POST 117. January 23, 2021. CORONAVIRUS. 1.Dr. Fauci:“The idea that you can get up here….”and.. let the science speak”… “It is somewhat of a liberating feeling.” 2.updated CDC guidance:”.. providers could give the second dose up to six weeks after the first dose..” 3.Dr. Fauci: people would be “taking a chance” if they follow the CDC’s updated guidance.

“In rare circumstances, it’s OK for people to receive one shot of Pfizer’s Covid-19 vaccine and one shot of Moderna’s vaccine at least 28 days apart, the CDC said in updated guidance.

“Most of the times Dr. Anthony S. Fauci made an appearance in the White House briefing room in 2020 — before eventually being banished from public view for his grim assessments of the coronavirus pandemic — he had President Donald J. Trump glowering over his shoulder.

On Thursday, Dr. Fauci, the nation’s foremost infectious disease specialist, was back, this time with no one telling him what to say. And he made no effort to hide how he felt about it.

“The idea that you can get up here and talk about what you know — what the evidence, what the science is — and know that’s it, let the science speak,” Dr. Fauci said, pausing for a second. “It is somewhat of a liberating feeling.”

Dr. Fauci’s presence in the room where Mr. Trump and other administration officials repeatedly spread misleading and false information about the virus was part of a daylong effort by the Biden administration to show a willingness to level with the public about how severe the pandemic is and what can be done to slow its spread…

But what he said about the virus on Thursday may have been less important than the mere fact that he was able to say it without the possibility that Mr. Trump or his aides would undercut him, challenge him or try to silence him.

As director of the government’s National Institute of Allergy and Infectious Diseases, Dr. Fauci has spent decades fighting the worst of the world’s diseases. He became something of a national celebrity as he sought to navigate the need to level with the public about the raging pandemic while dealing with Mr. Trump’s insistence that the threat was overblown and would “disappear” overnight.

Dr. Fauci recalled on Thursday how frustrating those days became.

“I don’t want to be going back over history, but it’s very clear that there were things that were said, be it regarding things like hydroxychloroquine and other things like that, that really was uncomfortable because they were not based on scientific fact,” he said, referring to Mr. Trump’s embrace of an unproven and untested drug for use as a treatment for the coronavirus.” (A)

“More than 40,000 people in Florida are overdue to receive their second dose of the coronavirus vaccine and officials say it is a problem some experts said they saw coming.

Out of the nearly 850,000 people who have been vaccinated in Florida, almost 80,000 have returned for their second shot.

Most people are still waiting for the time when they can get their booster shot, but the Florida Department of Health reports that 40,661 people are overdue for their second shot.” (B)

“New York Governor Andrew Cuomo said the state on Friday will run out of all the Covid-19 vaccines that have been delivered….

Mayor Bill de Blasio said the city postponed more than 22,000 appointments this week alone because of the shortage in supply. According to the city’s main vaccine page, all appointments scheduled at any of the 15 community COVID-19 vaccine hubs across the five boroughs for Thursday, Jan. 21, through Sunday, Jan. 24, are being rescheduled for one week from the original appointment….

All first responders in the city, including NYPD, FDNY and the hard-hit EMS workers, have had to suspend their first doses for the time being. The FDNY said they have enough doses to cover everyone from their department who has received a first dose to ensure everyone gets properly vaccinated. The fire department has vaccinated more than 7,100 of their 17,000 employees, while the NYPD has given dosages to 12,000 of their 54,000 members…

Second dose appointments have not been affected, officials said. The city does have vaccine centers apart from its “hubs,” including state-run facilities like the one at the Javits Center and two 24/7 sites. Those remain open, as do an additional three sites run by the city’s public hospital system, with another 45,000 doses having been administered Wednesday, the mayor said. But all are running low on doses…

More than 300,000 of those total doses are reserved for second shots; the city has administered 23 percent of those, which makes sense considering a person can’t have a second shot without a first — and supply has been prohibitive. Complicating matter further, the city said, was a shipment of 100,000 Moderna vaccines that never arrived.”  (C)

“Ninety-seven percent of New York State’s vaccine inventory, accumulated over the past five weeks, has been administered, the governor noted, and a total of 28,000 first doses were left in inventory Friday morning. Mr. Cuomo added that the state inoculates roughly 80,000 people per day….

Mr. Cuomo urged vaccine providers to only schedule appointments based on the number of doses they know they will receive.

“Some providers think if they schedule appointments ahead of time, people will feel more comfortable — not if you cancel those appointments,” Mr. Cuomo said. “So don’t schedule any appointment unless you know you have an approved state allocation coming, and appointments will be honored. “

Some parts of the state — including New York City and the Rochester and Buffalo areas — have had to delay vaccination appointments scheduled for this week because of supply issues.

New York State should receive 250,400 vaccine doses for use next week, with some arriving Friday. If supply allowed, New York State could inoculate 700,000 people each week, Mr. Cuomo said.

On Friday afternoon, Mayor Bill de Blasio sent a letter to President Biden requesting more doses and the “flexibility” to use second doses to vaccinate more New Yorkers sooner.

