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InflaRx N.V. today announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
The FDA granted EUA based on Phase 3 clinical trial results showing a significant relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in critically IMV COVID-19 patients.
As of January 26, 2023, the FDA had withdrawn its EUA(s) for monoclonal antibodies (mAbs) for COVID-19.
“COVID-19 treatments remain a priority for CDER, as the disease continues to impact the lives of Americans,” said Center Director Patrizia Cavazzoni, M.D. “Today's authorization offers another potentially lifesaving treatment option for the sickest COVID-19 patients.”
The Annals of Internal Medicine recently published results from a study that concluded early mAb treatment among outpatients with COVID-19 was associated with a lower risk of hospitalization or death.
Prof. Niels C. Riedemann, CEO and Founder of InflaRx, commented in a press release on April 4, 2023, "We are thrilled and very proud that the FDA has issued a EUA for vilobelimab to treat this very sick patient group, recognizing the lifesaving potential of this first-in-class drug."
"Despite the availability of vaccines and other treatments for earlier disease stages of COVID-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation."
"As a consequence, we continue to see mortality rates in the range of approximately 2,000 COVID-19-reported deaths per week in the U.S., as reported by the U.S. Centers for Disease Control and Prevention."
"Today's announcement brings new hope to these patients and their loved ones, and we will work diligently to make this important new treatment available to patients as rapidly as possible."
InflaRx stated it plans to apply for full approval to treat critically ill COVID-19 patients in Europe.
Additional mAbs news is posted at CoronavirusToday.com.
Global News reported today the Canadian Food Inspection Agency (CFIA) confirmed a dog in Oshawa, Ontario, contracted avian influenza (bird flu) and died.
On April 1, 2023, the CFIA reported the dog was infected with bird flu after chewing on a wild goose.
“Further testing is underway,” CFIA said in a related statement. “It is the only case of its kind in Canada.”
“Based on the current evidence in Canada, the risk to the general public remains low, and current scientific evidence suggests that the risk of a human contracting avian influenza from a domestic pet is minor,” the CFIA stated.
Previously, on August 30, 2022, a case of H5N1 infection in a black bear was confirmed in Quebec.
And in May 2022, two red fox kits in Ontario tested positive for HPAI.
Those kits were the first reported cases of the current HPAI outbreak in a wild mammal in North America.
Additional news regarding mammals infected with bird flu is posted at Precision Vaccinations.
And bird flu vaccine news is posted at this link.
The Annals of Internal Medicine today published the results from a University of Pittsburgh Medical Center hypothetical randomized study that estimated administering monoclonal antibodies (mAbs) within two days of a COVID-19 diagnosis lowered the risk of hospitalization or death by about 39%.
The risk for hospitalization or death at 28 days was 4.6% in 2571 treated patients and 7.6% in 5135 nontreated control patients (risk ratio [RR], 0.61 [95% CI, 0.50 to 0.74]). In sensitivity analyses, the corresponding RRs for 1- and 3-day treatment grace periods were 0.59 and 0.49, respectively.
In subgroup analyses, those receiving mAbs when the Alpha and Delta variants were presumed to be predominant had estimated RRs of 0.55 and 0.53, respectively, compared with 0.71 for the Omicron variant period.
Relative risk estimates for individual mAb products all suggested a lower risk for hospitalization or death. The RR was 0.45 (CI, 0.28 to 0.71) among immunocompromised patients.
mABS are human-made antibodies designed to prevent a pathogen, such as the coronavirus that causes COVID-19, from entering human cells, replicating, and causing serious illness.
The U.S. Food and Drug Administration granted emergency use authorization to five different COVID-19 mAbs treatments between 2020 and 2022.
As of April 4, 2023, one mAbs (Gohibic) is authorized for use in the U.S.
Australia's Department of Health and Aged Care recently announced the Vaxzevria (AstraZeneca) COVID-19 is no longer available in-country.
Australia initially confirmed AstraZeneca's vaccine for use as a primary course and booster dose in people aged 18 years and over in February 2021.
And the government provisionally approved for use in Australia as a booster on February 8, 2022.
As of April 4, 2023, Pfizer, Moderna, or Novavax COVID-19 vaccines are the preferred COVID-19 vaccines for people under 60 years.
This assessment was based on the higher risk and observed severity of a rare side effect called thrombosis with thrombocytopenia after receiving AstraZeneca in people under 60 years compared with those aged 60 years or older.
Previously, the Australian Technical Advisory Group on Immunisation recommended in February 2023 that all adults are eligible for a 2023 booster dose this year, provided they have not had a COVID-19 vaccine dose or been infected with COVID-19 within the previous six months.
The U.S. Federal Retail Pharmacy Program for COVID-19 Vaccination is part of the government’s strategy to ensure access to COVID-19 vaccines during the pandemic.
