Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate.
The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according to a news release.
Get the full story at our sister site, Drug Discovery & Development.
Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate.
The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according to a news release.
Prevention of symptomatic COVID-19 in SARS-CoV-2 naive adults constitutes the primary endpoint, while the prevention of severe COVID-19 disease and prevention of asymptomatic infection makes up the secondary endpoints.
Stage one of the study will investigate the efficacy of the vaccine formulation targeting the original D.614 virus (Wuhan) while a second stage will evaluate a second formulation targeting the South African (B.1.351) variant. The global study offers a chance to evaluate the vaccine candidate against a number of circulatin…
This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]
The U.S. Department of Health and Human Services (HHS) has recommended pausing the combination of Eli Lilly’s (NYSE:LLY) bamlanivimab/etesevimab in eight states, including Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon and Washington.The agency’s reasoning for the decision is grounded in lab data that found the antibody cocktail is not effective against P.1 (Brazilian) or B.1.351 (South African) variants. Those variants comprise more than 10% of COVID-19 infections in the eight states mentioned above.
HHS still recommends Regeneron’s (NSDQ:REGN) REGEN-COV antibody cocktail in areas with significant spread of the P.1 and B.1.351 v…
In an SEC filing, Eli Lilly (NYSE:LLY.N) revealed that it had received a subpoena from the U.S. Department of Justice connected to a manufacturing site in New Jersey that produces bamlanivimab, one of two COVID-19 monoclonal antibodies it produces. The plant also produces the blockbuster Trulicity and cancer drugs.
Lilly did not state which types of documents the federal government had requested but noted that it is cooperating with the criminal probe. The U.S. government has not made any specific accusations against Lilly.
According to a Reuters report, Lilly employees had accused an executive of modifying federal documents to cover up quality control problems at the facility in Branchburg, New Jersey.
FDA officials inspected the plant in November 2019 and reported discovering missing data related to various manufacturing processes. The agency concluded that the facility had two counts of inadequate “control of computer systems.”
The FDA used its…
Pharma industry contract manufacturer Exelead recently announced that it has delivered its first precursor batch of Prizer-BioNTech’s COVID-19 vaccine, produced at its recently expanded facility in Indianapolis.
Exelead plans to add 50 jobs to help it meet COVID-19 vaccine demand.
“We are extremely proud to be part of the manufacture of the Pfizer-BioNTech COVID-19 vaccine, knowing our work has the potential to help millions of people,” said Exelead CEO John Rigg said in a news release. “As a leader in complex drug manufacturing, Exelead is committed to leveraging our manufacturing capabilities and years of experience to help support the supply of the Pfizer-BioNTech COVID-19 vaccine and increase the number of doses available.”
Kevin Nepveux, VP of Pfizer Global Supply, added that contract manufacturer support is one way the pharmaceutical giant has ramped up manufacturing capabilities to produce more COVID-19 vaccine doses.
Charlotte, N.C.-based Honeywell expanded operations at the Smithfield eye protection products plant so that the facility could also manufacture millions of N95 masks at the beginning of the pandemic in March 2020.
Get the full story at our sister site, Medical Design & Outsourcing.
N95 respirator (Image from the FDA)
Honeywell is laying off approximately 470 employees on its Smithfield, R.I.-based N95 respirator mask production line.
Charlotte, N.C.-based Honeywell expanded operations at the Smithfield eye protection products plant so that the facility could also manufacture millions of N95 masks at the beginning of the pandemic in March 2020.
The company said at the time that it had plans to immediately start the hiring process to bring on at least 500 new workers to support the efforts, which was slated to deliver masks to the U.S. Department of Health and Human Services to boost the national stockpile.
A Honeywell spokesperson confirmed that the layoffs pertained only to employees on the N95 production line and nowhere else in the facility. The affected employees received notice of the layoffs throughout the day on Wednesday. The spokesperson told Medical Design &…
Healthcare workers have administered almost 288 million doses of COVID-19 vaccines in the U.S., which now has more than enough vaccine for the present demand.
Against that backdrop, FDA has released updated emergency use authorization (EUA) guidelines for COVID-19 vaccines that state the agency could decline some future EUA requests. “For the remainder of the current pandemic, FDA may decline to review and process further EUA requests other than those for vaccines whose developers have engaged in an ongoing manner with the Agency,” the guidelines explain.
In its most recent guidance, the FDA also stresses the need for EUA vaccine candidates to undergo rigorous product quality review, including scrutiny of manufacturing and clinical trials.
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have already begun filing a Biologics License Application for full FDA approval for their COVID-19 vaccine. Moderna (NSDQ:MRNA) is also pursuing full approval. …
Moderna Logo (PRNewsFoto/Moderna Therapeutics)
Moderna (NSDQ:MRNA) has joined Pfizer (NYSE:PFE) in announcing that its vaccine was 100% effective in a Phase 2/3 study involving adolescents. It will seek regulatory authorization to expand the use of its vaccine to adolescents as young as 12 in early June.
In the TeenCOVE study, no participants who received two doses of the mRNA-1273 vaccine contracted symptomatic COVID-19.
Using a secondary CDC case definition of COVID-19 that includes milder illness, the trial found that the vaccine was 93% effective in seronegative participants. The secondary case definition requires the presence of one COVID-19 symptom and a positive reverse transcription-polymerase chain reaction (RT-PCR) test. The company used that definition because COVID-19 transmission in adolescents is lower than in adults.
Side effects in the trial were generally mild or moderate for v…
Barclays analysis projects that medtech might be on its way to a stretch of “outperformance” even in the wake of the COVID-19 pandemic.
According to SeekingAlpha, the report cited eight reasons that make the investment bank bullish on the industry in the coming years, starting with what it calls “robust innovation.”
On top of the evolving innovation in medtech, Barclays expects the canceled procedures of 2020 (as a result of COVID-19) to return, while new technology could increase diagnoses.
Direct-to-consumer advertising, a potential return to “normality” in a post-pandemic scape, surveys indicating a resurgence in elective surgeries, healthy balance sheets and an aging population as a tailwind round out the reasons why Barclays expects success for medtech over the next several years.
Medtech companies that Barclays stands “overweight on” include Abbott (26.72% upside), Boston Scientific (18.55% ups…
A previously undisclosed U.S. intelligence report revealed that three scientists from China’s Wuhan Institute of Virology became sick enough in November 2019 to seek hospital care, according to the Wall Street Journal.
The illnesses were consistent with both COVID-19 and common seasonal illnesses, but the report fuels speculation that the scientists at the Wuhan lab were among the first to contract the SARS-CoV-2 virus.
Get the full story at our sister site, Drug Discovery & Development.
[Image from Wikimedia Commons/Russell Watkins/DFID]
World Health Organization (WHO) director-general Dr. Tedros Adhanom Ghebreyesus announced the organization’s aims for global COVID-19 vaccinations.During an address to the annual World Health Assembly today, Ghebreyesus called for all countries to have at least 10% of their populations vaccinated by September and at least 30% by the end of 2021.
In low- and middle-income countries, about 250 million more people would need to get vaccinated if the world were to reach the September threshold, with Ghebreyesus saying all healthcare workers and the most at-risk groups should have priority.
“This is crucial to stop severe disease and death, keep our health workers safe and reopen our societies and economies,” Ghebreyesus said. “We must be very clear: the pandemic is not over, and it will not be over until and unless transmission is controlled…