Coronavirus Breaking News

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

Apr 22, 2021 • 3:24 pm CDT

To reduce the introduction of SARS-CoV-2 virus infections, the state of Alaska implemented a program on June 6, 2020, for arriving air, sea, and road travelers that required either molecular testing for beta coronavirus that causes COVID-19 or a 14-day self-quarantine after arrival.

The Alaska Department of Health and Social Services requested ten participating Alaska airports evaluate air traveler choices to undergo testing or self-quarantine, traveler test results, and airport personnel experiences while implementing the program.

Among 386,435 air travelers who arrived in Alaska during June 6–November 14, 2020, a total of 184,438 (48%) chose to be tested within 72 hours before arrival, 111,370 (29%) chose to be tested on arrival, and 39,685 (10%) chose to self-quarantine without testing after arrival.

An additional 15,112 persons received testing at airport testing sites; these were primarily travelers obtaining a second test 7–14 days after arrival, per state guidance.

Of the 126,482 airport tests performed in Alaska, 951 (0.8%) results were positive, or (1) per 406 arriving travelers.

The U.S. CDC confirmed on April 22, 2021, 'airport testing program administrators reported that clear communication, preparation, and organization were vital for operational success; challenges included managing travelers’ expectations and ensuring that sufficient personnel and physical space were available to conduct SARS-CoV-2 virus testing.

And, 'post-travel self-quarantine and testing programs might reduce travel-associated SARS-CoV-2 transmission and importation, even without enforcement,' says the CDC.

Apr 22, 2021 • 12:24 pm CDT

 Researchers with the US Centers for Disease Control and Prevention (CDC) or the Food and Drug Administration published a study in the NEJM on April 21, 2021 that concluded 'Preliminary findings did not show obvious safety signals among pregnant females who received an mRNA COVID-19 vaccine, such as the Pfizer-BioNTech or Moderna vaccines.

Among 3,958 participants enrolled in the US V-Safe Pregnancy Registry, 827 females had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth.

Most of these women had the mRNA vaccination in the third trimester.

Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%).

However, no neonatal deaths were reported.

Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against COVID-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women conducted before the COVID-19 pandemic.

'Longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes,' wrote these researchers. The study authors are U.S. government employees or contractors and do not have any material conflicts of interest.

As of March 18, 2021, the CDC says, 'Getting vaccinated is a personal choice. Based on how these vaccines work in the body, experts believe they are unlikely to pose a specific risk for pregnant women. Any of the currently authorized COVID-19 vaccines can be offered to women who are pregnant or breastfeeding.'

'If you have questions about getting vaccinated, a conversation with your healthcare provider might help but is not required.'

The Moderna and Pfizer-BioNTech experimental mRNA vaccines do not contain the live virus that causes COVID-19 and, therefore, cannot give someone COVID-19, says the CDC.

Apr 22, 2021 • 6:57 am CDT

The Russian Direct Investment Fund (RDIF), the Egyptian pharmaceutical company Minapharm and its subsidiary, ProBioGen, announced an agreement to produce more than 40 million doses of the Sputnik V vaccine per year.

Beginning in the 3rd quarter of 2021, Sputnick V vaccine production is scheduled to launch at Minapharm's biotechnology facilities in Cairo, Egypt. ProBioGen, with expertise in vector technology, vaccine manufacturing, and gene therapy, will support streamlining production processes in the future.

Vafik Bardissi, Chairman and CEO of Minapharm, stated in a press release issued on April 22, 2021, “This agreement will strengthen Minapharm's regional leadership in biotechnology, which has been achieved through extensive international expertise in cell engineering and adenovirus vector technology."

"We are delighted to join RDIF in the fight against the coronavirus pandemic. ”

The Sputnik V vaccine uses two different vectors for two shots during the vaccination process, which creates stronger immunity than vaccines that use the same delivery mechanism for both shots. And the safety, efficacy, and lack of long-term negative effects of adenovirus vaccines have been proven in more than 250 clinical studies over two decades, says the RDIF.

