POST 109.January 9, 2021. CORONAVIRUS. “President-elect Joe Biden will aim to release nearly every available dose of the coronavirus vaccine when he takes office, a break with the Trump administration’s strategy of holding back half of US vaccine production to ensure second doses are available.

Releasing nearly all vaccine doses on hand could quickly ratchet up the availability of coronavirus vaccines by allowing more people access to a first dose. It could also be a risky strategy as both Pfizer/BioNTech and Moderna’s vaccines require two doses, administered at specific intervals, and vaccine manufacturing has not ramped up as rapidly as many experts had hoped.

“The President-elect believes we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible. He supports releasing available doses immediately, and believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now,” said TJ Ducklo, a spokesman for Biden’s transition. “He will share additional details next week on how his Administration will begin releasing available doses when he assumes office on January 20th.”

A transition official said the Biden team believes that vaccine manufacturers will be able to produce enough second doses in a timely fashion while administering first doses to more Americans. Biden’s team plans to use the Defense Production Act to produce vaccine materials and other supplies in order to ensure there’s enough vaccine for both doses.

The transition official added that the Biden team may hold back a small amount of doses in case of unforeseen circumstances. The Trump administration also does this — in addition to holding back the second doses — in the event of incidents such as shipment errors or vaccine spoilage.

The comment from Biden’s transition comes after a group of governors wrote a letter to Health and Human Services Secretary Alex Azar and Operation Warp Speed Chief Operating Officer Gen. Gustave Perna pressing the federal government to distribute “reserved doses” of the Covid-19 vaccine to states that need them.

“Our states are ready to work around the clock to ramp up distribution, get more shots in arms, and save more American lives. General Perna, as you have stated before, ‘a vaccine sitting on a shelf is not effective,'” the letter reads. “We couldn’t agree with you more. That’s why we are asking for your help now. When we work together, we can end this pandemic and return to a life of normalcy sooner.”

But Azar said Friday that he worries that might backfire if manufacturing goes wrong.

“We have product that is going through QC right now — quality control — for sterility, identity check — that — we have tens and tens of millions of product. We always will. But batches fail. Sterility fails. … And then you don’t have a product for that second dose,” Azar told the American Hospital Association, according to a transcript released by HHS.

“And frankly, talking about that or encouraging that can really undermine a critical public health need, which is that people come back for their second vaccine,” he said.

The Trump administration has insisted it’s necessary to hold back doses to ensure Americans who receive the first course of the two-dose vaccine will be sure to have access to a second dose. But the move has sparked a debate about whether a better strategy would be releasing all available doses as quickly as possible, particularly amid rising death and hospitalization rates. A study published Monday in the Annals of Internal Medicine also found that administering first doses of a Covid-19 vaccine to more individuals instead of withholding available supply for use as a second dose may reduce the number of new cases.” (A)

“After a glow of hope when the first vaccines were approved last month, the nation’s inoculation campaign has gotten off to a slow start. Of 29.4 million doses distributed, about 5.9 million have been administered, or 28%, according to the U.S. Centers for Disease Control and Prevention.

The American Hospital Association estimates the nation would need to vaccinate 1.8 million people a day, every day, from Jan. 1 to May 31, to reach the goal of having widespread immunity by the summer. That’s also called “herd immunity” and would involve vaccinating at least 75% of the population.

Both vaccines authorized for use were studied in a two-dose regimen, with the Pfizer-BioNTech doses given 21 days apart and Moderna’s 28 days apart.

Health and Human Services Secretary Alex Azar said Friday in a conversation with the American Hospital Association later released to the media that the administration believes it’s too risky to release the second doses.

The vaccines are in the early stages of manufacturing at large scale, Azar said, and too many things could still go wrong.

“We’re pushing the system as much as we believe prudent; we’re pushing the system as much as I as Secretary believe is ethically and legally appropriate,” he said.

Azar emphasized that he designed Operation Warp Speed, the government’s vaccination effort, precisely to keep people out of hospitals and morgues. “We have no interest in holding back a single dose of vaccine from the American public that could save a life,” he said.

