Coronavirus Breaking News

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

May 7, 2021 • 8:53 am CDT

GlaxoSmithKline plc (GSK) and California-based Vir Biotechnology, Inc. announced that the European Medicines Agency (EMA) had started a rolling review of data on an investigational compound known as Sotrovimab (VIR-7831), a dual-action SARS-CoV-2 monoclonal antibody.

The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1, indicating that the epitope is highly conserved and less likely to mutate over time. Sotrovimab, which incorporates Xencor’s Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

The EMA will evaluate all data on Sotrovimab, including evidence from clinical trials, as they become available.

The EMA's decision to start the rolling review is based on the interim analysis of efficacy and safety data from the Phase 3 COMET-ICE clinical trial, which evaluated Sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. The interim analysis demonstrated an 85% reduction in hospitalizations over 24 hours or deaths in those receiving Sotrovimab.

The companies submitted an Emergency Use Authorization application for Sotrovimab to the US Food and Drug Administration. Sotrovimab is also under review by other global regulators, including Health Canada. Sotrovimab has not been granted a marketing authorization anywhere globally.

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses. GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. For further information, please visit www.gsk.com/about-us.

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May 7, 2021 • 6:22 am CDT

Understanding Adverse Events (AEs) associated with COVID-19 vaccination has various public health implications, especially future vaccine hesitancy.

A recent study conducted in the United Kingdom focused on whether individuals with prior history of COVID-19 were more likely to experience AEs after a new vaccination than those without previous COVID-19.

These researchers found of 974 respondents, 27% reported a previous COVID-19 infection.

The proportion of people (81% female, mean age 48) reporting one moderate/severe symptom was higher in the previous COVID-19 group (56% v 47%, OR=1.5 [95%CI, 1.1–2.0], p=.009), with fever, fatigue, myalgia-arthralgia, and lymphadenopathy significantly more common.

In the smaller sensitivity analysis cohort (412 people), similar findings were obtained, although only myalgia and arthralgia remained significant.

This non-peer-reviewed study's finding indicates 'prior COVID-19 infection but not ongoing Long-COVID symptoms, were associated with an increase in the risk of self-reported adverse events following BNT162b2/Pfizer vaccination.'

'And COVID-19 illness-vaccination interval did not significantly influence AEs.'

'This data can support education around vaccine-associated AEs and, through improved understanding, help to combat vaccine hesitancy,' stated these researchers.

Funding for the CHOIS study was from the North East and North Cumbria Academic Health Sciences Network and Siemens Healthcare Ltd, who provided biomarker and serological assays, but had no input into the study design, analysis, or interpretation.

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May 6, 2021 • 11:49 am CDT

Urgent international support is needed to prevent a worsening humanitarian catastrophe in countries across South Asia, announced the International Federation of Red Cross and Red Crescent Societies (IFRC) on May 5, 2021.

In Nepal, many hospitals are full and overflowing with COVID-19 patients.

Southern towns near the Indian border are unable to cope with the growing number of people needing medical treatment. Nepal is recording 57 times more COVID-19 cases than this time last month.

Across Nepal, 44% of tests recently returned positive results according to government authorities, indicating many thousands of infections are undiagnosed.

Nepal Red Cross Chairperson, Dr. Netra Prasad Timsina, said in an IFRC statement, “What is happening in India right now is a horrifying preview of Nepal’s future if we cannot contain this latest COVID surge that is claiming more lives by the minute."

“Every effort is being made to save lives right now across Nepal with increased medical treatment. Nepal Red Cross volunteer health teams are also reducing record infections by helping with testing, vaccinations, handwashing, mask-wearing, and isolating infected people."

“It is beyond distressing to see that people cannot say goodbye to their loved ones as cremations are taking place at record levels due to these new COVID variants, which are striking down people of all ages in Nepal.”

All South Asian countries have started vaccinating people who are most at-risk, yet in Nepal, only 1% of the population has received two doses of a COVID-19 vaccine, as of May 5th.

The IFRC's Asia Pacific Director Alexander Matheou added, "This coronavirus has no respect for borders. Nepal urgently needs support, to save more lives and treat people who are suffering. We will not succeed in overcoming this terrible disease until vaccines are available to protect everyone, regardless of nationality or income.”

