One of the sunnier takeaways from the mess that AstraZeneca got itself into this week is that shows the value of data and safety monitoring boards (DSMBs). But it has also hurt the vaccine’s already somewhat sullied reputation, Stat’s star COVID-19 reporter Helen Branswell said in a podcast interview yesterday (March 26) that there is a possibility that the vaccine won’t ever be distributed in the U.S.
To briefly recap, early Monday (March 22) the company announced that results from its U.S.
phase 3 trial showed 79% efficacy at preventing symptomatic COVID-19 and 100% efficacy against severe disease hospitalization. The press release said it would seek an emergency use authorization from the FDA in the coming weeks.
But Monday night, the data and safety monitoring board (DSMB) appointed to review trial data of all the COVID-19 vaccines sent a letter to the company raising concerns about the data that the company was trumpeting.
The Washington Post obtained a copy of that letter, “The DSMB is concerned that AstraZeneca chose to use data that was already outdated and potentially misleading in their press release,” the letter states, according to the newspaper. The data “they chose to release was the most favorable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process.”
The DSMB letter was also sent to Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID). On Tuesday, (March 23), NIAID put out a statement that urged the company to work with the DSMB to review the data and “ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.” During an interview on Good Morning America, Fauci called it an unforced error: “The fact is that this is very likely a very good vaccine.”
On Wednesday (March 24), AstraZeneca put out second, do-over press release, this time saying its vaccine has 76% efficacy (not 79%) against symptomatic COVID-19. The figure 100% efficacy against severe cases or hospitalizations didn’t change.
Of course this is all happening against the backdrop of some safety concerns about the AstraZeneca vaccine and whether it is associated with very rare instances of blood clots. The company has also been under fire in Europe for not keeping its production promises.
Americans, as a group, seem a little bipolar when it comes to COVID-19 vaccination. Vaccine hesitancy (some of it now resistance) remains high in many quarters, and there’s discernable blue-red state divide. On Wednesday (March 24) the Texas Tribune reported the results of a poll it does with the University of Texas that showed that 61% of white Republicans in the state are reluctant to get a vaccine and 59% of all GOPers regardless of race. In contrast, 25% of Texas Democrats were in the hesitant-resistant camp.
And this morning, a number of local news outlets in blue states had stories about people clamoring to get a Pfizer, Moderna or J & J jab. “Mad rush for COVID-19 vaccine is on for Californians ages 50 to 64 as expansion nears” was a headline on the Los Angeles Timeswebsite. The Star Tribune in the Twin Cities reported this morning that a “frenzy for COVID-19 emerged” yesterday when the Minnesota governor announced that everyone 16 and older could get a shot starting Tuesday of next week (March 30). The Boston Globe has a story this morning about volunteers working the sign-up sites to book appointments for people they don’t know. “They’re up at all hours of the night booking appointments for strangers,” said the subhead.
In his opening statement at his first press conference on Thursday (March 25), President Joe Biden announced the goal of having 200 million shots administered by his 100th day in office, which will be April 30.
“That’s right. 200 million shots in 100 days,” Biden said. “I know it is ambitious. Twice our original goal. But no other country in the world has even come close, not even close, to what we are doing. I believe we can do it.”
The Axios “yes but” take: “The massive scale and complexity of the vaccine rollout could bring hurdles that slow the current pace of distribution, such as a drop in demand, logistical issues, or unforeseen supply problems.”
As of yesterday (March 26) at 1:24 p.m., the CDC vaccine tracker showed that 136,684,699 vaccine doses had been administered and that 89,559,225 people (27% of the population) had received at least one dose.
Vaccination of children remains something of a wild card in the worldwide vaccination effort, partly because children are not as susceptible to severe cases. But trials in children are getting underway. The first participants in a trial of Pfizer’s vaccine, a pair of 9-year-old twin girls were immunized on Wednesday (March 24), according to a New York Times story.
A spokesperson told the newspaper that results are expected in the second half of the year. The trial’s identification number of clinicaltrials.gov is NCT04816643. It is described there as a phase 1 and phase 2/3 study with total enrollment goal of 4, 644.
Politico reported on Monday (March 22) that of the 4.3 million doses of the J & J vaccine that have been delivered, only 2.3 million have been administered. The news site said the gap is “sparking confusion and finger-pointing between the states and the Biden administration over why millions of doses are sitting unused.”