Coronavirus Breaking News

Medical Review by

Mar 23, 2021 • 8:41 am CDT

Breast Milk Unlikely to Transmit SARS-CoV-2 to Infants

In a study led by the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), researchers investigated the possibility that the SARS-CoV-2 coronavirus that causes COVID-19 could be transmitted to infants through breast milk.

The study enrolled 18 breastfeeding mothers who tested positive for SARS-CoV-2.

Of the 64 total breast milk samples collected, only one had a detectable level of SARS-CoV-2 RNA (the genetic material of the virus).

Notably, none of the samples contained any detectable coronavirus capable of replicating or causing infection, including the sample that tested positive for SARS-CoV-2 RNA.

Furthermore, results from a separate experiment showed that in milk samples to which SARS-CoV-2 was intentionally added, the virus was not detectable after Holder pasteurization—a process used to kill potentially harmful germs in donated breast milk.

These findings suggest that SARS-CoV-2 is unlikely to be transmitted to their infants through breast milk consumption, wrote the U.S. NIAID on March 22, 2021.

The IMPAACT Network is co-funded by NIAID and is dedicated to significantly decreasing HIV and HIV-associated infections as well as decreasing mortality and morbidity due to HIV and HIV-associated infections and co-morbidities among infants, children, adolescents, and pregnant/postpartum women.

—

Mar 23, 2021 • 8:30 am CDT

Men at Increased Risk for Severe COVID-19

Increasing evidence shows that men tend to have more severe symptoms of COVID-19 and a higher death rate than women with the disease, reported a U.S. NIAID-funded clinical research study enrolled males and females who were admitted to the hospital with moderate or severe COVID-19.

As COVID-19 progressed in study participants, males, but not females, showed associated poor T-cell responses.

Likewise, T-cell responses declined with age in males but not females.

Several key differences in immune responses were seen between males and females with COVID-19. Males had higher blood levels of several proteins called cytokines, which regulate the immune response, including two inflammatory cytokines known as IL-8 and IL-18, at the time of study enrollment (baseline) and over the disease course.

Males also had lower baseline activation of immune cells called CD8 T cells, which can recognize and help eliminate invading viruses.

By contrast, researchers identified elevated levels of a different set of cytokines in females, but not males, that were associated with worsening of the disease.

These findings reveal a possible immunological basis for the differences in disease outcomes between males and females with COVID-19 and provide a potential basis for taking sex-dependent approaches in the treatment of COVID-19, says the NIAID.

—

Mar 23, 2021 • 7:00 am CDT

Switzerland Authorizes COVID-19 Vaccine Janssen (J&J)

Swissmedic announced today it has temporarily authorized the "Covid-19 vaccine Janssen" developed by the pharmaceutical corporation Johnson & Johnson for people in Switzerland aged 18 and over.

On December 7, 2020, Janssen-Cilag AG, a company in the Johnson & Johnson healthcare group, submitted an application to Swissmedic for the authorization of its vaccine candidate (Ad26.COV2.S). Swissmedic reviewed this authorization application, too, in the greatly accelerated rolling procedure.

Additionally, the Human Medicines Expert Committee, Swissmedic's external advisory body, voiced its support for this decision during an extraordinary meeting.

With this authorization of the COVID-19 Vaccine Janssen from Johnson & Johnson, Swissmedic has now approved three of the four applications for COVID-19 vaccines submitted to date. The vaccines from Pfizer/BioNTech (Comirnaty) and Moderna have already been authorized. The application from AstraZeneca is still under review.

Swissmedic is the national authorization and supervisory authority for drugs and medical products. The agency ensures that only high-quality, safe, and effective medical products are available in Switzerland, thus making an important contribution to protecting human and animal health.

—

Mar 22, 2021 • 1:30 pm CDT

Enhanced Coronavirus Variant of Concern-Discriminating PCR Test Launches

Hungary-based Eurofins Technologies announced it's GSD NovaType II launched on March 22, 2021. This upgraded RT-PCR kit to identify mutations associated with SARS-CoV-2 Variants of Concern (VOC) and delivers results in under two hours.

