Senator Markey pushes U.S. to develop universal COVID-19 vaccine

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Senator Edward J. Markey (D-Mass.) has sent a letter to the National Institute of Allergy and Infectious Disease (NIAID) asking for a status update regarding ongoing research to develop a universal COVID-19 vaccine.

NIAID had awarded $36.3 million to academic institutions to conduct research that will help develop a coronavirus vaccine that protects against multiple types of coronaviruses.

Coronavirus outbreaks have resulted in three outbreaks in the past two decades. First, there was severe acute respiratory syndrome (SARS) from 2002 to 2004. Then, Middle East respiratory syndrome (MERS) appeared in 2012 and SARS-CoV-2 seven years later.

“Had a universal coronavirus vaccine existed at the onset of the pandemic, hundreds of thousands of American lives could have been saved,” wrote Senator Markey in a press release. “And we remain at risk of variants that have the pot…

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NIH to study third dose of COVID-19 vaccine in people with autoimmune disease

The National Institutes of Health (NIH) has launched a study to gauge the antibody response of a third dose of mRNA COVID-19 vaccine in patients with autoimmune disease. Participants in the study had an insufficient immune response to the primary series of vaccination.

The Phase 2 study will also test the impact of pausing immunosuppressive medication to determine if it improves the antibody response.

The study, titled “COVID‐19 booster vaccine in autoimmune disease non‐responders,” will test an additional dose of vaccines from both Pfizer-BioNTech and Moderna.

The National Institute of Allergy and Infectious Diseases (NIAID), an NIH division, is sponsoring the study.

The study will first focus on people with one of the following autoimmune diseases: multiple sclerosis, pemphigus, rheumatoid arthritis, systemic lupus erythematosus or systemic sclerosis.

On Aug. 12, FDA authorized an additional dose of Pfizer-BioNTech and Moderna COVID-19 va…

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U.S. buys 200 million more Moderna vaccine doses for potential boosters and use in children

Health experts remain divided over the need for COVID-19 vaccine boosters in the coming months, but the U.S. government is preparing for that possibility by purchasing 200 million additional doses of the COVID-19 vaccine from Moderna (NSDQ:MRNA).

The purchase of additional doses will also enable the U.S. government to inoculate children aged 12 to 17 in coming months, assuming FDA authorizes that use. Two doses of the vaccine were 100% effective in that age group, according to a recent Phase 2/3 trial.

In May, FDA amended its EUA for the Pfizer-BioNTech vaccine to include adolescents aged 12 to 15.

The U.S. has committed to buying 500 million doses of Moderna’s vaccine to date. The company expects to deliver 110 million doses in the fourth quarter of 2021 and another 90 million in the first quarter of 2022.

To date, Moderna has provided 217 million doses to the U.S.

The NIH has launched a clinical trial involving fully vaccinated participan…

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Adamis Pharmaceuticals’ Tempol shows promise against SARS-CoV-2 in preclinical research

The investigational drug Tempol from Adamis Pharmaceuticals Corp. (NSDQ:ADMP) could be a potent oral antiviral treatment for COVID-19 based on cell culture research, according to scientists at the National Institutes of Health (NIH). 

The positive research news caused Adamis Pharmaceuticals’ stock to jump 61% from $0.69 to $1.13 today. The quick jump in its stock valuation triggered a trading halt. 

Tempol belongs to a growing class of anti-COVID-19 drugs that aim to stop viral replication. 

Pfizer (NYSE:PFE) is also developing a similar potential COVID-19 treatment known as PF-07321332 that is a protease inhibitor. That investigational drug binds to a viral enzyme known as protease to stop viral replication.

Remdesivir, the subcutaneous injectable drug from Gilead Sciences (NSDQ:GILD) that won FDA approval on October 22, 2020, binds to the RNA polymerase and protease of SARS-CoV-2.  

Tempol relies on a different mode of action. The drug in…

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What are the top COVID-19 vaccine candidates?

This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]

As of yesterday, five COVID-19 vaccine candidates had begun Phase III clinical trials as they seek to determine the safety and efficacy of their formulas.

Researchers worldwide are testing 132 COVID-19 vaccine candidates, including 42 that are in clinical trials on humans and at least 92 in preclinical or animal trials, according to the New York Times.

With the U.S. alone topping 200,000 COVID-19 deaths this week and continued pressure to deliver a safe and effective vaccine, these companies and several others are working very quickly to make a vaccine that meets regulatory standards. Seven pharma companies have received funding for vaccine development and…

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Moderna launches Phase 3 study of its COVID-19 vaccine candidate

Moderna Logo (PRNewsFoto/Moderna Therapeutics)

Moderna (NSDQ:MRNA) announced today that it began dosing participants in the Phase 3 clinical study of its mRNA-1273 COVID-19 vaccine candidate.

Cambridge, Mass.-based Moderna’s COVE (coronavirus efficacy) study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Dept. of Health and Human Services.

The company had previously announced on June 11 that it expected to begin the Phase 3 trial at some point this month. At that point, it had already fully enrolled the first cohort of healthy adults between ages 18-53 in the Phase 2 study, 13 days after the first participant was dosed, having prev…

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Plakous lands $1.7m from NIH to develop newborn treatment

Plakous Therapeutics announced that it received more than $1.7 million in a research grant from he Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health (NIH).

The Phase I-II fast-track small business innovation research (SBIR) grant, worth up to $1.725 million, is slated to help Plakous develop novel therapies for preventing the necrotizing enterocolitis (NEC) disease in premature babies. The grant is set to supplement Plakous’ currently open $4 million seed round.

Winston-Salem, N.C.-based Plakous develops the Protego-PD system to prevent NEC by accelerating intestinal maturation of premature infants. Protego-PD is an orally delivered acellular biotherapeutic developed from post-delivery placentas.

The company’s chief scientific officer Seth Tomblyn will be the principal investigator for the three-year project funded by the grant, according to a news release.

“This …

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Partnership will study use of existing drugs for COVID-19 and and more

A new collaboration funded by in part by $1.1 million from the FDA is working on finding new uses for existing drugs for areas of high unmet medical need — with a pilot project focused on treatments for COVID-19.

The Critical Path Institute (C-Path) this week announced the launch of the CURE Drug Repurposing Collaboratory (CDRC). The National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), is also supporting the public-private partnership, which aims to create a network connecting major treatment centers, academic institutions and researchers, private practitioners, government facilities and health care professionals around the world.

CDRC will focus on capturing relevant real-world clinical outcome data through the FDA-NCATS CURE ID web platform and mobile app. CURE ID is designed to serve as a centralized source of reliable, curated, clinician-submitted information.

“The CURE ID platform enabl…

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Battelle under fire for decontamination system performance

Contaminated shipment of personal protective equipment delivered for Battelle CCDS decontamination system (Image from Battelle)

Major media outlets are questioning the ability of the Battelle Critical Care Decontamination System (CCDS) to safely reprocess used N95 respirators up to 20 times, as the company has claimed.

The FDA granted the nonprofit tech development company an emergency use authorization in March for its vaporized hydrogen peroxide system to decontaminate N95 respirators used by healthcare providers during the COVID-19 pandemic.

Nurses and nurses’ organizations have complained that respirators reprocessed by Battelle’s system began to fail after far fewer than the 20 cycles the company claims is safe, according to reports by NBC and the Boston Globe.

In April, National Institutes of Health scientists said N95 respirators can be decontaminated effectively and maintain…

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