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The antivirus will take a break during the holidays. We will be back on January 9th.
When healthcare workers started giving the first injections of the Pfizer / BioNTech vaccine in the US this week, they noticed something strange. There was an extra dose left in the bottom of the small glass bottle.
“Initially they thought they had done it incorrectly because there was so much left in the bottle after removing all five doses,” said Erin Fox, senior director of pharmacy at the University of Utah. The New York Times. “They sent us a photo and said, can we use the extra?”
On Wednesday, the Food and Drug Administration announced on Twitter yes, pharmacists can use the extra. They can use each full dose in one vial, but, the FDA added, they can’t improvise a multiple-vial dose.
At this time, given the public health emergency, the FDA advises that it is acceptable to use every obtainable full dose (the sixth, or possibly even the seventh) from each vial, pending resolution of the problem.
– US FDA (@US_FDA) December 17, 2020
Slipping an extra vaccine into vials can seem strange to a business, especially with something as valuable as this. But it is standard practice for injectable drugs and products like vaccines. Just like molasses sticks to the sides of a measuring spoon, the liquid can stick to the sides of sterile vials. The syringe used to give the injection can also cause small parts of the contents of a vial to be lost; Those losses can be on the order of microliters, but every little amount adds up. Putting it inside exactly Enough for, say, five doses runs the risk of leaving a few short vials and a patient without the injection they need.
But leaving too much content can also be a problem in certain circumstances. If there is too much medicine in a bottle, there is the possibility of giving the patient the wrong amount of medicine and there is a temptation to misuse the leftovers. It is also extremely expensive for pharmaceutical companies to include many leftovers in their products.
In part, that’s why in 2015 the FDA developed guidelines for the pharmaceutical industry to help them determine how much ‘overfill’ was acceptable for their products. The guide is quite vague – since there are many different types of drugs or vaccines that can be injected, there is no prescription for the additional amount that 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 (such as the Pfizer / BioNTech vaccine) the recommendation is simply that “they should not contain more than 30 ml of pharmaceutical product except in specific circumstances “.
Pfizer / BioNTech vaccine vials easily fall within that range. Each contains only 0.45 ml of vaccine material, which is then diluted with 1.8 ml of a saline solution. Since each dose is only 0.3ml, that’s definitely enough for an additional dose or two, but still much less than the 30ml limit the FDA recommends.
The fate of the additional doses of vaccine is still being decided. Between Monday, when the first vaccines were distributed in the US, and Wednesday, when the FDA said they could be used, many additional doses were simply discarded. Health systems are also concerned about the two-dose nature of the vaccine. Shipments of the vaccine in the US 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 it is “working with Pfizer to determine the best way forward.” Pfizer is asking institutions to figure it out for now: “Vaccinators should consult their institution’s policies for the use of multi-dose vials,” said a Pfizer spokesman. STAT.
The United States ordered 100 million doses of the Pfizer / BioNTech vaccine, enough to vaccinate 50 million people. More than 200 million doses of the newly licensed Moderna vaccine are on the way. But with a population of more than 328 million and a pandemic still out of control, every extra dose counts.
This is what happened this week.
Investigation
Does COVID-19 spread on buses, metro? New York aims to find out
A study on how well the coronavirus spreads on public transportation will begin soon in New York City. The researchers plan to use decommissioned buses and train cars to see how different types of aerosols move in different modes of transit. (Paul Berger /The Wall Street Journal)
A wild mink from Utah has COVID-19. Veterinarians fear this is just the beginning.
Animals can also get COVID-19. Take a look at this deep dive where wildlife is also vulnerable to disease. (Brian Resnik /Vox)
Yes, the COVID penis is a thing
Some people notice erectile dysfunction as they recover from the virus. How often this problem occurs remains anecdotal, but researchers are trying to track down this symptom. (Wudan Yan /Elementary)
How effective is the mask you are using? You may 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
The Modern COVID-19 vaccine is the second to gain FDA approval in the US.
On Friday night, the FDA cleared a second COVID-19 vaccine for use in the US This vaccine will begin shipping in the US next week. (Nicole Wetsman /The Verge)
The vaccines are here. we have to talk about side effects
Both FDA-cleared vaccines have side effects. That fact should be clearly communicated when vaccination campaigns begin and people begin receiving both the injections and the accompanying side effects. (Maryn McKenna /Cabling)
‘I haven’t even told my wife’: inside the frantic and secret sprint to name the Covid-19 vaccines
COVID-19 vaccines won’t get a name for long, but companies have already started trying to come up with the perfect name for their prized product. (Damian Le Garde /STAT)
Has COVID-19 permanently altered the development schedule for other vaccines?
The vaccine development schedule has been drastically shortened over the past year. Some of those 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 vaccine, I have a shot of hope. We hope this is the beginning of the end for this terrible pandemic that we have all been experiencing, but we on the front lines have really seen the suffering and tragedy associated with it. “
-Dr. Maggie Hagan, director of infection prevention at Ascension Via Christi hospitals in Kansas says 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 a patient who asked, “If I donate $ 25,000 to Cedars, would that help me queue? ? ” he said no.
—Laura J. Nelson and Maya Lau report on wealthy people trying to get past the vaccine line at The Los Angeles Times.
More than numbers
For the more than 75,508,468 people worldwide who have tested positive, may your road to recovery be smooth.
To the families and friends of the 1,671,772 people who have died around the world, 313,246 of those living in the United States, their loved ones have not been forgotten.
Stay safe, everyone.
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