A doctor and nurse practitioner who live on Bainbridge Island have written a report regarding waste with the Pfizer vaccine.
They blame the waste on Food and Drug Administration regulations. They saw the waste firsthand working at the mass vaccination sites on BI and elsewhere.
Dr. Stephen Hubbard said the waste might not mean that much to people living in the U.S. People who don’t get vaccinations here do it as a matter of choice – not because the vaccine isn’t available.
But that wasted vaccine could mean life or death in developing countries. For instance, in Africa, the shortage is epidemic. Morroco leads those nations with only about 10% of residents vaccinated.
Hubbard, 73, a retired cardiologist, and colleague Rajlaxmi Bais, ARNP, volunteered to do COVID-19 vaccinations for Bainbridge Prepares. Instead of giving the shots, Hubbard worked in the sterile back room prepping for them. Those volunteers were nurses, veterinarians, etc., – people licensed to handle medication.
While the other vaccines came in vials ready to be administered, Pfizer had to be diluted with saline after the vaccine was taken out of a deep freeze and thawed for a few hours. FDA originally allowed five shots per vial, but when people complained about the waste it then allowed six.
That wasn’t good enough, Hubbard said.
“I noticed a good amount of vaccine was still left,” he said. “Because of FDA regs, we had to throw those vials away.”
He said while there wasn’t enough for a full dose, there would have been if it was combined with the leftover amount from another vial. He said about 10% of the Pfizer vaccine is being wasted.
When the doctor and Bais talked about it, Hubbard said, “We’re throwing away the most valuable substance on earth. This is nuts.”
He said there have been stories in the media about waste caused by the vaccine being thawed and not used in time because people weren’t getting shots.
“But that amount of loss is actually very small – less than one percent,” Hubbard said. “Nobody’s talking about throwing away ten percent of the vaccine.”
He said he doesn’t know why the FDA isn’t allowing the mixing of the leftover medicine.
“Healthcare clinicians have pooled doses for decades with medications such as flu and other vaccines, chemotherapy, steroids, antibiotics and insulins. If the technique of pooling from the Pfizer multi-dose vial is done in the same aseptic manner as the first six doses and done immediately with a new vial from the same lot number, then risk of contamination would be low,” Bais says in an email response to questions.
Hubbard agreed. “An infection is highly unlikely. That’s not a legitimate issue,” he said, adding the handlers wipe everything with alcohol and know the sterile techniques to use. The only other reason he could think of is the FDA wants to keep it simple for the volunteers, but he said it really wouldn’t take any more time. “It adds almost nothing to the effort.”
Bais did admit Pfizer’s product does not contain preservatives like other medications that stop microbial growth. That’s why she and Hubbard recommend to only use vials within the same lot number “to be able to trace a possible allergic reaction to a specific product lot.”
Not to sound like a conspiracy theorist, but Hubbard said like everything it could come down to money. “Maybe I’m being too cynical, but that could be the heart of the matter,” he said.
For example, he said if Pfizer makes 500 million doses that means about 50 million are being thrown away because of this FDA procedure limitations. They get $7 per dose, and “that starts to add up.” Pfizer predicts three billion doses in sales this year, which would mean $27 billion. So if the vaccines were saved with a new procedure, that would cost Pfizer $2.6 billion.
“A tiny little thing multiplied by real-world numbers becomes a big deal,” he said.
Bais agreed, saying contamination risk is always a concern, but “pretty much everything comes down to some sort of profit incentive. If Pfizer could get reimbursed for these additional doses created by pooling doses, or companies could bill for it, I can see it being approved.”
Hubbard said even though it’s a simple problem to solve people need to start asking questions about it. “I don’t think it’s in Pfizer’s best interest to do it,” he joked. Getting the FDA to change is like moving a “bureaucratic mountain. Public outcry is going to be the best thing.”
He said the U.S. should be saving “every last drop” and helping developing nations that are “way behind on the vaccine. It’s a precious commodity out there. Any little thing to make the vaccine available to those countries would be a big deal.”
Again, Bais agreed. “In countries that are already struggling to get enough vaccines, the risk of getting critically ill from COVID is much higher than the minimal risk that would be involved of obtaining an extra dose through pooling of vaccine.”
She said some countries are already pooling with the same vaccine brand anyway, then shared a personal story from India, where she is visiting family.
“We have lost several family members and friends from COVID,” she said, adding in July vaccination rates in Delhi declined by 60% due to lack of vaccine – they needed 15 million doses but only had about 2 million available. “I saw a video of a man in India literally climbing the side of a building (clinic site) to get a chance to get a vaccine, and it brought tears to my eyes. Tears because people here are desperate for even the first shot.”
Bais said it hasn’t been easy getting the word out about the waste of the Pfizer vaccine.
“We were met with resistance from some of the bigwigs at neighboring medical centers…However, Stephen and I decided to push through and continue with our passion because we knew that sometimes the biggest changes start with the smallest of steps.”
Costs online
Hubbard found out something interesting as he went to get their report published. The process has changed since COVID.
Because of the rapid dissemination of information on the internet on the topic, many reports don’t even get peer review.
Many online publications don’t have time to deal with subscribers and advertising so they charge the authors of the reports as their way to make money.
That has resulted in a number of scam operations, called “predatory journals.” They take your money, but never print anything. “It’s a cottage industry,” Hubbard said.
The report by Hubbard and Bais has received peer review and a request to print it from the Journal of Clinical Trials.
Hubbard said Bainbridge Prepares has offered to pay the $2,000 in this case. “In most cases the institution (the author represents) comes forward and pays.”
The study
The report has been printed online without cost or peer review at medrxiv.org
It says they did the study in April by taking the residual medicine left in 172 vials after six doses had been withdrawn per Centers for Disease Control and Prevention guidelines. It says 1,036 doses were given from the vials. Another 102 doses could have been provided using the extracted vaccine.
It suggests further studies are warranted, along with clinical trials.
