnostic tests results.

Additionally, the U.S. FDA confirmed on October 22, 2021; it had authorized 419 coronavirus diagnostic tests during the pandemic.

These innovative tests include molecular, antibody, and antigen tests.

Furthermore, FDA authorizations can be used with home-collected samples. There is a molecular prescription at-home test, antigen prescription at-home tests, OTC at-home antigen tests, and OTC molecular tests.

However, SARS-CoV-2 virus antibody tests are not validated to evaluate specific immunity or COVID-19 vaccine protection.

Visit the FDA website for a list of authorized COVID-19 diagnostic methods.

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Oct 23, 2021 • 3:31 pm CDT

Statin Treatments May Moderate COVID-19 Mortality

During the COVID-19 pandemic, it has been debated whether statins influence the risk of death from COVID-19. Researchers at Karolinska Institutet in Sweden conducted an extensive population study to date to answer that question.

This new, extensive study found statin treatment was associated with a moderately lower risk of COVID-19 mortality (hazard ratio (HR), 0.88; 95% CI, 0.79 to 0.97), after accounting for a series of preexisting health conditions and other factors.

And the association was corroborated by sensitivity analyses and did not vary substantially across risk groups.

The study was published in the journal PLOS Medicine on October 14, 2021, says 'Statin treatment had a modest negative association with COVID-19 mortality.'

'While this finding needs confirmation from randomized clinical trials, it supports the continued use of statin treatment for medical prevention according to current recommendations also during the COVID-19 pandemic.'

Statins are a recommended and common intervention for preventing cardiovascular events by reducing lipoprotein cholesterol levels in the blood.

Statins are used to lower the cholesterol level – the lipid count – in the blood and are standard preventative treatment in patients at high risk of cardiovascular events.

Earlier studies have not provided an unequivocal answer and have often suffered from the limitation that they have only included hospital inpatients, said these researchers.

Using data from Swedish health registers, a cohort of 963,876 residents of Stockholm, Sweden, were followed from March 2020 until mid-November 2020.

"All in all, our findings support the continued use of statins for conditions such as cardiovascular disease and high levels of blood lipids in line with current recommendations during the COVID-19 pandemic," says co-first author Viktor Ahlqvist, a doctoral student at the Department of Global Public Health, Karolinska Institutet.

One limitation of the study concerns the use of prescription data without the possibility of checking individual drug use. The researchers were also unable to control for risk factors such as smoking and high BMI, only diagnosed health status.

The researchers received no financing for the study.

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Oct 23, 2021 • 8:44 am CDT

COVID-19 Booster Shot Eligibility Expands

The U.S. C.D.C. Director Rochelle P. Walensky, M.D., M.P.H., announced on October 21, 2021, her endorsement and approval of the Advisory Committee on Immunization Practices' (ACIP) recommendation for a booster shot COVID-19 vaccines in specific populations.

There are now booster recommendations for all three COVID-19 vaccines available in the United States.

Available data shows that all three of the COVID-19 vaccines approved or authorized in the U.S. continue to be highly effective in reducing the risk of severe disease, hospitalization, and death.

For over 15 million people who got the Johnson & Johnson Janssen COVID-19 vaccine, booster shots are also recommended for those 18 and older and vaccinated two or more months ago.

For individuals who received a Pfizer-BioNTech (Comirnaty) or Moderna (SpikeVax) COVID-19 vaccine, the following groups are eligible for a booster shot at six months or more after their initial series:

65 years and older
Age 18+ who live in long-term care settings
Age 18+ who have underlying medical conditions
Age 18+ who work or live in high-risk settings

Dr. Walensky stated in a press release, "The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given."

"And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even amid the widely circulating Delta variant."

The ACIP recommendation for use is an important step forward as it works to stay ahead of the mutating SARS-CoV-2 coronavirus and keep Americans safe.

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Oct 22, 2021 • 10:29 am CDT

Childhood Obesity Concerns Increased During COVID-19 Pandemic

The U.S. CDC confirmed on October 15, 2021, fewer cases of COVID-19 have been reported in children (ages 0-17 years) compared with adults. And, the rates of COVID-19-associated hospitalizations are also lower in children of all ages.

However, children with underlying medical conditions, including obesity, are at increased risk for severe COVID-19 illness.

Children diagnosed with obesity may experience worse outcomes from COVID-19.

A recent CDC study examining body mass index suggests that many children gained weight faster during the COVID-19 pandemic than in prior years. This trend was especially true among those who had been overweight or obese before the pandemic.

According to the CDC, there have been 542 deaths in people under 18 attributed to COVID-19 (vaccination and comorbidity status undisclosed) since January 2020 (22 months).

The CDC says, 'All eligible people, including adolescents aged 12-17 years, should get vaccinated to help stop the COVID-19 pandemic.'

There are three COVID-19 vaccines Approved and/or Authorized for this age group in the U.S. And about twenty other COVID-19 vaccines available for adolescents globally.

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Oct 21, 2021 • 5:31 pm CDT

U.S. Proceeds with Boosters and Mixing COVID-19 Vaccinations

The US Centers for Disease Control and Prevention (CDC) vaccine advisory committee unanimously voted in the affirmative late on October 21, 2021, supporting booster vaccinations for the SpikeVax COVID-19 vaccine from Moderna and the Janssen COVID-19 vaccine from Johnson & Johnson.

