Coronavirus Breaking News

The first randomized, placebo-controlled, single-blind clinical study of Ondine Biomedical Inc.'s Steriwave™ nasal photodisinfection was published in Frontiers in Cellular and Infection Microbiology.

This limited study, announced on January 31, 2023, met its primary endpoint, with a highly significant decrease in viral infectivity recorded as early as two days after treatment (p<0.0001).

Steriwave therapy also significantly improved the immune-protective status of treated patients, as measured by PCR testing one week after treatment (over six times fewer PCR-positive patients compared to controls).

The study was conducted at the Clínica Universidad de Navarra in Spain during the sixth Omicron outbreak in late 2021 and early 2022. Over 90% of the patients recruited into the study were fully vaccinated.

Ondine is seeking to offer a therapeutic approach to those patients who test positive but are not yet symptomatic or to those individuals who have had known exposure to a COVID-19 patient.

Currently, there are no U.S. FDA-approved approaches for killing the coronavirus while it is still located in the nose and throat.

Ondine Biomedical Inc. is a Canadian life sciences company innovating in the field of photodisinfection therapies.

The U.S. Centers for Disease Control and Prevention (CDC) recently confirmed COVID-19 vaccination remains the most effective way to prevent SARS-CoV-2–associated serious illness, hospitalization, and death.

And everyone, including those who are immunocompromised and their household members and close contacts, should stay up to date with COVID-19 vaccination.

Although moderately to severely immunocompromised persons might not mount a strong vaccine-mediated immune response, staying up to date with COVID-19 vaccinations does provide some protection.

A recent CDC study of preliminary data showed that a bivalent booster dose provided additional protection against symptomatic SARS-CoV-2 infection among immunocompetent persons who had previously received 2, 3, or 4 monovalent vaccine doses.

Among persons with immunocompromise and their household members and close contacts, prevention measures, including wearing a high-quality and well-fitting mask, maintaining physical distance from others, improving indoor ventilation, practicing frequent handwashing, and developing a care plan, should be considered in addition to receipt of a bivalent booster dose.

Furthermore, early outpatient treatment of mild to moderate COVID-19 with a recommended first-line therapy, Paxlovid or Veklury, has been shown to reduce the risk for severe COVID-19.

These medications are expected to retain activity against the currently circulating Omicron sublineages.

Available COVID-19 treatment does not supplant the need for persons to stay current on their COVID-19 vaccinations, which are highly effective at preventing COVID-19–related morbidity and mortality, stated the CDC's Morbidity and Mortality Weekly Report on January 27, 2023.

According to the U.S. Centers for Disease Control and Prevention (CDC) Weekly Influenza Surveillance Report, a total of 91 influenza-associated pediatric deaths have occurred during the 2022-2023 flu season.

During week #3, six influenza-associated pediatric deaths were reported to CDC.

All six pediatric deaths were associated with influenza A viruses.

Four of the influenza A viruses had subtyping performed; one was an A(H1N1) virus, and three were A(H3) viruses.

As of January 27, 2023, the CDC stated the cumulative hospitalization rate was 1.4 times higher than the highest cumulative in-season hospitalization rate observed for week #3 during previous seasons going back to 2010-2011.

However, this in-season rate is still lower than end-of-season hospitalization rates for all but four pre-COVID-19-pandemic seasons going back to 2010-2011.

Most influenza viruses tested are in the same genetic subclade as and antigenically similar to the influenza viruses included in this season’s influenza vaccine.

As of January 14, 2023, about 171 million influenza vaccines had been distributed in the U.S.

All flu shots this flu season are quadrivalent and remain available at clinics and pharmacies. According to the CDC, these vaccines are authorized for most people over six months.

Moderna, Inc. today announced that its investigational mRNA vaccine candidate for the respiratory syncytial virus (RSV) mRNA-1345, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) in adults aged 60 years or older.

Moderna also confirmed it intends to submit a license application to the FDA for regulatory approval in the first half of 2023.

"The FDA's Breakthrough Designation for mRNA-1345 further emphasizes the significant health impact of RSV in older adults and the high unmet need," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release on January 30, 2023. 

Moderna's mRNA platform has demonstrated two positive Phase 3 infectious disease trial results."

This designation is granted to expedite the development and review of drugs intended to treat a serious condition and when preliminary clinical evidence indicates the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

mRNA-1345 was previously granted Fast Track designation by the FDA in August 2021.

RSV can cause severe disease, with an estimated 5.2 million cases and nearly half a million hospitalizations in adults 60 years or older reported across high-income countries in 2019, says the U.S. Centers for Disease Control and Prevention.

Each year in the U.S., approximately 60,000-120,000 older adults are hospitalized, and 6,000-10,000 die due to RSV infection.

As of January 30, 2023, the FDA has not approved any RSV vaccine candidates but authorized RSV antibody treatments.

