FDA authorizes Moderna vaccine as average daily cases and deaths hit records


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FDA authorizes a second vaccine as average daily cases and deaths hit records

By Jason Hanna, Theresa Waldrop and Christina Maxouris, CNN

Updated 8:31 PM ET, Fri December 18, 2020

(CNN) The US Food and Drug Administration on Friday night authorized a second coronavirus vaccine for emergency use as Covid-19 hospitalizations rose to another record and cases and deaths are piling up in unprecedented ways.

The latest on the coronavirus pandemic and vaccines

The FDA had signaled it would issue the authorization quickly for Moderna’s vaccine candidate, after the agency’s vaccine advisers voted Thursday to recommend approval.

“The emergency use authorization allows the vaccine to be distributed in the U.S. for use in individuals 18 years and older,” the FDA said in a tweet.

The Centers for Disease Control and Prevention still needs to green-light the vaccine before shots can be administered — and a CDC advisory panel is meeting this weekend to discuss it.If all hurdles are cleared, Moderna’s vaccine could be given in the US next week — joining Pfizer and BioNTech’s vaccine, which rolled out this week, with first doses primarily being given to health care workers and residents of long-term care facilities.

“It’s an exciting time, but it’s a heartbreaking time,” Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told CNN Friday of the vaccines’ arrivals.”

The numbers (of cases, deaths and hospitalizations) are almost unspeakable at this point.”In the US, average daily cases, total hospitalizations and average daily deaths are still rising to levels not previously seen, as hospital staff around the country warn they’re running out of space and energy to provide sufficient care:

Cases:The country’s average number of daily cases across a week was 216,674 on Thursday — a record high, John’s Hopkins University data show. That’s more than three times what the daily case average was during a summer peak in July.

More than 1.51 million new coronavirus cases were reported in the US this past week — the most ever for one week, according to JHU. That means new infections were reported in roughly 1 in 216 people in the US this week alone.

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Categories: Vaccine

2 replies

  1. Based in the southern end of Greater Buenos Aires, Argentina, Eurnekian Public Hospital recently sponsored a clinical trial targeting COVID-19 called the IVERCAR study. The sponsor was joined by other local hospitals acting as trial site organizations. With study results in, the Argentinian group has discovered that while in the control group, 58% of the participants were infected with COVID-19 during the trial, but the intervention arm (carrageenan plus ivermectin) revealed that the compound’s virucidal effects can actually protect patients against SARS-CoV-2 and serve as a sort of prophylaxis. These study results follow up on other positive results out of another randomized controlled study out of Egypt published by TrialSite last week.

    Intervention Combination

    This study used a combination of ivermectin (Ivercass) and iota Carrageenan. The hypothesis involving iota carrageenan comes out of a recently published study in preprint server bioRxiv found that the compound typically used as a thickening agent in food products successfully inhibited SARS-CoV-2 in cell cultures at a concentration as low as 6ug/ml.

    Numerous case series in hospitals and health centers around the world have revealed the potential of ivermectin. A few random controlled trials have been completed and published in TrialSite. Medical journals have exhibited little interest in any ivermectin research based on observations thus far.

    PharmaLetter on the Combination

    In regards to the combination of ivermectin and carrageenan, recently the well-established PharmaLetter reported on the findings, confirming the potential of carrageenan, the sulfated polymer from red seaweed, as a inhibiting force against SARS-CoV-2, while quoting Vienna, Austria-based Marinomed Biotech.

    Apparently, Marinomed develops carrageenan-based products. In this recent study, involving researchers from Tennessee, USA and Argentina, Marinomed Biotech’s CEO Andreas Grassauer noted, “We are extremely delighted about these results. They show that Carragelose (carrageenan) is a powerful tool to project people worldwide from being infected with COVID-19.” He continued “A prophylactic application could also sustainability optimize the protection of personnel in the healthcare system, but also in the personal care and education sector.”

    The PharmaLetter also highlighted the IVERCAR study showcasing that a nasal spray combining ivermectin and carrageenan “offers a very high level of protection when used as a preventive measure.”

    The Study

    The IVERCAR study (NCT04425850) included two arms including a control arm and the carrageenan and ivermectin arm. The study team sought to test the hypothesis that ivermectin plus carrageenan introduce material virucidal effects that have the potential to actually reduce the contagion.

    This study was observational, hence carries less weight of evidence as does the randomized controlled study TrialSite reported out of Zagazig University last week. The study, formally titled “Usefulness of Topic Ivermectin and Carrageenan to Prevent Contagion of COVID Among Healthy People and Health Personnel” had a start date of June 1, 2020 and an estimated study completion date of August 10, 2020. The study team recruited 1,195 health professionals of which 407 received no treatment and 788 self-administered ivermectin oral drops and an iota-carrageenan nasal spray five times per day over a 14 day period.

    The Results

    The Argentinian study team reported that the study data revealed that of the participants in the control group (e.g. not taking the study drug combination) 58% of the participants were infected with COVID-19 during the duration of the trial. The study team reported no contagions were recorded in the carrageenan and ivermectin arm, showcasing the compounds’ virucidal effects can potentially protect against COVID-19.

    The study’s primary endpoint in a 30 day time period was “Reduction in contagion” for health personnel. The study team established in the protocol that the average desertion worldwide was established at 27%. The study team established that the aim would be to “reduce dramatically” and assuming these claims are factual the results are striking. Out of 788 self-administered from the intervention arm, not one person fell ill to SARS-CoV-2.

    The team also reported that “both molecules accumulate in the salivary glands, so they have the potential to prevent viral spread by asymptomatic patients by inactivating the viral particles in the saliva.”

    Research Sponsor and Sites

    The responsible party listed in Clinicaltrials.gov is Hector E. Carvallo of Eurnekian Public Hospital while other parties associate with the results included Argentina’s Hospital Zonal General de Agudos, Hospital Municipal Angel Marzetti, Hospital Curenca Alta and Centro Medico Caseros.

    Lead Research/Investigator

    Hector E. Carvallo, Eurnekian Public Hospital


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