Pfizer and BioNTech’s Omicron vaccine development has been delayed; a US judge said HHS violated procedural rules in a dispute with AstraZeneca over the 340B drug discount program; Texas filed suit against the CDC’s mask mandate for airline passengers.
Pfizer/BioNTech’s Omicron booster dose of its COVID-19 vaccine was delayed several weeks because of a slower-than-expected data gathering process, according to a report from Reuters. The companies previously expected to launch the new dose by the end of March but said that the official date would depend on how much clinical data regulators would require. When the vaccine is ready, BioNTech’s CEO said that the company would reassess whether it is still needed. The news comes as the Associated Press reports that about 73% of the US population is immune to the Omicron variant, which is expected to rise to 80% by mid-March.
A US judge ruled Wednesday that HHS, which threatened AstraZeneca with penalties, was incorrect in telling the company to resume providing discounts through the 340B drug discount program, which primarily serves low-income patients. The 340B program requires drug developers to offer discounts on all outpatient drugs to hospitals and other safety-net facilities. The discounts are typically estimated to be 25% to 50% but could be more. Bloomberg Law reported that the ruling vacated a violation letter sent by HHS and directed the company and HHS to decide how and whether the case should proceed.
The state of Texas is suing over the CDC’s mask mandate for passengers on airlines, saying that the agency lacks the authority to implement such a blanket provision for the country and that the rule is not backed by science, according the Dallas Morning News. The federal government’s mask requirement for airline passengers has been in place for over a year. The defendants claim that although the CDC’s power to require masks over all commercial airlines is in line with Section 361 of the Public Health Services Act, it does not give it the power to implement such a requirement for all travelers regardless of whether they are suspected of carrying communicable diseases.