Outgoing FDA commissioner Stephen Hahn says he needs some time to reflect on his future after leading the FDA for a little over a year.
It’s hard to blame him.
Hahn’s brief tenure at FA has been rocky, to say the least.
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Reports of severe allergic reactions to COVID-19 vaccines have made consistent headlines in recent weeks. Still, such anaphylactic reactions are rare, occurring in approximately 11 out of every million doses for the vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), according to CDC.
While that is roughly 10 times the flu vaccine rate, COVID-19 vaccines so far have been generally well-tolerated in the vast majority of patients.
“The anaphylaxis rate for COVID-19 vaccines may seem high compared to flu vaccines, but I want to reassure you that this is still a rare outcome,” said Dr. Nancy Messonnier, the director of the CDC’s National Center for Immunization and Respiratory Diseases in a recent call with reporters.
More recent CDC data suggests a lower rate of anaphylactic reactions of 5.5 per 1 million injected vaccine doses.
Anaphylaxis, a severe …
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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) and BioNTech (NSDQ:BNTX).
We reached out to Dr. Whitney Bowe, a board-certified dermatologist and expert injector, to shed light on the topic.
1. Facial fillers ≠ BotoxDelayed inflammation is possible for patients who receive either hyaluronic acid or non-hyaluronic acid fillers. The former option, comprising brands such as Juvéderm from AbbVie subsidiary Allergan (NYSE:ABBV) and Restylane from Galderma Laboratories, is the most common.
Facial fillers, however, are distinct from Boto…
The BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) seems to offer protection against the new, more transmissible variant of the novel coronavirus identified in the U.K., according to a study from Pfizer and the University of Texas Medical Branch.
The study has not been currently peer-reviewed.
In additional testing, the Pfizer-BioNTech vaccine appeared to be effective against 15 other strains of SARS-CoV2.
The so-called “UK variant” of COVID-19, also known as the B.1.1.7 strain, has spooked the world in recent weeks, given its potential to exacerbate the pandemic. While the U.K. and South African strains may be transmitted more readily than others, researchers have not linked them to increased severity of COVID-19 infections.
Some commentators had suspected that the mutations would be unlikely to have a significant impact on COVID-19 vaccine performance.
For one thing, the mutations have not led to substantia…
Moderna Logo (PRNewsFoto/Moderna Therapeutics)
The European Union has authorized the mRNA-1273 COVID-19 vaccine from Moderna (NSDQ:MRNA) ahead of schedule, responding to criticism that it had been too slow in its mass vaccination plans. The E.U. drug regulator had planned on meeting later in the month to discuss the vaccine.
“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of European Medicines Agency (EMA), in a statement. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.”
EMA has also authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) on Dec. 21. It has not, however, given the greenlight to the vaccine from Oxford University and AstraZeneca, which is now available in the U.…
[Photo by Daniel Schludi on Unsplash]
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have decided to offer to inform clinical trial volunteers in its COVID-19 vaccine whether they received a vaccine or placebo. Those who received a placebo will be eligible to receive the first dose of vaccine by March 1 and stay in the study. A second dose will be administered roughly three weeks after the first dose.Roughly half of the 44,000-plus participants in the BNT162b2 vaccine trial received a placebo.
The question of whether to vaccinate placebo recipients in COVID-19 vaccine studies is difficult to answer. “We face this in every clinical trial, particularly on data monitoring committees,” said Dr. Steven Goodman, professor of epidemiology at Stanford University, in an FDA advisory meeting for the Pfizer-BioNTech vaccine on Dec. 10. “There is tension between actions that are good for an individual, which in the…
For the third time in the past four weeks, stocks within the medtech industry climbed to never-before-seen heights as 2021 reared its head.
Previous highs have largely been a result of the FDA granting Moderna emergency use authorization for its vaccine candidate and its subsequent rollout to the U.S., joining the one made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), which began to be administered last month.
With the industry plugging along, MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 104.67 (Jan. 1), marking its highest-ever total and a 1% uptick from the 103.63 points registered at the end of the week prior (Dec. 25, 2020).
A slight downturn came after the index hit a new high (100.75) on Dec. 4, 2020, beating the mark of 100.65 set on Nov. 9 and setting a new all-time high since the index started being recorded on Jan. 1, 2001. However, stocks have continued to rise …