Breaking News: Hmmm?

[Boats]

Breaking News: Scientists are studying vaccine data to see if the Moderna supply can be doubled by cutting doses in half, a move that could help alleviate shortages.
By: The New York Times - 01-05-21 By: Abby Goodnough
Re: https://mail.google.com/mail/u/0/?ta...WKxcHNttvGbVrQ

The New York Times

BREAKING NEWS: (or is it?)

Scientists are studying vaccine data to see if the Moderna supply can be doubled by cutting doses in half, a move that could help alleviate shortages.
Tuesday, January 5, 2021 2:38 PM EST

The data analysis, which has been long planned as part of the vaccine research effort, comes amid a broader scramble to increase vaccine supply.

Topic: Covid-19 Live Updates: Scientists Are Studying Whether Moderna Supply Can Be Doubled By Cutting Doses in Half

Countries are falling short of the inoculation targets set by leaders. Priority group guidelines should not slow down vaccinations, the U.S. surgeon general warned. Germany will extend its national lockdown.

RIGHT NOWAdvisers to the W.H.O. recommend sticking with Pfizer’s timetable for vaccine doses, with some exceptions.
Here’s what you need to know:

Scientists are studying if the Moderna vaccine supply can be doubled by cutting doses in half.

The U.S. surgeon general warns not to let priority guidelines slow down vaccinations.
Vaccination drives are off to slow starts around the world.

The head coach of the Cleveland Browns tests positive ahead of the playoff game.
California endures more hospitalizations and deaths after its post-holiday infection surge.

Merkel announces an extension of the lockdown in Germany.

With the virus subdued, China enjoys its own kind of freedom.

Nearly 1,500 inmates in Mississippi have been infected, but officials won’t say how many have died.

Many Chicago teachers stay home to protest school reopening plans.

Scientists are studying if the Moderna vaccine supply can be doubled by cutting doses in half.

Scientists at the National Institutes of Health and the drugmaker Moderna are analyzing vaccine research data to see if they can double the supply of the company’s coronavirus vaccine by cutting doses in half, a move that would help alleviate vaccine shortages as the country tries to fight off a surging virus.

The research, which also involves scientists from Operation Warp Speed, the government’s vaccine initiative, could take about two months, Dr. John Mascola, the director of the Vaccine Research Center at the N.I.H., said in an interview Tuesday.

The data analysis, which Dr. Mascola said has been long planned as part of the vaccine research effort, comes amid a broader scramble to increase vaccine supply. Late last month, the Trump administration sealed a deal with Pfizer to increase that company’s vaccine supply by 100 million doses.

“It’s important to do these analyses that we’re doing, and have all that data in our pocket in the event that there’s a need to use it,” Dr. Mascola said.

The vaccine rollout has been troubled from the start. For the moment, the problem is not a shortage of vaccine, but rather that state and local governments are having trouble distributing the vaccine doses they already have.

The prospect of doubling the supply of Moderna doses was first raised on Sunday by Dr. Moncef Slaoui, the head of Operation Warp Speed, who said on the CBS program “Face the Nation” that data from Moderna’s clinical trials demonstrated that people between the ages of 18 and 55 who received two 50-microgram doses showed an “identical immune response” to the two 100-microgram doses.

That is true, said both Dr. Mascola and Dr. Anthony S. Fauci, the director of the National Institute for Allergy and Infectious Diseases, which includes the vaccine research center. But Dr. Slaoui also went one step farther, and said federal officials and Moderna were discussing possibly halving each of Moderna’s two doses — a remark that prompted pushback from the Food and Drug Administration, which would have to approve any change in the dosing regimen.

In a statement posted on its website Monday night, the F.D.A. said a proposal for half-doses of the Moderna vaccine was “premature and not rooted solidly in the available science.” The finding Dr. Slaoui cited came from an early Phase II clinical trial, which involved hundreds of people and was designed to test only for immune response, and not for the effectiveness of the vaccine, Dr. Fauci said. It compared the immune response in people given 50 micrograms against those given 100 micrograms.

The larger Phase III trial that found the vaccine effective involved 30,000 people, half of whom were given the 100-microgram dose and half of whom were given placebo.

