Exclusive: Biden to release all available vaccine doses in violation of Trump administration policy of withholding stocks for second dose



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Releasing all available vaccine doses could quickly increase the availability of coronavirus vaccines by allowing more people to access a first dose. It could also be a risky strategy because the Pfizer / BioNTech and Moderna vaccines require two doses, given at specific intervals, and vaccine manufacture has not grown as quickly as many experts had hoped.

“The president-elect believes we need to speed up the vaccine distribution while continuing to ensure that Americans who need it most get it as quickly as possible. He supports the immediate release of available doses and believes the government should stop to withhold the vaccine supply so we can get more hugs from Americans now, “said TJ Ducklo, a spokesperson for Biden’s transition.” He will share more details next week on how whose administration will begin to release the available doses when he takes up his duties on January 20. “

Biden’s transition comment comes after a group of governors wrote a letter to Health and Human Services Secretary Alex Azar and Operation Warp Speed ​​CEO Gen. Gustave Perna urging the federal government to distribute “reserved doses” of the Covid-19 vaccine to states in need.

“Our states are ready to work around the clock to speed up distribution, get more shots and save more American lives. General Perna, as you have already said,“ a vaccine lying on a shelf is not effective, “letter reads.” We could not agree with you more. That is why we are asking for your help now. When we work together, we can end this pandemic and get back to normal life sooner. “

The Trump administration has insisted on the need to withhold doses to ensure that Americans who receive the first cycle of the two-dose vaccine will have access to a second dose. But the move sparked a debate over whether a better strategy would be to release all available doses as quickly as possible, especially amid rising mortality and hospitalization. A study published Monday in the Annals of Internal Medicine also found that administering the first doses of a Covid-19 vaccine to more people instead of withholding the available supply for use as a second dose. may reduce the number of new cases.

“Operation Warp Speed ​​continues to ensure that second doses are available to vaccine delivery sites, at appropriate intervals, as directed by jurisdictional leaders,” an HHS spokesperson said. . “We would be delighted to hear that jurisdictions have in fact administered far more doses than they are currently reporting. We encourage jurisdictions to expand their priority groups as needed to ensure that no vaccines are left on them. shelves after being delivered to the proper authorities. Locations. “

The spokesperson also noted that the US Food and Drug Administration recently reiterated the importance of requiring two doses for the Pfizer and Modern vaccines.

The vaccines from Pfizer / BioNTech and Moderna are both approximately 95% effective after two full doses.
Earlier this week, two senior FDA officials said anyone receiving these vaccines needed both doses, rejecting the idea of ​​stretching the supply by allowing a single dose or cutting the doses in half.

They also rejected other ideas to stretch the vaccine supply, and said people who speculate on whether to stick to just one dose or cut doses in half are misinterpreting the data.

“We have been following the discussions and reporting on reducing the number of doses, lengthening the time between doses, changing the dose (half dose) or mixing and matching vaccines to vaccinate more people. people against COVID-19, “FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, who heads the FDA’s vaccine division, said in a statement.

FDA says people need two doses of coronavirus vaccine

“These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-approved dosage or schedules of these vaccines is premature and not firmly grounded in the “Available evidence. Without adequate data to support these changes. In vaccine delivery, we run a significant risk of endangering public health, undermining historic vaccination efforts to protect the population against COVID-19” , they added.

Hahn and Marks also said the data supports administration of the second dose of each vaccine at the specified interval – 21 days after the first dose for the Pfizer / BioNTech vaccine and 28 days after the first dose for the Moderna vaccine.

According to the study published Monday in the Annals of Internal Medicine, by reducing the amount of vaccine doses withheld to 10% for the first three weeks and providing a consistent dose of 6 million doses per week, the United States could avoid up to 29% more cases over eight weeks.

The US government is currently withholding 50% of the available vaccine supply, distributing to states and other jurisdictions weeks later to be administered as the second in a 2-dose series.

The researchers modeled various scenarios, with variables such as vaccine supply, protection provided by the first dose, and the decrease in effectiveness of the first dose if the second dose is delayed. Only in the unlikely worst-case scenario of a collapse in supply and minimal protection among people who received the first dose does the model suggest that withholding 50% of the available supply provides better protection.

“We find that in most plausible scenarios, a more balanced approach that withholds fewer doses during early distribution in order to immunize more people as soon as possible could dramatically increase the benefits of vaccines, while still allowing most recipients to receive second doses on schedule, ”write the study authors, who were supported by the Canadian Institutes of Health Research and the US Centers for Disease Control and Prevention.

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