Good Day BIO: WHO's global framework for regulating human genome editing

The World Health Organization's (WHO) Expert Committee recently released “the first global recommendations to help establish human genome editing as a tool for public health, with an emphasis on safety, effectiveness, and ethics.” Here’s the international biotech industry’s take. 

The new gene editing reports include:

• Governance framework, which identifies “specific tools, institutions, and scenarios to illustrate practical challenges in implementing, regulating, and overseeing research into the human genome.”
• Recommendations in nine areas, including leadership by the WHO, international collaboration for effective governance and oversight, intellectual property, and more.

“Potential benefits of human genome editing include faster and more accurate diagnosis, more targeted treatments, and prevention of genetic disorders,”says the WHO’s press release. 

Watch: CRISPR could treat or cure “some of the most challenging diseases we face,” said Dr. Jennifer Doudna 

“However, some risks exist, for example, with germline and heritable human genome editing, which alter the genome of human embryos and could be passed on to subsequent generations, modifying descendants’ traits,” WHO continues. 

The International Council of Biotechnology Associations (ICBA) appreciates “the comprehensive and deliberative efforts.” (BIO is part of ICBA.) Importantly, the report “recognizes the potential benefits and risks of the emerging technology, the importance of scientific advancement, and the need for education and outreach.” 

“Although governance ranges significantly across geographies, regulatory authorities in the US and European Union have established effective frameworks,” continues ICBA. “We look to the WHO and key regulatory authorities to work together to ensure the proper safety measures are established globally to ensure patient safety.” 

The next steps: WHO will convene experts and stakeholders to discuss issues like monitoring clinical trials and confidential reporting of concerns, as well as lead educational webinars and build an inclusive dialogue on these emerging technologies. The ICBA welcomes the opportunity to continue to partner with the WHO, the Science Council, and Member States as this work evolves, particularly to assist in expanding education and outreach. 

As COVID cases are climbing in the U.S., “[t]he more contagious Delta variant may be getting the blame, but fueling its rise is an older, more familiar foe: vaccine hesitancy and refusal, long pervasive in the United States,” reports The New York Times. Here’s what we know about this hesitancy and how to address it.

By the numbers: “In 48 states, the rate of new COVID-19 cases this past week jumped by at least 10% compared to the previous week, according to data from Johns Hopkins University,” reports CNN. “In 34 of those states, the rate of new cases increased by more than 50%.” Meanwhile, just under 50% of the population has been vaccinated.

But here’s the thing: virtually all COVID deaths in the U.S. are among the unvaccinated.

The challenge is vaccine hesitancy. “Among the unvaccinated, just a quarter—or fewer—say they would be likely to get the vaccine under certain circumstances,” found a recent Axios/Ipsos poll. “A vast majority remain unconvinced, showing how these ‘vaccine holdouts’ may not budge anytime soon.” 

Listen: Voices of Vaccine Hesitancy  

There are things that could sway some of the hesitant—including if they could get the vaccine at their doctor’s office (26% somewhat or very likely to get it) or get paid time off (24% somewhat/very likely), Axios explains.

Furthermore: “people who were initially hesitant to get a vaccine in January but ultimately did so often say that family, friends, and their personal doctors helped change their minds,”found a recent KFF COVID-19 Vaccine Monitor report.

This is why we need outreach programs from community pillars, such as “pastors, family doctors, and other trusted local influencers—even hairstylists,” as BIO President & CEO Dr. Michelle McMurry-Heath has written.  

Learn more about the COVID vaccines at www.COVIDVaccineFacts.org.

More Health Care News:

BBC: Moderna jab approved for teenagers in EU
“The European Medicines Agency has approved use of Moderna's COVID vaccine for children aged between 12 and 17.” 

The New York Times: Fauci wants to make vaccines for the next pandemic before it hits
“The idea is to make ‘prototype’ vaccines to protect against viruses from about 20 families that might spark a new pandemic. Using research tools that proved successful for COVID-19, researchers would uncover the molecular structure of each virus, learn where antibodies must strike it, and how to prod the body into making exactly those antibodies.”

President Biden’s Monday: Delivering remarks for the 31st anniversary of the Americans with Disabilities Act, which President Biden cosponsored as a U.S. Senator. Then, meeting with Prime Minister of Iraq Mustafa Al-Kadhimi. 

What’s Happening on Capitol Hill: The House Rules Committee will consider H.R. 4502, which includes FY22 Health and Human Services spending.