Good Day BIO: Why the Pfizer-BioNTech approval matters

The FDA fully approved the Pfizer-BioNTech COVID-19 vaccine yesterday, providing an opportunity to address hesitancy.   

The FDA approved the Pfizer-BioNTech vaccine for people 16 and older,making it the first fully approved COVID-19 vaccine. The vaccine continues to be available for people ages 12-15 under emergency use authorization. 

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,”said Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.” 

“The science and data are very clear: vaccines are the most effective tool we have to combat this virus,” said BIO President and CEO Dr. Michelle McMurry-Heath.  

Read: How are vaccines developed? 

Why it matters: The Kaiser Family Foundation (KFF) recently found “three in ten unvaccinated adults, rising to about half of those in the ‘wait and see’ group, say they would be more likely to get vaccinated if one of the vaccines currently authorized for emergency use were to receive full approval from the FDA.” 

Watch: BIO’s Dr. Michelle spoke to MSNBC about the importance of full approval 

What’s next: Expect more vaccine mandates, reports POLITICO. Meanwhile, Moderna applied for full approval in June, and Johnson & Johnson expects to apply later this year. 

Dr. Michelle’s Diagnosis: The FDA’s approval of the Pfizer vaccine is a tremendous step forward towards ending this pandemic. I applaud both Pfizer and the FDA for their commitment to science and their role in supplying the data necessary to build public confidence and credibility in existing vaccines. I am extremely proud of our industry’s unprecedented response to the COVID-19 pandemic and hope today’s news will strengthen public confidence in science, vaccines, and other therapies available against COVID-19. – BIO President & CEO Dr. Michelle McMurry-Heath

A new study found recent extreme flooding in Europe was “made more likely by climate change,” reports The New York Times. What does carbon have to do with it—and how can biotech help? 

“[W]hile rare, such an event was 1.2 to 9 times more likely now than it would have been more than a century ago, before emissions of heat-trapping gases warmed the world by more than 1 degree Celsius (about 2 degrees Fahrenheit),” explains The New York Times.  

What’s carbon have to do with it? Carbon exists in the atmosphere as carbon dioxide, which is a greenhouse gas (GHG)—a gas that absorbs and radiates heat.  

How much has carbon dioxide increased? “The annual rate of increase in atmospheric carbon dioxide over the past 60 years is about 100 times faster than previous natural increases,” says Climate.gov. 

Okay, so what does carbon have to do with climate? “Each of the last four decades has been successively warmer than any decade that preceded it since 1850,” according to a recent UN Intergovernmental Panel on Climate Change (IPCC) report. The climate is warming faster than it has for at least 2,000 years, the report says. 

It’s too late to prevent negative impacts and extreme weather in the coming decades,says the IPCC, but dramatic carbon reductions now may avert worst-case scenarios. 

But if the world warms to 2 degrees Celsius, “as is likely without drastic cuts in emissions,” the likelihood of events like the extreme flooding in Europe last month will increase, continues The New York Times. 

What can we do? Reduce carbon dioxide emissions and pull carbon out of the air.  

Here are a few ways biotech can help:

• Sustainable aviation fuel (SAF) can cut carbon from jets by 80%. BIO testified on the advantages of SAF and supports the Sustainable Skies Act.
• Gene editing can empower plants to capture more carbon, reduce food waste, and cut fertilizer use.
• Bio-based manufacturing can reduce GHG emissions and replace traditional plastics made from fossil fuels.

Read More: Biotech Solutions for Climate

President Biden’s Tuesday: Meeting with his national security team and G7 leaders to discuss coordination on Afghanistan policy, humanitarian assistance, and evacuations. At 12 PM ET, he will deliver remarks on Afghanistan including on evacuation efforts. 

What’s Happening on Capitol Hill: The House is back in session from recess to consider both budget and infrastructure bills. Reportedly, after working into the night, the House finds itself at a standstill as moderate Democrats and House leadership go back and forth on how to proceed with votes, according to the AP. These moderate House Democrats first want to pass the $1 trillion bipartisan infrastructure deal that was passed in the Senate before voting on the $3.5 trillion budget vote, per CNN. The Senate still stands adjourned until Sept. 13.