Good Day BIO: We don't need a vaccine IP waiver – here's why

Back to work—and we take a deeper dive into why we don’t need the COVID vaccine waiver. Meanwhile, extreme heat is killing cows in Kansas—but the FDA’s already given the green light to a biotech solution for cattle welfare. (695 words, 3 minutes, 28 seconds)

We really don’t need a COVID vaccine IP waiver ­– here’s why

ICYMI: The World Trade Organization (WTO) agreed to a waiver of COVID-19 vaccine IP protections—and a lot of people aren’t happy about it. The waiver will harm innovation—but we also just don’t need it, say experts and countless news reports detailing the excess vaccine available worldwide.

“In 2021 alone, companies produced more than 11 billion doses of COVID vaccines, enough to give two shots to every adult on the planet,”said BIO President and CEO Dr. Michelle McMurry-Heath in May. “We anticipate that number jumping to 18.6 billion by the end of this year.”

OK, but what about developing countries? “A total of 632 million doses of COVID-19 vaccines have been delivered in the African Region, including 64% from the COVAX Facility. This represents 56 doses per 100 population and accounts for 40% of the doses needed to reach 70% of people fully vaccinated in all countries,” according to the World Health Organization (WHO). 

But they aren't getting into arms: “27 countries out of 46 (59%) have administered fewer than 50% of doses received,” per WHO—and South African pharma Aspen has ZERO orders for its “made in Africa for Africa” COVID vaccine, manufactured in partnership with Johnson & Johnson.

Worldwide, vaccines are being stockpiled without takers, said Hans Sauer, BIO’s Deputy General Counsel and VP for IP: “South Africa, for example, tried to donate 15 million doses of Pfizer and J&J vaccine last month because they have an oversupply, but no African country wanted it. Egypt is offering 30 million doses to African countries, with no takers.”

Tragically, doses are getting ditched or destroyed—from the EU, which has thrown away around 50 billion-plus expired doses, to the Serum Institute of India (SII), which may need to destroy 200 million doses in August/September due to oversupply.

The bottom line: “We need to be focusing on the real challenges we face,” said BIO’s Dr. Michelle McMurry-Heath on Friday. “We need to work together to ensure that, in areas where vaccine rates are lagging, we can get more shots in arms. To do that, we must apply the best practices developed over the last few years to overcome global vaccine hesitancy and to strengthen local health care systems.”

Extreme heat is killing cattle – but we have a biotech solution

America’s third-largest cattle state is seeing mass cattle deaths due to extreme heat—but the FDA has already given the green light to a biotech solution that could help the cows and the farmers. 

“The Kansas Department of Health and Environment knew of at least 2,000 cattle deaths due to high temperatures and humidity as of Tuesday,”says Reuters. “The toll represents facilities that contacted the agency for help disposing of carcasses.” 

What’s happening: “Cattle began suffering heat stress as temperatures and humidity spiked over the weekend in western Kansas and cooling winds disappeared, said Scarlett Hagins, spokesperson for the Kansas Livestock Association. The animals could not acclimate to the sudden change,” explains Reuters.

But we’ve got biotech for that:cattle that have been gene edited to have what’s called a “slick” coat,” making them more tolerant to heat and therefore able to function more efficiently. 

In March, the FDA determined “the intentional genomic alteration (IGA) does not raise any safety concerns,” meaning the developer (BIO member Acceligen) does not need to pursue FDA approval prior to marketing. The FDA decision came on the heels of a similar announcement in Brazil.

Why it matters: “We expect that our decision will encourage other developers to bring animal biotechnology products forward for the FDA’s risk determination in this rapidly developing field, paving the way for animals containing low-risk IGAs to more efficiently reach the marketplace,” said Steven M. Solomon, D.V.M., M.P.H., Director of FDA’s Center for Veterinary Medicine.

President Biden’s Tuesday: Lunch with the VP before visiting a COVID vaccination center in Washington, D.C., where he’ll give remarks at 3:45 PM ET on COVID vaccines being available for children under five (and now virtually all Americans). 

What’s Happening on Capitol Hill: Congress returns from the holiday weekend. Of note, the House Rules Committee will prepare four bills for the floor, including the legislation establishing the Advanced Research Projects Agency-Health (ARPA-H).