LI hospitals discover extra dose of Pfizer-BioNTech vaccine in vials

Regional hospitals opening Pfizer-BioNTech’s COVID-19 vaccine vials are finding the unexpected: an additional dose.

Hospitals have started to draw a sixth dose from each vial after pharmacists noticed there was residual volume left over after the standard fifth dose was administered.

The U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research Prevention late Wednesday said "... there is the potential sixth and potential seventh dose from each of the vials."

Dr. Jason Golbin, chief quality officer at Catholic Health Services, which operates six hospitals on Long Island, said the extra dose is like "finding liquid gold. The more vaccine we have, the quicker we can protect staff and the quicker we can protect the population."

New York-based Pfizer and German pharmaceutical company BioNTech codeveloped the first COVID-19 vaccine approved for use in the United States. Pfizer has said about 25 million doses would be available in the United States this month. A person needs two doses, 21 days apart, to be considered vaccinated.

Pfizer-BioNTech said the vaccine has proved 95% effective through clinical trials.

Hospitals in New York have not disclosed how many doses they’ve received. The state is expected to initially receive enough doses to fully vaccinate 170,000 people, including health care workers and nursing home staff and residents, state officials have said. Another delivery is expected later this month.

It was unclear what percentage of vials already received were yielding an extra dose, said Dr. Mark Jarrett, chief quality officer at Northwell Health, the largest health system in the state.

"We’ve just started tracking this, so we don’t know yet," Jarrett said. "In a few days, or a week, we will have a much better idea."

Dr. Joseph Greco, chief of hospital operations at Mineola-based NYU Langone Hospital-Long Island, said "there is often residual volume in a vaccine vial" and that Pfizer-BioNTech put on the vial "that there could be residual volume. This isn’t unprecedented."

Dr. Aaron Glatt, chairman of medicine and chief of infectious diseases at Mount Sinai South Nassau hospital in Oceanside, cautioned, though, that "you’re not always going to have the exact amount left over to make an effective dose."

The FDA also said pharmacists should "not pool from multiple vials to create an additional dose, as this product is preservative free."

"It’s generally not a good idea to mix vaccines from different vials," Golbin said. "Even though they’re supposed to be the same, they could be very slightly different. It’s not worth taking a chance."

Hospitals are optimistic that they’ll get doses of a second COVID-19 vaccine, developed by Moderna and the National Institutes of Health.

The FDA said its preliminary analysis confirmed the Moderna vaccine’s effectiveness — 94.5% — and safety. A panel of experts was expected to recommend the formula, with the FDA’s green light coming soon thereafter.

Like Pfizer, the Moderna vaccine is delivered in two doses, but it’s easier to handle because it doesn’t need to be kept in the deep freeze at minus 94 degrees Fahrenheit.

"Certainly it will be a little easier to manage than the Pfizer vaccine, because it doesn’t have to be in a deep freeze," Jarrett said. "All indications are the Moderna vaccine will have very similar success rates. If both end up at over 90%, that’s fantastic news."

Golbin said Catholic Health Services is anxious to get the vaccine.

"The more vaccine, the merrier," Golbin said. "We can vaccinate the rest of our staff, including our medical staff. It’s a very exciting time."

With AP