“While maintaining a secure reserve of second doses (two-week supply), the City is seeking the flexibility during this time to temporarily use the remaining supply of second doses to bridge the gap to a time of increased production, replenishing the second dose supply as production ramps,” Mr. de Blasio’s letter to Mr. Biden read.

But it was not immediately clear whether the Biden administration could guarantee any increase in supply. Federal health officials and corporate executives agree that it will be impossible to increase supply before April because of the lack of manufacturing capacity. And the current vaccination effort, which had little central direction under the Trump administration, has so far sown confusion and frustration. Some areas are complaining they are running out of doses, while others have unused vials sitting on shelves.” (D)

“U.S. health authorities said it is OK to delay second doses of Covid-19 vaccines up to six weeks after the first injection, which for some shots would be twice as long as recommended.

The Covid-19 vaccines from Pfizer Inc. and BioNTech SE, as well as Moderna Inc., are given in two doses several weeks apart, with the second aimed at giving the fullest-possible protection. Pfizer’s shot is given three weeks apart and Moderna’s four weeks later.

The U.S. Centers for Disease Control and Prevention said Friday that health providers could give the second dose up to six weeks after the first dose, should they be unable to adhere to the recommended intervals. There is limited data on the efficacy of the vaccines beyond six weeks, the agency said.

Second doses shouldn’t be scheduled earlier than the recommended intervals, but they can be given within a grace period of four days earlier than the recommended date, the agency said.

Given the limited vaccine supply around the world, adjusting the schedules of doses has been scrutinized and been subject to debate by vaccine experts and other scientists. The U.K. has told the country’s state-run health service to delay second doses of the vaccines and give priority to getting initial doses into as many vulnerable people as quickly as possible. Parts of Canada and some countries in Europe followed with similar approaches.

The U.S. Food and Drug Administration has criticized tinkering with planned dosing schedules as too risky.” (E)

“The second dose should be administered as close to the recommended interval as possible,” the latest guidance says.

“However, if it is not feasible to adhere to the recommended interval, the second dose of Pfizer-BioNTech and Moderna COVID-19 vaccines may be scheduled for administration up to 6 weeks (42 days) after the first dose. There are currently limited data on efficacy of mRNA COVID-19 vaccines administered beyond this window. If the second dose is administered beyond these intervals, there is no need to restart the series.”

The updated CDC guidance appears to clarify earlier language that said “there is no maximum interval between the first and second doses for either vaccine.”

Delaying the second dose up to six weeks is in line with what WHO advisers said earlier this month.

CDC says its guidance may be updated as new information and new types of Covid-19 vaccines become available.

Fauci’s response: Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said people would be “taking a chance” if they follow the CDC’s updated guidance.

“You’re taking a chance, the data from the clinical trials, showed that in the Moderna trial, you should get the boost 28 days after the prime, that’s what I got, I got it exactly 28 days later, when you’re dealing with Pfizer it’s 21, that’s where the data show is the optimal effect,” Fauci told CNN Chris Cuomo on Thursday.

Fauci said it’s possible that delaying the second dose is “not going to be a big deal.” However, he said, we don’t know for sure because the vaccine data hasn’t been looked at for this extended time-period between doses.” (F)

“In rare circumstances, it’s OK for people to receive one shot of Pfizer’s Covid-19 vaccine and one shot of Moderna’s vaccine at least 28 days apart, the CDC said in updated guidance.

The agency says the two products are not interchangeable.

The CDC acknowledged that it hadn’t yet studied whether its new recommendations would change the safety or effectiveness of either vaccine.

The Centers for Disease Control and Prevention quietly changed its guidance on Covid-19 vaccine shots, saying it’s now OK to mix Pfizer’s and Moderna’s shots in “exceptional situations” and that it’s also fine to wait up to six weeks to get the second shot of either company’s two-dose immunization.

While Pfizer’s and Moderna’s vaccines, which both use messenger RNA technology, were authorized to be given 21 and 28 days apart, respectively, the agency now says you can receive either shot so long as they are given at least 28 days apart, according to new guidance posted Thursday on its website.

Although “every effort” should be made to ensure a patient receives the same vaccine, in rare situations “any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses” — if supplies are limited or the patient doesn’t know which vaccine they originally received, the CDC’s new guidance says.

The agency says the two products are not interchangeable, and acknowledged that it hadn’t yet studied whether its new recommendations would change the safety or effectiveness of either vaccine. But vaccine research specialists who spoke with CNBC said that the two immunizations are so similar in design that people shouldn’t be worried about the rare instances in which the doses will be mixed…”  (G)

“Some experts say there are not enough data on the amount and length of protection these altered dosing schedules provide, however. They argue that the bigger problem is distributing the existing vaccine supply and that changing the schedules without rigorous evidence could compromise public trust in vaccines.

“We should really think long and hard any time we advise people to deviate from what the evidence actually shows in terms of efficacy, which has only been tested for those standard dosing regimens,” says Angela Rasmussen, a virologist at Georgetown University’s Center for Global Health Science and Security. “Before we start tinkering with the vaccine regimens, we should worry about making sure that we can actually give people the vaccines that we already have.”…

Here’s what the data suggest about tweaking vaccine doses.