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May 6, 2021 • 10:42 am CDT

Novavax, Inc. today announced that it had finalized an advance purchase agreement (APA) with Gavi, the Vaccine Alliance (Gavi), for the Novavax COVID-19 Vaccine.

Under the new APA, Novavax is expected to manufacture and distribute 350 million vaccine doses of NVX-CoV2373 to countries participating under the COVAX Facility. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the coronavirus that causes COVID-19 disease.

Under the APA, Novavax expects to deliver doses with antigen and adjuvant manufactured at facilities directly funded by the $400 million investment Novavax received from the Coalition for Epidemic Preparedness Innovations.

Under a separate APA with Gavi, the Serum Institute of India is expected to manufacture and deliver the balance of the 1.1 billion doses of the Novavax COVID-19 vaccine.

Stanley C. Erck, President, and CEO, Novavax, commented in a press release issued on May 6, 2021, "This arrangement is the culmination of a collaboration among CEPI, Gavi, Serum Institute, and Novavax, who are partnering in our urgent mission to deliver significant amounts of vaccines to all countries, regardless of income level."

Gaithersburg-based Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases.

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May 5, 2021 • 12:29 pm CDT

New Jersey Governor Phil Murphy announced via Twitter on May 3, 2021, We’re launching our “Shot and a Beer” program to encourage eligible New Jerseyans ages 21+ to get vaccinated, with a COVID-19 vaccine.

Any New Jerseyan who gets their first COVID-19 vaccine dose in May 2021 and takes their vaccination card to a participating brewery will receive a free beer. The bars include the Hackensack Brewing Company, Gaslight Brewery, and Restaurant, Battle River Brewing, and others.

"We need that push," Dr. Perry N. Halkitis, dean of the Rutgers School of Public Health, told ABC News. "You have to find a way to motivate people. This is one way to do it."

In New Jersey, there are several ways to find vaccination providers, such as:

  • Visit Vaccines.gov to find vaccination providers near you. In some states, information may be limited while more vaccination providers and pharmacies are being added. Learn more about COVID-19 Vaccination Locations on Vaccines.gov.
  • Check your local pharmacy’s website to see if vaccination appointments are available. Find out which pharmacies are participating in the Federal Retail Pharmacy Program.

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May 5, 2021 • 11:12 am CDT

Ottawa-based Health Canada today announced the mRNA Pfizer-BioNTech COVID-19 vaccine 'is now safe to give to children ages 12 and up.'

Canada is the first country to sign off on giving shots to these younger age groups.

“After completing a thorough and independent scientific review of the evidence, the department determined that this vaccine is safe and effective when used in this younger age group,” said Health Canada’s chief medical adviser Dr. Supriya Sharma.

Health Canada's authorization was based on Pfizer-BioNTech’s Phase 3 clinical trial results involving 2,260 adolescents aged 12 to 15, conducted in the USA.

The Pfizer-BioNTech COVID-19 mRNA vaccine was issued the first U.S. Food and Drug Administration emergency authorization for individuals 16 years of age and older on December 11, 2020.

Media reports indicate the U.S. CDC is considering a similar expanded use for this vaccine.

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May 4, 2021 • 8:15 am CDT

The European Medicines Agency (EMA) announced today the human medicines committee had started a rolling review of CoronaVac COVID-19 Vaccine (Vero Cell) Inactivated, developed by China-based Sinovac Life Sciences Co., Ltd.

Clinical studies suggest that the CoronaVac vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease.

CoronaVac COVID-19 Vaccine is expected to prepare the body to defend itself against infection with the SARS-CoV-2 beta coronavirus. The vaccine contains SARS-CoV-2 that has been inactivated (killed) and cannot cause the disease.

CoronaVac also contains an ‘adjuvant,’ a substance that helps strengthen the immune response to the vaccine.

When a person is given the vaccine, their immune system identifies the inactivated virus as foreign and makes antibodies against it. If, later, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognize the virus and be ready to defend the body against it.

While the EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review. And the EMA will communicate further when the marketing authorization application for the vaccine has been submitted.

Founded in Beijing during 2009, Sinovac Life Sciences is listed on NASDAQ as (SVA).