In order to provide the F.D.A. with the kind of data it would need to approve a change in dosing, scientists must first study blood samples from patients who participated in the Phase III trial to determine precisely what immune response correlates with protection against Covid-19.

Then, Dr. Mascola said, researchers would have to either look back at patients from the Phase II trial, or conduct a new one, to demonstrate that patients who received the 50 milligram dose developed the threshold immune response. If the results looked promising, he said, “all this then needs to be put together as a data package for review and discussion with F.D.A.”

On Tuesday, Dr. Jerome Adams, the U.S. surgeon general, urged states not to stick rigidly to the Centers for Disease Control and Prevention guidelines about whom to vaccinate first. He said states should “move quickly to other priority groups” if fewer health care workers agree to be vaccinated.

Asked about Dr. Adams’s remarks, a C.D.C. spokeswoman said the agency had made clear in written guidance that states did not need to vaccinate everyone in a priority group before moving on to the next group.

Acknowledging that coronavirus vaccination around the United States was going slowly, Dr. Jerome Adams, the surgeon general, urged the states on Tuesday not to stick rigidly to the Centers for Disease Control and Prevention guidelines about whom to vaccinate first.

If fewer health care workers are agreeing to be vaccinated, he said, states should “move quickly to other priority groups,” such as people older than 75 and essential workers.

“Your headline today really should be, ‘Surgeon General tells states and governors to move quickly to other priority groups,’” Dr. Adams said on NBC’s “Today” show. “If the demand isn’t there in 1a, go to 1b and continue on down. If the demand isn’t there in one location, move those vaccines to another location.”

“The problem really is that we need to continue to do a better job of matching up supply and demand at the local level,” he said.

An advisory committee to the C.D.C. recommended last month that nursing home residents and health care workers who are especially at risk of being exposed to the virus should be the first group (“1a”) to get the vaccine, followed by other people 75 and older and certain other essential workers (“1b”). The C.D.C. endorsed and published the recommendations, but they are not binding. Each state sets its own priority list, with some following the federal guidelines exactly and others not.

Nearly all states have made getting health care workers and nursing home residents immunized a top priority. But the effort, now three weeks old, has been slower than many governors and public health officials hoped.

The federal government has shipped more than 15 million vaccine doses to states, but only 4.5 million people have received them so far. There are 21 million health care workers nationwide, and three million residents of nursing homes and other long-term care facilities.

Some states, like Texas and Florida, have already begun offering shots to people 65 and older who are not nursing home residents, and to those of any age with medical conditions that raise their risk of dying if they contract Covid-19.

Dr. Adams said in some cases, health officials “feel beholden” to the C.D.C. priority recommendations, resulting in a lot of vaccine sitting unused in freezers.

An effort to have the C.V.S. and Walgreens drugstore chains manage the vaccination of most nursing home residents and employees around the country has been slow to get off the ground. And anecdotally, health care workers are turning down the vaccine, sometimes in large numbers.

Asked about Dr. Adams’s remarks, a spokeswoman for the C.D.C. said the agency had made clear in written guidance that states did not need to vaccinate everyone in a priority group before moving on to the next group.

But some officials, including Gov. Andrew M. Cuomo of New York, have said poor execution by hospitals is largely to blame for the slow start. Mr. Cuomo, for one, is resisting calls to start offering shots to lower-priority groups just yet.

— Abby Goodnough

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Personal note: I don't know about you folks but 1/2 does doesn't seem to me to be ideal.
So what does that mean we will get 4-half does? I think they are playing with fire and it could prove to be a problem anyway. Some folks immune system may need the two full does - to keep the virus from killing them!?

I think their guessing and hoping for the best but I don't think its a good idea I don't know about you guys - hell I'm 74 nearly 75 and I'm not what I once was and it may require a full shot rather than 4-1/2 shots? They got to get their act together and get it done and right.

I'm not happy with this call - what if they only give us 2 - 1/2 shots max will our odds be less to get or could we still get it. Do the job right guys get more medicine! Don't guess and kill 1/2 of us with half a shot!

Also how many leaders in this country will take 1/2 shot I bet they will want a full shot 2x and us lowlifes get 2/1/2 shots yea what a deal!

Boats