Helping you make wiser investment decisions

Pfizer aims to ship COVID-19 vaccine doses ‘within hours’ of regulatory nods, CEO says. Will a ‘race to regulate’ ensue?

November 19, 2020 Eric Sagonowsky


After Pfizer’s leading COVID-19 vaccine turned in strong data in a late-stage trial, the company planned to submit its program to U.S. authorities for an emergency use authorization “within days.” And as soon as it gets go-aheads from regulators, it’ll be ready to distribute, CEO Albert Bourla says.

Once granted an authorization, Pfizer plans to begin shipping doses “within hours” of the notice, Bourla told Sky News after the company’s positive phase 3 announcement. And it’ll start shipping those doses wherever the vaccine is authorized first, he added, raising the prospect of a “race to regulate” as authorities seek to quickly review data and secure early doses for their countries.

If one drug regulator signs off on the shot before another, the “ethical thing to do is to start sending vaccines to the citizens of this jurisdiction because every day means lives,” Bourla told Sky News. Still, he stressed the importance of patience as demand will outpace supply early in the vaccination process.  

Whitepaper

The Rise of HPAPI Molecules – Trends in Highly Potent API Manufacturing

Highly potent active pharmaceutical ingredients are increasing in pharma pipelines. Lonza offers all HPAPI-related expertise to support your product development from concept to commercial use in an integrated manner.

RELATED: Despite impressive data, FDA’s coronavirus vaccine reviews will take weeks, not days, official says 

The company and its partner BioNTech have already started a rolling review of the vaccine in Europe, where regulators also began reviewing Moderna’s mRNA candidate this week. 

This week, the FDA official in charge of overseeing the vaccine review process said the agency’s detailed look at the data will take weeks, not days. High-priority vaccinations could begin in the U.S. next month, with everyday Americans getting vaccines as soon as April, U.S. health officials said this week.  

Pfizer has already made 20 million doses and plans to produce around 50 million by the end of 2020. The company has a much more ambitious goal of 1.3 billion doses for 2021. 

While there are other companies quickly advancing their vaccine candidates, Pfizer is open to enlisting other drugmakers to expand production, Bourla told Sky News. It’s “very challenging” to transfer the technology, he said, but Pfizer will “explore any possible avenue.” 

RELATED: Pfizer passes COVID-19 vaccine safety milestone, reveals 95% efficacy ahead of EUA 

Moderna, the only other company to turn in efficacy data so far, has said it plans to submit its vaccine to the FDA for emergency consideration in the coming weeks. Besides Pfizer and Moderna, a host of other players such as Johnson & Johnson, AstraZeneca and Novavax are advancing their own programs. Behind them, established vaccine giants Sanofi and Merck are in phase 1/2 studies.



Source link