U.S. Says AstraZeneca Has Submitted Outdated Data — J&J May Miss Vaccine Delivery Dates
GoLocalProv News Team
U.S. Says AstraZeneca Has Submitted Outdated Data — J&J May Miss Vaccine Delivery Dates
The National Institute of Allergy and Infectious Diseases (NAID) in a statement released shortly after midnight Tuesday are raising concerns about the data.
"The Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible," according to the statement.
GET THE LATEST BREAKING NEWS HERE -- SIGN UP FOR GOLOCAL FREE DAILY EBLASTThe institute urged AstraZeneca to work with the monitoring board “to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”
On Monday, AstraZeneca announced its Covid-19 vaccine was shown to be safe and 79% effective in preventing symptomatic disease in U.S. clinical trials involving more than 32,000 people, the U.K. drugmaker said Monday.
The company said it would continue to analyze the data and prepare to request an emergency use authorization (EUA) in the U.S. in coming weeks, a move that—if approved—would make the vaccine America’s fourth behind Pfizer, Moderna, and Johnson & Johnson.
Recently, a number of European countries suspended the use of the vaccine following questions about its efficacy and serious blood-clotting issues in a very small number of people in Europe who received the shot.
The European Union’s medical boards then reaffirmed the efficacy of the vaccine.
“Companies sponsoring drug or vaccine trials typically wait for the monitoring board to run analyses and conclude that the study has yielded an answer before they announce trial results. In recent days, the monitoring board’s analysis of the AstraZeneca trial was delayed several times because the board had to ask for revised reports from those handling trial data on behalf of the company, according to a person familiar with the matter who was not authorized to discuss it publicly,” reported the New York Times. “The monitoring board ultimately conveyed the results of the study to AstraZeneca in a meeting over the weekend, leading to the company’s announcement Monday morning.”
“Dr. Eric Topol, a clinical trials expert at Scripps Research in San Diego, said it was ‘highly irregular’ to see such a public display of friction between a monitoring board and a study sponsor, which are typically in close concordance,” said the NYT.
Johnson and Johnson Concerns -- Rhode Island in Focus
Meanwhile, Biden administration officials are increasingly concerned Johnson & Johnson may not deliver the 20 million doses of coronavirus vaccine it promised would be available by the end of this month, according to three senior administration officials, as reported by Politico.
"The full tranche of vaccine Johnson & Johnson committed in February to delivering may not be ready to ship until the second or third week of April, the officials said, potentially complicating preparations for states expecting millions of J&J shots," Politico continued.
As GoLocal reported:
Technology issues and poor communication continues to plague the Rhode Island Department of Health’s management of the vaccination program — a program that has been helter-skelter at best.
The Department of Health’s website still states that first shot eligibility won't start for some until May.
McKee claims “If Rhode Island can get the vaccine supply we need, we can achieve and beat this goal.”
But supply is just part of the problem. The Rhode Department of Health has bungled nearly every aspect of the pandemic.
Cases are beginning to move up— Covid ActNow shows that Rhode Island cases have been going up since March 9.
RIDOH Says More Appointments Available for Eligible Rhode Islanders Starting Tuesday at 9 AM
"Roughly 4,000 first dose appointments will be made available on vaccinateRI.org tomorrow at 9 a.m. These appointments will be for 3/30, 4/1, 4/2, and 4/3 (1,000 appointments per day) at the Dunkin’ Donuts Center in Providence. These will be appointments for Moderna vaccine," said RIDOH spokesperson Joseph Wendelken.
"We will be opening more first dose appointments tomorrow morning than we did on Tuesday or Friday last week," he added. "However, we are still doing a lot of second dose vaccinating. (We expect to administer roughly 35,000 second doses this week.) We expect larger numbers of first dose appointments to be available next week."