Minapharm Pharmaceuticals is a leading pharmaceutical company with about 1,400 employees located in Africa, Egypt, and the Middle East. Minapharm sells over 100 products, from molecules to complex genetically engineered proteins. ProBioGen AG, a 100% subsidiary of Minapharm in Germany, is a globally renowned contract pharmaceutical company specializing in developing cell lines and supplying proprietary protein and viral vector technologies.

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Apr 21, 2021 • 8:34 am CDT

Massachusetts-based Moderna, Inc. announced a new supply agreement with the State of Israel for 2022. Under the terms of this agreement confirmed on April 20, 2021, Israel retains an option to purchase doses of one of Moderna’s variant-specific vaccine candidates subject to regulatory approval.

Today’s announcement follows two earlier agreements between Israel and Moderna to supply a total of 10 million doses of the COVID-19 Vaccine Moderna, which the Israeli Ministry of Health authorized on January 4, 2021.

Stéphane Bancel, CEO of Moderna, stated in a press release, “Recent preclinical results have shown that our variant-specific booster candidates were effective against COVID-19 variants of concerns, and we hope to continue to see positive results from the clinical studies.”

The experimental COVID-19 Vaccine Moderna is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike protein, which was co-developed by Moderna and investigators from the US National Institute of Allergy and Infectious Diseases’ Vaccine Research Center.

Moderna's COVID-19 vaccine received an Emergency Authorization and has not been Approved by the U.S. FDA.

Cambridge-based Moderna has transformed into an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and unprecedented speed.

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Apr 20, 2021 • 8:45 pm CDT

Valneva SE today announced it is now focusing on bilateral country discussions to supply its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001, and is consequently deprioritizing the ongoing centralized discussions with the European Commission (EC).

Saint-Herblain, France -based Valneva previously announced the advanced stage of its discussions with the EC on January 12, 2021. In September 2020, Valneva announced a collaboration with the UK government to provide up to 190 million doses of VLA2001 through 2025, of which 100 million doses have already been ordered.

Thomas Lingelbach, CEO of Valneva, stated in a press release issued on April 20, 2021, “We’ve committed significant time and effort to try to meet the needs of the central EC procurement process. Despite our recent clinical data, we have not made meaningful progress and have not yet secured a supply agreement."

"We are therefore now focusing our efforts on those European Union member states and interested parties outside the EU, who would like to include our inactivated approach within their vaccination strategy. We are convinced that VLA2001 has an important role to play in the future, including boosters or potential modifications to the vaccine to address variants.”

This follows the recent announcement on April 6, 2021, of positive initial results from the Phase 1/2 clinical trial of VLA2001.

Valneva has the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe and is preparing a pivotal, comparative immunogenicity Phase 3 clinical trial expected to commence by the end of April 2021 to make regulatory licensure submissions in the autumn of 2021.

The VLA2001 vaccine candidate is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, combined with two adjuvants, alum and CpG 1018.

This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and has shown a shift of the immune response towards Th1.

Valneva is a specialty vaccine company focused on developing and commercializing prophylactic vaccines for infectious diseases with significant unmet medical need.

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Apr 20, 2021 • 2:37 pm CDT

The Moscow-based Russian Direct Investment Fund (RDIF) and Laboratorios Richmond SACIF pharmaceutical company of Argentina today announced the production of the first batch of the Sputnik V vaccine in Argentina.

Argentina has become the first country in Latin America to register Sputnik V officially. 

Full-scale production of the vaccine is anticipated for June 2021. Sputnik V vaccine produced in Argentina could be exported to Central and Latin America countries at a later stage.

Alberto Fernández, President of Argentina, commented in an RDIF press release issued on April 20, 2021, “We are very excited about the possibility of producing Sputnik V in Argentina, a vaccine with which we are already protecting a large part of our population with excellent results. It will be a great opportunity to advance in the fight against the pandemic not only in Argentina but also in Latin America.”

