FDA gives approval for syringes to extract an extra dose from vials of the Covid-19 vaccine


Syringes wand vials of the Pfizer-BioNTech Covid-19 vaccine are prepared to be administered to front-line health care workers under an emergency use authorization at a drive up vaccination site from Renown Health in Reno, Nevada on December 17, 2020. (Photo by Patrick T. Fallon / AFP) (Photo by PATRICK T. FALLON/AFP via Getty Images)

(CNN) — As the US set a new daily record for Covid-19 inoculations and states clamored for more vaccine supplies, Pfizer and the FDA said pharmacists and health practitioners can in some cases extract an additional dose from each vial.

Originally, each vial of Pfizer’s Covid-19 vaccine was designed to contain five doses, but some pharmacists reported they could extract six doses when using certain syringes.

As a result, the FDA approved an updated label that states: “Low dead-volume syringes and/or needles can be used to extract six doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.”

Pfizer CEO Albert Bourla said this increase in doses per vial “provides an additional 20% capacity.” The New York Times first reported Pfizer’s plans to base its vaccine commitment on doses instead of vials.

However, CNN chief medical correspondent Dr. Sanjay Gupta said Friday the ability to garner the sixth dose with these syringes does not exist everywhere.

“Many places have them,” Gupta told CNN’s John Berman, “but not every place.”

McKesson, a medical supplies company the federal government has contracted to help with distribution, said syringe kits that allow extraction of the sixth dose are being made available.

These changes highlight the push to get as many people vaccinated as possible amid an inconsistent supply chain.

About 5% of the US population — roughly 16.2 million people — has received at least one dose of the vaccine, and 2.75 million people are fully vaccinated, according to CDC data updated Friday. Nearly 1.6 million vaccine doses were administered Friday, the largest one-day increase reported.

New cases are down, but things remain dire

As inoculation efforts build, the pandemic continues unabated. And while CNN’s analysis of data shows encouraging trends in new daily cases and hospitalizations, health officials remain concerned about the more-transmissible variant first identified in the UK.

“You’re going to see people traveling again, probably, for spring break, in March and April,” said Dr. Celine Gounder, a former member of the Biden transition’s Covid-19 advisory board. “And that is exactly when we expect that these variants — in particular, the UK variant — to have taken hold in the US.”

• Cases: Johns Hopkins University reported more than 186,000 new cases on Friday. The US is currently averaging 180,816 new daily cases across seven days. That’s the lowest since December 2, and down 27% from the peak seen January 11, when the average of new cases across a week hit 249,168. But the current average is still 2.7 times above the summer’s highest level in July.

• Hospitalizations: On Friday, there were 116,264 Covid-19 patients in US hospitals, a metric that continues to drop day by day, according to data from the COVID Tracking Project. That’s the lowest since December 21, but it’s still nearly twice the reported peak in the summer.

• Deaths: There were 3,655 new deaths reported Friday, per Johns Hopkins data. The US is averaging more than 3,000 new deaths a day across a week.

‘This shouldn’t be the Hunger Games’

A lack of information and a lack of financial support has left states struggling to manage a slow Covid-19 vaccine rollout, according to Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

“I am eligible in Minnesota to get a vaccination also and I can’t find one,” Osterholm, a former coronavirus adviser to President Joe Biden, told CNN’s Erin Burnett on Friday. “I want to share that frustration loud and clear.”

Utah governor Spencer Cox told CNN’s Chris Cuomo that the state is well-positioned for distribution, but that the vaccine allotment has been bottled up at private pharmacies nationwide.

“Long-term care facilities in Utah, they have way too much vaccine. We estimate they have 15 to 16,000 extra doses that they don’t need and can’t use right now. So, we’re taking that back and we’re giving it to our local health departments and it will be gone next week,” Cox said.

The frustrations with vaccine distribution and concerns about supply have echoed across the country.

Louisiana does not have any mass vaccination sites set up because it doesn’t have enough vaccine to manage a site, Governor John Bel Edwards said Friday.

The state of New York has administered 97% of its allocated first doses of the Covid-19 vaccine, Gov. Andrew Cuomo said Friday, and is expected to run out shortly.

On Saturday, Cuomo spoke from a vaccine pop-up site at a public housing complex in Brooklyn, where he emphasized the importance of equal access to vaccines for Black and Brown communities that have disproportionately suffered from the pandemic.

“Wealthier, White communities had more Covid testing,” he said. “When it comes to this vaccine, access has to be fair across the board.”

In Texas, the Houston Health Department’s 1,600 new vaccination appointment slots were filled by eligible citizens within approximately five minutes of opening. Houston Mayor Sylvester Turner said the telephone system received about 250,000 calls which “literally overwhelmed” the system.

Atlanta Mayor Keisha Lance Bottoms told CNN’s Wolf Blitzer that she receives daily calls from people “desperately looking for the vaccine,” adding “I’m just not seeing an abundance of vaccine.”

The Los Angeles County Department of Public Health on Friday said it was receiving enough doses to inoculate just 1 in 4 people currently eligible.

Utah’s Cox said the competition between states early in the pandemic, when the federal government forced states to scrounge for supplies such as personal protective equipment, should be avoided in the case of vaccines.

“This shouldn’t be the Hunger Games, like it was with PPE, right. That was ridiculous and we all had to play that game,” he said. “We’re all in this together. Governors are in this together. We just need insight from the federal government and the manufacturers,” Cox said.

New administration, new realities

Biden’s coronavirus advisers have high hopes that shortages can be avoided, Dr. Vivek Murthy, who is the nominee for Surgeon General, said Friday on a webcast to mayors.

Conversations with companies have “given us more confidence that there is more supply coming, and that it will continue to steadily increase over the next few months,” Murthy added.

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said Friday he expects positive news about a Johnson & Johnson single-dose coronavirus vaccine in the next couple of weeks.

“I don’t want to get ahead of them, but I have to tell you I would be surprised if it was any more than two weeks from now that data will be analyzed, and decisions would be made,” Fauci said on MSNBC.

Fauci spoke with CNN on Friday about the coronavirus variant known as B.1.1.7, which was first identified in the United Kingdom and is believed to be more contagious. He says its transmission in the US needs to be monitored carefully.

At least 195 cases of the variant have been identified in 22 states, according to the CDC. That number doesn’t represent the total number of cases in the US, the agency said, but just those that have been found through analysis.

“It has not become dominant,” Fauci said. “It might. That’s the reason why you have to watch it carefully as we go from January into February, and really take a good look.”

A CDC report this month said the variant has the potential to “increase the US pandemic trajectory in the coming months,” and people should focus on using masks, maintaining social distance and other measures that reduce transmission.

Fauci agreed with the health recommendations. “That’s the kind of thing that prevents surges regardless of … the type of virus.”

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