Coronavirus Breaking News

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

Oct 1, 2021 • 12:32 pm CDT

Regeneron Pharmaceuticals, Inc. announced on September 30, 2021, that a trial assessing investigational REGEN-COV™ in patients hospitalized with COVID-19 met its primary endpoint.

Clinical trial results show that REGEN-COV significantly reduced viral load in patients hospitalized with COVID-19 who entered the trial without mounting their antibody response (seronegative) and required low-flow or no supplemental oxygen (p=0.0172).

Numeric improvements with REGEN-COV were observed for all clinical endpoints, including a 36% reduced risk of death by day 29 in the overall population, increasing to 56% reduced risk in patients who were seronegative at baseline.

And similar efficacy was observed with both doses (2,400 mg and 8,000 mg).

The trial also had clinical results supporting the much larger UK RECOVERY trial in hospitalized patients, with numeric improvements observed across all clinical endpoints assessed.

"COVID-19 continues to have a devastating impact on patients, our communities, and healthcare systems, and has so far killed more than one in every 500 Americans," commented Eleftherios Mylonakis, M.D., Ph.D., primary investigator of the trial and Professor of Medicine, Molecular Microbiology and Immunology, and Director of Infectious Disease at Brown University and the Lifespan hospitals, in a press release.

The U.S. FDA is currently reviewing the request to add treatment in hospital settings to REGEN-COV authorization, says the company.

REGEN-COV is an investigational medicine authorized by the FDA under an emergency use authorization to treat people at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in specific post-exposure prophylaxis settings.

In the U.S., it is not currently authorized in patients who are hospitalized due to COVID-19 infection.

Monitor SARS-CoV-2 virus variants with Regeneron's COVID-19 Dashboard.

Regeneron (NASDAQ: REGN) is a leading biotechnology company located in Tarrytown, NY, which invents life-transforming medicines for people with serious diseases. 

Oct 1, 2021 • 8:53 am CDT

Florida-based Merck Ridgeback Biotherapeutics and Merck today announced that an investigational oral antiviral medicine known as molnupiravir (MK-4482, EIDD-2801) significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT clinical trial in at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19. 

At the Interim Study Analysis, 7.3% of patients who received molnupiravir were hospitalized through Day 29, compared with 14.1% of Placebo-Treated Patients who were hospitalized or died.

Merck stated in a press release it plans to seek Emergency Use Authorization in the U.S. and submit Applications to Regulatory Agencies worldwide. If Authorized, molnupiravir could be the first Oral Antiviral Medicine for COVID-19.

Robert M. Davis, CEO and president, Merck, commented, “On behalf of all of us at Merck, I thank our network of clinical investigators and patients for their essential contributions to the development of molnupiravir.”

Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. 

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases.

Sep 30, 2021 • 1:22 pm CDT

Texas Governor Greg Abbott today announced that the Texas Division of Emergency Management (TDEM), in partnership with local officials, will open another COVID-19 therapeutic infusion center. Local partners include Burnet County, Baylor Scott & White Health Hill Country, and the City of Burnet.

The new facility in Burnet opens to the public on October 1, 2021, and has been provided with monoclonal antibodies to treat outpatient cases of COVID-19 with a doctor's referral.

This treatment is available at no cost to the patient.

In a related press release, Burnet County Judge James Oakley stated, "This life-saving treatment will serve many rural Texans."

One of the treatments offered is Regeneron's REGEN-COV Monoclonal Antibody Cocktail, which combines casirivimab and imdevimab. This treatment was designed to block the infectivity of SARS-CoV-2, the coronavirus that causes COVID-19.

Gov. Abbott was successfully treated with REGEN-COV in August 2021, following two doses of a COVID-19 vaccine and COVID-19 reinfection.

COVID-19 antibody infusion treatment can prevent a patient's condition from worsening and requiring hospital care. These facilities also help increase bed capacity in hospitals so that resources are available for the illest patients.

Governor Abbott, TDEM, and the Texas Department of State Health Services have established and expanded antibody infusion centers in communities across the state over the past several months. 

