Coronavirus Breaking News

The U.S. Food and Drug Administration (FDA) announced guidance on February 22, 2021, for medical product developers to address the emergence and potential future emergence of variants of SARS-CoV-2, the beta coronavirus that causes COVID-19.

The new Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests provides information on evaluating the potential impact of emerging and future viral genetic mutations, which may be the basis of viral variants, on COVID-19 tests, including design considerations and ongoing monitoring. The FDA has already issued a safety alert to caution that the presence of viral genetic mutations in a patient sample can potentially change the performance of a diagnostic test.

The FDA identified a few tests that are known to be impacted by emerging viral mutations, though at this time, the impact does not appear to be significant.

The clinical impact of viral genetic mutations on a test’s performance is influenced by various factors, such as the variant sequence, the design of tests. For example, molecular tests designed to detect multiple SARS-CoV-2 genetic targets are less susceptible to the effects of genetic variation than tests designed to detect a single genetic target.

The guidance describes the FDA’s activities to understand better the public health impact of new virus variants and the impact on test performance, such as monitoring publicly available genomic databases for emerging SARS-CoV-2 genetic mutations and monitoring the potential effects of genetic variation on molecular tests that have been issued a EUA.

The guidance also provides recommendations to test developers, such as considering the potential for future viral genetic mutations when designing their test and conducting their own routine monitoring to evaluate the potential impact of new and emerging viral genetic mutations, which may be the basis of viral variants, on the performance for molecular, antigen and serology SARS-CoV-2 tests.

The FDA is an agency within the U.S. Department of Health and Human Services.

A new study stated, 'Influenza vaccination was associated with decreased positive COVID-19 testing and improved clinical outcomes and should be promoted to reduce the burden of COVID-19.'

This study found the odds of testing positive for COVID-19 were reduced in patients who received an influenza vaccine by 24%.

And, influenza-vaccinated patients testing positive for COVID-19 were less likely to require hospitalization or mechanical ventilation and had a shorter hospital length of stay.

These researchers concluded by saying, 'The influenza vaccine should be promoted to reduce the burden of COVID-19.' The American Journal of Infectious Diseases published: 'Impact of the Influenza Vaccine on COVID-19 Infection Rates and Severity' on February 22, 2021.

North Carolina-based EmitBio Inc. announced on February 17, 2021, significant efficacy results from its Phase I/II clinical trial conducted with an investigational treatment device for COVID-19 that directs precise wavelengths of safe, visible light targeted to the back of the throat and surrounding tissues.

The EmitBio self-treatment device achieved clinically and statistically significant results in reducing SARS-CoV-2 viral load and accelerated time to symptom resolution in adults with COVID-19. EmitBio is a rechargeable, handheld device that bathes the back of the throat with safe, non-UV light during a five-minute treatment.

“The ability to show statistical significance on both viral load and symptom endpoints with this sample size is a direct illustration of just how powerful our light treatment device can be,” stated Nate Stasko, Ph.D., Chief Scientific Officer at EmitBio, in a related press statement.

Due to these statistically significant results and findings, the company concluded its Phase I/II trial early and initiated activities to prepare additional COVID-19 trials in other populations. The clinical trial results and the results from a Phase I safety study in healthy volunteers have been submitted as part of a comprehensive package to the FDA requesting Emergency Use Authorization.

Salivary viral load is a powerful predictive indicator for disease progression to more severe manifestations of COVID-19, says the company. Researchers at Yale University and other major institutions recently published evidence demonstrating a clear-cut relationship between SARS-CoV-2 viral load measured in saliva and COVID-19 symptom severity.

EmitBio Inc. is a life science company using the precise delivery of safe, visible light to stimulate, heal and protect the body.

Maryland-based Novavax, Inc. announced the complete enrollment of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety, and immunogenicity of the COVID-19 vaccine candidate NVX-CoV2373. About 30,000 participants have been enrolled across 118 sites in the USA and Mexico.

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease.

Gregory M. Glenn, President of Research and Development, Novavax, commented in a press release issued on February 22, 2021, “We thank the thousands of volunteers and individuals, including our partners at NIH, the COVID-19 Prevention Network, and trial sites in the USA and Mexico, who enabled rapid recruitment and enrollment in the trial, which we believe is a critical aspect to building vaccine trust and uptake across the globe.”

PREVENT-19 is being conducted with support from U.S. government partners, including the Department of Defense and the Biomedical Advanced Research and Development Authority, which provides up to $1.75 billion in funding under a Department of Defense agreement.

Novavax has previously reported positive interim efficacy results of NVX-CoV2373, its recombinant protein-based vaccine candidate, in an ongoing Phase 3 clinical trial taking place in the United Kingdom.

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.

The Indian Council of Medical Research (ICMR) announced interim results of the ongoing Covaxin vaccine clinical trials, indicating that the indigenous Covid-19 vaccine would be effective against SARS-CoV-2 coronavirus strains from the United Kingdom.

The beta coronavirus that causes COVID-19 is mutating, and that's to be expected, stated the U.S. CDC on December 22, 2020.

Addressing an international webinar on February 18, 2021, Dr. Balram Bhargava, Director General of ICMR, said a paper on 'Covaxin's neutralization potential against the UK strain had been accepted for publication,' reported The Hindustan Times. And, efforts to isolate the mutated virus strains from South Africa and Brazil were underway.'

Furthermore, media reports indicate 240 new strains of the coronavirus have surfaced across India, Dr. Shahshank Joshi, a member of Maharashtra's Covid Task Force, told NDTV on February 21st.

India's Drugs Controller General on Restricted Emergency announced the approval of the Bharat Biotech's emergency use produced Covaxin vaccine on January 3, 2021.

According to media reports, there are now eleven COVID-19 vaccines being administered globally. On February 19, 2021, the Russian Federation announced the registration of their 3rd locally-produced COVID-19 vaccine, called CoviVac.

According to the general director of the Chumakov Center, Aydar Ishmukhametov, none of the international companies working on this method of obtaining vaccines has yet released whole virion vaccines against COVID-19. “I am sure that six months later, maybe earlier, all the same, whole-virion vaccines will dominate in the same way as it happened in other types of vaccines, in other developments,” reported Medexpert.ru on February 20, 2021.

Russia's CoviVac is a two-shot vaccination and is recommended for use from 18 to 60 years old.

In the USA, the experimental Pfizer-BioNTech Comirnaty and the Moderna COVID-19 mRNA vaccines are available, says the U.S. CDC.

Canada's Prime Minister Justin Trudeau participated in a virtual meeting of the G7 Leaders on February 19, 2021, and announced Canada would provide an additional $75 million to top-up its support to the Access to COVID-19 Tools (ACT) Accelerator that develops and provides tests, treatments, and vaccines around the world.

“Together, we can tackle the most pressing global challenges and build a safer and more resilient future for everyone. Today’s G7 meeting was an opportunity to address the health and economic impacts of the global COVID-19 pandemic and discuss other important issues, including the climate crisis. Canada looks forward to continuing these discussions and supporting the UK’s ambitious agenda throughout their 2021 G7 Presidency," said the Rt. Hon. Justin Trudeau, in a press statement.

Including this announcement, Canada has committed $940 million to the ACT Accelerator.

Canada has also mobilized more than $2 billion in international assistance in response to COVID-19. This includes $940 million for the ACT-Accelerator; Over $740 million in humanitarian and development assistance to respond to the immediate needs created by COVID-19; and Canada has worked with organizations to adapt their existing funding arrangements with Global Affairs Canada to ensure their activities could address the immediate needs created by the pandemic in developing countries for a total of $488 million.