COVID booster: How doses for the vaccinated could create new variants

Happy Thursday, readers.

It was a major week for COVID vaccine boosters to put it lightly. In the past seven days, the Food and Drug Administration (FDA) and Centers for Disease Control (CDC) green lit the first tranche of COVID-19 booster shots for certain Americans with compromised immune systems such as organ transplant recipients or cancer or HIV patients. That’s just a tiny subsection of the population made smaller still by the expanded authorization’s limited scope, which only opens up eligibility for a third shot to immunocompromised Americans who have already received two doses of Pfizer/BioNTech’s or Moderna’s COVID jabs.

Then the Biden administration on Wednesday unveiled a more ambitious booster shot agenda that would open up eligibility for a third dose of Pfizer’s or Moderna’s existing COVID treatments to all fully vaccinated American adults who are at least eight months out from their second shot of an mRNA vaccine beginning the week of September 20. There’s no word yet on what the 13 million Americans who received Johnson & Johnson’s single-shot coronavirus vaccine should do about boosters as authorities wait for more robust data on the effects of a second dose, or mixing-and-matching vaccine types, like some Americans have already done by jumping the line and getting an mRNA shot early (this guidance and messaging gap has led prominent physicians to criticize the federal government for leaving J&J recipients in limbo on an important public health matter).

But while the administration’s plan is subject to future decisions by the FDA and CDC, it would encompass a gigantic swath of the U.S. populace who could start getting extra doses by the fall as America tries to claw itself free from the maw of the pathogenic beast that is the Delta variant. And some global health experts warn that the push for boosters among the already-vaccinated is misguided and can actually lead to the rise of new and unknown COVID variants without immunizing those who are still unvaccinated in much of the world.

Viral variants emerge in different parts of the globe before spreading to other nations. The evolution of a virus can be spurred on by people who have a weak or ineffective immune response to a particular strain, such as the unvaccinated, since a pathogen like the coronavirus can then better sniff out the body’s vulnerabilities and make adjustments to take advantage of them. And given that nearly half of the world’s nations haven’t been able to get even 10% of their populations vaccinated, the fear is that a lack of resources and immunization in those highly under-vaccinated regions could create more insidious biological adversaries that can make things worse for, well, humans anywhere. Global pandemics have a way of ignoring man made borders.

Madhu Pai, a physician, professor, and Canada research chair of epidemiology and global health at McGill University, highlights a recent study (which must still be peer-reviewed and officially published in a medical journal) to illustrate the point. University of Maryland researchers found a clear inverse correlation between a country’s vaccination rate and the emergence of new mutations in the COVID Delta variant, which is of course itself the result of a viral mutation of the novel coronavirus. “Why is vaccine equity so critical? It is a powerful way of preventing new variants,” Pai wrote in a tweet on Wednesday.

That’s been a major part of the reason that World Health Organization (WHO) officials including director-general Tedros Adhanom Ghebreyesus and chief scientist Soumya Swaminathan have been critical of the booster push in wealthier nations like the U.S., asserting that it amounts to more vaccine hoarding that’s ultimately short-sighted and could make the pandemic worse over the long term. The WHO has called for a moratorium on any COVID boosters for the vaccinated until at least the end of September as less fortunate nations catch up, especially with the help of developed countries with hundreds of millions of secured doses.

“Vaccination can prevent new variants arising by reducing transmission, and reduce deaths by protecting the vulnerable. Two good reasons to ensure equitable vaccine distribution globally. @WHO is calling for 40% population coverage of EVERY country by end 2021,” Swaminathan wrote in Wednesday tweet.

The Biden administration and other prominent physicians vociferously disagree with that standpoint. For one thing, some point out that many vaccine doses in the U.S. are set to expire this summer and that given the specialized cooling and storage requirements for mRNA-based vaccines, it would be too late to get the doses to countries which may not have the necessary medical infrastructure to house them. Others say it’s important to prioritize the health and safety of the U.S. public given those practical challenges and the reality that millions of people in the United States remain unvaccinated themselves, lending to the Delta variant’s spread.

