Coronavirus Breaking News

Jiangsu Recbio Technology Co., Ltd. today announced in a press release that by the Mongolian law on the prevention of COVID-19, the Company was granted an Emergency Use Authorization ("EUA") for its two-component recombinant vaccine ReCOV.

As of March 21, 2023, this is the first novel adjuvant recombinant subunit COVID-19 vaccine developed in China and approved overseas.

ReCOV is a recombinant COVID-19 vaccine developed by the Company with its technology platforms, including its novel adjuvant, protein engineering, and immunological evaluation platforms.

And the adjuvant used therein is its self-developed novel adjuvant BFA03.

The Company has successively conducted multiple late-stage clinical studies for ReCOV in China, the Philippines, the United Arab Emirates, Nepal, and Russia.

Studies have shown that ReCOV has demonstrated a favorable safety profile, with mild adverse reactions and no vaccine-related serious adverse events.

In particular, in a comparative clinical study with a positive control of Pfizer's mRNA vaccine, a sequential booster of ReCOV among subjects who have completed vaccination of inactivated vaccines induced durable and widespread cross-neutralizing antibodies against various Omicron variants, including BF.7, BA.5, BA.2.75, and BA.2, with all subgroups achieving superior levels of neutralizing antibodies as compared to the Pfizer's mRNA vaccine (with statistically significant differences).

The granting of the EUA to ReCOV in Mongolia will play a positive role in promoting registrations in other countries and regions.

Invivyd, Inc. recently announced the election of VYD222 to advance into the clinic as a novel monoclonal antibody (mAb) therapeutic option for COVID-19.

The company confirmed on March 6, 2023, it aims to leverage evolving COVID-19 regulatory paradigms and maximize efficiency to deliver this much-needed product for immunocompromised individuals and other vulnerable populations.

As of January 2023, no monoclonal antibodies (mAbs) are authorized or approved in the U.S. for the prevention or treatment of COVID-19.

mAbs are well suited to meet the need of immunocompromised individuals because they provide a prompt onset of protection, have a well-characterized safety profile, and do not rely on the individual’s immune response.

“The lack of commercially available mAbs in the U.S. is an unacceptable situation for the estimated 8 million people with impaired immune systems who don’t respond to vaccination and means a return to the isolation many of us experienced early in the pandemic,” stated Pete Schmidt, M.D., M.Sc., Chief Medical Officer of Invivyd, in a press release.

“This urgent need was recently acknowledged by the FDA and EMA at a joint workshop in December where various options such as the use of surrogate endpoints and immunologic bridging studies were discussed.”

The company plans for a Phase 1 clinical trial starting in Q1 2023. Once aligned with regulatory authorities, pivotal studies are designed to follow swiftly.

Despite the worldwide decrease in COVID-19 cases in 2023, there is still a steady demand for SARS-CoV-2 virus tests, according to current GlobalData estimates.

As of March 17, 2023, data indicates that the COVID-19 test market revenue for January 2023 was equivalent to 70% of December 2020, when testing began.

Aidan Robertson, Medical Analyst at GlobalData, commented in a press release, "While for many people COVID-19 has become a thing of the past due to vaccine rollouts and health and safety policies, a certain percentage of the population still take these tests to monitor potential infections or in preparation for international travel or in some cases with companies that require employees to provide a negative test to return to work."

"All of which has resulted in a more resilient market than expected."

In the U.S., the NIH's COVID-19 Treatment Guidelines Panel recommends, as of March 6, 2023, using either a nucleic acid amplification test or an antigen test with a sample collected from the upper respiratory tract to diagnose acute SARS-CoV-2 infection.

The U.S. Centers for Disease Control and Prevention COVID-19 Testing Locator enables consumers to search for free testing sites.

The U.S. Centers for Disease Control and Prevention (CDC) today announced updated Omicron variant proportion estimates.

As of March 11, 2023, the CDC reported the XBB.1.5 SARS-CoV-2 coronavirus variant makes up nearly 90% of new cases in the U.S.

This is an increase from the 87% reported last week.

SARS-CoV-2 is the virus that causes COVID-19, is constantly changing and accumulating mutations in its genetic code over time, says the CDC.

And given the diminished activity, the CDC now provides updated variant proportions for weighted estimates and Nowcast estimates every week on Friday.

The CDC also confirmed the number of COVID-19 cases and related fatalities continued to decrease since a peak in early January 2023.

The World Health Organization (WHO) weekly epidemiological update #132 today reported over 4.8 million new COVID-19 cases, and over 39,000 deaths were reported in the last 28 days.

This data published on March 1, 2023, indicates a decrease of 76% and 66%, respectively, compared to the previous 28 days.

At the country level, the highest numbers of new 28-day cases were reported from the United States of America (1,085,170 new cases; -29%), Japan (752,935 new cases; -77%), and China (537,561 new cases; -95%).

As of February 26, 2023, over 758 million confirmed cases and over 6.8 million deaths have been reported globally.

Xlear Inc. today announced it had supplemented the numerous scientific studies it has already provided the U.S. Department of Justice(DOJ) and the Federal Trade Commission (FTC) in the government's lawsuit against Xlear.

The DOJ-FTC sued Xlear alleging prior statements about nasal hygiene and COVID-19 lacked adequate substantiation.

As of February 27, 2023, Xlear stated in a press release it provided additional studies showing that simple nasal sprays are effective in helping reduce the transmission of (the SARS-CoV-2 virus) COVID-19 and reduce the severity of illness when used by individuals already infected with the virus.

One of the studies Xlear provided to DOJ is a peer-reviewed, double-blind, placebo-controlled, randomized clinical trial (RCT) involving 556 "high-risk healthcare professionals," finding that a nasal spray containing water, saline, and xylitol significantly reduced the transmission of COVID-19 and the severity of cases among those infected.

Specifically, the study finds: "[The spray] significantly reduced SARS-CoV-2 infection compared to placebo [36 cases (13.1%) Vs. 97 cases (34.5%); OR 0.29 (95% CI; 0.18–0.45), p < 0.0001].

Fewer clinical symptoms were also seen in the test group [57 cases (17.6%) vs. 112 cases (34.6%); OR 0.40, (95% CI; 0.27–0.59), p < 0.0001].

No harmful effects were associated with taking the [nasal spray] . . . This represents a 62% relative risk reduction in infection rate."

"[T]he spray was administered up to three times per day with . . . 6–8 [hour] between doses."

The study concludes: "[The nasal spray] has been shown to significantly reduce SARS-CoV-2 infections in healthcare workers, with 62% fewer infections when compared to placebo."

The company says, 'This product is not intended to diagnose, treat, cure, or prevent any disease.'

The U.S. Centers for Disease Control and Prevention (CDC) reported today there are 2.1% of counties, districts, or territories in the U.S. with a high COVID-19 Community Level.

As of February 23, 2023, the 7-day average for new daily cases, 33,722, decreased by 9.2% from a week ago.

As the COVID-19 pandemic fades from national headlines, the CDC noted that it would produce data every other week beginning in early March 2023.

A few weeks ago, the U.S. federal government announced plans to end the COVID-19 Public Health Emergency on May 11, 2023.

However, until then, COVID-19 remains a public health priority.