Exclusive: Whistleblower Alleges Queens Company Ordered Health Clinic Workers To Over Dilute Doses Of COVID Vaccine
NEW YORK (CBSNewYork) -- A lawsuit has been filed against a health care company that runs several vaccination sites in New York City by an employee who was fired.
It alleges that vaccinators at one location were told to over dilute vaccines, CBS2's Alice Gainer reported Monday.
Andrew Palazzo alleges 16,000 Pfizer doses could have been over diluted and administered at Korean Community Services' vaccination site in Bayside, Queens.
"When I was the lead vaccinator, I was instructed to have everybody do the over diluting," Palazzo said.
"This is direct from the CEO?" Gainer asked.
"Correct," Palazzo replied. "I assumed he was the higher medical authority. I thought it was OK."
Palazzo, who was fired, filed a lawsuit against his employer, Centers Urgent Care, based in Middle Village.
Palazzo alleges while he worked at the KCS site from the end of March until May, CEO Scott Orlanski told him, "to utilize between 1.9mL and 2.0mL of dilutant per vial to obtain at least seven (7) doses per vial," of the Pfizer COVID-19 vaccine.
According to CDC guidelines, 1.8mL is to be used.
The FDA says, "Do not add more than 1.8 mL of diluent."
According to Pfizer, after dilution, COVID-19 vaccine vials contain five to six doses.
Back in December, the FDA acknowledged some vials had extra product, tweeting, "... FDA is advising that it is acceptable to use every full dose obtainable (the sixth, or possible even a seventh) from each vial..."
At this time, given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue.
— U.S. FDA (@US_FDA) December 17, 2020
CBS2 spoke to several former and current employees. One current vaccinator wanted their identity hidden, out of fear.
"They heavily pressured the vaccinators to get seven doses," they said.
Encrypted WhatsApp messages between management were shown to us, as well as text messages sent between vaccinators that show a concern about what was going on.
Some went to management.
"We said that either they had to stop doing it, they had to correct what, like, this management had been telling people, or they had to, or we would leave. So a group was going to quit," the employee said. "They agreed that they weren't going to be doing this going forward. They said there had been a miscommunication."
We went to the KCS site to talk to the manager and director.
"We never advised anybody to over dilute anything," said Dr. Josef Schenker, medical director and owner of Centers Urgent Care.
"They're saying there was over dilution going on. You're saying you know nothing about that," Gainer said.
"At no time was anybody instructed to draw up more diluent than 1.8mL," Schenker said. "If you're very careful and you're very precise with your measurements, you can get a 7th dose."
"Why push for this 7th dose, these extra doses? There's no vaccine shortage," Gainer said.
"It's just a cushion. If you, if accidentally there's spillage. If there's a loss of, once it's drawn up, if you accidentally, a syringe falls and it has to be discarded. Nothing is used that falls," he said.
Dr. Purvi Parikh is an immunologist with the Allergy and Asthma Network and a researcher on the Pfizer COVID-19 vaccine clinical trials.
"If a vaccine is over diluted, it can lose it's efficacy and it's potency," Dr. Parikh said.
Gainer asked Parikh what could happen if 1.9 mL was added instead of 1.8mL.
"We frankly don't know, because it hasn't been studied if it was diluted slightly a little bit more or not," she said. "But, just from a medical standpoint, likely in that small amount it won't make a huge difference."
Centers Urgent Care said it won't comment on Palazzo's termination while there's an active investigation. Palazzo's lawsuit states he wants the site shut down and money for lost wages.
The New York City Health Department said senior city staff carried out an unannounced site visit - checked the vaccine, interviewed staff and observed - and said no major issues have been identified to date.