Administration officials say that, ultimately, a two-pronged approach is most appropriate for protecting Americans while helping less fortunate areas and preventing the nightmare possibility of an even deadlier and more transmissible COVID variant. “I do not accept the idea that we have to choose between America and the world. We clearly see our responsibility to both, and we believe we have to work on both fronts as we have been,” said Surgeon General Vivek Murthy recently, defending the U.S. plan for boosters in conjunction with global supply deals the government has struck with countries that need a vaccination boost.

The question is whether developed nations will transition more aggressively to global vaccination efforts if and when boosters begin to keep the pandemic in check.

Read on for the day’s news, and see you again next Thursday.

Sy Mukherjee
sy.mukherjee@fortune.com
@the_sy_guy

DIGITAL HEALTH

Jabra Enhance hearing aid headphone. High-end headphone maker Jabra has released a new set of true wireless earbuds with a medical twist: They're also meant to be a hearing aid that assists people with mild to moderate hearing loss. The Jabra Enhance Plus can adjust sounds in various settings to optimize your hearing ability and are diminutive enough to be barely noticeable, unlike many conventional hearing aids. The product will also require a licensed hearing care professional to test and analyze a customer's hearing before they can go out and buy them since the headphones are technically a medical device. (Digital Trends)

J&J partners with upstart lung health AI firm to tackle lung cancer. Johnson & Johnson has partnered with medical AI startup Optellum in a collaboration opening up the smaller firm's technology (which, as you might suspect, is driven by artificial intelligence) in order to detect lung cancer earlier so that doctors may be able to intervene in a timely manner and increase a patient's shot at survival. Optellum's fairly new to the smart diagnostics market, with its software granted FDA clearance in March. J&J isn't a bad partner to nab less than six months later.

INDICATIONS

Sequencing giant Illumina defies FTC to buy liquid biopsy firm Grail. Speaking of diagnostics, Illumia, a titan in the DNA sequencing space, is charting its own path to securing the liquid biopsy startup Grail despite the protestations of the Federal Trade Commission (FTC) and European regulators. The FTC has actually taken legal action to try and scuttle the $8 billion deal for Grail, which makes blood tests that are less invasive than standard tissue biopsies and could be used to detect cancers through telltale biological markers in the blood at an earlier stage of the disease. The European Union is investigating the arrangement as well. But that didn't stop Illumina from moving forward. The company says it believes it's in the clear and that Grail's technology can save lives. “We felt a moral obligation even to make sure this deal does get through the regulatory process and we feel that by acquiring the company and keeping it separate, we achieve both aims,” said Illumina chief Francis deSouza in a conference call on the decision. "We get the deal to get its full review through the regulatory process and we respect the process happening through the European Commission by keeping the companies separate." (STAT News)

Lilly, Boehringer diabetes drug scores key FDA endorsement for heart failure. Eli Lilly and partner Boehringer Ingelheim notched a major win on Wednesday as the Food and Drug Administration (FDA) expanded the label for its type 2 diabetes drug Jardiance for use in heart failure patients who don't have diabetes but whose hearts aren't pumping out as much blood as the body needs. That's the first non-diabetes related indication for Jardiance and a boost for its efforts to elbow into a heart failure drug market that includes products from the likes of U.K. giant AstraZeneca and Switzerland's Novartis.

THE BIG PICTURE

Insurance companies are starting to push COVID treatment costs back on to patients. A new Kaiser Family Foundation (KFF) analysis finds that most private health insurers have discontinued existing policies to waive patients' out of pocket costs for COVID-19 treatment. Nearly three-quarters of each U.S. states' and D.C.'s two largest insurers, or 102 popular health plans across the nation, are no longer waiving these costs with others set to follow in the fall and winter. The timing is probably convenient for insurers as the Delta variant overwhelms hospital beds and ICUs in the pandemic's latest wave. But nothing about the decision to push costs back to consumers is illegal. COVID testing and vaccines may have to be provided for free, but that's not the case with actual medical care. "[W]hile a handful of states required or created agreements with insurers to waive COVID-19 out-of-pocket treatment costs for their fully-insured plan enrollees, there is no federal mandate requiring insurers to do so," write the study authors. (Kaiser Family Foundation)