Adverse events are not uncommon in large trials, and some outside experts see pauses as a good sign that companies are paying close attention to possible safety problems with the experimental COVID-19 vaccines. AstraZeneca paused its COVID-19 vaccine trial in early September because of what it also called an “unexplained illness” in a study volunteer; media reports and some trial documentation identified the illness as transverse myelitis. The AstraZeneca trial is still on pause in the U.S.
Johnson & Johnson announced the launching of the ENSEMBLE trial on September 23. The drugmaker aims to enroll 60,000 volunteers in the double-blind, placebo-controlled study of the company’s single-dose vaccine.
The statement posted last night about the pause didn’t say whether the patient with the unexplained illness had received the vaccine or the placebo. It noted, though, that in placebo-controlled trials it is not always “immediately apparent” which the patient has received.
Fasten your seatbelts, it’s going to be bumpy when the COVID-19 vaccine(s) are available
Writing in the New York Times, Carl Zimmer says to be prepared for a lot of confusion about what will presumably be several COVID-19 vaccines. The first ones may provide only moderately effective, which could have all sorts of negative unintended consequences, not the least of which would be eroding public trust in COVID-19 vaccination. Some vaccines may get on the market but be withdrawn because safety issues will emerge when they are used in large numbers. Others may be commercial flops for various reasons. In an opinion piece posted yesterday on the Times‘ website, Zimmer sketches out a scenario whereby better vaccines may never get fully tested or approved because inferior vaccines have already been approved and are on the market.
In Zimmer’s view, the root cause of the possible (perhaps probable) confusion was the decision to allow companies with vaccine candidate to run their own trials rather than having a “master protocol” that would have compared the vaccinees against each other — and against a placebo — in one, large single trial, according to Zimmer.
The counterargument (from Moncef Slaoui, among others) is that kind of multivaccine trial would have taken longer to organize and execute. The World Health Organization has organized such a trial, which is called the Solidarity Vaccine Trial.
Zimmer writes that it took nine months to get the Solidarity Vaccine Trial off the ground, which Slaoui’s perhaps would say helps prove his point.
Pfizer trial gets teen spirit
Last month Pfizer announced that it was expanding enrollment in its COVID-19 trial from 30,000 to 44,000 people and that doing so would allow the company to enroll people as young 16 and those with stable HIV, hepatitis C, or hepatitis B. Business Insider reported yesterday that the company had gotten FDA go-ahead to possibly (IRBs will have to approve) enroll even younger teenagers in COVID-19 trial. Here is the exact wording from the Pfizer website:
“We have also received permission from the FDA to seek institutional review boards (IRB) or ethics committee approval of an amendment to our protocol, which will enable us to study adolescents as young as 12 years old. As with the vaccine candidates we test in adult populations, we are following a careful, stepwise approach as we move down to younger groups.”
Last week, Politico reported that Pfizer had embarked on a campaign to persuade influential people that it was not cutting corners on safety. The political news website reported the company’s top scientists met with Eric Topol and that a meeting between CEO Albert Bourla and Ezekiel Emanuel, who is advising the Biden campaign, was in the works.
Gallup: Waning American willingness to get the COVID-19 vaccine
Results from a new Gallup poll show the proportion of Americans who are willing to be vaccinated against COVID-19 is fading
The poll, which was conducted Sept. 14–27 among 2,730 adults, shows that 50% of Americans are willing to be vaccinated, an 11 percentage drop from August, when 61% were willing and a 16 percentage point drop from July when 66% were.
Here is the wording of the question that Gallup asked:
“If an FDA approved vaccine to prevent COVID-19 was available right now at no cost would you agree to be vaccinated?”
The vaccine willingness trends were headed in opposite directions among Democrats and Republicans. The proportion of Democrat who are willing to be vaccinated decreased from 78% in August to 53% in September, a 25 percentage point drop. During the same time span, the proportion of Republicans who were willing to be vaccinated increased from 37% to 47%, a 10 percentage point difference.
Backlash at HBCUs
The presidents of two historically Black universities in New Orleans are navigating controversy and backlash after they encouraged students, faculty, staff and alumni to consider participating in a COVID-19 vaccine trial, according to an article posted on Stat yesterday. The presidents, Walter M. Kimbrough of Dillard University and C. Reynold Verret of Xavier University of Louisiana, sent out the letter encouraging participation after they received injections as volunteers in the Pfizer’s COVID-19 trial. The Ochsner Health System in New Orleans is a study site for the Pfizer trial.
“Our children are not lab rates for drug companies,” said one post, according to Stat.
“The episode illustrates the challenges historically Black colleges and universities face as they seek to leverage their legacies of trust within African American communities to bolster lagging enrollment in COVID-19 vaccine trials,“ said the Stat story written by Nicholas St. Fleur. The story discusses the high level distrust of drug companies and medical researchers among African Americans because of the history of racial injustice perpetrated. A salient episode in that history is the infamous Tuskegee Study conducted by the Public Health Service that involved withholding treatment of Black men with syphilis.
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