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
This year has already witnessed a handful of memorable FDA approvals. But the race isn’t over yet. Looking to close out 2021 with FDA approvals stand four potential blockbusters from the likes of Argenx, UCB, Pfizer and Roche, according to Evaluate Pharma. Those meds combined are worth roughly $7.1 billion in sales cumulatively by 2026, according to Evaluate’s estimates.
Getting started is often the most difficult part—and that’s especially true in rare diseases and diagnoses. Patients and families often spend many years searching for their diagnosis starting point. For Horizon Therapeutics’ first innovation challenge, it took that struggle to heart and asked for technology-based rare disease solutions that result in faster or more accurate diagnoses.
Researchers from the Quadram Institute and the University of East Anglia (UEA) discovered that treating mice with broad-spectrum antibiotics increased the rate at which their breast cancer tumours grew.