The only vaccine strategy that the Biden administration does not consider



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Ultimately, experts don’t think reducing the vial size would significantly reverse the months-long slippage in vaccinations, but some local and state officials say they don’t want to give up any opportunities that could make it. even easier to inject more vaccines. arms.

“It’s something that should be done because it’s more effective and because we’re doing it with other vaccines,” said Nirav Shah, Maine’s health officer, who is also the association’s president. state and territory health officials.

The three vaccines used in the United States – from Pfizer, Moderna and Johnson & Johnson – contain between five and 15 doses per vial. Once the vials have been opened, Pfizer and J&J vaccines should be used within six hours and Moderna vaccines within 12 hours.

Encouraging vaccine makers to pack their wares in smaller vials remains one of the few strategies the White House has ruled out in the short term, even as senior administration officials are running out of ideas on how to overcome the hesitations. White House officials have said they understand the potential appeal of the smaller vials, but they and pharmacy experts have said it would be next to impossible to make the switch quickly and likely wouldn’t have a major impact on vaccination rates. It would take years and cost billions of dollars more to change production lines – an effort further complicated by a shortage of everything from glass to staff to production space.

“Theoretically smaller vials make sense in the normal course of practice. But to do vaccinations at the volume that we did, it’s just not practical, ”said a senior administration official.

Wasted doses were not a major concern earlier in the vaccine rollout when people eager to receive their vaccines flocked to mass vaccination sites that administered thousands of doses per day. With the pace of daily immunizations slowing to about half a million, from a peak of 3.3 million doses in mid-April, health officials say trusted members of the community, such as primary care providers and pharmacists, are key to reaching unvaccinated people.

But some of these healthcare providers, especially in areas with low immunization rates, have been reluctant to open a new vial when they believe that most doses are unlikely to be administered before they expire. . That’s even if the Centers for Disease Control and Prevention and state officials advise them not to worry about doses being thrown away.

Oklahoma Assistant Health Commissioner Keith Reed said some doctors in rural areas were refusing to provide Covid vaccines due to concerns about waste.

“Even though we tell them it’s okay to have this waste because we don’t want to miss an opportunity to vaccinate someone, it is difficult for those providers who have recognized that this vaccine is such a valuable resource to consider that it’s okay to waste 70 to 80 percent of a vial a day, ”Reed said. “It becomes an obstacle for them to accept responsibility for this type of vaccine knowing that they will not use it enough to avoid significant waste. “

Chris Weintraut, executive director of the Indiana section of the American Academy of Pediatrics, said no doctor feels good about wasting doses, even though he’s been told it’s okay to do it.

“It’s difficult when you have so many doses per vial,” he said.

White House officials have told state officials for months they are talking to manufacturers of the smaller vial vaccines. Instead, Biden officials urged the companies to ship the vials in smaller packages, so that vaccination sites could receive several hundred doses rather than a minimum of 1,000. However, there has been surprisingly little ‘use of these small packs, said a senior administration official, who attributed the weak demand to states building allocation plans around larger orders. A White House spokesperson declined to comment.

Pfizer and Moderna told POLITICO they were working on different packaging but did not offer a timeline for when that would happen. A Moderna spokesperson said its larger vial was intended to ensure faster delivery of its vaccines. Moderna plans to “gradually” reduce the size of the vials, the spokesperson said, adding that the company was working with the US government to optimize supply and minimize waste. J&J declined to comment.

Other vaccines are usually packaged in single-dose vials or pre-filled syringes as the vast majority are given in doctor’s offices. This includes most flu shots, although multi-dose options are still offered for large clinics and high traffic sites like driving flu shots, said Erin Fox, a pharmacy expert at the University of the Utah which monitors drug shortages.

Fox said reducing vial size for Covid-19 vaccines is a much more difficult task in the short term because of the cost and time it would take.

“Single pre-filleddose syringes like the ones we have for the flu would be fantastic, ”she said. “I think what makes it frustrating is the critical need we see for vaccines in other countries – they don’t have enough, yet we are wasting vaccines in the US because people don’t want to. not take it. “

Major obstacles remain, however. Vaccine makers are expected to secure hundreds of millions of smaller vials in a global glass market that was already in shortages before the coronavirus emerged. Before companies can even move production, they would have to seek and receive clearance from the FDA and other international regulators for the new packaging, which might require different materials.

Manufacturers then have to shut down production lines to switch to new materials or, even more difficult, start new lines. Already, companies trying to fill existing orders of Covid snapshots are scrambling to secure production plants, trained staff and necessary equipment. AstraZeneca, for example, took months to find a new home for vaccine production after it started from a facility in Maryland this spring due to contamination concerns.

Experts have said single-dose vials for Covid-19 vaccines may eventually become available, particularly if people need additional vaccinations to maintain their protection against the virus. However, scientists and regulators are still studying whether people will need booster doses – and if so, how often.

And while U.S. doctors clamor for smaller vials, the larger packaging is still ideal to meet the vast global demands, said Krishna Udayakumar, director of the Duke Global Health Innovation Center.

“Most low- and middle-income countries are still at low levels of immunization where mass immunization campaigns for adults remain the most effective short-term approaches,” he said, but added that the need for smaller vials and “personalized” vaccination efforts will intensify in the coming months.

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