Sanofi says US may Get Covid Vaccine first

29.04.2020 - Sanofi has urged the EU to create an equivalent of the US government’s Biomedical Advanced Research and Development Authority (BARDA) to coordinate research into a Covid-19 vaccine, or face being left behind.

The US agency in some cases finances the manufacturing of millions of doses even before efficacy has been proven, and this has been shown to accelerate time to market, the French drugmaker’s CEO, Paul Hudson, said in a conference call to report first-quarter earnings figures late last week.

Hudson criticized the lack of coordination at a European level, while commenting at the same time that “pandemic preparedness is very, very low.” This could mean that the US will get a vaccine first, he said.

In the US, where pandemic preparedness also has been criticized as low, BARDA in mid-February inked several deals with vaccine manufacturers, including Sanofi, to develop products to immunize populations against Covid-19.

The agency is reportedly providing support worth up to $483 million for US start-up biotech Moderna, which has already begun clinical trials, and has a separate deal with Johnson & Johnson worth as much as $1 billion. Sanofi’s vaccines arm Sanofi Pasteur also has a pact with BARDA but has not disclosed its value.

To avoid a scenario in which all Covid vaccines are initially manufactured in the US, Hudson said Sanofi plans to manufacture in Europe even without government support.

In Europe, the French pharma major is cooperating with UK drugs giant Glaxo SmithKline (GSK), which will supply the adjuvant for a Sanofi vaccine candidate. Its US cooperation focuses on an mRNA type vaccine, up to now untested in clinical trials. The GSK deal involves a traditional protein-based vaccine.

Hudson said he is confident that Sanofi could deliver an effective vaccine within the next 18 months; however, it would be a bigger challenge to ramp up production to meet potentially massive demand.

Sanofi is one of only a few companies that will be able to manufacture a vaccine at scale, the CEO noted, estimated that the drugmaker could ramp up production to more than 1 billion doses within 12 months.

BARDA Has its own Political Problems

While acknowledging deficits in the EU’s response to the coronavirus crisis, some observers warned about creating a political unit modeled on the BARDA example. Last week, the US agency made negative headlines as its director, Rick Bright, was removed from his position to a narrower slot at the National Institutes of Health (NIH).

As Bright began pressing his case against being shunted aside, the US cabinet-level department that oversees BARDA, Health and Human Services (HHS), appointed his deputy to succeed him.

Although Bright said he thought the move was in response to his resisting President Donald Trump’s touted “miracle cure” hydroxychloroquine, Trump later defended him, putting the onus on HHS Secretary Alex Azar, a former Eli Lilly executive.

Among other things, Azar’s office accused the BARDA chief of being unprepared for a pandemic. After subsequent suggestions that Azar was in danger of being fired, Trump publicly defended him, too.

A day or two on either side of these developments, the US Food and Drug Administration (FDA) and NIH both withdrew their support for hydroxychloroquine as a Covid-19 treatment, due in particular to cardiovascular risks.