These state-sponsored infusion centers are in addition to the infusion treatment centers provided by more than 200 private health providers across the state.

Texans can visit meds.tdem.texas.gov to find a therapeutic provider.

Sep 28, 2021 • 4:13 pm CDT

Russian Foreign Minister Sergey Lavrov announced a general debate during the 76th session of the UN General Assembly on September 25, 2021, 'Russia supports mutual recognition by countries of COVID-19 vaccines approved at a state-level," reported TASS.

"We support mutual recognition of vaccines approved by national oversight bodies, in the interests of lifting restrictions on international travel of citizens as soon as possible," Lavrov said. COVID-19 is our common enemy."

Russia was the world's first country to register a coronavirus vaccine, Sputnik V, on August 11, 2020, and applied for its registration in the European Union and with the World Health Organization. 

The Sputnik V vaccine is currently in use by seventy countries globally.

"We do not tolerate the attempts to restrict, discriminate against the vaccines that have not been registered in the United States but have proved their efficacy multiple times."

"We already have several EU countries which have registered our vaccines on their soil," he added.

Sputnik V is a two-dose vaccine that uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response. It is a vector vaccine based on adenovirus DNA, in which the SARS-CoV-2 coronavirus gene is integrated.

The Sputnik Light Vaccine is a single-dose vaccine.

According to GAVI, on September 22, 2021, there were 117 COVID-19 vaccine candidates undergoing clinical trials and 194 candidates in pre-clinical development.

Sep 26, 2021 • 7:11 am CDT

Radio Free Europe reported on September 26, 2021, Russian Foreign Minister Sergey Lavrov stated to the UN General Assembly, "We support mutual recognition of vaccines approved by national oversight bodies, in the interests of lifting restrictions on international travel of citizens as soon as possible."

While speaking in New York City on September 25, Minister Lavrov continued to say, "COVID-19 is our common enemy."

With over twenty COVID-19 vaccines in use globally, and 117 vaccine candidates conducting clinical trials, populations have ample choices when selecting a vaccine, reports GAVI.

Here is a link to GAVI's at-a-glance overview of those vaccines and recent developments of candidates in clinical trials.

As of September 26, 2021, the USA recognizes three COVID-19 vaccines, and European leaders have authorized a total of five vaccines.

Sep 24, 2021 • 9:31 am CDT

The U.S. C.D.C. Director Rochelle P. Walensky, M.D., M.P.H., announced today she endorsed the Advisory Committee on Immunization Practice (ACIP) recommendation on September 23, 2021, for a booster (3rd) shot of the Pfizer-BioNTech COVID-19 (Comirnaty) vaccine in specific populations.

Dr. Walensky also recommended a booster dose for those in high-risk occupational and institutional settings, regardless of age.

The C.D.C.'s guidance is for two-dose Comirnaty, but not the U.S. Food and Drug Administration's Authorized Moderna's SpikeVax or Janssen COVID-19 vaccines.

'We will also evaluate with similar urgency available data in the coming weeks to swiftly make additional recommendations for other populations and people who got the Moderna or Johnson & Johnson (Janssen) vaccines,' stated the C.D.C. press release issued on September 24, 2021.

The C.D.C. works 24/7 protecting America's health, safety and security. Whether diseases start at home or abroad, are curable or preventable, chronic or acute, or from human activity or deliberate attack, C.D.C. responds to America's most pressing health threats. The C.D.C. is headquartered in Atlanta, GA.

 

Sep 23, 2021 • 6:26 am CDT

The European Centre for Disease Prevention and Control (ECDC) published updated maps on September 23, 2021, supporting the Council Recommendations on a coordinated approach to travel measures in the European Union EU.

To limit the spread of the COVID-19 outbreak, the EU’s 27 Member States have adopted travel measures that have impacted citizens’ right to move freely across the EU, including requirements to undergo quarantine or take a coronavirus test, says the ECDC.

The color-coded maps indicate a 14-day notification rate, testing rate, and coronavirus test positivity.

