Travel Vaccine Breaking News

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As of January 26, 2023, the FDA had withdrawn its EUA(s) for monoclonal antibodies (mAbs) for COVID-19.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.

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.

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.

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.

Following assessing the primary endpoints of the Phase II/III study, PharmaJet partner Gennova Biopharmaceuticals Limited has submitted data for its mRNA-based Omicron-specific Covid-19 booster shot for Emergency Use Authorization to the office of the Drug Controller General of India.

This is the first booster in India explicitly targeting the SARS-CoV-2 coronavirus Omicron variant.

GEMCOVAC-OM is a lyophilized vaccine, stable at 2-8 °C, which means it can be distributed through the existing refrigeration supply chain Pan-India and in low- and middle-income countries.

The vaccine, GEMCOVAC-OM, will be delivered exclusively with the PharmaJet Tropis Precision Delivery System.

"Our partnership with Gennova Pharma and their Omicron booster clinical program confirms the value of choosing our widely validated and rapidly scalable Precision Delivery Systems to improve the effectiveness of DNA and mRNA vaccines," said Chris Cappello, President, and CEO, PharmaJet, in a press release on April 3, 2023. 

"The Tropis System is already commercially available in India, and we are well-prepared to rapidly support demand for the GEMCOVAC-OM Omicron booster."

"In addition, we look forward to continuing our partnership with Gennova with additional novel vaccines."

For more information, visit Pharmajet's website.

The COVID-19 pandemic fundamentally changed expectations for public health, especially the speed at which credible health information is delivered, wrote the U.S. Centers for Disease Control and Prevention (CDC).

Throughout the pandemic, the CDC has been improving the timeliness, completeness, and quality of critical data for the response.

Through the Data Modernization Initiative, the CDC empowered 'data to move faster than a disease.' 

Updated on March 31, 2023, a series of Weekly Review issues coinciding with the end of the COVID-19 public health emergency (May 2023) and what it means for CDC and the data reported.

The first issue was published on February 24, 2023, and the final two issues will publish on April 14 and May 12, 2023.

To view current and historical maps of COVID-19 vaccination by demographics in the U.S. as of April 2, 2023, please visit this webpage: Maps of COVID-19 Vaccinations by Age and Sex over Time.