Pharma coming to moral crossroads

OK, NOW WHAT? J&J’s COVID vaccine is being promoted by the media to have a 98% immune system response. Will it lead to an early approval with limited testing or will J&J ensure the vaccine goes thru thorough testing?

A single dose of Johnson & Johnson’s J&J experimental COVID-19 vaccine produced a strong immune response against the novel coronavirus in an early-to-mid stage clinical trial, according to interim published results. What exactly does that mean is still unknown as more testing is needed but will that vaccine get thorough testing?

As you all know Trump has promised a vaccine shortly before the election while Secretary Azar barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

So the question becomes could the current administration try and approve a COVID-19 vaccine without complete testing in order to try and win votes from a public who is scared of COVID?

Perhaps the more important question is “would J&J allow their vaccine to go to market without thorough clinical trials?”. The speedy vaccine development protects pharma companies from litigation if patients get sick from nasty side effects but morally this is a serious question of judgment.

J&J received more than $1 billion from the U.S. government to manufacture 100 million doses of its investigational COVID-19 vaccine.  But what does that billion dollars buy as far as approving the product for market?

Under NO circumstances should any pharmaceutical product be allowed into the market without complete and thorough testing. Every pharma company has indicated that they will conduct full clinical trials but we’re dealing with an administration that takes the moral low road and there is a lot of money at stake here.

J&J, over time, has paid substantial fines for illegal marketing including a $572 million for fueling the opioid crisis on top of an $8 billion fine in punitive damages because Johnson & Johnson failed to warn young men that they could grow breasts if they used its drug Risperdal.

Surely J&J is looking to recoup some of these fines which have since been reduced by new judges. The fact that we even have to ask the question around vaccine use shows just how low pharma’s reputation has sunk.

Hopefully, NO vaccine will be forced thru approval without full and comprehensive testing but the question about money versus patient safety will always be there and that’s a shame.