Good Day BIO: Moderna approved, Novavax applies for EUA

Happy February. Important vaccine announcements today, plus what happened at the WHO Executive Board meeting regarding pandemic preparedness and One Health. (763 words, 3 minutes, 48 seconds)

Moderna gets full approval, Novavax applies for EUA

Two major announcements yesterday about COVID-19 vaccines could help address vaccine hesitancy.

The FDA approved Moderna’s COVID-19 vaccine,saying it “meets the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality required for approval.” Spikevax has been available under emergency use authorization (EUA) since December 18, 2020.

What they’re saying: “Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization, and death,” said Moderna CEO Stéphane Bancel. “The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved.”

Why it matters: “While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” said Acting FDA Commissioner Dr. Janet Woodcock.

Throwback: Moderna’s CEO on the I am BIO Podcast on March 30, 2020 

Also: Novavax applied for EUA for its COVID vaccine,the company announced.

The vaccine uses “Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein,”the company says. The vaccine has shown to be highly effective including against the Delta variant.

Watch: How do we protect ourselves against COVID-19 variants?

Why it matters: “We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” said Novavax President and CEO Stanley C. Erck. 

Read: Inside Novavax, the Maryland biotech with a promising COVID-19 vaccine 

More Health Care News: 

The Wall Street Journal (Opinion): Robert Califf for the FDA
“Dr. Califf doesn’t deserve the abuse. In 2016 the Senate confirmed him as FDA Commissioner, 89-4, and he led the agency for 10 months without major controversy. The pandemic has shown how crucial it is to have competent FDA leadership, especially in this era of biotech innovation and therapeutic breakthroughs,” says The Wall Street Journal Editorial Board. 

The Washington Post (Opinion): Antibiotic resistance is growing
“We need better stewardship of antibiotics—avoiding overprescribing or wrongly prescribing them for viral infections. More attention must be devoted to preventing resistant infections in the first place. Accelerated development of new antibiotics is essential,” says The Washington Post Editorial Board.

WHO highlights links between health, agriculture, and environment

Pandemic preparedness was a theme during last week’s meeting of the World Health Organization (WHO) Executive Board (EB)—here’s what happened and what it has to do with agriculture and the environment.

“The pandemic shows we need to be much more ambitious, much better prepared, and improve the way we measure protection against health emergencies,” said WHO Director-General Tedros Adhanom Ghebreyesus to open the meeting.

The EB made some moves on this front—asking member states to consider amendments to the International Health Regulations, the legal regime that provided the primary global legal guidance during the COVID-19 pandemic. Austria proposed a Standing Committee on Pandemic and Emergency Preparedness and Response. Action on pandemic preparedness is expected before March 1, by which time an intergovernmental negotiating body is supposed to discuss a WHO convention on pandemic prevention. 

A key part of pandemic preparedness is One Health, which WHO and global food and ag organizations now formally define as “an integrated, unifying approach that aims to sustainably balance and optimize the health of people, animals and ecosystems.” 

“Most neglected tropical diseases occur at the human–animal interface,”said WHO’s report on the topic. “Implementing One Health approaches to prevent and manage these diseases generates momentum for substantial long-term gains.” 

Biotech has solutions—gene editing can make food animals resistant to disease and eliminate mosquito-borne illness, and biofuels and bioplastics that can help improve our relationship with nature while stopping climate change that allows diseases to flourish. 

So, what now? We need a national One Health framework and modernized animal biotech regulations that allow this technology to be developed and deployed—read more.

More Agriculture and Environment News: 

Biomass Magazine: EPA issues final rule extending RFS compliance deadlines
“The U.S. EPA released a final rule on Jan. 28 extending and modifying certain Renewable Fuel Standard compliance deadlines.”

President Biden’s Tuesday: Meeting with Senate Judiciary Chair Dick Durbin (D-IL) and Ranking Member Chuck Grassley (R-IA) to discuss the forthcoming Supreme Court vacancy. He’s expected to relaunch his “cancer moonshot” tomorrow. 

What’s Happening on Capitol Hill: The House Rules Committee will mark up several bills including the Bioeconomy Research and Development Act of 2021, a.k.a. the America COMPETES Act. The Senate HELP Committee will hold a hearing on mental health and substance abuse disorders.