The FDA today issued guidance for medical product developers to address the emergence of variants of SARS-CoV-2, which causes COVID-19. Variants of the virus have been detected in multiple countries across the globe, including the U.S., and they pose a major threat to potentially ending the COVID-19 pandemic as protocols such as mask-wearing and hand-washing […]
Pfizer
Pfizer vaccine stable at standard freezer temps, effective with single dose
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have submitted data to FDA indicating that their vaccine is stable at –25° C to –15°C. Currently, the vaccine can be stored in an ultra-cold freezer between –80° C and –60° C, according to current CDC guidelines. Updating the companies’ emergency use authorization prescribing information would be simplify logistics. It would […]
Biden announces $4B to support global vaccinations worldwide
President Joe Biden announced that the U.S. is set to provide $4 billion to the COVAX Facility to support access to safe and effective COVID-19 vaccines. Money appropriated by a December 2020 Congressional vote will comprise an initial $2 billion contribution to Gavi, the Vaccine Alliance for the COVAX advance market commitment (AMC) covering 92 […]
Pfizer, BioNTech start trial to evaluate COVID-19 vaccine’s effect on pregnant women
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that it dosed the first participants in a trial of its COVID-19 vaccine for pregnant women. The companies, which developed one of the two COVID-19 vaccines to be authorized in the U.S. so far, are conducting a global Phase 2/3 study to evaluate the safety, tolerability and immunogenicity of the vaccine […]
MedTech 100 roundup: Rise to new heights continues
The medtech industry hit another high as 2021 continues to bring strong performances out of some of the biggest companies around. MassDevice‘s MedTech 100 index ended the week (Feb. 12) at 110.63 points, marking a 2.2% rise from the 108.23-point mark set at the end of the previous week (Feb. 5). The final mark for the […]
Feds order 200M more vaccine doses from Pfizer, Moderna
U.S. government agencies announced that they purchased a total of 200 million additional doses of COVID-19 vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA). The orders of 100 million doses from each of the only two FDA-authorized vaccines in the U.S. were made by the U.S. Health & Human Services Dept. (HHS) and the Defense Dept. (DoD). The […]
Report: Pfizer speeding up vaccine production
Pfizer (NYSE:PFE) is reportedly expecting to trim the time needed to produce COVID-19 vaccine batches to speed up production. The company, which along with BioNTech (NSDQ:BNTX) developed one of two COVID-19 vaccines currently authorized in the U.S., is slated to cut the amount of time it takes to produce a batch of the vaccine from 110 […]
Feds to order 61M more at-home coronavirus tests, build surgical glove factories
Just days after ordering 8.5 million at-home tests from Ellume, the Biden administration announced today that it’s in talks with six other at-home coronavirus test manufacturers. In an online briefing, Tim Manning, the national supply chain coordinator for COVID response, told reporters that these companies could produce another 61 million at-home tests by the end of […]
Study suggests Pfizer-BioNTech COVID-19 vaccine is effective against emerging variants
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 […]
Sanofi to provide COVID-19 vaccine manufacturing for rival Pfizer
Sanofi (NYSE:SNY) announced today that it entered into an agreement to support the manufacturing and supply of the Pfizer/BioNTech COVID-19 vaccine. Pfizer and BioNTech’s vaccine is one of two to receive FDA emergency use authorization in the U.S. and it also has clearance in Europe, having received both nods in December 2020. The deal between Sanofi provides BioNTech access […]
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 […]