As of week #37 in 2021, over 229 million cases of COVID-19 have been reported to the ECDC, including 4.6 million deaths.

Furthermore, the total number of COVID-19 vaccines distributed by manufacturers to EU/EEA countries had exceeded 680 million, with 29 countries reporting data.

A well-coordinated, predictable and transparent approach to the adoption of restrictions on freedom of movement is necessary to prevent the spread of the SARS-CoV-2 coronavirus, safeguard the health of citizens, and maintain free movement within the EU under safe conditions.

The Council Recommendations are available at this link.

The ECDC is an agency of the EU.

Sep 22, 2021 • 2:57 pm CDT

The American Journal of Obstetrics & Gynecology published a Research Letter - High antibody levels in cord blood from pregnant women vaccinated against COVID-19 - on September 21, 2021.

This minimal study's findings demonstrate transplacental antibody transfer following mRNA COVID-19 vaccination during pregnancy, with 100% of cord blood specimens having high levels of anti-S antibodies.

Given the combination of positive anti-S IgG and negative anti-N IgG, the neonatal antibodies were secondary to the vertical transfer of antibodies from maternal vaccination rather than natural infection.

The moderately high anti-S IgG titers in two women with longer latency between vaccination and delivery suggest that cord blood antibody level may correlate with an interval of time from vaccine administration to delivery.

Further investigation is needed to determine if vaccination in the second half of pregnancy may confer higher levels of antibody transfer than vaccination earlier in pregnancy.

Most guidance on the importance of vaccination during pregnancy stems from concern for pregnancy as a risk factor for severe COVID illness in the mother. Unfortunately, recent data suggests only 16.3% of pregnant women have been vaccinated despite evidence of prenatal vaccine safety.

Sep 22, 2021 • 12:19 pm CDT

Germany-based BioNTech SE and Pfizer Inc. announced plans to expand their agreement with the U.S. government by providing an additional 500 million doses of the companies' mRNA COVID-19 vaccine Comirnaty at a not-for-profit price for donation to low- and lower-middle-income countries and the organizations that support them.

This expanded agreement brings the total number of doses to be supplied to the U.S. government for donation to these countries to one billion.

Deliveries of the initial 500 million doses began in August 2021, and the total of one billion doses under the expanded agreement is expected to be delivered by the end of September 2022.

The current plan is to produce these doses in Pfizer's U.S. facilities located in Kalamazoo, MI, Andover, MA, Chesterfield, MO, and McPherson, KS.

Consistent with the initial agreement in June 2021, the U.S. government will allocate doses of the Comirnaty Vaccine to 92 low- and lower-middle-income countries as defined by Gavi's COVAX Advanced Market Commitment and the 55 member states of the African Union.

"BioNTech, Pfizer, and our partners are working day and night to make our vaccine available to people around the world. We are therefore particularly excited and grateful to mark the next milestone in collaboration with the U.S. government, which will further accelerate the delivery of our vaccine to people in the poorest regions," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech, in a related press statement.

"In the short term, we have pledged to deliver at least one billion doses this year and at least one billion doses next year to low- and middle-income countries. In parallel, we are exploring how to build a sustainable mRNA production infrastructure in low-income countries to democratize access to vaccines in the mid-and long term. This applies to both individual production steps and complete manufacturing."

Overall, Pfizer and BioNTech have shipped more than 1.5 billion COVID-19 vaccine doses worldwide.

The Comirnaty vaccine is based on BioNTech'sproprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

The U.S. FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. Therefore, an individual may be offered either COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine to prevent COVID-19 caused by the SARS-CoV-2 betacoronavirus.

Biopharmaceutical New Technologies (BioNTech, Nasdaq: BNTX) is a next-generation immunotherapy company located in Mainz, Germany, pioneering novel therapies for cancer and other serious diseases.

