J&J To File This Week For Booster Shot Approval
Johnson & Johnson plans to apply early this week to the Food and Drug Administration for authorization to administer a second dose of its covid vaccine.
The New York Times:
Johnson & Johnson To Seek F.D.A. Authorization For Booster Shot
Johnson & Johnson is planning to ask federal regulators early this week to authorize a booster shot of its coronavirus vaccine, according to officials familiar with the company’s plans. The firm is the last of the three federally authorized vaccine providers to call for extra injections, amid mounting evidence that at least the elderly and other high-risk groups need more protection. Federal officials have become increasingly worried that the more than 15 million Americans who received the Johnson & Johnson vaccine face too much risk of severe Covid-19. The Food and Drug Administration on Friday scheduled a meeting on Oct. 15 of its expert advisory committee to discuss whether to grant emergency use authorization of a booster shot of Johnson & Johnson’s vaccine. (LaFraniere, 10/4)
In other news about Johnson & Johnson's covid vaccine —
Reuters:
EU Finds J&J COVID Shot Possibly Linked To Another Rare Clotting Condition
The European Union's drug regulator on Friday identified a possible link between rare cases of blood clotting in deep veins with Johnson & Johnson's COVID-19 vaccine and recommended the condition be listed as a side-effect of the shot. The European Medicines Agency also recommended that immune thrombocytopenia (ITP), a bleeding disorder caused by the body mistakenly attacking platelets, be added as an adverse reaction with an unknown frequency to the J&J vaccine product information and to AstraZeneca's vaccine. J&J said while the chances of experiencing these conditions were very low, the product information would be updated accordingly as it continues to work closely with authorities including EMA. (10/1)
NBC News:
FDA Won't Extend Shelf Life Of J&J Covid Vaccine Doses, May Extend Life Of Millions Of Moderna Shots
The government will not extend the shelf life of hundreds of thousands of unused Johnson & Johnson Covid vaccine doses, but may soon extend the life of millions of Moderna vaccine doses, according to an internal email obtained by NBC News. In an email sent to state health officials and health-care providers Friday morning, the Centers for Disease Control said the Food and Drug Administration will not further extend the life of Johnson & Johnson vaccines sitting on states' shelves across the country, leading to the potential waste of hundreds of thousands of doses. (Strickler and Tirrell, 10/1)
Also —
Fierce Biotech:
J&J's RSV Vaccine Offers 80% Efficacy Against Severe Illness In A Race Crowded By Big Pharmas
After years in development, the floodgates for RSV vaccines may open up soon, with more and more Big Pharmas piling on data. Now, Johnson & Johnson’s Janssen is adding to the fray, announcing efficacy as high as 80% in preventing severe infections in a mid-stage clinical trial. Janssen revealed the proof-of-concept data at IDWeek Saturday, showcasing a trial called CYPRESS that featured more than 5,700 people aged 65 years and up randomized to receive the RSV vaccine candidate or placebo. The main goal was the preventing the occurrence of lower respiratory tract disease as a result of RSV infection. A dozen secondary endpoints looked for adverse events, neutralizing antibodies and other outcomes. Protection from Janssen’s vaccine ranged from 80% in preventing severe lower respiratory tract infection caused to 70% for more mild cases. The study concluded that the vaccine was effective in protecting against RSV-caused infections through the first viral season. (Armstrong, 10/2)