Marcelo Figueiras, President of Richmond Laboratories, added, “We celebrate this recognition that we will reward with work, commitment, and professionalism, to facilitate the availability of the vaccine in the shortest possible time for Argentina and the entire Latin American region.”

RDIF is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors.

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Apr 20, 2021 • 12:44 pm CDT

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) announced on April 20, 2021, it concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen

The PRAC also concluded that these events should be listed as very rare side effects of the vaccine. And, based on the currently available evidence, specific risk factors have not been confirmed.

The EMA confirmed it had reviewed eight cases of thrombosis in combination with thrombocytopenia in people who received Janssen’s COVID-19 vaccine in the USA. All cases occurred in people below 60 years of age, and most were in women within three weeks of the person being vaccinated.

These very rare types of thrombosis (with thrombocytopenia) included venous thrombosis mostly in unusual sites such as cerebral venous sinus thrombosis and splanchnic vein thrombosis, and arterial thrombosis and a fatal outcome in one case.

Thrombosis in combination with thrombocytopenia requires specialized clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., hematologists, specialists in coagulation) to diagnose and treat this condition, says the EMA.

As for the mechanism, it is thought that the vaccine may trigger an immune response leading to a heparin-induced-thrombocytopenia-like disorder. The pathophysiological mechanism has not been established at this time, and it is currently not possible to identify specific risk factors.

Healthcare professionals should be alert to the signs and symptoms of thromboembolism and thrombocytopenia so that they can promptly treat people affected in line with available guidelines.

The COVID-19 Vaccine Janssen was authorized in the EU on March 11, 2021. However, the rollout of the vaccine in the EU was temporarily delayed by the company on April 13, 2021.

Apr 20, 2021 • 6:29 am CDT

Researchers at the University of Oxford in England announced on April 19, 2021, they have launched a COVID-19 vaccine human challenge trial to look at what kind of immune response can stop people from becoming re-infected.

These researchers also want to see how the immune system reacts the second time around.

A human challenge trial in medical research is a carefully controlled study that involves purposefully infecting a subject with a pathogen or bug to study the effects of that infection, says the Oxford press statement.

Any participants who develop any symptoms will be given medical treatment with the Regeneron monoclonal antibody treatment. They will only be discharged from the quarantine unit when they are no longer infected and not at risk of infecting others. The full length of the study will be 12 months, including a minimum of eight follow-up appointments after discharge. Participation in the study is completely voluntary.

The virus used in the study will be the original strain from Wuhan, China.

The study participants will be quarantined in a specially designed hospital suite for a minimum of 17 days under the care of the research team. They will undergo numerous medical tests, including CT scans of the lungs and MRI scans of the heart. The risks to participants will be minimized by ensuring that those who take part are completely fit and well and have completely recovered from their first infection with COVID.

Helen McShane, Professor of Vaccinology at the Department of Paediatrics, University of Oxford and Chief Investigator on the study, said in a press release, ‘Challenge studies tell us things that other studies cannot because, unlike natural infection, they are tightly controlled."

"When we re-infect these participants, we will know exactly how their immune system has reacted to the first COVID infection, exactly when the second infection occurs, and exactly how much virus they got. As well as enhancing our basic understanding, this may help us to design tests that can accurately predict whether people are protected."

"In phase two, we will explore two different things. First, we will define the baseline immune response in the volunteers very carefully before we infect them. We will then infect them with the dose of virus chosen from the first study and measure how much virus we can detect after infection. We will then be able to understand what kind of immune responses protect against re-infection."

"Second, we will measure the immune response at several time points after infection to understand what the virus generates immune response.

"A challenge study allows us to make these measurements very precisely because we know exactly when someone is infected. The information from this work will allow us to design better vaccines and treatments and understand if people are protected after having COVID and for how long."

The Wellcome Trust funds the study. Shobana Balasingam, Vaccines Senior Research Advisor at Wellcome.