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May 3, 2021 • 8:36 pm CDT

The JAMA published an Original Investigation on April 29, 2021 that reviewed the 'Association of Maternal SARS-CoV-2 Infection in Pregnancy With Neonatal Outcomes' of 88,159 infants from Sweden.

A SARS-CoV-2 infection in pregnancy was significantly associated with a higher risk of any neonatal respiratory disorder (2.8% vs. 2.0%; odds ratio, 1.42) and some other neonatal morbidities. But not neonatal mortality (0.30% vs 0.12%; odds ratio, 2.55).

This study could neither confirm nor rule out an association between maternal SARS-CoV-2 test positivity and increased fetal distress during delivery or birth asphyxia.

All SARS-CoV-2–exposed infants underwent SARS-CoV-2 PCR testing at least once (those admitted for neonatal care were tested 3 times), and a majority tested negative for SARS-CoV-2 in the neonatal period.

And, given that mothers and their infants were kept together, the results presented herein suggest that the risk of viral transmission from mothers to their newborns and older infants is low. Should it occur, infants are not severely affected. These findings suggest that routine interventions such as mother-infant separation and stopping breastfeeding may not be necessary.

An additional message of this study is that SARS-CoV-2 test positivity in mothers did not prolong hospital stay for families.

Given the small number of events for many of the outcomes and the large number of statistical comparisons, the findings should be interpreted as exploratory, stated these researchers.

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May 3, 2021 • 1:34 pm CDT

The European Medicines Agency (EMA) confirmed on May 3, 2021, it is evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to include adolescents aged 12 to 15.

Known as the Pfizer-BioNTech vaccine in the USA, the Comirnaty is currently authorized for people aged 16 and older.

The EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by New York-based Pfizer and Germany-based BioNTech, including results from a large ongoing clinical study involving adolescents from 12 years of age, to decide whether to recommend the extension of indication.

The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States. The EMA will communicate its evaluation outcome, which is expected in June 2021, unless supplementary information is needed.

The Comirnaty vaccine contains a molecule called messenger RNA with instructions for producing a protein, known as the spike protein, naturally present in SARS-CoV-2, the beta coronavirus that causes COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2.

Comirnaty was first authorized in the EU in December 2020. The U.S. FDA Authorized the experimental Pfizer-BioNTech COVID-19 vaccine in 2020 but has not Approved it as of May 2021.

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May 3, 2021 • 1:17 pm CDT

'The COVID-19 pandemic continues to create stress and anxiety for many Canadians, particularly those who do not have ready access to their regular support networks,' stated Dr. Theresa Tam, Canada’s Chief Public Health Officer, on May 3, 2021.

'As COVID-19 activity continues in Canada, we are tracking a range of epidemiological indicators to monitor where the disease is most active, where it is spreading and how it is impacting the health of Canadians and public health, laboratory, and healthcare capacity.

The latest national-level data show a 7-day average decrease of 7% compared to the previous seven days. For the week of April 18-24, 2021, 6.6% of tests were positive for COVID-19, decreasing from 7.4% the week prior.

However, the nationwide mortality trend is still on the rise, with the 7-day average of 50 deaths reported daily.

The vast majority of COVID-19 cases were reported in Ontario.

Canadians are urged to remain vigilant, continue following local public health advice, and consistently maintain individual practices that keep us and our families safer,' concluded Dr. Tam's comments.

Dr. Theresa Tam was named Canada’s Chief Public Health Officer on June 26, 2017.

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May 3, 2021 • 6:57 am CDT

India's Ministry of Health and Family Welfare today announced 'as of May 2, 2021, the Government of India had provided more than 16.54 crore COVID-19 vaccine doses to States/UTs Free of Cost.

And more than 78 lakh doses remain available with the States/UTs to be administered.

Furthermore, 56 Lakh vaccine doses will be received by the States/UTs in the next 3 days.

In the future, under the Liberalised Pricing & Accelerated National COVID-19 Vaccination Strategy, the Govt of India will continue to procure its share of 50% of the monthly Central Drugs Laboratory cleared vaccines. These COVID-19 vaccines would continue to be available to the State Govts totally free of cost, as was being done earlier.

The Ministry clarified that 100% advance of Rs. 1732.50 cr (after TDS Rs. 1699.50 cr) was released to Serum Institute of India on 28.04.2021 for 11 crore doses of Covishield vaccine during May, June, and July and was received by them on 28.04.2021. As of date, against the last order of 10 crore doses for supplies of Covishield vaccine, 8.744 crore doses have been delivered till 03.05.2021.

