The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-0, with one abstention, that the benefits of Pfizer Inc.-Biontech SE pediatric formulation of its two-dose COVID-19 vaccine outweigh its risks for children ages 5 through 11. Many of those votes came with caveats, as the VRBPAC members struggled with the unknowns of the vaccine and the fear that schools would mandate its use, even though it would still be considered experimental if the FDA grants it an emergency use authorization.

The brain-computer interface (BCI) is the subject of keen medical interest for those dealing with neurological damage, but military applications are also a point of interest among a number of national governments. With all this in mind, an agency at the Department of Commerce has posted a request for comments regarding a possible imposition of export controls on BCI devices due to national security concerns, a proposal that could complicate exports of such devices for medical use.

Apollo Endosurgery Inc. presented strong results from its endoscopic sleeve gastroplasty study with patients achieving an excess body weight loss of 49.2% at 12 months and the great majority maintaining that loss for two years. Serious adverse events occurred in 2% of patients and all resolved without intensive care or surgical intervention.

Despite that the device has been available for more than a decade under the 510(k) program, an FDA advisory committee voted narrowly that the benefits of the Surgimend device for breast reconstruction do not outweigh the risks. Another interesting feature of the application is that the pivotal study was based on real-world evidence (RWE), but while the FDA had direct access to the data, Integra Lifesciences Holdings Corp. did not, thus raising questions about whether RWE is necessarily useful for class III device premarket applications.

Pfizer Inc. said that, in children aged 5 through 11, the COVID-19 vaccine it co-developed with Biontech SE showed 90.7% efficacy against all variants of concern following two doses. The data were included in briefing documents filed ahead of a full discussion at the FDA’s Vaccines and Related Biological Products advisory committee meeting set for Oct. 26.

Enforcement against false claims filed with federal health care programs continues to snare a number of testing clinics as demonstrated by the recent news that a clinical lab has come to terms with federal prosecutors over urine drug testing. MD Spine Solutions LLC, of Reno, Nevada, has agreed to pay up to $16 million to settle allegations that it performed unnecessary urine drug tests, a case brought to the attention of the courts not by a former employee, but by Omni Healthcare Inc., which has been active in the False Claims Act space, thus highlighting the hazards of third-party litigation to clinical lab operators.

The push for legislation that would lower prescription drug prices in the U.S. has mounted in recent months, but support for Medicare pricing negotiations has faltered in the past few weeks. Sen. Bob Menendez (D-N.J.) is the latest Senate Democrat to signal his aversion to giving the government the authority to negotiate prices with drugmakers, breathing new life into hopes that the pharmaceutical industry will yet again escape a mechanism that critics say would suppress innovation at the expense of patients in desperate need of state-of-the-art therapies.

Despite some concerns from a few members, the Advisory Committee on Immunization Practices unanimously approved recommendations to the CDC that boosters be made available to those wanting them. The advisory committee recommended that a single COVID-19 vaccine booster dose be given six months or more after completing an mRNA primary series in the same risk group for whom the CDC recommended a booster dose of Pfizer Inc-Biontech SA’s vaccine. The CDC presented data to the committee that the single mRNA COVID-19 vaccine dose be given to those age 65 and older, for those at least 18 years old and reside in long-term-care settings, and also for those ages 50 to 60 with certain underlying medical conditions.

The COVID-19 testing rebound driven by the Delta variant’s extended surge pushed Abbott Laboratories’ earnings per share for the third quarter nearly 50% higher than consensus estimates. Sales climbed to $10.928 billion, up 15% from expected estimates of $9.564 billion. COVID-19 testing accounted for $1.9 billion in sales, but even without that boost, the company posted year-over-year growth of 11.7% compared to the third quarter of 2019. With COVID testing included, Abbott had organic sales growth of 22.4% compared to the same quarter of 2020 and up 35% compared to the third quarter of 2019. With the third-quarter results, the company announced an increase in the full-year guidance to $5 to $5.10, nearly 40% higher than last year.