Sep 21, 2021 • 2:31 pm CDT

The Virginia Department of Health (DOH) announced on September 16, 2021, the addition of short-response (QR) codes to Virginia COVID-19 vaccination records. QR codes enable anyone to show proof of vaccination with a digital or printed QR code instead of a paper card without an app.

A person vaccinated in Virginia can visit vaccinate.virginia.gov to obtain their free vaccination record with a QR code, which can be saved to a phone, printed on paper, or stored in a compatible account.

QR codes are available to anyone whose vaccination record includes a working phone number and is in the Virginia Immunization Information System.

Because the Virginia Department of Health digitally signs the QR code, it cannot be altered or forged.

And information from QR codes is only available if and when the individual chooses to share it, says the Virginia DOH.

Virginia is now the fifth U.S. state to adopt the SMART Health format for QR codes. The framework and standards were developed by VCI, a coalition of more than 800 public and private organizations, including The Mayo Clinic, Boston Children’s Hospital, Microsoft, MITRE, and The Commons Project Foundation.

The U.S. CDC says Immunization information systems are confidential, population-based, computerized databases that record all immunization doses administered by participating providers to persons residing within a given geopolitical area.

Sep 20, 2021 • 10:40 am CDT

Local media in Thailand reported today the Chulabhorn Royal Academy (CRA) began its COVID-19 vaccination campaign for schoolchildren aged 10-18 years in Bangkok. The CRA offered 2,000 students the Sinopharm Covid-19 vaccine.

CRA staff administered this China-produced COVID-19 vaccine with parents' approval, confirmed the Bangkok Post on September 20, 2021.

The CRA plans to vaccinate about 180,000 students from 132 schools near Bangkok who have applied to the academy for vaccination.

The Royal College of Chulabhorn began offering the Sinopharm COVID-19 vaccine to various populations in Thailand on August 24, 2021.

The Sinopharm COVID-19 vaccine (BBIBP-CorV) is an inactivated vaccine made of virus particles grown in culture and lack disease-producing capability.

The Lancet published results on September 15, 2021, from a limited study that found the inactivated COVID-19 vaccine BBIBP-CorV was safe and well-tolerated at all tested dose levels in participants aged 3–17 years.

Separately, Thailand's health ministry plans to offer the Comirnaty (Pfizer-BioNTech) mRNA vaccine to older students aged 12-18 located in 29 provinces beginning in October 2021. First, however, the students' parents must give their pre-approval.

Previously, Thailand's National Vaccine Board approved a policy of procuring 150 million doses of COVID-19 vaccines by 2022.

To meet this goal, the Chulabhorn Royal College announced on September 14th it would procure and distribute 8 million doses of the SpikeVax Covid-19 Vaccine Moderna (100 mcg/dose) as a booster vaccine. The first shipments are expected in the first quarter of 2022 and will continue through the third quarter.

Thailand's COVID-19 pandemic dashboard, updated as of September 20th, is available at this link.

Sep 19, 2021 • 3:01 pm CDT

To support disease mitigation strategies for children who are at high risk of developing severe COVID disease, a group of physicians at Monroe Carell Jr. Children’s Hospital at Vanderbilt, located in Tennessee, studied data from 45 children’s hospitals around the USA.

The retrospective cohort study noted that approximately 20% of children admitted to hospitals with COVID developed severe disease and required Intensive care unit care during April and September 2020.

Older children and adolescent patients had a lower risk of hospitalization. However, when hospitalized, they had greater illness severity.

Those with selected comorbidities (cardiovascular, obesity, type 2 DM, pulmonary and neurologic or neuromuscular disease had both increased odds of hospitalization and in-hospital illness severity. 

The study, “Factors Associated with COVID-19 Disease Severity in U.S. Children,” published in the Journal of Hospital Medicine on September 15, 2021, determined the factors associated with severe disease and poor health outcomes among 2,000 children presenting to the hospital with COVID.

These included older age and chronic comorbidities such as obesity, diabetes, and neurologic conditions, among others.

“This is one of the largest multicenter studies of children with COVID-19 in the United States,” stated James Antoon, M.D., Ph.D., FAAP, assistant professor of Pediatrics at Children’s Hospital and lead author of the study, in a press release.

