A Pfizer-BioNTech preprint published today suggests that their BNT162b2 vaccine will be effective against SARS-CoV2 variants from the U.K. and South Africa, leading to “small differences in viral neutralization” compared with earlier variants. The U.K variant has been identified in 26 states in the U.S., while the South Africa variant has been found circulating in […]
Moderna
Moderna details ‘proactive’ strategy to fight emerging COVID-19 variants
While the so-called ‘U.K. variant’ of COVID-19 has triggered alarm, it may be a harbinger of things to come, as the novel coronavirus mutates across the world, complicating mass-vaccination efforts. Moderna (NSDQ:MRNA) detailed its plans to combat the matter in a briefing with investors. While it expects two 100-µg doses of its mRNA-1273 vaccine to be […]
Authorities investigating death of California recipient of COVID-19 vaccine
Last week, Norwegian officials raised eyebrows when they announced that they were investigating the deaths of 23 elderly patients who had recently received COVID-19 vaccine doses. Now, California authorities are investigating the death of a Placer County-based patient who received a COVID-19 vaccine dose on Jan. 21. The patient died hours afterward. Placer County officials […]
6 questions about facial swelling and COVID-19 vaccines answered
The news that Moderna’s (NSDQ:MRNA) COVID-19 had a small risk of facial swelling for patients with dermal fillers has spooked scores of patients. Dermatologists and plastic surgeons have been inundated with queries from concerned patients. But the risk of problems is minuscule, according to Dr. Wilbur Hah, the president of the American Board of Cosmetic Surgery […]
New COVID-19 variants could diminish vaccine efficacy
COVID-19 is mutating. And while early data suggest vaccines will be effective against more infectious COVID-19 variants that emerged in the U.K., South Africa and Brazil, the mutations could have a measurable impact on vaccine efficacy. There’s perhaps a 50/50 chance that such new variants could lead to a “numerically meaningful drop” in vaccine efficacy, […]
Facial swelling and COVID-19 vaccines: 4 facts
Patients with dermal fillers have a small potential risk of developing facial swelling after obtaining mRNA vaccines. To date, the FDA has noted the problem in three clinical trial recipients of the COVID-19 vaccine from Moderna(NSDQ:MRNA). The agency hasn’t observed facial swelling in the Phase 3 clinical trial for the COVID-19 vaccine from Pfizer (NYSE:PFE) […]
BREAKING: FDA grants emergency use authorization to Moderna COVID-19 vaccine
FDA has decided to permit emergency use of Moderna’s (NSDQ:MRNA) mRNA-1273 COVID-19 vaccine. A week ago, FDA granted the same designation for the vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). The U.S. government will collaborate with the company to distribute the vaccine. Although the EUA permits the vaccine to be used in individuals 18 and older, medical workers […]
CDC and FDA to monitor recipients of Moderna, Pfizer COVID-19 vaccines for Bell’s Palsy
CDC and FDA have committed to monitoring recipients of two COVID-19 vaccines for Bell’s palsy, a type of facial paralysis. FDA, however, concluded that there is insufficient data to determine whether the mRNA-based vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE)/BioNTech (NSDQ:BNTX) are linked to the condition, which is often temporary. Both vaccines use messenger RNA technology, which is […]
FDA data says Moderna’s COVID-19 vaccine is safe and effective
Ahead of a meeting to discuss the potential approval of the COVID-19 vaccine from Moderna (NSDQ:MRNA), FDA data says the candidate is safe and effective. Cambridge, Mass.-based Moderna filed for emergency use authorization in November, having conducted a Phase 3 study, known as the COVE study, that enrolled more than 30,000 U.S. participants, with 196 confirmed cases of COVID-19. […]
BREAKING: Moderna is filing for a COVID-19 vaccine EUA
Moderna (NSDQ:MRNA) announced today that it will apply for emergency authorization from U.S. FDA and the European Medicines Agency for its COVID-19 vaccine candidate. The company said it has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel, and […]
HHS confirms involvement in presidential transition process
U.S. Health and Human Services Dept. Secretary Alex Azar confirmed that HHS is working with president-elect Joe Biden on a presidential transition. Speaking during a press briefing, Azar said HHS is in contact with the transition team after the General Services Administration formally recognized Biden as the president-elect, having previously sidestepped questions regarding the potential […]