Johnson & Johnson will cut COVID-19 vaccine shipments by 86% in the coming week, according to CDC projections. The week of April 5, the company shipped nearly 5 million doses. Next week, that figure could fall to approximately 700,000. The company anticipates that it can eventually deliver up to 8 million doses weekly, assuming FDA authorizes […]
AstraZeneca vaccine linked to rare blood clots, according to EMA official
European Medicines Agency (EMA) official Marco Cavaleri said there was a link between AstraZeneca’s COVID-19 vaccine and rare reports of blood clots, including pulmonary embolism, deep vein thrombosis and thrombocytopenia, according to a Reuters report. Two separate research groups in Europe had reached similar conclusions regarding the blood clots in March. Get the full story from our sister […]
Whistleblower: FDA downplayed safety issues at Merck vaccine plant
A former FDA inspector accused the agency of downplaying safety problems at a Merck plant tapped to manufacture Johnson & Johnson’s COVID-19 vaccine. The whistleblower alleged that a 2018 inspection uncovered evidence that employees in the facility in Durham, N.C.engaged in a host of unsanitary practices. A letter to President Biden from the U.S. Office […]
Pfizer-BioNTech COVID-19 vaccine 91.3% effective after six months
The first COVID-19 vaccine to win emergency use authorization in the U.S. is highly effective for at least six months after the second dose. Developed jointly by Pfizer (NYSE: PFE) and BioNTech (NSDQ: BNTX), the BNT162b2 vaccine The durability of COVID-19 vaccines had been something of an open question, although early clinical data suggested that Moderna’s mRNA-1273 […]
Factory error ruins 15M J&J COVID-19 vaccine doses
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,” […]
Early Pfizer COVID-19 vaccine doses may have had potency problems
Some of the first commercially available doses of Pfizer-BioNTech COVID-19 vaccine had lower levels of intact mRNA than anticipated, according to leaked documents reviewed by BMJ. The documents in question relate to a December breach of the European Medicines Agency (EMA), which was one of the many victims of pharma-related cyber breaches in 2020. A Pfizer […]
Pfizer launches trial for novel oral COVID-19 therapeutic
An experimental oral antiviral from Pfizer will be the focus of a Phase 1 study involving healthy adults. Known as PF-07321332, the drug has shown promise during in vitro studies against SARS-CoV-2. PF-07321332 belongs to a class of drugs known as protease inhibitors, which are commonly used to treat HIV/AIDS and hepatitis C. Protease inhibitors bind to […]
BioNTech and Moderna set their sights on treating cancer
COVID-19 vaccines launched BioNTech and Moderna into the limelight, making these once little-known companies prominent companies. But neither wants to be pigeonholed as a COVID-19 vaccine company. BioNTech cofounder Özlem Türeci stressed in a recent interview with AP that the mRNA vaccine technology that is its focus could be a powerful weapon against cancer. “We have several different […]
U.S. government classifies threat levels of SARS-CoV-2 variants
The number of SARS-CoV-2 variants with enhanced transmissibility and resistance to antibodies is increasing, prompting the U.S. government to issue guidance on how to classify them. The criteria divide variants into three categories including the following: Variant of interest: This virus type has genetic markers that have been linked to a potentially increased risk. Examples […]
No clear link between COVID-19 vaccines and sudden hearing loss
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, […]
Frequency Therapeutics drug shows promise in restoring hearing in small study
Frequency Therapeutics (Woburn, Mass.) recently announced data related to its experimental FX-322 drug. The small Phase 1/2 study, published in Otology & Neurotology, found hearing improvements in adults with age-related sensorineural hearing loss. At present, there are no FDA-approved drugs for preventing or restoring such hearing loss. However, administering steroids can facilitate recovery of hearing […]