Additionally, 100% advance of Rs. 787.50 cr (after TDS Rs. 772.50 cr) was released on 28.04.2021 to Bharat Biotech India Ltd for 05 crore Covaxin vaccine doses during May, June, and July and was received by them on 28.04.2021. As of date, against the last order of 02 crore doses for supplies of Covaxin vaccine, 0.8813 crore doses have been delivered till 03.05.2021.

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May 1, 2021 • 2:58 pm CDT

Researchers at Karolinska Institutet and the Public Health Agency of Sweden studied newborn babies whose mothers tested positive for SARS-CoV-2 during pregnancy or childbirth. The results show that although babies born of test-positive mothers are more likely to be born early, and extremely few were infected with COVID-19.

"By cross-referencing the three registries, we've been able to monitor and report outcomes for the neonates in real-time during both the first and second waves of COVID-19," stated these researchers.

The study published in the journal JAMA on April 29, 2021, supports the Swedish recommendation not to separate mother and baby after delivery.

The population-based study in Sweden comprised 92% of all neonates - almost 90,000 births.

The results show a slightly higher level of morbidity in neonates whose mothers tested positive for SARS-CoV-2, including an increased risk of respiratory disorders, which were largely due to the higher number of preterm births in this group. No direct correlation between maternal infection and neonatal respiratory infection or pneumonia could be observed.

A total of 2,323 babies were born to SARS-CoV-2-positive mothers.

Only 21 (0.9%) of the babies of these women tested positive for the virus at some point during the newborn period (the first 28 days), the majority without displaying any symptoms; a few babies were treated for other reasons than COVID-19.

Mikael Norman, professor of pediatrics at the Department of Clinical Science, Intervention and Technology, Karolinska Institutet, and one of the researchers leading the study, said in a press release, "Our study suggests that mother and baby can be cared for together and that nursing can be recommended without danger to the baby's health."

"This is good news for all pregnant women, their babies, and postnatal and neonatal staff."

The study was made possible through daily reports to three Swedish registries: the National Quality Register for Pregnancy, the National Quality Register for Neonatal Care, and the Communicable Diseases Register.

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Apr 30, 2021 • 3:39 pm CDT

Brazil's Senate passed legislation on April 29, 2021, that would permit the government to temporarily suspend any and all patents for medical products that could be used to fight Covid-19 reported Reuters.

Any license would be valid only for the duration of such an emergency.

Over 400,000 people had died in Brazil during the COVID-19 pandemic, based on data from Johns Hopkins University. And less than 6% of Brazilians have been fully vaccinated against COVID-19, according to Our World in Data.

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Apr 30, 2021 • 1:07 pm CDT

The US Centers for Disease Control and Prevention (CDC) reported today the current 7-day moving average of daily new COVID-19 cases (52,528) decreased 16.2% compared with the previous 7-day moving average.

Compared with the highest peak on January 8, 2021 (249,669), the current 7-day average has decreased by 79%.

The CDC confirmed a total of 32 million COVID-19 cases had been reported in the USA during the pandemic as of April 28, 2021.

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Apr 30, 2021 • 9:55 am CDT

To address the intensifying COVID-19 crisis in India, Merck announced on April 27, 2021, it has agreed to facilitate the manufacture and distribution of molnupiravir, an investigational antiviral drug.

Molnupiravir, previously known as EIDD-2801, was initially developed by Emory University's DRIVE as a broad-spectrum antiviral against equine encephalitis and influenza. However, laboratory tests showed it was also active against coronaviruses.

“To advance a drug quickly and across the globe in all the countries where it is needed, you need the capacity of a company like Merck,” commented George Painter, Ph.D., CEO of the non-profit Emory-owned DRIVE (Drug Innovation Ventures at Emory), at a media briefing.

“It’s gratifying to see how quickly they moved and how they’re getting this into the hands of people in India to meet this threat.”

Emory University is a private research university founded in Atlanta, GA, in 1836.

Molnupiravir was licensed to Merck through its partner Ridgeback Biotherapeutics last year, and Merck is currently conducting Phase III clinical trials of the drug in the USA.

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