Additionally, the CDC's vaccine committed embraced the option of "mixing and matching" between the three Authorized/Approved COVID-19 vaccines in the U.S.

The CDC committee's two-day meeting presentations are available at this link.

The CDC committee and Director previously approved the Comirnaty vaccine from Pfizer-BioNTech. And the US Food and Drug Administration had already authorized such authorizations.

As of October 21, 2021, the CDC data dashboard reported about 57.2% of eligible persons in the U.S. are fully vaccinated.

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Oct 21, 2021 • 5:13 pm CDT

UK Reports Accelerating COVID-19 Cases and Fatalities

Sajid Javid, Member of Parliament for Bromsgrove & Secretary of State for Health and Social Care, acknowledged to the media on October 20, 2021, 'Covid-19 cases could yet climb as high as 100,000 per day.'

The UK government posted a presentation that reflects the surge of new COVID-19 cases. And the real-time data is available at this link.

And today, Javid Tweeted late on October 21, 2021, '234,000 booster vaccine bookings were made yesterday alone, a record achievement!

The NHS says 'booster vaccine doses will be available for people most at risk from COVID-19 who have had a 2nd dose of a vaccine at least six months ago.'

And, people in England can use this digital service to book a COVID-19 vaccination or manage their appointments.

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Oct 21, 2021 • 4:51 pm CDT

Moscow Confronts New COVID-19 Sub-Variant

The Moscow Times reported Moscow Mayor Sergei Sobyanin imposed a non-working period between October 28, 2021, and until November 7, 2021, to "break the SARS-CoV-2 virus transmission chain."

Russia reported on October 21, 2021, a record-high number of both new coronavirus cases and deaths. Officials reported 36,339 new coronavirus cases and 1,036 fatalities from Covid-19 over the last 24 hours.

Furthermore, a Russian scientist warned 'a new sub-variant of the Delta strain of the SARS-CoV-2 virus (AY.4.2) had been identified.

COVID-19 vaccinations have not become mandatory in Russia.

The announced restrictions suspend businesses, services, catering, sports, recreation, entertainment, and film screenings, except for the sale of essential goods like medicines and food.

Mass events, except those authorized by health officials, will be banned.

And theater and museum attendance will be capped at 50% with mask-wearing and digital-code rules in place.

In-person public services will be suspended, as will kindergartener and schools.

The Moscow region introduced identical restrictions shortly after Sobyanin's announcement.

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Oct 19, 2021 • 4:53 pm CDT

Ireland’s COVID-19 Vaccination Program Includes Boosters

Ireland's Minister for Health, Stephen Donnelly TD, announced several updates to Ireland's COVID-19 Vaccination Programme on October 19, 2021.

These updates follow the National Immunisation Advisory Committee (NIAC) recommendation to the Chief Medical Officer.

The NIAC recommended a booster dose of the mRNA Comirnaty® (Pfizer-BioNTech) COVID-19 vaccine be offered to those aged 60 to 79 years who have completed their primary course with any COVID-19 vaccine.

The Comirnaty booster dose should ideally be given six months following the primary two or one-dose vaccination schedule.

However, if a person for whom a booster dose is recommended had a laboratory-confirmed COVID-19 infection after the primary vaccine course, known as a Breakthrough Infection, the booster dose should be delayed for at least six months.

Minister Donnelly said in a press statement, "Since Ireland's Vaccination Programme began late last year, I have announced several updates of the vaccine prioritization program, each with the same aim - to protect those most at high risk from severe illness and death from COVID-19."

"The roll-out of the booster program continues to rely on using vaccines which are safe and effective, and in doing so, means that we are continuing to prioritize our at-risk loved ones."

Ireland's actions are related to the European Medicines Agency, which concluded on October 4, 2021, that booster doses may be considered at least six months after the second dose for people aged 18 years and older. At a national level, public health bodies may issue official recommendations on the use of booster doses, taking into account emerging effectiveness data and the limited safety data.

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Oct 19, 2021 • 11:04 am CDT

U.S. FDA Advisory Committee Meeting to Discuss COVID-19 Oral Treatment

The U.S. Food and Drug Administration announced an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback's request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19.

On November 30, 2021, the AMDAC will meet to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate COVID-19.

Molnupiravir is an oral antiviral developed initially to treat influenza. Molnupiravir is a bioavailable form of a potent ribonucleoside analog that inhibits replicating multiple RNA viruses, including SARS-CoV-2, the causative agent of COVID-19.

"The FDA is evaluating the safety and effectiveness data submitted by Merck and Ridgeback in their emergency use authorization request for molnupiravir, a new oral treatment for high-risk individuals with a newly diagnosed COVID-19 infection."

"We believe that, in this instance, a public discussion of these data with the agency's advisory committee will help ensure a clear understanding of the scientific data and information that the FDA is evaluating to decide whether to authorize this treatment for emergency use," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, in a press release.

The agency may convene an advisory committee to solicit advice from independent outside experts on various complex scientific, technical, and policy issues at the FDA's discretion.

The FDA does not always convene an advisory committee meeting in connection with EUA reviews but may do so under certain circumstances when discussion with the advisory committee will help inform agency decision making.

The FDA intends to live stream the AMDAC meeting on the agency's webcast from the FDA website.

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