CDC Quietly Changes Vaccine Recommendations To Mitigate Myocarditis

The Centers for Disease Control and Prevention this week quietly changed its vaccine recommendations for males between the ages of 12 and 39 to reduce the risk of myocarditis, encouraging them to wait for eight weeks after their first dose of an mRNA COVID-19 vaccine to get their second dose -- a longer timeframe than CDC’s previously recommended three to four weeks between the doses. The two mRNA vaccines authorized for use in the United States, developed by Pfizer and...
Article Type: 
Daily News
Tags: 
vaccine
drug-safety
corona
emergency-response
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 02/25/2022
FDA Volume: 
Vol. 28, No. 8
Author: 
Kelly Lienhard
Topics: 
ISSUE: FDA WEEK
Mid Day E-mail
Coronavirus
Emergency Response
Rx Drugs


CEPI Announces Funding For COVID-19 Vaccine R&D

The Coalition for Epidemic Preparedness Innovations announced this week it is investing in an initiative to develop mRNA vaccines for mutations of COVID-19. The marks the latest COVID-19 vaccine effort by CEPI, which is a global partnership of public, private, philanthropic and civil society groups working to boost development of vaccines against emerging infectious diseases and provide equitable access to those vaccines. CEPI granted $12.5 million toward the development of multi-epitope, nanoparticle-based vaccine candidates and will be joined by an...
Article Type: 
Daily News
Tags: 
drug-trial
corona
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 02/25/2022
FDA Volume: 
Vol. 28, No. 8
Author: 
Gabrielle Wanneh
Topics: 
ISSUE: FDA WEEK
Coronavirus
Rx Drugs

Law Lets Pharmacists Prescribe COVID-19 Drugs, But EUAs Don’t

The Public Readiness and Emergency Preparedness Act lets pharmacists prescribe coronavirus treatments, but the emergency use authorizations for two antivirals exclude pharmacists, so pharmacists are urging FDA to revise those EUAs. Pharmacy groups also are urging CMS to revise guidance to require that insurers pay pharmacists for services related to prescribing and dispensing coronavirus therapies. “The federal government has already authorized pharmacists to order and dispense oral therapeutics under the PREP Act,” according to a statement by several pharmacy organizations...
Article Type: 
Daily News
Tags: 
drug-trial
corona
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 02/25/2022
FDA Volume: 
Vol. 28, No. 8
Author: 
John Wilkerson
Topics: 
ISSUE: FDA WEEK
Coronavirus
Rx Drugs

Appeals Court Refuses To Rehear ‘Skinny Label’ Case

A federal appeals court in Delaware refused to rehear a lawsuit over so-called skinny labels, and generic drug makers say the ruling will delay generic competition. Teva reportedly plans to appeal the case to the U.S. Supreme Court, but the company didn’t not respond to requests for confirmation. The lawsuit (case no.: 2018cvpri1976) is over Teva’s generic of the GlaxoSmithKline heart drug Coreg. Teva asked for a rehearing after the court ruled that Teva improperly promoted its generic Coreg, approved...
Article Type: 
Daily News
Tags: 
generics
Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 02/25/2022
FDA Volume: 
Vol. 28, No. 8
Author: 
John Wilkerson
Topics: 
ISSUE: FDA WEEK
The Courts



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