With President Donald Trump and others touting accelerated timelines for COVID vaccines—potentially ending in an emergency authorization before the U.S. election—public confidence in the process has taken a hit.
But nine biopharma CEOs are seeking to turn that sentiment around with a joint safety and efficacy pledge.
Tuesday, the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi vowed to not seek approvals or emergency use authorizations for their vaccine candidates without conclusive positive data.
The drugmakers will “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA,” they said.
Pfizer CEO Albert Bourla last week said his company expects to know by late October whether its vaccine works. Aside from that drugmaker, Moderna and AstraZeneca are also in phase 3 testing in the U.S., but it’s unclear exactly when they could see early data.
Meanwhile, Trump and other officials in his administration have continued emphasizing that a vaccine is nearing.
On Friday, Trump said he spoke with Pfizer CEO Albert Bourla and that the company expects results “very, very shortly.” And in a Labor Day press briefing, Trump said a vaccine could be available by a “very special day,” appearing to reference the November 3 election.
The CDC is already working with states and localities to prepare for potential vaccine distribution as early as November 1. While the goal appears to center on the election, NIH director Francis Collins recently defended the effort, telling CNN the CDC is right to prepare for distribution in case any of the vaccines show early efficacy.
Even as the programs move ahead at record speeds, it’s “extremely unlikely, but not impossible” a vaccine will be ready in early November, Operation Warp Speed head and GlaxoSmithKline veteran Moncef Slaoui told NPR last week. He would resign if he felt inappropriate pressure to rush the process, he previously told Science.
By: Eric Sagonowsky
Source: Fierce Pharma
Sequana, a company focusing on liver disease, heart failure and cancer has announced positive top-line results from SAHARA – the phase 2a study using its first-generation direct sodium removal (DSR) product, DSR 1.0. Data from ten evaluable diuretic-resistant heart failure patients confirmed long-lasting clinical benefits.
Bristol Myers Squibb has officially opened its Cruiserath Biologics site in Dublin. The site, which represents a $1bn investment – was officially opened by the company’s chief executive officer, Giovanni Caforio, who arrived from New York, and site general manager Pádraig Keane.
Like it or loathe it, and whatever its new direction, Twitter is still a powerful platform for doctors, and pharma should not abandon the troubled social media site yet, according to a new report from healthcare consultants at ZoomRx.