Coronavirus Breaking News

Massachusetts-based Moderna, Inc. announced a Memorandum of Understanding (MoU) with the government of Canada to build a state-of-the-art messenger RNA (mRNA) vaccine manufacturing facility in Canada.

The goals of this MoU are to build the foundation to support Canada with direct access to rapid pandemic response capabilities and to provide access to Moderna’s vaccines in the development, such as SpikeVax, formerly known as COVID-19 Vaccine Moderna.

The collaboration aims to provide Canadians with access to a domestically manufactured portfolio of mRNA vaccines against respiratory viruses, including COVID-19, seasonal influenza, respiratory syncytial virus, and potential other vaccines, pending licensure.

The new facility is intended to also be activated on an urgent basis to support Canada with direct access to rapid pandemic response capabilities. The MOU includes access to Moderna’s mRNA development engine.

“We are excited to expand our presence and continue our long-term collaboration with Canada,” said Patricia Gauthier, Moderna’s Canadian General Manager. “With our industry-leading mRNA technology platform and rapid drug development capabilities, we look forward to being an active participant in Canada’s robust life sciences ecosystem.”

The MoU was announced on August 10, 2021, by the Hon. François-Philippe Champagne, Minister of Innovation, Science and Industry of Canada, and Stéphane Bancel, Moderna’s Chief Executive Officer in Montreal, Canada.

To help build confidence for COVID-19 vaccination, the Centers for Disease Control and Prevention (CDC) announced on August 6, 2021, it is partnering with the Georgia Department of Public Health (DPH) and several other organizations on an innovative community initiative leveraging local artists as trusted vaccine messengers.

The COVID-19 Georgia Arts is a unique collaboration between CDC, the David J. Sencer CDC Museum, DPH, Community Organized Relief Effort (CORE) Georgia, and two local arts organizations – Dashboard and Living Walls – to increase vaccine uptake through public art.

A series of recently launched art installations and events will continue throughout August in select neighborhoods in cities including Atlanta, Savannah, and Athens.

Some of the events – which focus on communities disproportionately impacted by COVID-19 – will feature pop-up vaccination sites, providing convenient opportunities to access COVID-19 vaccines.

“There is a long history in the U.S. of partnering with arts and media organizations to promote health education,” said Peggy Honein, Deputy Incident Manager for CDC’s COVID-19 Response, in a press statement.

“Local artists can play an important role in delivering fact-based information and serving as trusted messengers within their communities to increase confidence in vaccines."

"This is a truly unique opportunity to work together to demonstrate the power and potential of the arts as a public health strategy to protect communities.”

This pilot is part of DPH’s broader “Say ‘Yes’ to COVID-19 vaccines” campaign, and the lessons learned can be applied to communities nationwide.

The journal Nature Communications volume report a longitudinal study on August 6, 2021, assessing the antibody response to a wide panel of antigens from the SARS-CoV-2 virus and Human Cold Coronaviruses (HCoV) up to 7.7 months after infection.

The SEROCOV study conducted in Barcelona, Spain, shows evidence of COVID-19 protection by pre-existing HCoV antibodies, such as those related to the common cold.

This is an important finding to understand better why some people may be less affected by COVID-19.

Importantly, these researchers observed a trend towards higher levels of antibodies against HCoVs N proteins at baseline in those participants who did not become infected with the SARS-CoV-2 virus, suggesting some level of cross-protection against infection.

Moreover, asymptomatic SARS-CoV-2 seropositive participants tended to have higher anti-HCoV N IgA and IgG levels before seroconversion than symptomatic participants, suggesting cross-protection against disease.

In addition, asymptomatic seropositive participants had higher anti-HCoV N IgG levels after infection than symptomatics, pointing towards a disease-protective back-boost of anti-HCoV antibodies.

Combined with the observation that higher baseline anti-HCoV N antibody levels correlated with less de novo anti-SARS-CoV-2 N antibody production, the researchers propose a protective effect of previous exposure to HCoVs, which could be the result of a diminished exposure (decreased viral load) due to the suggested protective role of anti-HCoV antibodies.

“Although cross-protection by pre-existing immunity to common cold coronaviruses remains to be confirmed, this could help explain the big differences in susceptibility to the disease within the population,” stated ISGlobal researcher Carlota Dobaño, in a related press statement.

Previous studies have reported a lack of anti-disease cross-protection. Some studies have associated severe COVID-19 with a back-boosting of antibodies against S2 from betacoronaviruses, and N, and S from OC4331.

Moreover, these studies included only hospitalized patients instead of this cohort, mainly asymptomatic and participants with mild/moderate symptoms.

Knowing the duration of HCoV protective immunity to reinfection and disease will be key to understanding HCoV’s role in COVID-19 epidemiology and pathology at a population level.

In conclusion, these researchers stated that antibody levels and neutralizing capacity are generally maintained for up to 7.7 months. However, in a substantial number of individuals, antibody levels increase after some months post symptoms onset.'

Importantly, previous exposure to HCoVs could have a protective effect against SARS-CoV-2 infection and symptoms development and may partly explain the differential susceptibility to disease in the population.