As of March 9, 2023, more than 301 million COVID-19 vaccines have been administered in the U.S. since 2020.
One aspect of this success story is that about 90% of Americans live within 5 miles of a community pharmacy.
To offer these vaccines, the U.S. government spent over $30 billion on COVID-19 vaccines, including the new bivalent boosters, reported Kaiser Family Foundation News.
As of April 4, 2023, the COVID-19 vaccines continue to be provided free of charge to the U.S. population.
Over twenty-five authorized COVID-19 vaccines and therapies are listed in the Precision Vaccinations library.
According to a new study published in Health Affairs, most hospitals in the U.S. are not fulfilling patient privacy promises made when websites were launched in the late 1990s.
Published in April 2023, this study by researchers at the University of Pennsylvania found that third-party tracking was present on 98.6 percent of hospital websites, including data transfers to large technology companies, social media companies, advertising firms, and data brokers.
By including third-party tracking apps on websites, hospitals are facilitating the profiling of their patients by third parties, such as major tech companies and data brokers.
This analysis included hospitals in health systems, hospitals with a medical school affiliation, and hospitals serving more urban patient populations, all exposing visitors/patients to high levels of data tracking.
These data include a person's medication and vaccination histories.
In addition to personal privacy concerns, these practices may lead to increased online health-related advertising targeting patients' mobile phones.
In 1996, the privacy rule within the Kassebaum-Kennedy Act (HIPAA) offered initial privacy protection for a person's health information.
While the U.S. Food and Drug Administration (FDA) has not approved an Alzheimer's disease (AD) vaccine, there is progress in developing monoclonal antibody therapies.
For example, Eli Lilly and Company presented on March 31, 2023, an Interim Analysis from a Phase 1 Study of Remternetug, an IgG1 monoclonal antibody directed at the pyroglutamate modification of the third amino acid of amyloid-beta peptide that is present only in brain amyloid plaques.
Lilly stated Remternetug demonstrated rapid and robust amyloid plaque reduction in participants with AD.
Furthermore, to determine the safety, tolerability, and pharmacokinetic/pharmacodynamic data, Lilly is conducting a phase 3 trial (NCT05463731).
Separately, Lilly's donanemab is conducting a Phase 3 clinical trial.
Other Alzheimer's vaccine and antibody development news is posted at PrecisionVaccinations.com/Alz.
The Republic of Kenyan health authorities recently launched its first-ever cholera vaccination drive to bolster outbreak control efforts.
This program was strategically needed as Kenya has recorded more than 7,800 cholera cases and 122 related fatalities as of March 26, 2023.
The 10-day vaccination campaign launched with support from World Health Organization targeted 2.2 million people in the four worst-affected areas.
Vaccination teams went door-to-door to provide residents with the vaccine at homes, schools, health centers, markets, and other strategic public spaces.
According to Dr. Emmanuel Okunga with Kenya’s Ministry of Health, the vaccination campaign reached about 99% of the target population.
“It has been very successful,” he commented in a WHO Africa article on March 31, 2023.
“We are now monitoring the impact of the vaccine on the number of cases, and we have already seen a decline across the affected counties.”
Cholera infections are caused by ingesting contaminated food or water, with symptoms including acute watery diarrhea, which can quickly lead to severe dehydration.
The U.S. Centers for Disease Control and Prevention (CDC) published Cholera Vaccine recommendations on September 30, 2022. The CDC currently recommends the Vaxchora® vaccine for adult travelers.
The global supply capacity was 36 million oral cholera vaccine doses in 2022, whereas demand exceeded 70 million.
In the first quarter of 2023, 11.7 million doses have been requested (by six countries), of which 2.2 million doses have been shipped.
Other cholera vaccine news is posted at this link.
Researchers recently published a study in the American Journal of Health-System Pharmacy that concluded pharmacist-led culture follow-up programs to deprescribe antibiotics for patients with negative cultures has the potential to save significant antibiotic exposure.
According to these researchers, there was an opportunity to save a median of five antibiotic days per patient.
Published on March 28, 2023, this peer-reviewed, retrospective, descriptive study reviewed bacterial cultures of adult patients at an emergency department or urgent care in August 2022.
For one month, pharmacists reviewed 398 cultures, of which 208 (52%) were urine cultures or chlamydia tests with negative results.
Fifty patients (24%) with negative results had been prescribed empiric antibiotics.
The median duration of antibiotic treatment was seven days (interquartile range [IQR], 5-7 days), while the median time to culture finalization was two days (IQR, 1-2 days).
Thirty-two patients (15.3%) followed up with their primary care physician within seven days; of these patients, 1 (0.05%) had their antibiotic prescription discontinued by the primary care physician.
Previous studies in 2022 and 2019 also concluded pharmacist interventions deliver measurable, positive results.