The new GSD NovaType II kit can now detect the N501Y and E484K mutations common to most VOC and the K417N mutation (specific to B.1.351 first identified in South Africa), with high sensitivity.

The initial GSD NovaType RT-PCR kit was launched in February 2021 and quickly supported health authorities in detecting variants in more than 100,000 COVID-19 positive patients across Europe.

Eurofins Technologies is a global provider of fast, reliable, and easy to use diagnostic test kits and instruments in the fields of bioanalytical testing for the food, feed, environmental, biopharma, and clinical industries.

—

Medical Review by

Mar 22, 2021 • 10:58 am CDT

Hyderabad-Based Biotech to Produce 200 Million Sputnik V Vaccines Annually

The Russian Direct Investment Fund (RDIF) and Virchow Biotech Private Limited, one of the leading manufacturers of vaccines and pharmaceuticals in India, announced an agreement to manufacture in India up to 200 million doses of the Sputnik V vaccine annually.

Completing the technology transfer is planned for the 2nd quarter of 2021, when the full-scale production of the Sputnik V vaccine will be launched.

Dr. Tummuru Murali, Managing Director of Virchow Biotech, commented in a press release, “Virchow’s proven capabilities in large-scale drug substance manufacturing should help meet the global demand for this vaccine. We are also happy to learn of the positive feedback that this vaccine has been receiving from all сountries.”

Hyderabad-based Virchow Biotech Private Limited is part of the Virchow Group, which has an operational experience of over 4 decades has a global footprint in over 100 countries, supporting about 3,500 employees with an annual turnover of over $600 million.

The Sputnik V vaccine has been approved in 55 countries with a total population of over 1.4 billion people, says the RDIF. The Sputnik V (Gam-COVID-Vac) vaccine reduces the time taken for the actual development of immunity to SARS-CoV-2, the virus behind the COVID-19 pandemic.

—

Medical Review by

Mar 22, 2021 • 10:27 am CDT

The Philippines Purchases Additional Moderna COVID-19 Vaccines

Massachusetts-based Moderna, Inc. announced that the Philippines had secured an additional 7 million additional doses of COVID-19 Vaccine Moderna through a new supply agreement, bringing its confirmed order commitment up to 20 million doses.

Stéphane Bancel, CEO of Moderna, stated in a press release, “This agreement supports the ongoing efforts in the Philippines to secure access to a safe and effective COVID-19 vaccine and reflects Moderna’s continued commitment to expanding access to its vaccine around the world.”

The initial procurement by the Philippines of 13 million doses was announced on March 6, 2021. Under the terms of this agreement, deliveries would begin in mid-2021. The COVID-19 Vaccine Moderna is not currently approved for use in the Philippines, and the Company is working with regulators to pursue necessary approvals before distribution.

On December 18, 2020, the U.S. FDA issued an emergency use authorization enabling the Moderna COVID-19 Vaccine to be distributed in the USA for use in individuals 18 years of age and older.

—

Medical Review by

Mar 22, 2021 • 7:23 am CDT

No Thrombosis Events in this AstraZeneca COVID-19 Study

UK-based AstraZeneca plc announced today an interim safety and efficacy analysis of the Phase III clinical trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization.

The AZD1222 vaccine was well tolerated, and the independent data safety monitoring board (DSMB) identified no safety concerns related to the vaccine.

The DSMB conducted a specific review of thrombotic events and cerebral venous sinus thrombosis (CVST) with the assistance of an independent neurologist. The DSMB found no increased risk of thrombosis or events characterized by thrombosis among the 21,583 participants receiving at least one dose of the vaccine.

The specific search for CVST found no events in this trial called D8110C00001.

Ann Falsey, Professor of Medicine, University of Rochester School of Medicine, US, and co-lead Principal Investigator for the trial, commented in a press release, “These findings reconfirm previous results observed in AZD1222 trials across all adult populations, but it’s exciting to see similar efficacy results in people over 65 for the first time."

"This analysis validates the AstraZeneca COVID-19 vaccine as a much-needed additional vaccination option, offering confidence that adults of all ages can benefit from protection against the virus.”

Additional AstraZeneca COVID-19 vaccine disclosures are published on this webpage.

AstraZeneca plc is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England.

