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, […]
COVID-19 vaccine
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) […]
Norway investigating deaths of 23 individuals who received COVID-19 vaccine
In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). To date, it has analyzed data from 13 of those individuals. The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly […]
What’s next for the FDA and for Stephen Hahn?
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. Get the full story on our sister site, Medical Design & Outsourcing.
MedTech 100 roundup: Industry skyrockets as hot streak continues
The medtech industry’s seemingly unstoppable rise over the past several weeks shows no signs of slowing down. For the fourth time in five weeks, and for the third consecutive week, the MassDevice MedTech 100 Index — which includes stocks of the world’s largest medical device companies — hit an all-time high. Previous highs have largely been […]
MedTech 100 roundup: Ringing in the New Year with another high
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), […]
AstraZeneca vaccine recipients in U.K. will wait up to 12 weeks for second dose
An inexpensive COVID-19 vaccine from AstraZeneca (LON:AZN) — now authorized in the U.K. — could go on to become the most widely used in the world. It is inexpensive and easy to produce. But a major hurdle that could slow its rollout in the U.K. after yesterday’s approval is the question of how to best […]
Biden to bolster COVID-19 vaccine production with Defense Production Act
Joe Biden is reportedly planning on invoking the Defense Production Act to shore up the production of COVID-19 vaccines in the U.S. While FDA has authorized the distribution of vaccines from Moderna Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX), distribution has been patchy thus far. Get the full story at our sister site, Pharmaceutical […]
Why AstraZeneca and Sinovac’s COVID-19 vaccines have similar data challenges
A vaccine jointly developed by Oxford University and AstraZeneca (LON:AZN) is on the cusp of authorization in the U.K., according to media reports. Meanwhile, health officials in Turkey and Brazil have indicated that a vaccine from the Chinese firm Sinovac is safe and effective. But one factor that could slow the deployment of both vaccines globally is […]
11 COVID-19 therapies you need to know
The pharmaceutical industry launched a herculean effort to battle the COVID-19 pandemic early in 2020, developing an array of vaccines and other therapeutics while also identifying existing drugs suitable for treating patients sick with severe coronavirus infections. FDA recently granted emergency authorization to two SARS-CoV-2 vaccines and several other treatments. Here are 11 of the […]
BREAKING: Pfizer’s COVID-19 vaccine receives European authorization
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that they received conditional authorization from European regulators. The European Commission confirmed that it granted a conditional marketing authorization for the vaccine developed by the two companies, making it the first available COVID-19 vaccine in the European Union. The news follows an earlier announcement that the companies had received […]
