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, […]
Pfizer
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 […]
Taking the fight to COVID-19 – BD, DHL, Novant on delivering, shipping and administering the vaccine
This week’s DeviceTalks Weekly podcast shares the stories of the professionals who are working to get the new COVID-19 vaccines into the hands – and arms – of the front-line fighters and people at greatest risk. Leading off, Elizabeth Woody, SVP of public affairs at BD, explains how the company is preparing for the increasing […]
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 […]
MedTech 100 roundup: Stocks stay near last week’s peak
The medtech industry is poised for a big week with the U.S. rollout of the COVID-19 vaccine and stocks remain high from previous peaks. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 100.03 (Dec. 11), marking a minor 0.7% uptick from the 100.75 points […]
BREAKING: FDA authorizes Pfizer’s COVID-19 vaccine
The U.S. FDA tonight authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), providing a much-hoped-for tool to roll back the deadly coronavirus pandemic. The FDA authorization came a day after an advisory commission for the agency provided an upbeat assessment of the two companies’ vaccine. The agency is also coordinating with the CDC and the […]
The top 5 MassDevice stories of the week — December 11, 2020
The medtech industry continues to plug along as major news comes in about vaccines, the incoming presidential administration and more. This week’s top stories include the latest on COVID-19, Joe Biden and some additional FDA clearances, plus a major royalties spat. Want to hear more about the week’s top medtech news on MassDevice? Tom Salemi will […]
While FDA advisory panel backs Pfizer’s COVID-19 vaccine, patient advocates urge caution
Today, an FDA advisory panel recommended that the COVID-19 vaccine candidate from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) be granted emergency use authorization (EUA). A total of 77% of the 22 panelists voted “yes” to issue an EUA for the vaccine. In the past week, three countries — UK, Canada and Bahrain — granted emergency use […]
Canada signs off on Pfizer-BioNTech COVID-19 vaccine
Canada’s health regulator has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). Pfizer submitted documentation related to the BNT162b2 vaccine to Canadian regulators on Oct. 9, 2020. “Canadians can feel confident that the review process was rigorous and that we have strong monitoring systems in place,” Health Canada explained in a statement. The agency also stressed […]
BREAKING: FDA says Pfizer’s COVID-19 vaccine meets success criteria
The FDA today said that the COVID-19 vaccine candidate made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) meets success criteria. Ahead of an advisory meeting on Thursday, Dec. 10, to review the vaccine candidate, the FDA found that data from Pfizer and BioNTech’s trials was “consistent” with its recommendations for emergency use authorization and that the candidate […]
BREAKING: U.K. approves Pfizer and BioNTech’s COVID-19 vaccine
The United Kingdom today approved its first COVID-19 vaccine, created through a partnership between Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). The Medicines and Healthcare products Regulatory Agency (MHRA) approval came after a “rolling review” in which assessment takes place as the packages of data become available from ongoing studies on a staggered basis. The idea is to evaluate […]