—

Mar 21, 2021 • 1:40 pm CDT

COVID-19 Fatalities Significantly Decreased During 2021

In recent weeks, the number of COVID-19 related fatalities has declined, announced the US centers for Disease Control and Prevention (CDC) on March 19, 2021. Overall, fatalities have decreased for the past 9 weeks.

The current 7-day moving average of new COVID-19 fatalities (1,025) decreased 69.7% compared to the highest peak on January 13, 2021.

The CDC also published demographic data related to hospitalization during the COVID-19 pandemic. Younger people under 18 years of age have seldom (3%) been admitted to a hospital. In contrast, those people over 65 years are most often (46%) hospitalized for severe COVID-19.

These seniors generally have underlying medical problems such as obesity, high blood pressure, heart problems, or diabetes, stated the CDC.

—

Medical Review by

Robert Carlson, MD

Mar 20, 2021 • 2:40 pm CDT

Millions of COVID-19 Vaccinations Completed Daily in the USA

The US Food and Drug Administration (FDA) had authorized three experimental COVID-19 vaccines for use in the USA as of March 20, 2021. And, various media sources indicate there are elevenCOVID-19 vaccines currently authorized worldwide.

The latest segmented data indicates the USA has administered 79,367,225 first-dose vaccines had been administered, and the number of people receiving two vaccine doses had reached 43,036,818.

According to Our World in Data, as of March 18, 2021, the USA leads all other countries with about 115 million COVID-19 vaccine doses administered. China has reported about 65 million, and the UK about 27.6 million vaccine doses administered.

—

Mar 19, 2021 • 12:02 pm CDT

Revised K-12 School COVID-19 Prevention Recommendations Issued

K-12 students in the USA can now sit just 3 feet apart in classrooms as long as they wear masks. And classrooms can remove physical barriers, announced the US Centers for Disease Control and Prevention (CDC) COVID-19 prevention guidelines issued on March 19, 2021.

The revised CDC recommendations represent a turn away from the 6-foot standard that has limited how many students schools can accommodate.

A highlighted area of concern is internal air ventilation.

Improve ventilation to the extent possible to increase circulation of outdoor air, increase the delivery of clean air, and dilute potential contaminants. This can be achieved through several actions, such as:

Bring in as much outdoor air as possible.
Ensure Heating, Ventilation, and Air Conditioning settings are maximizing ventilation.
Filter and/or clean the air in the school by improving the level of filtration as much as possible.
Use exhaust fans in restrooms and kitchens.
Open windows in buses and other transportation, if doing so does not pose a safety risk. Even just cracking windows open a few inches improves air circulation.

The CDC confirmed existing evidence suggests many K-12 schools that have strictly implemented prevention strategies have been able to open for in-person instruction and remain open safely. All prevention strategies provide some level of protection, and layered strategies implemented simultaneously provide the greatest level of protection, said the CDC.

—

Medical Review by

Mar 18, 2021 • 4:07 pm CDT

European Agency Confirms AstraZeneca's COVID-19 Vaccine Benefits

The European Medicine Agency (EMA) announced today 'COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets.'

Announced late on March 18, 2021, the EMA confirmed that:

the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and maybe fatal) continue to outweigh the risk of side effects;
the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it;
there is no evidence of a problem related to specific batches of the vaccine or particular manufacturing sites;
however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e., low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST).

However, the EMA validated it had reviewed only 7 cases of blood clots in multiple blood vessels (disseminated intravascular coagulation, DIC) and 18 cases of CVST.

In summary, 'A causal link with the AstraZeneca COVID-19 vaccine is not proven, but is possible and deserves further analysis,' said the EMA.

—

Mar 18, 2021 • 1:38 pm CDT

COVID-19 Defeats UConn Basketball Coach

As the 2021 Women's NCAA Basketball Tournament launches in San Antonio, TX this week, the University of Connecticut (UConn) Women's team Hall of Fame coach will be on the sidelines.

UConn coach Geno Auriemma tested positive for COVID-19 on March 14, 2021, and remains at home.

According to the U.S. CDC and Connecticut Department of Public Health guidelines, Auriemma will remain in isolation for 10 days. He received a second dose of a COVID-19 vaccine on March 10th and can rejoin the team on March 24th.

