BioNTech, CureVac tell regulators to lower clinical trial bar if they want a COVID-19 vaccine quickly

Two German biotech companies at the start of a race to create new vaccines against the COVID-19 pandemic are warning the European Medicines Agency and the FDA they will need traditional clinical trial hurdles removed if governments want the inoculations as quickly as possible.

Speaking to the Financial Times, both companies said some of the bigger clinical trial regulations will need to be cut in order for hundreds of millions of doses to be available by the end of the year.

Both BioNTech and CureVac, the former now partnered with Pfizer and the latter recently embroiled in a weird tale that allegedly saw the U.S. government try to lure it over the pond, are in preclinical trials for potential vaccines and are set to start testing on humans within the coming weeks.

In any normal time, and we’re far from that now, this would kick-start a long and laborious process that can take years to complete.

This is to accurately and thoroughly assess safety and efficacy. But given the ongoing spread of the pandemic, which at the start of April had infected at least 1 million people and killed more than 35,000, the pair said it wants to “abbreviate” these rules to speed up development.

This would include not having to do the final phase large-scale test, an expensive and time-consuming element, as well as making changes to how data are gathered.

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Speaking to the FT, a spokesman for CureVac, which intends to start trials on humans in June, said that, if the company were forced to go through all three clinical stages, “It would take too much time to get a vaccine to market to fight against the current pandemic on time.” He added, “To speed this process up, authorities would have to allow us to abbreviate the approval process.”

Ugur Sahin, the founder of BioNTech, also told the financial newspaper: “Governmental organizations, experts and regulators need to work together to identify potential ways of accelerating the approval and availability of the vaccine.” BioNTech intends to begin testing its prototype on 150 healthy volunteers this month.

Other ways companies want to cut down on time are by sidelining on-site visits for side effects data gathering, using phone interviews instead, and perhaps lowering the level on just how comprehensive clinical reports will have to be.

It’s not clear whether they will or can be granted these “abbreviations” nor whether a regulator would be happy passing vaccines that had foregone the normal path to approval.(Although they will likely be under major political pressure to do so.) It also opens the door to potentially unsafe or nonefficacious medicines flooding a global market, with billions of people being inoculated with medicines that had not been tested to the same rigorous standards as all other vaccines have been. 

But in a pandemic, which is also turning into an economic crisis, risk-benefit analysis starts to become a much harder proposition. The EMA, FDA and the U.K.'s MHRA have all already said they are willing to help speed up COVID-19 trials using a variety of methods.

Alongside U.S. biotech Moderna, the pair are using messenger RNA to develop these vaccines, which has the potential to speed up normal R&D lead times. There are, however, no mRNA vaccines on the market, making it more of an unknown. Both will also massively need to ramp up manufacturing capabilities.

CureVac told the FT it could produce 1 billion vaccines in one run, depending on the dose, once it completed its fourth manufacturing facility, which is being built.

BioNTech will manufacture BNT162 at its European mRNA manufacturing facilities with the support of its CDMO partner Polymun. However, global demand for an authorized SARS-CoV-2 vaccine could be huge, necessitating the coordination of other facilities to ensure fast access to the product.