No need 'to start at square one': FDA plans to lay out a speedy path for COVID-19 vaccines, drugs against variants

08 February 2021

Angus Liu / FiercePharma

New coronavirus variants have prompted COVID-19 vaccine makers to start developing updates to their existing offerings. To speed their journey to a pandemic-fatigued public, the FDA says it’s developing expedited review rules for the follow-up shots.

The FDA’s working on guidance for the types of data needed to support changes to COVID-19 vaccines. The new rules would provide for “streamlined clinical programs” that can demonstrate an immune response to new variants and “can be executed quickly,” FDA’s acting commissioner, Janet Woodcock, said in a statement Thursday.

The draft plan could come in two to three weeks, Politico reported, citing four people familiar with the agency’s internal discussions.

Updating vaccines with new variants while maintaining their underlying platforms isn’t new territory for the FDA. Flu shots are modified each year to target different circulating strains. Woodcock said the FDA will draw on that experience in devising a path for vaccines against emerging SARS-CoV-2 variants.

Of course, the pandemic requires a more rapid turnaround, so a new regulatory review process is necessary.

Despite the urgency, FDA officials still believe an advisory committee of independent experts should evaluate the booster shots, Woodcock said at a press briefing Thursday, according to The Wall Street Journal. Pfizer and BioNTech’s BNT162b2 and Moderna’s mRNA-1273 have already gone through that public deliberation process once before they snagged their FDA emergency use authorizations.

As the agency works on detailing the exact data needed to prove out COVID-19 booster shots, one thing is clear: “We do not believe there will be the need to start at square one with any of these products—we recognize we are in a pandemic and we need to arm healthcare providers with the most appropriate tools to fight this pandemic on the front lines,” Woodcock said.

So far, Pfizer/BioNTech and Moderna are already studying booster shots for their authorized mRNA vaccines to tackle new, more contagious variants of SARS-CoV-2.

Woodcock stressed that the information now available indicate that these existing vaccines effectively protect people against variants. Moderna previously found the B.1.351 variant—which was first found in South Africa—led to a sixfold reduction in its vaccine’s neutralizing titers even though the shot remains protective.

BioNTech CEO Ugur Sahin has said his company can come up with a shot for a new variant in about six weeks.

CureVac just teamed up with GlaxoSmithKline to develop an mRNA COVID-19 vaccine covering multiple variants or potential booster shots to CureVac's existing candidate, CVnCoV, to tackle them. CVnCoV is currently in phase 3 testing.

In addition to vaccines, the FDA’s also developing guidelines for virus-targeting monoclonal antibodies and diagnostics amid concerns that they may not work against new variants.

Eli Lilly’s AbCellera-partnered bamlanivimab and Regeneron’s REGN-COV2 two-drug cocktail have been authorized to treat COVID in the outpatient setting. And a Lilly combo adding Junshi Biosciences-licensed etesevimab has shown it can reduce the risk of COVID-19 hospitalizations and deaths in high-risk patients.

But a recent study by a team at Columbia University found neither solo bamlanivimab nor its etesevimab combo could neutralize the B.1.351 variant in the lab. Casirivimab, one component in the Regeneron cocktail, also had marked reduction in its ability to contain the variant, although the combo was still effective.

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