The independent data and safety monitoring board (DSMB) overseeing the AstraZeneca vaccine trial notified the National Institute of Allergy and Infectious Diseases (NIAID) late yesterday that promising safety data may have “included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
In a statement, NIAID said it is urging AstraZeneca to work with the DSMB and provide the panel with the most recent efficacy data available. Today, AstraZeneca responded that it would comply with the request.
Fauci: AstraZeneca likely a very good vaccine
AstraZeneca said the phase 3 US trial efficacy data were based on a specified interim analysis with a data cutoff of Feb 17 and that a preliminary review had found the primary analysis to be consistent with the interim analysis.
“We are now completing the validation of the statistical analysis,” the company said in a statement. “We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours.”
Today on “Good Morning America,” Anthony Fauci, MD, said the issue was unfortunate. “This is very likely a very good vaccine, and this kind of thing does, as you say, do nothing but really cast some doubt about the vaccines and maybe contributes to the hesitancy,” he said.
This is the latest bad news for AstraZeneca, which last week suffered a blow when dozens of European countries suspended use of the shot after Germany reported seven cases of blood clots, three deadly, in vaccine recipients.
Biden encourages conservatives to get vaccine
President Joe Biden has stated that his administration’s goal is for states to make every adult eligible for vaccination by May 1 and to have vaccinated the majority of Americans by the end of May, promising somewhat normal July 4th celebrations.
To that end, Biden is taking his vaccination message to the Christian Broadcasting Network, NASCAR, and the American Farm Bureau in an effort to sway older conservatives toward getting the vaccine and contribute to herd immunity, the Wall Street Journal reports.
The commercials will be produced by the Ad Council, a nonprofit that produces public-service announcements, and begin to run across digital and television platforms today. The videos include Willie Nelson singing “I’ll be seeing you” as images of crowded sporting events play across the screen.
Texas moves to make all adults eligible
Texas announced today that beginning next Monday, all adults in the state will be eligible for the COVID-19 vaccine.
“We are closing in on 10 million doses administered in Texas, and we want to keep up the momentum as the vaccine supply increases,” said Imelda Garcia, chair of the Expert Vaccine Allocation Panel. “As eligibility opens up, we are asking providers to continue to prioritize people who are the most at risk of severe disease, hospitalization and death—such as older adults.”
Currently, all adults are eligible for vaccination in only Alaska, Mississippi, and West Virginia, but other states, including Ohio, have announced plans to raise eligibility in early April.
The Centers for Disease Control and Prevention’s (CDC’s) COVID Data Tracker shows 164,300,795 COVID-19 vaccines doses have been delivered in the United States, and 128,217,029 have been administered, with 45,533,962 Americans fully vaccinated.
Yesterday, the United States reported 50,584 new COVID-19 cases and 590 deaths, according to the Johns Hopkins COVID-19 tracker. In total, the country has confirmed 29,899,000 COVID-19 cases, including 543,477 deaths.
Other US developments
- Beginning May 3, all 80,000 of New York City’s municipal workers will be compelled to return to work in-person. City officials hope private companies will soon follow suit.
- Sixty-nine percent of parents are at least somewhat concerned that their children will face setbacks in school because of the pandemic, according to a new poll from the University of Chicago and the Associated Press-NORC Center for Public Affairs Research, and 64% say they’re concerned a return to in-person instruction will lead to more people being infected.
- Regeneron this morning released phase 3 trial results showing its monoclonal antibody cocktail reduced hospitalization or death by 70% in nonhospitalized COVID-19 patients compared with a placebo. The treatment received emergency use authorization in November 2020.