Two Major COVID Trials Paused for Safety Issues

[Northerner]

Johnson & Johnson paused dosing and enrollment in all of its COVID-19 vaccine clinical trials due to an unexplained illness in a study participant, the company announced Monday.

Later in the day, Eli Lilly had to acknowledge a pause of a clinical trial of antibody treatment because of a "potential safety concern," The New York Times reported , citing emails U.S. government officials sent to researchers.

Eli Lilly had been testing the treatment on hospitalized COVID patients, all of whom also received remdesivir.

In a statement to the Times, Eli Lily spokesperson Molly McCully confirmed the pause in the trial and said, "Safety is of the upmost importance to Lilly. Lilly is supportive of the decision by the independent (safety monitoring board) to cautiously ensure the safety of the patients participating in this study."

But that wasn’t the only challenge facing Eli Lilly. Reuters reported late Monday that FDA inspectors found serious quality control problems at the Lilly plant where the antibody drugs are manufactured.

Two Major COVID Trials Paused for Safety Issues

"We want the vaccine to be safe and we’ve got to let the process play out, and it’s going to take a while…it's reassuring that companies are acting responsibly and pausing when they need to," the dean of the Brown University School of Public Health said.

www.medscape.com

 

[Robin]

Johnson & Johnson paused dosing and enrollment in all of its COVID-19 vaccine clinical trials due to an unexplained illness in a study participant, the company announced Monday.

Later in the day, Eli Lilly had to acknowledge a pause of a clinical trial of antibody treatment because of a "potential safety concern," The New York Times reported , citing emails U.S. government officials sent to researchers.

Eli Lilly had been testing the treatment on hospitalized COVID patients, all of whom also received remdesivir.

In a statement to the Times, Eli Lily spokesperson Molly McCully confirmed the pause in the trial and said, "Safety is of the upmost importance to Lilly. Lilly is supportive of the decision by the independent (safety monitoring board) to cautiously ensure the safety of the patients participating in this study."

But that wasn’t the only challenge facing Eli Lilly. Reuters reported late Monday that FDA inspectors found serious quality control problems at the Lilly plant where the antibody drugs are manufactured.

Two Major COVID Trials Paused for Safety Issues

"We want the vaccine to be safe and we’ve got to let the process play out, and it’s going to take a while…it's reassuring that companies are acting responsibly and pausing when they need to," the dean of the Brown University School of Public Health said.

www.medscape.com

It’s nothing new that trials have to be halted, but the US does seem to be more twitchy about restarting them. The Oxford vaccine has been paused several times, and then deemed safe to restart, except in the US where it remains on hold since early September.

Oxford vaccine trial resumes in UK after being halted

The University of Oxford has resumed its late-stage clinical trial of a COVID-19 vaccine candidate in the United Kingdom that was halted recently due ...

www.universityworldnews.com

 

[grovesy]

It’s nothing new that trials have to be halted, but the US does seem to be more twitchy about restarting them. The Oxford vaccine has been paused several times, and then deemed safe to restart, except in the US where it remains on hold since early September.

Oxford vaccine trial resumes in UK after being halted

The University of Oxford has resumed its late-stage clinical trial of a COVID-19 vaccine candidate in the United Kingdom that was halted recently due ...

www.universityworldnews.com

I saw this being discussed on CNN a couple of days ago.
I think I find it more reassuring that they have paused and review.
I think politicians seem to have put too much emphasis on vaccine. I was suprised when watching a commons debate last week that a number of backbenchers were sceptical about a vaccine being available soon.

 

[Northerner]

I saw this being discussed on CNN a couple of days ago.
I think I find it more reassuring that they have paused and review.
I think politicians seem to have put too much emphasis on vaccine. I was suprised when watching a commons debate last week that a number of backbenchers were sceptical about a vaccine being available soon.

Not before next Summer, I'd guess. At least the government aren't in control of it, although they will probably manage to stuff up distribution when it comes 🙄

 

[grovesy]

Not before next Summer, I'd guess. At least the government aren't in control of it, although they will probably manage to stuff up distribution when it comes 🙄

I am not convinced even on next summer. I have just remembered as I switched the telly this morning CNN were reporting from Russia.It seems the Russians claim that they had a working vaccine seems, to be more in doubt than their claims.

 

[Amity Island]

Johnson & Johnson paused dosing and enrollment in all of its COVID-19 vaccine clinical trials due to an unexplained illness in a study participant, the company announced Monday.

Later in the day, Eli Lilly had to acknowledge a pause of a clinical trial of antibody treatment because of a "potential safety concern," The New York Times reported , citing emails U.S. government officials sent to researchers.

Eli Lilly had been testing the treatment on hospitalized COVID patients, all of whom also received remdesivir.

In a statement to the Times, Eli Lily spokesperson Molly McCully confirmed the pause in the trial and said, "Safety is of the upmost importance to Lilly. Lilly is supportive of the decision by the independent (safety monitoring board) to cautiously ensure the safety of the patients participating in this study."

But that wasn’t the only challenge facing Eli Lilly. Reuters reported late Monday that FDA inspectors found serious quality control problems at the Lilly plant where the antibody drugs are manufactured.

Two Major COVID Trials Paused for Safety Issues

"We want the vaccine to be safe and we’ve got to let the process play out, and it’s going to take a while…it's reassuring that companies are acting responsibly and pausing when they need to," the dean of the Brown University School of Public Health said.

www.medscape.com

No doubt that many people will take this (pausing for safety) to mean that when they do make it available, it will be safe in the long term too. This doesn't mean that at all. Safety trials for most of the current safe and widely available vaccines had been tested over 10 years or more before being rolled out.

How else can you test for long term effects without testing long term?

I think this is where many people misunderstand the "anti-vaxxers". I'm sure many of the anti-vaxxers are against vaccines, full stop (rightly or wrongly) but many are just looking for safe vaccines.

 

[mikeyB]

I don’t understand anti-vaxxers because all our vaccines have been tested long term and found to be safe. If folk enjoy seeing their children die or become brain damaged then that’s their choice, just as long as herd immunity is maintained by the rest of us.

 

[Amity Island]

I don’t understand anti-vaxxers because all our vaccines have been tested long term and found to be safe. If folk enjoy seeing their children die or become brain damaged then that’s their choice, just as long as herd immunity is maintained by the rest of us.

Hi MikeyB,
I don't know either, as I've never had the opportunity to speak with an anti-vaxxer. However, I can see some possible reasons why they have been lead down that road.

Here's one.

Vaccines lead to an outbreak of polio that had already been eradicated.

Vaccine derived polio outbreak a week after WHO announce wild polio had been eradicated

A new polio outbreak in Sudan has been linked to the oral polio vaccine that uses a weakened form of the virus. News of the outbreak comes a week after the World Health Organization (WHO) announced that wild polio had been eradicated in Africa. The WHO linked the cases to a strain of the virus...

forum.diabetes.org.uk

 

[grovesy]

I don’t understand anti-vaxxers because all our vaccines have been tested long term and found to be safe. If folk enjoy seeing their children die or become brain damaged then that’s their choice, just as long as herd immunity is maintained by the rest of us.

I heard an expert saying that these days herd immunity needs vaccines!