The Pfizer-BioNTech and Moderna vaccines—both of which involve viral genetic material known as mRNA—were given to clinical trial participants in two doses (a “prime” dose followed by a “booster” three or four weeks later). After both doses, the Pfizer vaccine was found to be 95 percent effective in preventing COVID, and Moderna’s came in at 94.1 percent.

In the trials, the Pfizer vaccine provided partial immunity about two weeks after the first dose, with an efficacy of 82 percent. But there are no data on whether protection lasts longer than three weeks, when the second dose was given. Immunological evidence suggests the antibody response to the vaccine increased substantially after the second dose as well.

“While decisions on alternative dosing regimens reside with health authorities, Pfizer believes it is critical to conduct surveillance efforts on any alternative schedules implemented and to ensure each recipient is afforded the maximum possible protection, which means immunization with two doses of the vaccine,” the company said in a statement shared with Scientific American. Rasmussen agrees. “The bottom line is that there’s not really any efficacy to support a delayed second dose, at least of [the] Moderna and Pfizer [vaccines],” she says…

Some have also suggested skipping the second dose altogether. But given the lack of data on how long protection from a single dose lasts, many experts are wary of this idea.

“I don’t think a single dose with mRNA [which the Pfizer and Moderna vaccines rely on] makes any sense,” Crotty says. “There’s clearly a substantial increase in immune response after the booster immunization.”

Natalie Dean, a biostatistician at the University of Florida, agrees. “I think every company would have preferred to have a one-dose vaccine if it worked similarly well. But they made [the decision to have two doses] based on what was most likely to work and what they saw in the immunological data,” she says. The only way to truly know whether a single dose would work is to run a clinical trial, Dean notes. Doing so would likely require a lot of time and resources that are in short supply, however. By the time the trials would yield data, other vaccines might have been authorized and could alleviate the shortage…

Perhaps the most plausible suggestion put forth to extend the vaccine supply is to halve the dose of certain vaccines. Earlier this month, Moncef Slaoui, chief adviser of the Trump administration’s vaccine effort Operation Warp Speed, said officials were contemplating giving half-doses of the Moderna vaccine to Americans between the ages of 18 and 55. (This week Slaoui resigned from his position, but he will remain for 30 days.) In clinical trials, he said, people who received half of the Moderna vaccine’s 100 microgram dose had an identical immune response to those who received a full dose. But he added that it would ultimately be up to the FDA to decide whether to authorize such a change in dosing. Additionally, the data on half-doses were from a phase II clinical trial—so there is not sufficient evidence that half-doses prevent disease, Crotty notes.

Ultimately, the risks of altering data-backed vaccine-dosing strategies could outweigh the benefits. Discussions of changing the dosing regimen with no data to support them could create doubt and skepticism about the process and lead to increased vaccine hesitancy, Rasmussen says.

Crotty agrees. “In emergency situations, I think it’s reasonable to have [this] dialogue,” he says. “But in the end, I think it’s important to go with what’s proven.” (H)

(A)Banished by Trump but Brought Back by Biden, Fauci Aims to ‘Let the Science Speak’, By Michael D. Shear, https://www.nytimes.com/2021/01/21/us/politics/fauci-trump-biden-coronavirus.html

(B) More than 40,000 in Florida overdue for second coronavirus vaccine dose, https://www.wesh.com/article/florida-second-vaccine-dose-overdue/35231382

(C) NYC Shelves All 1st Dose Bookings at Vaccine Hubs Through Sunday, Won’t Take More for Now, By Jennifer Millman, https://www.nbcnewyork.com/news/coronavirus/nyc-vaccine-sites-face-closure-today-amid-shortage-cuomo-says-biden-admin-offers-new-sense-of-hope/2841498/

(D) Cuomo Says New York to Run Out of Vaccine Allocation Friday, by Stacie Sherman, https://news.yahoo.com/cuomo-says-york-run-vaccine-172849310.html

(E) Covid-19 Vaccine Second Doses Can Be Given Later Than Recommended, CDC Says, by Jared S. Hopkins, https://www.wsj.com/livecoverage/covid-2021-01-22/card/pWHkRoYDGoofSdO97gP0

(F) Covid-19 vaccine second doses may be scheduled “up to 6 weeks” later, CDC says, by Michael Nedelman, https://www.cnn.com/world/live-news/coronavirus-pandemic-vaccine-updates-01-22-21/h_e157db2e1b62d3ee189ea6d181017245

(G)CDC quietly changes Covid vaccine guidance to OK mixing Pfizer and Moderna shots in ‘exceptional situations’, by Will Feuer, https://www.cnbc.com/2021/01/22/cdc-changes-covid-vaccine-guidance-to-ok-mixing-pfizer-and-moderna-shots-in-exceptional-si.html

(H)Should We Change COVID Vaccine Doses to Reach More People? What the Data Say, By Tanya Lewis, https://www.scientificamerican.com/article/should-we-change-covid-vaccine-doses-to-reach-more-people-what-the-data-say1/

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