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 […]
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 […]
7 takeaways about the COVID-19 vaccine from infectious disease expert Paul Offit
Dr. Paul Offit is one of the most notable vaccine experts in the U.S. A member of the FDA’s Vaccines and Related Biological Products Advisory Committee for COVID-19 vaccines, Offit is the co-inventor of a rotavirus vaccine. In a conversation with JAMA editor-in-chief Dr. Howard Bauchner, Offit shared his opinion on a range of subjects […]
Regeneron antibody cocktail wins emergency use authorization
Regeneron Pharmaceuticals (NSDQ:REGN) has announced that the FDA has granted emergency use authorization (EUA) for the combination of casirivimab and imdevimab to treat COVID-19. The monoclonal antibody cocktail is reportedly the first treatment to show “statistically significant anti-viral activity” against COVID-19, according to its developer. In a trial, the combination of drugs cut hospitalization or emergency […]
5 takeaways from the latest White House Coronavirus Task Force meeting
The White House Coronavirus Task Force promised a swift rollout of COVID-19 vaccines — but one of a number of takeaways from its first briefing since July. The briefing yesterday gave the task force a chance to once again urge Americans to heed COVID-19 guidance while also providing an update on vaccines and therapeutics. The […]
Why the COVID-19 vaccine market won’t be ‘winner take all’
There are a dozen Phase 3 COVID-19 vaccine candidates with more than 50 in either Phase 1 or Phase 2 trials. But the fact that Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have vaccine candidates with efficacy greater than 90% could ultimately narrow the playing field. “Efficacy matters, but I don’t think [Pfizer’s and Moderna’s efficacy rate of] greater […]
Moderna and Pfizer COVID-19 vaccines set a high bar for competitors
Moderna (NSDQ:MRNA) is now the second company to release positive preliminary results from a Phase 3 trial of a COVID-19 vaccine candidate — and it appears to be more good news. Last week, Pfizer (NYSE:PFE) announced that early data suggested its BNT162 mRNA-based vaccine was more than 90% effective at reducing symptomatic COVID-19 infections. Today, […]
What a Biden administration could mean for the pharma industry
While President Trump continues to refuse to concede the election, a growing number of business associations and politicians have acknowledged Biden as the president-elect. What a Biden presidency would mean for the pharmaceutical industry continues to be an open question as the Senate outcome remains undecided, but two broadly similar outcomes are likely. Get the […]
Qiagen readies portable digital COVID-19 antigen test
Qiagen (NYSE: QGEN) and its partner Ellume are gearing up for the launch of the QIAreach SARS-CoV-2 antigen test, which can reportedly process samples in 2–15 minutes. Qiagen notes that the test can process up to 30 swab samples per hour while supporting parallel processing of antibody tests. The companies have submitted the test for […]
How AI could reassure you that COVID-19 vaccines are safe
As governments and health authorities worldwide gear up to deliver potentially billions of COVID-19 vaccine doses, artificial intelligence and data automation techniques could be a powerful tool combating one of the top hindrances to mass vaccination: vaccine hesitancy. In particular, natural language processing (NLP) could help health authorities transform adverse event reports from COVID-19 vaccines […]
