J&J Forecasts March Approval For Its Single-Dose Vaccine
While Johnson & Johnson expects to release trial results in the next two weeks, the vaccine maker also says that it is behind in its promised production schedule.
Bloomberg:
J&J Sees Decision On Vaccine Clearance Coming By March
Johnson & Johnson’s highly anticipated single-dose Covid-19 vaccine may not be authorized for use until March, weeks later than U.S. officials have suggested. Operation Warp Speed officials have said they believe that the shot could receive emergency clearance from U.S. regulators as soon as the middle of next month. But that timeline may be aggressive, based on the drugmaker’s expectations for when it will have reliable data in hand demonstrating the one-shot vaccine’s efficacy. (Griffin and Tozzi, 1/13)
The New York Times:
Johnson & Johnson Expects Covid Vaccine Results Soon But Lags In Production
Johnson & Johnson expects to release critical results from its Covid-19 vaccine trial in as little as two weeks — a potential boon in the effort to protect Americans from the coronavirus — but most likely won’t be able to provide as many doses this spring as it promised the federal government because of unanticipated manufacturing delays. ... Federal officials have been told that the company has fallen as much as two months behind the original production schedule and won’t catch up until the end of April, when it was supposed to have delivered more than 60 million doses, according to two people familiar with the situation who were not authorized to discuss it publicly. (Zimmer, LaFraniere and Weiland, 1/13)
Stat:
Data Fuel Debate On Whether J&J’s One-Dose Covid Vaccine Will Be Enough
Johnson & Johnson published updated early data on its Covid-19 vaccine Wednesday, showing that it provided participants in a clinical trial with at least some immunity after one dose. The data, published in the New England Journal of Medicine, offer only hints to a tantalizing question: Could the vaccine, given as a single shot, perform as well as the vaccines that U.S. regulators have already authorized, which are given as two? (Herper, 1/13)
The Hill:
Johnson & Johnson Vaccine Has Promising Immune Response In Early Trial
A coronavirus vaccine from Johnson & Johnson was found to be safe and to generate an immune response in early trials, promising signs as research continues. The results published Wednesday in The New England Journal of Medicine are from early-stage trials. The more conclusive results on the effectiveness of the vaccine are still to come in a phase three trial, which the company said Wednesday could be available soon, in "late January." (Sullivan, 1/13)
In other news from vaccine developers —
USA Today:
Moderna COVID-19 Vaccine Trial Struggles To Find Adolescent Volunteers
Not enough adolescents are signing up for Moderna's COVID-19 vaccine trial, a federal official said this week, potentially delaying vaccine authorization for this age group. Last month, the U.S. Food and Drug Administration OK'd use of the Pfizer-BioNTech vaccine for 16- to 17-year-olds, as well as adults. The companies did not have enough data in younger adolescents to apply for use in that age group, and Moderna had only tested its vaccine in adults, so it is only authorized for 18 and up. About four weeks ago, Moderna launched a trial in 12- to 17-year-olds, but apparently, the company is struggling to find enough adolescents volunteers. (Weintraub, 1/13)
FiercePharma:
JPM: How Did Pfizer Up Its COVID-19 Vaccine Capacity? 'Out Of The Box Manufacturing,' CEO Says
Earlier this week, Pfizer partner BioNTech upped the pair’s 2021 COVID-19 output projection to 2 billion doses for 2021, up from a previous estimate of 1.3 billion. But how will the companies get there? By doing things “very differently and very out of the box in manufacturing,” CEO Albert Bourla explained Tuesday during a fireside chat at the J.P. Morgan Healthcare Conference. (Helfand, 1/13)
