The case of postponing the second shot



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The rollout of the U.S. COVID-19 vaccine is going much slower than expected – so slow, in fact, that leading scientists are starting to question whether authorities should make the drastic decision to expand available supplies to twice as much. people delaying the second of two doses or cutting each dose in half.

Their fear is that the vaccine distribution system in the United States is too slow to keep up with – let alone stop – a pandemic that is increasingly raging due to new, more transmissible variants.

So far, only 4.6 million Americans have been vaccinated, according to the Centers for Disease Control and Prevention, well below the target that federal authorities have set for at least 20 million people. their first injection before the end of December, and far from 100 million. doses in 2020 initially promised by the Trump administration.

If vaccinations were to continue at the current rate, according to an NBC News analysis, it would take nearly 10 years to vaccinate enough Americans to bring the pandemic under control.

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 are showing signs of surging ( again) after weeks of holiday gatherings, experts inside and outside of government are starting to consider the idea of ​​spreading the doses differently to get more hits in more weapons as fast as our infrastructure bulky allows it.

This is a complex and controversial issue, and there can be significant drawbacks. But in theory, at least, the logic of rethinking the permitted regimen has some appeal.

The approach that has received the most attention is to delay the administration of the second doses until supplies catch up. In their clinical trials, Pfizer and Moderna tested two doses of 100 micrograms three weeks apart (Pfizer) or four weeks apart (Moderna). Both have found this diet to be around 95% safe and effective in preventing disease.

Yet both companies also reported that by the time contestants showed up for their second shot, their first shot already gave them a high level of immunity. In the case of Moderna, the first photo (or “primer”) appeared to be 92.1% effective in preventing COVID-19 after two weeks, well before volunteers receive their “booster” injection on day 28. Pfizer’s results suggest similar protection – over 80 percent – after 10 to 12 days.

Neither the Pfizer trial nor the Moderna trial were designed to study the effectiveness of a single dose, so it’s unclear how long or at what level this immune protection will last. But in real life, reminders are often given months or years after the initial initiation; an interval of three or four weeks is not set in stone.

Should America therefore continue to act as it is? The federal government said Monday it had delivered more than 15.4 million doses of the Pfizer and Moderna vaccines to the states. But that’s only about half of the federal stock; right now, Washington is holding the other half in reserve to make sure there are enough recalls to complete the tour in 21 to 28 days.

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

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

Meanwhile, more and more top US scientists are arguing that what might be better in a perfect world – like sticking to the initial vaccination schedule strictly – could be counterproductive in the depths of the spiraling pandemic, especially when a new variant of the virus is at 50%. more transmissible is already spreading.

“With improved transmission variants on the rise, we need a modified strategy,” said Akiko Iwasaki, senior immunologist at Yale tweeted Friday. “Unfortunately, vaccine deployment is much slower than expected. This means that even the most vulnerable have to wait months to receive their two vaccines. “

Iwasaki went on to note that “a mutant virus with 50% ⬆ transmission kills many more people than a mutant with 50% 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 care worker with 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)
A healthcare 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, while “I’m still a fan of the 2-dose vaccine,” Iwasaki concluded, the situation in the US is so dire that “we can delay the 2nd dose until more vaccines are available” , adding that a “reminder after a few months it might be fine.”

Writing in the Washington Post on Sunday, Robert M. Wachter, director 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 have supported the strict vaccination schedule, requiring two doses in one month,” they explained. But “between 50,000 and 100,000 Americans will die from covid-19 this month alone. Giving 100 million people – especially those at high risk – a single vaccine that is 80 to 90% effective will save many more lives than giving 50 million people two injections that are 95% effective. This is what we have to do.

Meanwhile, President-elect Joe Biden’s team thinks the idea is worth exploring. “The data from Pfizer – the level of protection you got with a single dose – was pretty impressive,” Dr. Zeke Emanuel, member of Biden’s COVID-19 advisory board, told Yahoo News. “This is something to take into account: how to exploit this absolutely scarce resource.”

Other experts remain skeptical. Some say it would be irresponsible to delay a second dose until studies explicitly prove that protection from the first dose lasts longer than 28 days. Some fear it would be unethical to tell those who have already accepted their first move – with the promise of a second to follow in three to four weeks – that they must wait. Some fear that delaying a second dose will boost immunity could give the virus more opportunities to multiply and mutate in partially protected people. And some believe that a change of course based on untested extrapolations from limited data would further undermine fragile public confidence in these already controversial vaccines.

For the record, Dr Anthony Fauci, America’s foremost infectious disease expert, is no fan of following in the UK’s footsteps and changing the dosing schedule. “I wouldn’t be in favor of that,” Dr Fauci told CNN on Friday. “We will continue to do what we are doing.”

But postponing the second vaccine may not be the only way to increase vaccine supply in the United States. Authorities are also planning to halve volume of vaccine in each dose, effectively doubling the amount of available doses. Sunday, Moncef Slaoui, head of the American vaccination effort Operation Warp Speed, tell CBS that participants in Moderna clinical trials aged 18 to 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 could be “a more responsible approach that will be evidence-based and data-driven to vaccinate more people,” Slaoui said. The United States Food and Drug Administration and Moderna are now “in discussions” on the implementation and “acceleration” of this regime on a larger scale, he added.

It remains to be seen what happens to these discussions. It also remains to be seen whether vaccine distribution itself will accelerate in the new year – a necessary part of getting more people vaccinated, regardless of the size or timing of doses.

Setting aside the federal stockpile of second doses, only about 30 percent of first doses delivered to the states were actually injected into living, breathing Americans. This means more than 10 million unused doses are just there, waiting to be used – the result, experts say, of the Trump administration’s decision to shift responsibility for vaccine distribution to health departments. individual states stretched by the pandemic, with little in the way of federal coordination or support. The new COVID-19 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 Pfizer / BioNTech vaccine twenty-one days after receiving the first vaccine from nurse Valerie Massaro of 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 Pfizer / BioNTech vaccine twenty-one days after receiving the first vaccine from RN Valerie Massaro of Hartford HealthCare, at the Hartford Convention Center in Hartford, Connecticut on January 4, 2021 (Joseph Joseph Prezioso / AFP via Getty Images)

But so far America has only vaccinated 1.38% of its population. Israel, on the other hand, vaccinated more than 14%. If the U.S. deployment continues to falter as cases, hospitalizations and deaths continue to skyrocket – and more frightening variants become dominant – impatient Americans may demand that leaders start thinking outside the box.

“It seems like we gain a LOT from delaying (some) the second shot by a short interval (maybe just a few weeks),” says Howard Forman, health policy expert at Yale. tweeted on Saturday. “The risk of ‘reserving’ a large number of doses when rampant spread is occurring appears to be HIGHER than the alternative. Let’s put logic and science ahead of dogma. “

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