Additional doses found in Pfizer’s coronavirus vaccine

The antivirus will take a break during the holidays. We will be back on January 9th.

When healthcare workers began administering the first injections of the Pfizer / BioNTech vaccine in the United States this week, they noticed something strange. There was an extra dose at the bottom of the small glass vial.

“At first they thought they had done it wrong because there was so much left in the vial after taking out the five doses,” said Erin Fox, senior director of pharmacy at the University of London. ‘Utah. The New York Times. “They sent us a picture and said, can we use the supplement?”

Wednesday, the Food and Drug Administration announced on Twitter that yes, pharmacists can use the supplement. They can use each full dose in one vial, but, the FDA added, they cannot concoct a dose from multiple vials.

Slipping extra vaccine into vials might seem strange for a business to do, especially with something as valuable as this. But it is common practice for injectable drugs and products like vaccines. Just as molasses gets stuck on the sides of a measuring spoon, liquid can cling to the sides of sterile vials. The syringe used to give the injection can also cause loss of tiny pieces of the contents of a vial – these losses can be on the order of microliters, but every little detail adds up. Put into exactly enough for, say, five doses runs the risk of leaving a few vials short and a patient without the vaccine they need.

But leaving too much can also be a problem in some circumstances. If there is too much medicine in a vial, it is possible to give a patient the wrong amount of medicine, and this presents a temptation to overuse leftovers. It is also extremely expensive for pharmaceutical companies to include a lot of leftovers in their products.

This is part of the reason why, in 2015, the FDA developed guidelines for the pharmaceutical industry to help them determine what level of “ overfill ” is acceptable for their products. The advice is quite vague – as there are many types of drugs or vaccines that can be injected, there is no single prescription for how much extra can be included. For single-dose vials, they say it’s probably best not to include enough for a full second dose, but for multi-dose vials (like the Pfizer / BioNTech vaccine), the recommendation is simply that they “shouldn’t contain more than 30 ml of pharmaceutical product except in special circumstances. ”

Pfizer / BioNTech vaccine vials easily fall within this range. Each contains only 0.45 ml of vaccine material, which is then diluted with 1.8 ml of saline solution. Since each dose is only 0.3ml, this is certainly enough for an extra dose or two, but still far less than the 30ml limit recommended by the FDA.

The fate of additional doses of vaccine is still being decided. Between Monday, when the first vaccines were distributed in the United States, and Wednesday, when the FDA said they could be used, many more doses were simply thrown away. Health systems are also concerned about the two-dose nature of the vaccine. Shipments of the vaccine across the United States are still uncertain, and healthcare providers want to have enough on hand to give everyone who receives a first dose the recommended second dose three weeks later.

There aren’t many answers yet. FDA says he is “working with Pfizer to determine the best way forward.” Pfizer is asking institutions to find out for now: “Vaccines should consult their institution’s policies regarding the use of multi-dose vials,” said a spokesperson for Pfizer. STAT.

The United States has ordered 100 million doses of the Pfizer / BioNTech vaccine, enough to immunize 50 million people. More than 200 million doses of the recently authorized Moderna vaccine are on their way. But with a population of over 328 million and a pandemic still out of control, every extra dose counts.

Here’s what happened this week.

Research

Is COVID-19 spread on buses, subways? New York aims to discover
A study on how the coronavirus spreads on public transportation will begin soon in New York City. The researchers plan to use out-of-service buses and railcars to see how different types of aerosols move in different modes of transport. (Paul Berger /The Wall Street Journal)

A wild mink in Utah has COVID-19. Vets fear this is just the beginning.
Animals can also catch COVID-19. Discover this deep dive in which wildlife is also vulnerable to disease. (Brian Resnik /Vox)

Yes, the COVID penis is one thing
Some people notice erectile dysfunction as they recover from the virus. The frequency with which this problem occurs is still anecdotal, but researchers are trying to track this symptom. (Wudan Yan /Elementary)

How effective is the mask you are wearing? You might know soon
For the most part, masks these days have no standards. Some government agencies are trying to change that. (Sheila Kaplan /The New York Times)

Development

Moderna COVID-19 vaccine second to gain FDA approval in United States
On Friday evening, the FDA cleared the use of a second COVID-19 vaccine in the United States. This vaccine will begin to be distributed in the United States in the coming week. (Nicole Wetsman /The edge)

The vaccines are there. we need to talk about side effects
There are side effects to both vaccines authorized by the FDA. This fact should be clearly communicated at the start of vaccination campaigns and people will begin to receive both the vaccines and the side effects that accompany them. (Maryn McKenna /Wired)

‘I didn’t even tell my wife’: in the frenzied and secret sprint to name the Covid-19 vaccines
COVID-19 vaccines won’t have a name for a long time, but companies have already started trying to come up with the perfect name for their precious product. (Damian Le Garde /STAT)

Has COVID-19 permanently altered the development schedule for other vaccines?
The vaccine development schedule has shrunk significantly over the past year. Some of these changes will last, some will not. (Annalisa Merelli /Quartz)

Perspectives

“I could almost cry talking to you now… I feel like I didn’t just get a shot, I got a dose of hope. We hope this will be the beginning of the end of this terrible pandemic that we have all known – but we, on the front lines, have truly seen the suffering and tragedy that comes with it.

—Dr. Maggie Hagan, director of infection control at Ascension Via Christi hospitals in Kansas, tells The New York Times.

Dr Jeff Toll, who has admitting privileges at Cedars-Sinai Medical Center, one of the first hospitals to stock the vaccine, recalled that one patient asked, “If I give Cedars $ 25,000, is it would help me to queue? ”. says no.

—Laura J. Nelson and Maya Lau report on the wealthy trying to sneak past the vaccination line in The Los Angeles Times.

More than numbers

To the more than 75,508,468 people around the world who have tested positive, may your journey to recovery be smooth.

To the families and friends of the 1,671,772 people who have died around the world – including 313,246 in the United States – your loved ones are not forgotten.

Stay safe, everyone.