FDA’s new guidance on COVID-19 vaccines and variants

Yesterday, the U.S. Food and Drug Administration (FDA) said vaccine clinical trials for COVID-19 variants can be narrower than the earlier trials—here’s what you should know.

Viruses are going to mutate—but what does this mean for COVID-19 vaccines? Early findings suggest some existing COVID-19 vaccines are just as effective against some of the new variant strains, but less effective against others.

Meanwhile: “Most of the vaccine manufacturers with authorized vaccines or candidates in late-stage trials have already announced plans to adjust their products to address the vaccine variants,” says The New York Times.

Yesterday, the FDA updated guidance on COVID-19 vaccine clinical trials to cover vaccines modified for new variants. The variant guidance begins on page 17 of Emergency Use Authorization for Vaccines to Prevent COVID-19.

To put it simply: “vaccine developers would not need to conduct lengthy randomized controlled trials for vaccines that have been adapted to protect against concerning coronavirus variants,” explains The New York Times. 

Additionally, the FDA issued guidance on diagnostics and monoclonal antibodies, and updated guidance on COVID-19 therapeutics and biological products.

What they’re saying: “The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Dr. Janet Woodcock. “By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts.”

Do you have questions about COVID-19 vaccines? Visit www.COVIDVaccineFacts.org.

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The Environmental Protection Agency (EPA) announced that it’s changed its view of a court ruling on Renewable Fuel Standard (RFS) exemptions—which is likely good news for the biofuels industry.

The Renewable Fuel Standard (RFS) requires a certain percentage of biofuels in transportation fuel in the United States—though small refineries can apply for waivers to the requirement.

The Trump administration’s EPA issued an unprecedented number of waivers—prompting the 10th Circuit Court of Appeals to rule the EPA “overstepped” on some exemptions, saying they need to reconsider them. The U.S. Supreme Court is expected to take up the case in April.

But now: EPA announced it “supports the court’s interpretation” of the RFS exemptions.

This “represents a change from EPA’s position before the Tenth Circuit. This change reflects the Agency’s considered assessment that the Tenth Circuit’s reasoning better reflects the statutory text and structure, as well as Congress’ intent in establishing the RFS program,” said the announcement.

Why it matters: This signals the Biden administration is likely to significantly rein in the record-breaking number of exemptions issued by the last administration. And if we administer the RFS as Congress intended (meaning: minimal exemptions), we can grow the biofuels sector and reduce emissions in transportation—both critical to achieving our economic and climate goals right now.

Next steps (from Politico): The agency said the shift better reflected Congress' goal in enacting the RFS and said it would not make any decisions on the 46 pending requests until the Supreme Court rules on the case before it, which it expects in July.

President Biden’s Tuesday: Roundtable with Black essential workers, then meeting with Canadian Prime Minister Justin Trudeau. 

What’s Happening on Capitol Hill: Democrats are pushing Biden’s $1.9 trillion stimulus package, “the first real test for Democrats’ full control of government since former President Donald Trump’s impeachment trial, with implications for the rest of Biden’s agenda and the pandemic-battered economy,” says Bloomberg. The Senate will vote on the confirmation of Tom Vilsack for Agriculture secretary. Meanwhile, we’re watching two hearings: Senate HELP’s hearing on Health and Human Services (HHS) nominee Xavier Becerra, and House Energy & Commerce’s hearing on COVID-19 vaccines, featuring witnesses from AstraZeneca, Johnson & Johnson, Moderna, Novavax, and Pfizer.