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FDA Advisory Committee Support Limited Use of Covid-19 Vaccine Booster Doses

The FDA’s Vaccines and Related Biological Products Advisory Committee recommended that the FDA grant emergency use authorization (not full approval) for boosters with Pfizer’s Comirnaty vaccine. The panel was concerned about: insufficient data, too soon, safety in boys age 16-17 because of the myocarditis, and emphasis should be on the unvaccinated. If there are going to be boosters, the panel recommended that they be restricted to people age ≥65, at high risk for severe Covid-19, or whose occupation puts them at risk of Covid-19. However, a senior FDA official told the panel that the FDA does not have to take the panel’s advice and can “tweak” it however it chooses.

FDA Advisory Committee to Consider Covid-19 Vaccine Boosters

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on September 17, 2021, to discuss Pfizer’s application for licensure of a booster dose for people age ≥16 of Comirnaty (BNT-162b2), the Covid-19 mRNA vaccine developed with BioNTech

HIMSS21

If HIMSS is any indication, Epic continues to do well. Many CIOs believe Epic is becoming the “private” EHR and Cerner the “government” EHR, saying Cerner has been neglecting hospitals as it focuses on its government contracts. · Hospital budgets are up an average of ~5% among CIOs questioned at HIMSS, but none is planning any major expenditures. This next year is focused on recovery from Covid-19, refining existing telehealth, interfaces, cybersecurity – and staffing, which is a real issue. There is interest in population health but less than in some past years. · The exhibit floor was sparsely attended, but exhibitors did not appear too unhappy. · Health Catalyst’s acquisition of Twistle looks like a good move as Twistle was getting a warm reception. · Linking retail primary care to EHRs is potentially a big problem for health-care IT.

ESC: Heart Failure and SGLT2 inhibitors

At last – a drug that is effective in heart failure with preserved ejection fraction (HFpEF). New data presented at ESC showed a reduction in heart failure hospitalizations (but not mortality) with an SGLT2 inhibitor – Boehringer Ingelheim and Lilly’s Jardiance (empagliflozin). The news raised the profile of all SGLT2 inhibitors, and there was a lot of discussion about when and how to use them and how to sequence them with other approved drugs. Here is a deep dive into SGLT2 inhibitors in heart failure, both reduced and preserved.

The Diagnosis of Melanoma

Dermatologists agree that full-body skin examinations, with use of a dermatoscope to examine specific lesions, are the best way to identify potential melanomas, which can then be biopsied for a definitive diagnosis. There is interest – but not much real excitement about or demand for – new technologies that help avoid the need for a biopsy, particularly, digital photography; digital apps; confocal microscopy; SciBase’s Nevisense, an electrical impedance spectroscopy device; Orlucent’s fluorescent biotag device; Canfield Scientific’s Vectra; and DermTech’s PLA and PLAplus genomic assays – with more technology on the way.