“But we especially in an era where we have seen a surge in vaccine confidence,”  he said, “we must respect the science, data, and evidence, and we must respect what FDA says about how the product should be used.”

The “safer” choice is to stick to the studied regimen, agreedAkiko Iwasaki, an immunologist at Yale University. But she thinks it makes sense right now to follow the British model, where officials have said people can wait up to 12 weeks to get the second shot.

Two new variants of the virus, one tied to Britain and the other to South Africa and Brazil, seem to increase the transmissibility of the virus – though not risk for serious disease – raising the urgency to get vaccine into arms, she said.

“Because of the fact that these variants are spread throughout the world and becoming rampant, we really need to vaccinate as many people as possible,” said Iwasaki, whose home state of Connecticut announced it had found two local cases of the British variant Thursday.

There’s biological reason to believe the vaccines will be even more effective with an 8- to 12-week gap between the shots rather than 3-4 weeks, she said.

The first shot alerts the immune system to the virus, which seems to be highly effective in the short-term. The second shot supports “memory” and long-term protection, she said, which takes some time for the body to build.

“You really want to give your immune system time to develop these things and then get a booster,” Iwasaki said.

It was logical earlier in the pandemic to test the vaccine with a short gap between the two shots, both to speed up the research studies and to promote full immunity as quickly as possible.

“That makes sense in a pandemic,” Iwasaki said, but the slow rollout of the vaccine and the urgency of the current need calls for a new strategy.

Changing strategies mid-stream however, could sow confusion and potentially doubt about the vaccine, she warned, and any shift should be coupled with a “good public campaign to promote that idea.”

People have to recognize that they remain vulnerable to the virus between the two shots, and must continue to wear masks, maintain distance, wash hands frequently and avoid crowds, particularly indoors, she said.” (B)

“The Biden transition office said its experts believe that pushing out available vaccine as fast as possible will not create problems for people needing their second dose. Biden will make broader use of a Cold War-era law to direct private industry to supply materials for vaccine production, should that become necessary, his office said. One-shot vaccines are moving through development.

Former Food and Drug Administration head Mark McClellan said he agrees with Biden’s decision, but the increased supply of vaccines has to be coupled with steps to get shots actually administered.

“We’re holding back more doses than we really need to,” McClellan said in an interview. But “this needs to be combined with steps to increase the administration of vaccines, or it won’t make much difference.” McClellan, who served under former Republican President George W. Bush, now leads a health policy center at Duke University.” (C)

“The president-elect has vowed to get “at least 100 million Covid vaccine shots into the arms of the American people” during his first 100 days in office…

Mr. Biden’s promise of 100 million shots in arms is an ambitious one, and the Trump administration’s rocky rollout — which Mr. Biden called “a travesty” on Friday — has not made his task any easier. As of Thursday, the Trump administration had shipped more than 21 million vaccine doses, and millions more were already in the federal government’s hands.

Yet only 5.9 million people had received a dose. State and local public health officials, already overwhelmed with rising infections, have been struggling to administer the vaccine to hospital workers and at-risk older Americans while most people remain in the dark about when they might be protected.

The biggest problem so far has not been a lack of vaccine, but the difficulties that state and local governments face in distributing the doses they have. Capacity and logistics, not shortages, are keeping vaccines from being administered.

Dr. Leana S. Wen, an emergency physician and public health expert at the George Washington University School of Public Health, said she was surprised and concerned about Mr. Biden’s new strategy.

“This is not the problem we’re trying to solve right now,” Dr. Wen said.

Speaking at a news briefing on Friday, Dr. Stephen M. Hahn, the F.D.A. commissioner, urged states that have used only a small part of their supply to begin vaccinating lower-priority groups, while still observing government guidelines. Most states are still prioritizing frontline health care workers and older Americans in group residential settings.

Expanding the targeted groups “will go a long way toward using these vaccines appropriately and getting them into the arms of individuals,” Dr. Hahn said.” (D)


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