"Game-changer" Paxlovid turns into pandemic enigma
Axios (9/2)
Experts are increasingly concerned about connections between Paxlovid, Pfizer’s COVID-19 antiviral drug, and COVID rebound in patients who complete the five-day regimen, especially as Paxlovid use has grown dramatically in recent months. The US Food and Drug Administration (FDA) has asked Pfizer to investigate whether a second course will prevent rebound. A large study previously showed that Paxlovid significantly reduced hospitalizations and deaths in those 65 years and older, but uncertainty remains over the drug’s effectiveness in younger people as well as the link between the drug and COVID rebound. Rebound has also been observed in people who have not taken Paxlovid as well.
'Beginning of the end': Patients hail new treatment for drug-resistant TB
France24 (8/31), features TB Alliance
A new study investigating the effectiveness of the BPaL drug regimen (a combination of bedaquiline, pretomanid, and linezolid) with linezolid at lower doses found that the treatment was still highly effective in patients with drug-resistant tuberculosis (TB) and the number of patients who experienced side effects related to linezolid dropped significantly. BPaL was approved by the FDA in 2019. Although studies showed the drug to be highly effective in drug-resistant TB patients, there was also a high rate of side effects found to be linked to linezolid. The new study, supported by TB Alliance, published in the New England Journal of Medicine indicated that the dosage of linezolid can be halved while maintaining similar efficacy, making the six-month regimen easier and more tolerable for patients.
Additional coverage from TB Alliance (8/31), CIDRAP (9/1), and Health Policy Watch (9/1)
Pfizer and Moderna's updated COVID boosters win FDA nods, with swift rollouts to follow
Fierce Pharma (8/31)
On Wednesday, August 31, the FDA gave emergency use authorizations to Moderna and Pfizer-BioNTech’s Omicron-updated COVID-19 booster shots to be used as single-dose inoculations at least two months after the first booster vaccination. Both vaccines are aimed at targeting both the original COVID-19 and B.A.4 and B.A.4 Omicron subvariants. Whereas Moderna’s booster is approved for all adults 18 years and older, the Pfizer-BioNTech booster is approved for all people 12 years and older. The CDC endorsed the vaccines on Thursday, clearing the way for a quick rollout in the coming weeks.
Additional coverage from Reuters (8/31), NPR (8/31), and Health Policy Watch (8/31)