UConn contact tracing protocols revealed that Auriemma did not have close contact with any other team member since March 12th, and all personnel has tested negative for COVID-19.

Team physician Deena Casiero said in a press statement, "Only household close contacts were identified. Given the fact that we have been doing daily testing for the past seven days, we feel confident that we were able to catch this very early on in the disease process."

"I'm feeling well but disappointed that I will be away from the team for the next several days," Auriemma said.

"Fortunately, I have a great coaching staff who will lead us during my absence. This revelation is a reminder that, while there is a light at the end of the tunnel, we are not on the other side of this pandemic yet. The full effect of vaccines does not occur until 14 days after our last vaccine dose, and for those of us getting a two-dose vaccine, that means we're not in the clear after just one dose."

"My team and I need to remain vigilant in the areas of mask-wearing and social distancing as we continue this fight against COVID."

The University of Connecticut is a national leader among public research universities, with more than 30,000 students seeking answers to critical questions in classrooms, labs, and the community. UConn has won eleven NCAA Division I national championships, the most in women's college basketball history.

—

Mar 17, 2021 • 7:40 pm CDT

Updated Guide for Using COVID-19 Self Tests in the EU/EEA

The ECDC published a document on March 17, 2021, that outlines the public health considerations for the use of self-tests to detect SARS-CoV-2 by public health authorities in the European Union/European Economic Area (EU/EEA).

Self-testing could therefore enhance disease control with prompt identification and isolation of cases. However, shifting the responsibility of reporting test results from health professionals and laboratories to individuals could lead to underreporting, and make response measures such as contact tracing and quarantine of contacts even more challenging, says the ECDC.

Only rapid antigen detection tests (RADTs) for self-testing for direct detection of SARS-CoV-2 virus particles in infectious individuals are considered within this document.

RADTs that can be used as self-tests to detect SARS-CoV-2 are becoming available in the EU/EEA. These tests require individuals to collect a specimen, conduct a test and interpret the results by themselves.

When writing this document, there were only a few RADTs available for self-testing for COVID-19, and there was no CE-marked RADT for self-testing placed on the EU market in compliance with Directive 98/79/EC. An additional challenge is that samples from self-testing would not be available for sequencing and monitoring variants of concern.

From a public health perspective, self-tests can offer advantages when complementing professionally administered RADTs or RT-PCR tests.

They can improve the accessibility to testing and enable individuals to obtain the result very quickly, supporting the early detection of infectious cases and reducing further community transmission.

—

Mar 17, 2021 • 2:42 pm CDT

USA Invests $12 Billion to Expand COVID-19 Testing

The U.S. Department of Health and Human Services (HHS) announced today it would invest $10 billion from the American Rescue Plan to ramp up coronavirus screening testing to help schools reopen, and $2.25 billion will be used to scale up COVID-19 testing in underserved populations.

Additionally, HHS will provide new guidance on asymptomatic screening testing in schools, workplaces, and congregate settings.

“COVID-19 testing is critical to saving lives and restoring economic activity,” said HHS Acting Secretary Norris Cochran in an HHS press statement. “As part of the Biden Administration’s National Strategy, HHS will continue to expand our capacity to get testing to the individuals and the places that need it most, so we can prevent transmission of the virus and defeat the pandemic.”

In February 2021, HHS announced additional actions to expand COVID-19 testing capacity across the USA as part of its national testing strategy.

The US Centers for Disease Control and Prevention reported on March 17, 2021, about 354 million RT-PCR diagnostic tests, excluding antibody and antigen tests, have been performed to confirm infections during the COVID-19 pandemic.

Recent data compiled by Statista on March 8, 2021, indicates the USA leads all other counties in COVID-19 tests processed. Followed by India (221m) and China (160m).

Furthermore, as of March 16, 2021, the U.S. Food and Drug Administration announced it had authorized 341 coronavirus diagnostic tests, including 254 molecular tests, 72 antibody tests, and 15 antigen tests during the COVID-19 pandemic. And 38 molecular authorizations for home-collected testing.

The U.S. Department of Health & Human Services is located in Washington, D.C.

—

Medical Review by