The case of postponing the second shot

The launch of the COVID-19 vaccine in America is going much slower than expected – so slow, in fact, that leading scientists are beginning to debate whether authorities should take the drastic step to stretch the available supplies to twice as many. people, delaying the second of the two doses or cutting each dose in half.

Their fear is that America’s vaccine delivery system will be too slow to keep up – let alone interrupt – a violent pandemic increasingly driven by new and more communicable variants.

So far, only 4.6 million Americans have been vaccinated, according to the Centers for Disease Control and Prevention, well short of the goal that established federal authorities have to give at least 20 million people their first chance before the end of December, and nowhere near the 100 million doses in 2020 initially promised by the Trump administration.

If vaccinations continued at the current rate, according to an analysis by NBC News, it would take nearly 10 years to inoculate enough Americans to keep the pandemic in check.

With more than 2,500 Americans succumbing to COVID-19 daily – and with no end in sight – the United States cannot afford to wait until 2022, let alone 2031. And so, coronavirus cases show signs of increasing (again ) after weeks of vacation At the meetings, experts inside and outside the government are starting to consider the idea of ​​dividing doses differently to put more photos into more weapons as fast as our heavy infrastructure allows.

It is a complex and controversial issue and there can be significant disadvantages. But, at least in theory, the logic of rethinking the authorized dosage regimen has a certain appeal.

The approach that has received the most attention is to delay the administration of second doses until the supply is reduced. In their clinical trials, Pfizer and Moderna tested two doses of 100 micrograms every three weeks (Pfizer) or four weeks (Modern). Both found that the regimen is safe and about 95% effective in preventing disease.

However, the two companies also reported that by the time participants appeared for the second attempt, the first was already providing a high level of immunity. In the case of Moderna, the first (or “primer”) shot appeared to be 92.1 percent effective in preventing COVID-19 after two weeks, long before the volunteers received their “booster” injection on Day 28. Pfizer the results suggested similar protection – greater than 80 percent – after 10 to 12 days.

Neither the Pfizer study nor Moderna was designed to study the effectiveness of a single dose, so it is unclear how long this immune protection would last or at what level. But in real life, booster shots are often administered months or years after the initial primer; an interval of three or four weeks is not defined in stone.

So, should America continue to act as it is? The federal government said on Monday that it had delivered more than 15.4 million doses of the Pfizer and Moderna vaccines to the states. But that is only about half the federal stock; now Washington is keeping the other half in reserve to ensure that there are sufficient booster doses for the entire 21 to 28 day period.

The question then is whether it makes more sense to use a stock of about 30 million shots to produce 95% protection in 15 million Americans next month – or to use the same stock to produce something like 85% protection in twice as much people in half the time.

The UK, Denmark and several Canadian provinces have already decided to postpone second doses (to 12 weeks in the UK and six weeks in Denmark). Belgium, Germany and Ireland are considering a similar change.

Meanwhile, more and more US scientists are saying that what may be preferable in a perfect world – how to strictly stick to the initial vaccination schedule – can be counterproductive in the depths of the spiraling pandemic, especially when a new variant of the virus is 50 percent more communicable is already spreading.

“Given the improved transmission variants on the rise, we need a modified strategy,” Yale immunologist leader Akiko Iwasaki tweeted Friday. “Unfortunately, the vaccine’s implantation is much slower than we expected. This means that even the vulnerable have to wait months to receive their two vaccines. “

Iwasaki went on to note that “a mutant virus with 50% transmissão transmission kills many more people than a mutant with 50% let lethality”; viruses spread exponentially and a small percentage of a very large number can easily be much larger than a large percentage of a small number.

A health worker from the Florida Department of Health in Broward is preparing to administer a COVID-19 vaccine at a drive-thru vaccination site in Vista View Park on January 4, 2021 in Davie, Florida.  (Joe Raedle / Getty Images)
A health worker from the Florida Department of Health in Broward prepares to administer a COVID-19 vaccine at a drive-thru vaccination site in Vista View Park on January 4, 2021 in Davie, Florida. (Joe Raedle / Getty Images)

And so, although “I am still an advocate of the 2-dose vaccine”, concluded Iwasaki, the situation in the USA is so dire that “we can delay the 2nd dose until more vaccines are available”, adding that a “boost after a few months may be fine. ”

Writing on Sunday in the Washington Post, Robert M. Wachter, head of the department of medicine at the University of California at San Francisco, and Ashish K. Jha, dean of the Brown University School of Public Health, agreed.

