Pfizer Vaccine Vials May Come with Extra Doses; FDA Advises on Usage

The first shipments of the Pfizer vaccine have been going out to major hospitals all week, but there’s not nearly enough to go around. Some facilities received just 975 doses during the first round with workforces of over 10,000 employees. The company says it will increase the number of shipments week after week, but until then, some healthcare workers will just have to wait for their doses.

However, there is a bit of good news. The FDA issued a statement late last night confirming that the vials containing the Pfizer vaccine come with additional doses, which could increase the nation’s supply by up to 40%. If you’re waiting for your first dose of the drug, you may not have to wait as long as you thought.

Saving the Leftovers

The first shipments from Pfizer caused some confusion when doctors discovered that each vial contained more of the vaccine than what was promised. Each glass vial is supposed to contain five doses, but pharmacists have found enough for six or seven.

“It was overtly clear early on there’s some extra volume,” said Russell Findlay, pharmacy manager at University of Utah Health.

Hospitals and providers quickly reported their findings to the FDA and Pfizer, but it took several hours for both parties to respond to the inquiry. Without clear guidelines from the manufacturer, many providers ended up throwing these extra doses away in fear of violating the rules the agency set last week.

“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,” the agency then said in a tweet. However, the vaccine manufacturer has yet to issue its final guidance in terms of how these extra doses should be used.

“The amount of vaccine remaining in the multidose vial after removal of 5 doses can vary, depending on the type of needles and syringes used,” according to Pfizer spokesperson Sharon Castillo. “At this time, we cannot provide a recommendation on the use of the remaining amount of vaccine from each vial. Vaccinators need to consult their institution’s policies for the use of multidose vials.”

Both the FDA and Pfizer agree that the leftover doses shouldn’t be mixed, due to the risk of contamination. If the vial doesn’t have enough left over for a full dose of 0.3 milliliters, it should be discarded, considering the vaccine doesn’t contain preservatives.

The former acting chief of the Centers for Medicare and Medicaid Services (CMS) Andy Slavvitt tweeted about the additional doses going to waste. He then confirmed that Pfizer is submitting paperwork to the FDA that would let doctors use any extra doses if they are available.

Spokesperson Castillo followed up by saying that Pfizer will continue “to closely coordinate with the FDA on this matter.”

The news brought some much-needed relief to hospital administrators trying to vaccinate their staff as the number of infections and hospitalizations continues to rise across the country. The change could expand the nation’s supply of the drug by up to 40%, which could help prevent what some people have called a “vaccine cliff”, in which demand for the vaccine exceeds supply.

How Did This Happen?

It’s not clear why some vials may contain additional doses of the vaccine; however, drug manufacturers often overfill these containers to safeguard against spills, accidents, and other mishaps that would otherwise render the container useless.

Erin Fox, a pharmacy expert at University of Utah who’s been monitoring the rollout of the vaccine, says, “It’s pretty unusual to have a full extra dose or more though — but it does seem to be there!”

Public health officials are easing concerns that Pfizer or the FDA somehow made a mistake in their initial rollout of the drug. Dr. David Kessler, a former FDA commissioner, says it’s not a sign that either party did anything wrong. “It’s not mismeasured,” he said. “It’s not sloppiness. It’s the way those vials are designed.”

Officials also say that the type of the needle used to administer the shot can have a slight effect on the size of each dose.

John Grabenstein, adviser to the American Pharmacists Association, says both parties should have issued clear guidelines regarding the possibility for additional doses, considering the urgent need to inoculate healthcare workers. “In a situation of limited supply, any waste is unfortunate,” he said.

Despite the initial confusion, many providers are celebrating the news as they begin making use of these additional doses. Grabenstien added, “Yesterday was the best day of work I’ve ever had.”