CATER Mask Decisions

January 8, 2021

Biden to Release Nearly All Available Vaccine Doses

Failure to Distinguish Between Good and Bad Masks Continues to be the Greatest COVID Failure

Boston Doctors Call for National High Efficiency  Mask Distribution Program to Prevent COVID-19 Spread

_________________________________________________________________________

Biden to Release Nearly All Available Vaccine Doses

President-elect Joseph R. Biden Jr. plans to release nearly all available coronavirus vaccine doses “to ensure the Americans who need it most get it as soon as possible,” the Biden transition team said Friday, a move that represents a sharp break from the Trump administration’s practice of holding back some of the vaccine.

The announcement coincided with a letter from eight Democratic governors — including Andrew M. Cuomo of New York and Gretchen Whitmer of Michigan, both of whom have clashed with President Trump — imploring the current administration to release all available doses to the states as soon as possible.

“The failure to distribute these doses to states who request them is unconscionable and unacceptable,” the governors wrote in the letter, which was obtained by The New York Times and sent Friday to the secretary of health, Alex M. Azar II, and Gen. Gustave F. Perna, who is in charge of vaccine distribution. “We demand that the federal government begin distributing these reserved doses to states immediately,” the letter said.

Because both of the vaccines with emergency approval require two doses, the Trump administration has been holding back roughly half of its supply to ensure those already vaccinated receive the booster dose. The vaccine rollout has been troubled from the start.

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. Mr. Biden has promised that 100 million doses of the vaccine would be administered by his first 100th day in office.

Releasing the vast majority of the vaccine doses raises the risk that second doses would not be administered on time. Officials from the Food and Drug Administration — experts whose advice Mr. Biden has pledged to follow — have spoken out strongly against changing the dosing schedule, calling such a move “premature and not rooted solidly in the available evidence.”

A transition official, speaking anonymously to provide insight into the president-elect’s thinking, said would use the Defense Production Act, if needed, to ensure that enough doses are available.

However, the official also noted that the Biden team has “faith in our manufacturers that they can produce enough vaccines to ensure people can get their second dose in a timely manner, while also getting more people their first dose.”

A spokesman for Operation Warp Speed, the Trump administration’s vaccine initiative, released a statement sharply criticizing Mr. Biden’s approach.

“If President-elect Biden is calling for the distribution of vaccines knowing that there would not be a second dose available, that decision is without science or data and is contrary to the FDA’s approved label,” said the spokesman, Michael Pratt. “If President-elect Biden is suggesting that the maximum number of doses should be made available, consistent with ensuring that a second dose of vaccine will be there when the patient shows up, then that is already happening.”

A spokesman for the transition team, T.J. Ducklo, said Mr. Biden “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,” Mr. Ducklo said. “He will share additional details next week on how his Administration will begin releasing available doses when he assumes office on January 20th.”

Dr. Leana Wen, an emergency physician and public health expert at the George Washington University School of Public Health, said she was surprised and concerned about the new strategy, which seemed to offer a solution incongruous with the biggest problems in the vaccine rollout. Distribution has sputtered in large part because of a lack of administering capacity and several logistical hurdles, rather than a severe shortage of doses.

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

For such a plan to work, Dr. Wen added, the Biden administration will need to be confident in both improved distribution tactics and sufficient vaccine production, “so all who receive the first dose of the vaccine will receive the second in a timely manner.”

Should a high number of delayed second doses occur — ostensibly shirking the regimens laid out in clinical trials — “it runs the risk of substantially eroding public trust in vaccines,” Dr. Wen said. The recommended timeframe for administering the second dose for the Pfizer-BioNTech vaccine is 21 days later, and for the Moderna vaccine, 28 days.

Mr. Biden’s announcement came amid growing pressure to step up the slow pace of mass vaccinations.

Speaking at a news briefing on Friday, Dr. Stephen Hahn, the F.D.A. commissioner, urged states that have utilized only a small part of their supply to begin vaccinating lower-priority groups, while still observing government guidelines.

“We think that will go a long way toward using these vaccines appropriately and getting them into the arms of individuals,” he said.