“Until recently, we supported the strict vaccine regime, requiring two doses in one month,” they explained. But “between 50,000 and 100,000 Americans will die of covid-19 this month alone. Giving 100 million people – especially those at high risk – a single 80 to 90 percent effective injection will save many more lives than giving 50 million people two 95 percent effective doses. It is what we must do. “

Meanwhile, President-elect Joe Biden’s team thinks the idea is worth exploring. “Pfizer’s data – the amount of protection obtained with a single dose – was quite impressive,” Dr. Zeke Emanuel, a member of Biden’s COVID-19 advisory board, told Yahoo News. “It is something that must be considered: how to stretch this resource absolutely scarce.”

Other experts remain skeptical. Some say it would be irresponsible to delay a second dose until studies have explicitly proven that protecting the first dose lasts more than 28 days. Some fear it would be unethical to tell those who have already accepted their first injection – with the promise of a second injection in three or four weeks – that they will have to wait. Some fear that delaying a second immunity-boosting dose can give the virus more opportunity to multiply and mutate in partially protected people. And some believe that changing the course based on untested extrapolations from limited data would further undermine the public’s fragile confidence in these already controversial vaccines.

For the record, Dr. Anthony Fauci, America’s leading infectious disease specialist, doesn’t like to follow in the UK’s footsteps and change the dosage schedule. “I would not be in favor of that,” Fauci told CNN on Friday. “We will continue to do what we are doing.”

But postponing the second injection may not be the only way to stretch America’s vaccine supply. The authorities are also considering halving the volume of vaccine in each dose, effectively doubling the amount of doses available. On Sunday, Moncef Slaoui, the head of America’s Operation Warp Speed ​​vaccine effort, told CBS that participants in Moderna clinical trials between the ages of 18 and 55 who received two half-doses of 50 micrograms each produced an “identical immune response” to those who received two full doses of 100 micrograms.

“Injecting half the volume” into adults under 55 can be “a more responsible approach, which will be based on facts and data to immunize more people,” said Slaoui. The Food and Drug Administration and Moderna USA are now “in discussions” about the implementation and “acceleration” of this regime on a broader scale, he added.

It remains to be seen what will happen with these discussions. It also remains to be seen whether the distribution of the vaccine itself will accelerate in the new year – a necessary part to inoculate more people, regardless of how the doses are scaled or scheduled.

Leaving aside the federal stock of second doses, only about 30 percent of the first doses delivered to the states were actually injected into living breathing Americans. That means more than 10 million unused doses are stopped, waiting to be used – the result, experts say, of the Trump Administration’s decision to shift responsibility for distributing the vaccine to individual state health departments overwhelmed by the pandemic, with little form of coordination or federal support. COVID-19’s new relief bill includes an additional $ 7 billion for the state’s vaccination efforts, which should help, and the new Biden administration has pledged to take a more practical approach.

Dr. Melisha Cumberland receives the second dose of the Pfizer / BioNTech vaccine 21 days after receiving the first injection of RN Valerie Massaro from Hartford HealthCare, at the Hartford Convention Center in Hartford, Connecticut, on January 4, 2021. (Joseph Prezioso / AFP via Getty Images)
Dr. Melisha Cumberland receives the second dose of the Pfizer / BioNTech vaccine 21 days after receiving the first injection of RN Valerie Massaro from Hartford HealthCare, at the Hartford Convention Center in Hartford, Connecticut, on January 4, 2021. (Joseph Prezioso / AFP via Getty Images)

But so far America has vaccinated only 1.38 percent of its population. Israel, in contrast, vaccinated more than 14%. If implementation in the US continues to falter as cases, hospitalizations and deaths continue to increase – and more frightening variants become dominant – impatient Americans may demand that leaders start thinking outside the box.

“Apparently, we gained A LOT by delaying (for some) the second injection for a short time (maybe just a few weeks),” Howard Forman, a health policy expert at Yale tweeted Saturday. “The risk of ‘reserving’ a large number of doses while widespread dissemination appears to be BIGGER than the alternative. Let’s put logic and science ahead of dogma. “

_____

Read more on Yahoo News:

Source