FDA releases COVID-19 vaccine guidance

Yesterday, the U.S. Food and Drug Administration (FDA) released new guidance related to the emergency use authorization of future COVID-19 vaccines—just days after BIO sent a letter to Health and Human Services (HHS) Secretary Alex Azar urging him to release it. 

ICYMI: Last week, the FDA was set to release vaccine guidelines “bringing the bar for emergency use of a coronavirus vaccine closer to the standard for a full approval,” per POLITICO. 

“But the guidance stalled last week when it reached the White House,” with President Trump and HHS Secretary Alex Azar reportedly expressing concerns about releasing it, POLITICO continued. 

BIO's Dr. Michelle McMurry-Heath sent a letter to Secretary Azar urging him to release the guidance, to “provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorized or approved.”  

It looks like they listened. Yesterday, FDA released Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry.

According to the guidance, data from phase 3 trials should “include a median follow-up duration of at least two months after completion of the full vaccination regimen,” and there must be five severe cases in the placebo group. 

Dr. Michelle’s Diagnosis: In the midst of a pandemic, transparency, and collaboration are critical if we are going to quickly and safely eradicate this global health threat. We applaud the FDA for following their tried and true tradition of releasing their guidance in a public and transparent way. We look forward to ongoing communication with the independent experts at the FDA to further clarify the steps needed to bring a safe and effective vaccine to the American public. – BIO President and CEO Dr. Michelle McMurry-Heath

Read BIO’s full statement.

More Health Care News:

MSNBC: Dr. Michelle McMurry-Heath on Morning Joe
“What’s been made incredibly clear this week is you cannot stop the virus by cutting out the science,” she said.

Here’s another example of the collaboration happening across the industry. Two BIO members recently announced that they’ll work together to produce low-carbon, biobased fuels and chemicals—using one’s innovative platform, and the other’s corn.

Cargill and Virent, Inc. announced a collaboration to evaluate the use of Cargill’s corn dextrose as a feedstock for Virent’s BioForming® technology to produce low-carbon biofuels and biochemicals. 

The Virent technology uses plant sugars from any source as a feedstock to produce “drop-in” renewable gasoline and jet fuel as well as biochemicals like bio-paraxylene, which can be used to make a fully renewable and recyclable polyester alternative.

"Drop-in" biofuels are important because they can literally be “dropped” in place of liquid petroleum-based fuels without needing to make too many changes to the vehicle or jet engine.

What Virent’s saying: “Establishing the Virent BioForming® process as a viable opportunity for producing jet fuel and renewable gasoline as a complement to ethanol will not only open new markets for corn but expand the greater opportunities for both renewable fuels and chemicals,” said Virent President Dave Kettner.

What Cargill’s saying: “Building out the bioeconomy and increasing the diversification of our corn grind are both at the core of our strategy,” said Cargill Managing Director Mike Wagner.

We have the technology—now we need the policy. Low-carbon fuel standards have been shown to reduce millions of tons of carbon pollution and improve human and environmental health. BIO continues to champion the Renewable Fuel Standard (RFS) and low-carbon fuel initiatives nationwide, as well as policies that support the development and growth of the bioeconomy.  

Learn more about sustainable biofuels.



More Ag & Environment News:

CNN: Nobel Prize in Chemistry awarded to scientists who discovered CRISPR gene-editing tool for 'rewriting the code of life'
"The Nobel Prize in Chemistry has been awarded to Emmanuelle Charpentier and Jennifer A. Doudna for the development of a method for genome editing. They discovered one of gene technology's sharpest tools: the CRISPR/Cas9 genetic scissors."

President Trump’s Wednesday: No public events scheduled. Vice President Mike Pence is scheduled to debate Sen. Kamala Harris at 9 PM ET in Salt Lake City (with a plexiglass barrier). 

What’s Happening on Capitol Hill: Trump tweeted yesterday that he would halt the ongoing COVID-19 relief talks between Democrats and the Trump administration until after the election, which The Hill calls “a risky move just weeks before voters head to the polls.” Then, later in the evening, he tweeted: “House & Senate should IMMEDIATELY Approve 25 Billion Dollars for Airline Payroll Support, & 135 Billion Dollars for Paycheck Protection Program for Small Business. Both of these will be fully paid for with unused funds from the Cares Act. Have this money. I will sign now!”