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COVID-19 vaccine

Intravacc touts preclinical, non-human results for COVID-19 nasal spray vaccine

April 7, 2021 By Sean Whooley Leave a Comment

Intravacc is today touting positive pre-clinical results of its SARS-CoV-2 nasal spray vaccine candidate in non-human subjects. Bilthoven, Netherlands-based Intravacc’s SARS-CoV-2 outer membrane vesicle (OMV)-based recombinant spike protein (rSp) nasal spray candidate was observed in four groups of mice and four groups of hamsters, all of which received two intranasal immunizations on day one and day […]

Filed Under: Clinical Trials, Drug-Device Combinations, Pharmaceutical Tagged With: coronavirus, COVID-19, COVID-19 vaccine, Intravacc

Emergent has reportedly had serious problems at Baltimore vaccine plant

April 6, 2021 By Chris Newmarker Leave a Comment

Emergent BioSolutions was not prepared to take on the mammoth task of churning out millions of COVID-19 vaccine doses to support U.S. efforts to end the pandemic, according to a report published today in The New York Times. Emergent was ill-equipped despite a $163 million federal contract to prepare the facility for high-volume production, according to the Times investigation, […]

Filed Under: Contract Manufacturing, Featured, Pharmaceutical Tagged With: coronavirus, COVID-19, COVID-19 vaccine, Emergent BioSolutions, Johnson & Johnson

Factory error ruins 15M J&J COVID-19 vaccine doses

March 31, 2021 By Brian Buntz Leave a Comment

Employees at an Emergent BioSolutions facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded. A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did not meet quality standards,” […]

Filed Under: Featured, Pharmaceutical Tagged With: coronavirus, COVID-19, COVID-19 vaccine, Johnson and Johnson

Pfizer, BioNTech report COVID-19 vaccine works well among adolescents

March 31, 2021 By Sean Whooley Leave a Comment

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that their COVID-19 vaccine produced 100% efficacy among adolescents. In adolescents aged 12 to 15 years old with or without prior evidence of SARS-CoV-2 infection, the BNT162b2 vaccine demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants between 16 and 25. The vaccine […]

Filed Under: Clinical Trials, Featured, Pharmaceutical Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, Pfizer

Trump advisor urged PPE push, drug scale-up early in pandemic

March 31, 2021 By Nancy Crotti Leave a Comment

A top advisor to former President Donald Trump urged his pandemic response team in February 2020 to respond swiftly to the spread of COVID-19, but told Trump that his recommendations had been largely ignored. Then-assistant to the president Peter Navarro wrote an impassioned memo to Trump on March 1, 2020, recommending that the federal government boost […]

Filed Under: Business/Financial News, Diagnostics, Distribution, Featured Tagged With: coronavirus, COVID-19, COVID-19 vaccine, Donald Trump, White House Coronavirus Task Force

EU allows Pfizer/BioNTech COVID-19 vaccine to be stored at higher temperatures

March 26, 2021 By Sean Whooley

Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature. Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures, […]

Filed Under: Featured, Pharmaceutical Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, European Medicines Agency (EMA), European Union, Pfizer

NIAID expresses concern over AstraZeneca’s COVID-19 vaccine data

March 23, 2021 By Sean Whooley

The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial. NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned that information the company released from its AZD1222 vaccine clinical trial may be outdated. In turn, that […]

Filed Under: Clinical Trials, Featured, Pharmaceutical, Regulatory/Compliance Tagged With: AstraZeneca, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

AstraZeneca touts COVID-19 vaccine study results, will seek FDA nod

March 22, 2021 By Sean Whooley

AstraZeneca announced today that its COVID-19 vaccine demonstrated statistically significant efficacy in preventing COVID-19 in a U.S. trial. AZD1222, developed in a collaboration between London-based AstraZeneca and Oxford University, was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization, according to a news release. Efficacy was consistent across ethnicity […]

Filed Under: Clinical Trials, Featured, Pharmaceutical Tagged With: AstraZeneca, coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccine trial, Oxford University

Oramed forms joint venture to develop oral COVID-19 vaccines with POD delivery tech

March 19, 2021 By Sean Whooley

Oramed Pharmaceuticals (NSDQ:ORMP) announced today that it is forming a joint venture to develop novel oral COVID-19 vaccines. New York-based Oramed entered into definitive agreements to form Oravax Medical, which is based on Oramed’s proprietary POD (protein oral delivery) technology and Premas Biotech’s novel vaccine technology, according to a news release. Get the full story […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Pharmaceutical Tagged With: coronavirus, COVID-19, COVID-19 vaccine, Oramed Therapeutics

Pfizer exec reportedly says COVID-19 vaccine pricing is a ‘signficant opportunity’ post-pandemic

March 18, 2021 By Sean Whooley

Pfizer CFO & EVP of supply chain Frank D’Amelio has said there could be an opportunity to potentially hike up prices on its COVID-19 vaccine in a post-pandemic state. Speaking last week at the Barclays Global Healthcare Conference, D’Amelio revealed that the company is considering what will become of the vaccine situation, especially involving pricing, […]

Filed Under: Business/Financial News, Contract Manufacturing, Featured, Pharmaceutical Tagged With: BioNTech, coronavirus, COVID-19, COVID-19 vaccine, Pfizer

No clear link between COVID-19 vaccines and sudden hearing loss

March 17, 2021 By Brian Buntz

Sudden onset sensorineural hearing loss — sometimes referred to as sudden deafness — occurs in anywhere from 11 to 77 per 100,000 people per year in the U.S. There have been a handful of case reports of COVID-19 patients having such hearing loss, including a report in BMJ. But as more COVID-19 vaccines become available, […]

Filed Under: Featured, Pharmaceutical Tagged With: coronavirus, COVID-19, COVID-19 vaccine, COVID-19 vaccines, sudden hearing loss, Vaccine Adverse Event Reporting System, VAERS

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