
NY: Staff mishap at Jones Beach vaccine site renders some doses ineffective

Some coronavirus vaccines were rendered ineffective at the state's Jones Beach drive-in site Feb. 15 after a staffer added a hand warmer to a cooler carrying syringes — and now anyone who got those doses must return for re-vaccination, according to a spokesman for the governor.
Those shots constituted 81 of the 1,379 doses administered Feb. 15 at Jones Beach, according to state Health Department spokeswoman Jill Montag.
The staffer had been transporting syringes that afternoon from an on-site pharmacy to tents where the vaccinations are administered, said Jack Sterne, the spokesman for Gov. Andrew M. Cuomo. When the staffer noticed the temperature reading on his cooler was nearing an unacceptable low, he added the hand warmer — which isn't protocol — to warm up doses, Sterne said.
In an email, Montag said "there was no health risk" for those receiving the ineffective shots, and the appointments are to be rescheduled.
Sterne said the state has increased staff training since the mishap, which was the first known instance of ineffective doses being administered at state sites. The sites began operating Jan. 13.
But it has occasionally happened elsewhere.
Earlier this month, residents at five Ohio nursing homes were told they needed to be revaccinated after Walgreens, whose pharmacists administered the shots, discovered that the doses might not have been stored at the right temperature. And about a week earlier, about 1,000 people in Sweden were given doses that had been kept at the wrong temperature during transport.
The Pfizer vaccine, which must be thawed from an ultracold freezer, is prepared in a mixture and placed into syringes. Once that is completed, the shot can be left at room temperature, between 35 degrees and 77 degrees, for up to 6 hours, according to the U.S. Centers for Disease Control and Prevention.
When rescheduling the Jones Beach appointments, Sterne said, the state is giving priority to the 81 affected people, but won’t cancel existing appointments to make room. State representatives have reached all 81 by phone, or left them voice messages, and those who got vaccinated at Jones Beach Feb. 15 but were unaffected would get notification emails, he said.
At a news conference Monday afternoon with Cuomo, Health Commissioner Dr. Howard Zucker, said: "You know, this vaccine is very sensitive to temperature ranges. We knew exactly who it was. We have contacted them. They will get revaccinated. This is the whole benefit of having a great checks-and-balances system in place, so we were able to identify this, and appropriately intervene."
Neither Sterne nor Montag said when the error was discovered.
Asked whether receiving the shot when it is too warm poses a danger to the patient, Dr. Leonard R. Krilov, chairman of pediatrics and chief of pediatric infectious diseases at NYU Langone-Long Island, said in an email: "A warmed-up vaccine shouldn’t be dangerous but could lower the effectiveness of the vaccine."
And what about receiving more than two doses? Krilov said there is no clear answer, but he cited experience with other vaccines, such as for measles, when there is uncertainty about the handling or storage: "The precedent in those cases is to give an extra dose. In general, an extra dose would not be expected to be harmful although the person might have more local reactions from an extra dose."
The two coronavirus vaccines approved in the United States — by pharmaceutical companies Pfizer-BioNTech and Moderna — require extra cold storage. The state sites use only Pfizer-BioNTech vaccines, Sterne said.
Each company's vaccine is administered in two doses, weeks apart, but the contents don't change between a first and second shot. The 81 shots were split between first and second appointments, with slightly more first appointments, Sterne said.
Since the Jones Beach site opened, tens of thousands of vaccines have been administered there, with over 3 million statewide, Montag said.
A worker who answered the phone Monday afternoon at the state's vaccine line, 833-NYS-4-VAX, said that she and her colleagues know only what's been reported in the news media about the ineffective doses.
"The only thing we have right now is what they say on the news," she said, adding: "People have been calling, and then we pull up the news, and then we know it was real what people were saying."
With Bart Jones
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