COVID-19 prompts Pfizer to stop enrollment in most studies

Albert Bourla incoming Pfizer CEO
Pfizer CEO Albert Bourla (Pfizer)

Pfizer has paused enrollment in many new and ongoing clinical trials in response to the COVID-19 pandemic, Reuters reports. The action sees Pfizer join Bristol Myers Squibb and Eli Lilly on the list of Big Pharma companies to revise their R&D plans in light of the novel SARS-CoV-2 coronavirus.

Each company has responded slightly differently to the situation. In Pfizer’s case, the current plan is to hold off on enrolling patients in many new and ongoing global trials for three weeks. The only exceptions are studies that are enrolling people with life-threatening conditions who are running out of treatment options.

Pfizer is still figuring out exactly how COVID-19 will impact its operations. In a Securities and Exchange Commission (SEC) filing published Wednesday, Pfizer said the impact of COVID-19 “will depend on the extent and severity of the continued spread of the coronavirus globally.” Pfizer thinks the impact could be material.

Free Webinar

From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx

Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Register Today.

The Big Pharma published the SEC filing on the same day Bristol Myers Squibb posted an investor fact sheet setting out the potential impact of COVID-19 on its business. Bristol Myers used the fact sheet to share details of how it is adapting its clinical operations to the pandemic.

Compared to Lilly and Pfizer, the changes at Bristol Myers appear relatively mild, at least in how they are worded. Existing sites will keep enrolling new subjects in Bristol Myers trials “when appropriate.” Bristol Myers took a harder line in other areas, hitting pause on the activation of new sites until at least mid-April and slamming the breaks on its cell therapy studies.

Screening, enrollment and apheresis in Bristol Myers’ cell therapy trials is on pause. Bristol Myers said the action is not considered an urgent safety measure and will not impact its ongoing efforts to win approval of bb2121 and JCAR017. 

How long the restrictions imposed by Bristol Myers, Lilly and Pfizer stay in place, and whether they need escalating, will depend on the progress of the virus and efforts to contain it. There remains a risk that trials outside of life-threatening indications will be disrupted to some degree for months in large parts of the world.

Suggested Articles

GE Healthcare has launched a new algorithm that can read X-rays and help assess the correct placement of ventilator tubes in critical patients.

Months after approving a COVID-19 shot based on early data, Russia is reporting data from nearly 19,000 people showing it is more than 90% effective.

Early-stage biotech Elevian has raised $15 million as it looks to target multiple age-related diseases.