Failure to Distinguish Between Good and Bad Masks Continues to be the Greatest COVID Failure

People are required to wear masks without any specification of mask quality. We have compared this  to the requirement to wear some sort of head covering in football. High quality helmets have been required. Despite evidence that good masks reduce COVID by as much as 70 times that of poor masks.  We continue to read about research which is very misleading. Here is one which compared poor masks to no masks and not surprisingly found little difference

Back in April, researchers split 6,000 Danish citizens into two roughly equal groups. The first group was asked to wear a paper surgical mask anytime they went out in public for the next month. Those masks are about 98% effective at screening small particles, but they don’t fit snugly to the face the way N95 masks do. There are still gaps where unfiltered air can reach the nose and mouth. (this can reduce the FFE to 60% or less).  A TE 90 mask will allow 10% of the virus to escape but if also worn by the recipient only 1% of the virus will be inhaled.  A 60% efficient mask allows 40% of the virus to reach the recipient who then inhales 16% of the total.  So there is a 16 x difference in virus transmission.

The mask group watched a video explaining how to wear masks properly and got 50 free masks in the mail. The control group was assigned not to wear face masks. In fact, the researchers excluded people who wore masks for protection on the job. The control group was told to follow the advice of public health authorities. Before the study began, everyone was tested for antibodies to make sure they hadn’t already been infected with the virus. If they were positive, they were excluded from the trial.

The study was “powered” -- meaning that it included enough people -- to detect whether following the advice to wear a mask could cut the risk of catching COVID-19 by 50%, or half. It didn’t.

“That’s a big number in any clinical trial,” says F. Perry Wilson, MD, an associate professor at Yale University. Wilson writes the Methods Man blog, where he breaks down the findings of clinical trials. He was not involved in the current research.

In other words, the trial was designed to look for a big benefit for people who wear masks. It didn’t find that large benefit.

After 1 month, 42 people out of 2,392 in the group that wore masks, or 1.8%, developed a COVID-19 infection, compared to 53 people out of 2,470 in the group that didn’t wear masks, or 2.1%.

That’s a smaller benefit -- about a 16% reduction in infections, on average -- in people who said they wore their masks as they were told.

That result didn’t pass a test for statistical significance, though, meaning that it could have been due to chance

It is too bad the test comparison was not run with masks 16 x more efficient.  There may even be more difference because of the evaporation of droplets on the mask interior surface and then release.  So a mask which initially is 60% efficient may only be 40% efficient when evaporation and re-emission is taken into account.

Boston Doctors Call for National High Efficiency  Mask Distribution Program to Prevent COVID-19 Spread

Doctors at Brigham and Women’s Hospital are pressing for a national initiative to distribute high-filtration masks, such as N95s, to every household in the United States to prevent the out-of-control spread of COVID-19 that is claiming thousands of lives daily.
 

Dr. Abraar Karan and Dr. Ranu Dhillon laid out the case for a National Hi-Fi Mask Initiative in an op-ed in STAT on Thursday, co-authored with Devabhaktuni Srikrishna, founder of Patient Knowhow.

“More and better masks can help get us to that point with fewer infections and deaths,” the doctors wrote. “With validated designs already on the market, mass production of hi-fi masks could be done relatively quickly.”

Hi-fi masks are the best protection against the small particles that spread the virus, the doctors wrote. Reducing the spread of the virus by protecting against those droplets is essential as the nation waits for the general population to get vaccinated, they said.  

“Ideally, a set of masks would be mailed to each U.S. household every month — the costs of doing so pale in comparison to the pandemic’s toll on lives and the economy,” they wrote in the op-ed. “The use of such masks would, in combination with other risk-reduction strategies, create safer workspaces for essential workers, many who are not currently prioritized to get early vaccinations. Since the pandemic began, surgical and cloth masks have become widely available at pharmacies, grocery stores, hardware stories, online, and elsewhere. Hi-fi masks should also be made ubiquitously available through these same venues, some of which are already coordinating with the federal government to roll out COVID-19 vaccines.”

On Twitter, Karan explained that Americans could then use the masks any time they were outside their homes in indoor spaces. 

“As the pandemic surges, most of the cases I am now seeing in the hospital do not know where or how they were infected,” he wrote. “A number of them report wearing cloth masks regularly, and this is much better than no mask, but we know that not all masks are created equal. N95 masks that healthcare workers like myself use in the hospital offer the best protection.

Ten months into the pandemic, many people have been unable to obtain N95s on their own and many health care workers still do not have adequate supplies of the protective equipment, the doctor wrote. 

“Better masks should be a serious priority here,” Karan said, stressing that the equipment focuses on stopping the way the virus transmits and, unlike vaccines, isn’t tied specifically to a variant.  

Ensuring everyone has access to more protective masks is another way of protecting against the new variant of COVID-19, which experts believe is more easily spread. 

“As vaccines roll out over this year, we cannot afford continued spread as it is happening,” Karn said. “We cannot rely on incremental policy changes with exponential viral growth. We need to do everything we can do urgently – better masks are central”