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Apr 19, 2021 • 2:54 pm CDT

Two new studies published in the journal Blood on April 15, 2021, suggest mRNA COVID-19 vaccines may have reduced efficacy in individuals with chronic lymphocytic leukemia (CLL) and multiple myeloma (MM), two types of blood cancer.

Interestingly, the research revealed wide variations in immune response among patients with CLL depending on where they were in their cancer treatment process.

The first study reports that people with CLL had markedly lower immune response rates to the two-dose of the Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) than healthy individuals of the same age. Because clinical trials of these vaccines did not include patients with blood cancers who are at high risk of severe illness and complications from the virus, gauging the vaccine's effectiveness in this population is critically important.

In this study of 167 patients with CLL, only four out of 10 (39.5%) had a positive antibody-mediated response to the mRNA vaccine.

The second blood cancer study reported similar findings after the first dose of the same mRNA vaccine in elderly patients with multiple myeloma.

Evangelos Terpos, M.D., Ph.D., of the National and Kapodistrian University of Athens in Athens, Greece, and colleagues compared outcomes of 48 patients with multiple myeloma and 104 healthy controls at Alexandra Hospital in Athens. The median age of all participants was 83.

On day #22, after the first dose of the vaccine but before the second dose, antibody titers were measured. The median response was 20.6%, neutralizing antibodies for the MM population compared to 32.5% for the healthy controls.

They also wrote that administering a second timely vaccine dose is essential for elderly patients with multiple myeloma to develop an adequate antibody-based response.

These researchers note that the same trends would be expected with other mRNA vaccines, such as the vaccine produced by Moderna, Inc.

For more information about COVID-19 vaccines for immunocompromised people, see the American Society of Hematology's FAQs, last updated on April 5, 2021.

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Apr 19, 2021 • 9:37 am CDT

New York-based Pfizer Inc. and BioNTech SE announced they have agreed to supply an additional 100 million vaccine doses of COMIRNATY®, the companies’ COVID-19 vaccine, to the 27 European Union (EU) member states later in 2021.

Comirnaty (Pfizer-BioNTech COVID-19 vaccine) was granted conditional marketing authorization by the European Medicines Agency to prevent COVID-19 in people from 16 years of age. 

This announcement results from the European Commission’s decision to exercise an option under its expanded Advanced Purchase Agreement signed on February 17, 2021. This new vaccine order brings the total number of Pfizer-BioNTech doses to be delivered to the EU to 600 million.

This vaccine order will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe, stated the companies.

“We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe,” commented Albert Bourla, Chairman and CEO, Pfizer, in a related press statement. “To date, we have met all of our supply commitments to the EC and we plan to deliver 250 million doses to the European Union in Q2'21, a four-fold increase on Q1’s agreed quantity.”

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

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Apr 18, 2021 • 6:02 am CDT

The U.S. CDC reported about 398 million RT-PCR diagnostic tests, excluding antibody and antigen tests, have been performed to confirm SARS-CoV-2 beta coronavirus infections as of April 17, 2021.

Recent data compiled by Statista on April 6, 2021, indicates the USA leads all other counties in COVID-19 tests processed. Followed by India (250m) and China (160m).

Furthermore, as of April 16, 2021, the U.S. Food and Drug Administration (FDA) announced it had authorized 363 coronavirus diagnostic tests, including 266 molecular tests, 75 antibody tests, and 22 antigen tests during the COVID-19 pandemic. Furthermore, 46 molecular authorizations can be used with home-collected samples.

The FDA recently published A Closer Look at COVID-19 Diagnostic Testing to offer those who might purchase COVID-19 tests more technical information and resources.

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Apr 17, 2021 • 7:28 pm CDT

The World Health Organization (WHO) confirmed on April 14, 2021, the National IHR Focal Point of the Kingdom of Saudi Arabia reported seven additional cases of Middle East respiratory syndrome (MERS-CoV) infection, including three associated deaths, between January 2021 and March 11, 2021.

These MERS-CoV cases were reported from Riyadh (four cases), Jeddah (one case), Al-Ahsaa (one case), Makkah (one case) regions of Saudi Arabia. 

MERS-CoV infections can cause severe disease resulting in high mortality, says the WHO. MERS is a beta coronavirus, similar but different than the SARS-CoV-2 virus that causes COVID-19.

From 2012 until March 11, 2021, a total of 2,574 laboratory-confirmed cases of MERS-CoV and 886 associated deaths were reported globally.

The WHO expects that additional cases of MERS-CoV infection will be reported from the Middle East and that cases will continue to be exported to other countries by individuals who might acquire the infection after exposure to dromedaries, animal products (for example, consumption of camel’s raw milk), or humans (for example, in a healthcare setting).

Based on the current situation and available information, WHO re-emphasizes the importance of strong surveillance by all Member States for acute respiratory infections and carefully review any unusual patterns.

However, the WHO does not advise special screening at entry points concerning this event, nor does it currently recommend applying any travel or trade restrictions.

As of April 17, 2021, there are no Approved MERS vaccines. Several MERS vaccine candidates are conducting clinical trials.

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Apr 17, 2021 • 8:29 am CDT

Two MIT professors proposed in the journal PNAS on April 15, 2021, a new approach to estimating a person's risks of exposure to the SARS-CoV-2 virus that causes COVID-19 under different indoor settings.

The new MIT guideline suggests a limit for exposure time, based on the number of people, the size of the space, the kinds of activity, whether masks are worn, and the ventilation and filtration rates.

This MIT model offers a detailed, physics-based guideline for policymakers, businesses, schools, and individuals to gauge their own risks.

'One clear thing, they say, is that simple rules, based on distance or capacity limits on certain types of businesses, don’t reflect the full picture of the risk in a given setting. In some cases, that risk may be higher than those simple rules convey; in others, it may be lower, stated these researchers in an April 15th MIT press statement.

The mission of Cambridge, MA-based MIT is to advance knowledge and educate students in science, technology, and other areas of scholarship that will best serve the nation and the world in the 21st century.

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Apr 16, 2021 • 11:50 am CDT

The U.S. CDC reported on April 16, 2021, COVID-19 cases and hospitalizations are increasing in some areas of the country. The reasons for these increases are various and complicated but potentially related to emerging SARS-CoV-2 variants that are becoming predominant in some communities.

Although the 7-day moving average of daily new deaths has generally decreased for the past 13 weeks, the recent 7-day average increased 10.8% compared with the prior week.

As of April 14, 2021, a total of 561,356 COVID-19 deaths have been reported to the CDC.

'As the access to vaccines for all Americans increases, we have reason to be hopeful. However, until more of the U.S. population is fully vaccinated, consistent use of prevention strategies will help to limit the spread of the SARS-CoV-2 coronavirus that causes COVID-19.'

'Even if you have been fully vaccinated against COVID-19, you should keep taking these everyday precautions in public places,' says the CDC.

On April 15, 2021, the U.S. CDC reported 78,498,290 people representing about 23.6% of the US population, have been fully vaccinated against COVID-19 with one of the authorized, experimental vaccines.

Our World in Data COVID Vaccination reported the USA leads all countries with about 195 million doses administered, followed by China with 175 million and India with 115 million.

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Apr 16, 2021 • 8:19 am CDT

A non-peer-reviewed study published on April 13, 2021, assessed the humoral immune response after the first dose of two vaccines, Covishield and the BBV-152 (Covaxin), in 552 healthcare workers in India.

Both vaccines showed seropositivity to anti-spike antibodies 21 days or more after the first vaccine dose.

These researchers concluded this study by saying, 'While both vaccines elicited immune response, seropositivity rates to anti-spike antibody were significantly higher in Covishield recipient than Covaxin after the first dose.'

'The ongoing COVAT study will further enlighten the immune response between two vaccines after the second dose.'

Both of these COVID-19 vaccines are produced in India.

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