The Pan American Health Organization (PAHO) updated its Arboviral Situation Summary stated is very important for the Southern Hemisphere to be prepared to intensify prevention and control actions in the face of any increase in Chikungunysa virus (CHIKV) cases in 2023.

On January 25, 2023, the PAHO highlighted the Republic of Paraguay's increase in CHIKV cases in late 2022.

After a normal start, the number of CHIKV cases reported weekly in the last three weeks averaged 750 cases. This data compares with 576 in 2021.

Throughout 2022, Paraguay's neighbor Brazil led all Southern Hemisphere countries with 265,265 suspected chikungunya cases.

Since 2004, outbreaks of CHIKV have become more frequent and have been identified in over 110 countries in Asia, Africa, Europe, and the Americas. 

Chikungunya is a viral disease transmitted to humans through the bites of mosquitoes infected with the CHKV, says the World Health Organization (WHO). Severe symptoms and deaths from chikungunya infections are rare and usually related to other coexisting health problems.

Mosquitoes transmit the Chikungunya virus.

Most patients recover fully from the infection; however, people at extremes of the age spectrum are at higher risk for severe disease.

Newborns infected during delivery and older people with underlying medical conditions may become severely ill, and CHIKV infection can increase the risk of death.

Once an individual is recovered, available evidence suggests they will likely be immune from future infections.

As of January 29, 2023, the U.S. Food and Drug Administration (FDA) has not approved any chikungunya vaccine candidates currently conducting late-stage clinical trials.

However, Valneva SE completed the rolling submission of the Biologics License Application to the U.S. FDA on December 23, 2022, for VLA1553, a monovalent, single-dose, live-attenuated chikungunya vaccine.

From a traveling perspective, the United Kingdom stated in December 2022, before traveling, check the 'Entry requirements' section for Paraguay's current entry restrictions and requirements.

And all travelers to and from Bolivia, Brazil, Peru, and Venezuela are obliged to present an International Yellow Fever Vaccination Certificate to authorize their entry and exit of the country.

There are two yellow fever vaccines available worldwide.

The Pan American Health Organization (PAHO) updated its Arboviral situation summary today with data indicating that a coral island in the Lesser Antilles of the West Indies was confronted with an extensive Zika virus (ZIKV) outbreak last year.

Zika transmission can occur in most areas where the mosquito Aedes aegypti is found. This means there is the potential for transmission throughout much of the Caribbean Islands, says the PAHO.

In 2022, the PAHO reported a total of 37,869 ZIKV cases in the Region of the Americas in 15 out of 52 countries and territories. 

The most significant number of Zika cases in the Region was reported by Brazil, with 34,176.

But on a cumulative incidence per 100,000 population basis. Barbados, with about 280,000 residents, led the Region at 48.

Brazil's rate was just 16, based on a population of 214 million.

To alert international visitors of their potential ZIKV health risk when visiting Barbados, the U.S. Centers for Disease Control and Prevention (CDC) issued an Alert - Level 2, Practice Enhanced Precautions. However, the CDC withdrew this Alert on June 30, 2021.

The CDC currently says, 'We do not have accurate information on the current level of risk.'

However, both Canada and the United Kingdom (UK) had enough information to publish ZIKV advice for people visiting Barbados last year.

The UK represented about 50% of all international visitors in 2022.

Because Zika is a cause of severe congenital disabilities, such as microcephaly, the CDC, Canada, and the UK recommend pregnant women and couples trying to become pregnant within the next few months speak with their healthcare providers to carefully consider the risks and possible consequences of travel to areas with risk of Zika.

Furthermore, if a woman is pregnant, she should not visit areas with ZIKV outbreaks, says the CDC.

Furthermore, these countries have not approved a Zika-prevention vaccine as of January 28, 2023.

Roche and its subsidiary TIB Molbiol, recently announced they had developed a COVID-19 PCR test for researchers that detects and differentiates the latest variant of concern, XBB.1.5.

The XBB.1.5 variant is prevalent in the U.S. and is quickly spreading to other countries.

XBB.1.5 is a sub-variant of a SARS-CoV-2 beta coronavirus variant named XBB.

Differentiating emerging variants and understanding their similarities and mutations empowers experts to make predictions about treatment strategies.

The VirSNiP SARS-CoV-2 Spike F486P test is for use on the LightCycler® 480 II and cobas® z 480.

“Roche continues to develop timely diagnostic innovations related to COVID-19 by providing valuable insights - helping scientists and physicians understand this new strain, how it differs from other variants, and the impact it may have on public health,” said Matt Sause, CEO of Roche Diagnostics, in a press release on January 26, 2023.

“Since the start of this global health crisis, Roche has been committed to bringing effective diagnostic solutions to address unmet needs to healthcare communities worldwide.”

The research-use-only test, VirSNiP SARS-CoV-2 Spike F486P, adds to the broad suite of COVID-19 test kits developed by Roche and TIB Molbiol.

In the U.S., the Food and Drug Administration has authorized numerous COVID-19-related tests as of January 27, 2023.