Note: Additional work focusing on prospective cohorts would allow the assessment of mechanisms and confirm causality in anti-HCoV antibodies on SARS-CoV-2 acquisition, disease progression, immune response maintenance, and correlates of protection. A strength of the present study is the availability of sequential sampling within a random cohort, including asymptomatic and symptomatic subjects.

But, further studies are needed to elucidate the mechanisms and nature of these increases and their implications for virus shedding and disease progression.

The study had funding from the European innovation network EIT Health. No conflicts of interest were disclosed.

China-based Brii Biosciences Limited announced that the Phase 3 portion of the ACTIV-2 study evaluating its monoclonal neutralizing antibody combination therapy, BRII-196/BRII-198, has completed enrollment of 846 participants in sites in the USA, Brazil, South Africa, Mexico, and Argentina.

The participants enrolled are being evaluated for the combined primary endpoint of hospitalizations and death, relative to placebo, in the 28 days following treatment.

Upon completion of the study, the analysis of the ACTIV-2 dataset will include participants enrolled between January and July of 2021 – a period of the rapid global emergence of novel SARS-CoV-2 variants.

In addition, data on the clinical efficacy of combination BRII-196/BRII-198 by variant type will also be evaluated as part of the study analysis.

BRII-196/BRII-198 have been specifically engineered to reduce the risk of antibody-dependent enhancement and prolong the plasma half-lives for a potentially more durable treatment effect. In addition, their non-overlapping epitope binding regions provide a high degree of neutralization activity against SARS-CoV-2.

Current in vitro pseudovirus testing data suggests that combination BRII-196/BRII-198 retains activity against major SARS-CoV-2 coronavirus variants of concern, including the following commonly identified variants, B.1.1.7 (Alpha), (B.1.351 (Beta), P.1 (Gamma), B.1.429 (Epsilon) and B.1.617.2 (Delta).

Combination BRII-196/BRII-198 was generally safe and well-tolerated in Phase 1 and Phase 2 clinical trials.

The ACTIV-2 trial is sponsored by NIAID, one of the institutes of the U.S. NIH, and is led by the NIAID-funded AIDS Clinical Trials Group (ACTG). ACTIV-2 is part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership program to create a coordinated research strategy that prioritizes and speeds the development of the most promising treatments and vaccines.

BRII-196 and BRII-198 are non-competing SARS-CoV-2 monoclonal neutralizing antibodies derived from convalesced COVID-19 patients.

Investigational New Drug applications have been submitted for the combination therapy to the U.S. Food and Drug Administration, the China National Medical Products Administration, and the Department of Health in Hong Kong, China.

Brii Biosciences Limited is a biotechnology company based in Beijing, China, and the United States, committed to advancing therapies for significant infectious diseases, such as hepatitis B virus, human immunodeficiency virus, multi-drug resistant, or extensive drug-resistant gram-negative infections, and other illnesses, such as the central nervous system diseases.

For more information, visit www.briibio.com.

New Jersey-based Quest Diagnostics announced on August 3, 2021, it had performed and reported over 51 million COVID-19 molecular diagnostic and antibody serology tests since it launched these services in 2020. 

'We continue to perform and report most COVID-19 diagnostic tests within 1 day,' confirmed Quest in a related press statement.

'We continue to see our molecular test volumes increase as we work to meet the demand caused by the current COVID-19 surge in the USA.'

'Our average positivity rate has also steadily increased over the past six weeks, making it more difficult to pool specimens. While we have ample capacity to meet current demand, we are currently evaluating measures to increase capacity should testing volume and positivity rates continue to surge.'

'Our COVID-19 molecular diagnostic tests are effective in detecting individuals infected with the Delta variant, which is now the dominant strain of SARS-CoV-2 circulating in the United States, as well as other known circulating strains.'

The U.S. Food and Drug Administration announced that the FDA authorizes 398 tests and sample collection devices under emergency use authorizations (EUAs).

These include 279 molecular tests and sample collection devices, 87 antibody and other immune response tests, and 32 antigen tests. In addition, there are 53 molecular authorizations and one antibody authorization that can be used with home-collected samples.

And there is one molecular prescription at-home test, three antigen prescription at-home tests, six antigen over-the-counter (OTC) at-home tests, and two molecular OTC at-home tests.

Moreover, the FDA has authorized 13 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 595 revisions to EUA authorizations.

The U.S. CDC reported today COVID-19 cases, hospitalizations, and deaths are once again increasing in nearly all states, fueled by the B.1.617.2 (Delta) variant, which is much more contagious than past versions of the SARS-CoV-2 beta coronavirus.

• The current 7-day moving average of daily new cases (66,606) increased 64.1% compared with the previous 7-day moving average.
• The current 7-day average for hospitalization was 5,475. This is a 46.3% increase from the prior 7-day average. This moving average for new admissions has consistently increased since June 25, 2021.
• The current 7-day moving average of new deaths (296) has increased 33.3% compared with the previous 7-day moving average. The current 7-day moving average is 91.8% lower than the peak observed on January 13, 2021.

Vaccines help protect people from getting COVID-19 or from getting severely ill from it.

COVID-19 vaccines are very effective, but no vaccine is perfect. In some instances, fully vaccinated people will get COVID-19 again and may become contagious.

If you or someone you know is hesitant about COVID-19 vaccination, the CDC has information and answers to frequently asked questions to help them inform their decision.