“And given the recent, concerning increases in COVID cases nationwide and the fact that the vast majority of children remain unvaccinated and susceptible, these findings should be taken into account when considering preventive strategies in schools and planning vaccinations when available for children less than 12 years of age,” Antoon added.

“These factors help identify vulnerable children who are most likely to require hospitalization or develop severe COVID-19 disease,” said Antoon. “Our findings also highlight children who should be prioritized for COVID-19 vaccines when approved by the FDA.”

“Across the country, there is a raging debate on how best to protect children and schools from COVID-19,” said Antoon. “Some children are at increased risk for more severe disease, and many of them are not yet eligible for a vaccination against COVID.

No industry conflicts of interest were disclosed by the researchers.

Sep 17, 2021 • 10:21 am CDT

France's health minister confirmed on September 16, 2021, about three thousand health care workers across the country have been suspended without pay for failing to get a required COVID-19 vaccine.

"Some 3,000 suspensions were notified yesterday to employees at health centers and clinics who have not yet been vaccinated," Olivier Véran told France's RTL radio, reported NPR.

Defending the decision to suspend those who did not meet the deadline, Véran said that "the continuity of care, the security of care, and the quality of care were assured yesterday in all hospitals and health-care facilities" in France.

Additionally, several dozen employees resigned rather than meet the vaccine requirement, Veran added.

As of September 17, 2021, four COVID-19 vaccines are Approved for Use in France.

A toll-free hotline service (French only) can answer your questions about the Coronavirus COVID-19: 0 800 130 000 (from abroad: +33 800 130 000, depending on your operator).

Sep 17, 2021 • 9:50 am CDT

Nearly half of New York City (NYC) mothers who had been trying to become pregnant again before the coronavirus pandemic began stopped in the first few months of the COVID-19 outbreak, a new study led by researchers at NYU Grossman School of Medicine shows.

This survey of 1,179 mothers in NYC also found that one-third of women who had been thinking about becoming pregnant before the pandemic but had not yet begun trying said they were no longer considering having another child.

Published on September 15, 2021, in the JAMA Network Open, this is the first to examine pregnancy plans among mothers during the first wave of COVID-19. 

“Our findings show that the initial COVID-19 outbreak appears to have made women think twice about expanding their families and, in some cases, reduce the number of children they ultimately intend to have,” said study lead author and epidemiologist Linda Kahn, Ph.D., MPH, in a press statement.

Early evidence has already identified a birthrate decline in the United States during the COVID-19 pandemic.

Recent data showed that the country saw roughly 300,000 fewer births in 2020 than experts had expected based on annual fertility trends, with a particular drop in the last two months of the year, which corresponds with fewer conceptions at the beginning of the outbreak.

“These results emphasize the toll the coronavirus has taken not only on individual parents but perhaps on fertility rates overall,” says study senior author epidemiologist Melanie Jacobson, Ph.D., MPH.

The study authors next plan to repeat the survey with the same group of mothers and explore the potential impact of COVID-19 vaccination, an option not available at the survey time. 

National Institutes of Health grants provided funding for the study. No researcher disclosed industry conflicts of interest.

Sep 16, 2021 • 4:09 pm CDT

Pfizer Canada ULC and BioNTech SE announced that Health Canada had granted Approval for COMIRNATY® to prevent COVID-19 in individuals 12 years of age and older.

The vaccine was initially authorized for use in Canada under an Interim Order Authorization on December 9, 2020, and has been referred to as the Pfizer-BioNTech COVID-19 Vaccine.

The formulation for Pfizer-BioNTech COVID-19 Vaccine is the same formulation as COMIRNATY, and they are considered interchangeable by Health Canada.

“Based on the longer-term follow-up data that we submitted, today’s decision by Health Canada affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” said Fabien Paquette, Vaccines Lead, Pfizer Canada, in a press statement issued on September 16, 2021.

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in Canada, the United States, the European Union, and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies.