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Secrets, details and challenges of the distribution of a coronavirus vaccine

2020-11-14T14:14:02.735Z


How Pfizer, the US Government and the US Public Health Community Prepare to Reach Millions of People.R. Robbins and D. Gelles / The New York Times 11/13/2020 13:05 Clarín.com Society Updated 11/13/2020 1:12 PM Scientists and public health experts have been saying for months that the most crucial part of defusing the COVID-19 pandemic will be developing a safe and effective vaccine . So there were celebrations this week when Pfizer announced that a first analysis showed that its candidate vaccin


R. Robbins and D. Gelles / The New York Times

11/13/2020 13:05

  • Clarín.com

  • Society

Updated 11/13/2020 1:12 PM

Scientists and public health experts have been saying for months that the most crucial part of defusing the COVID-19 pandemic will be developing a

safe and effective vaccine

.

So there were celebrations this week when Pfizer announced that a first analysis showed that its candidate vaccine was more than 90% effective.

Now the pharmaceutical company, the US government, and the public health community face a

new challenge

: rapidly produce millions of doses of the vaccine and deliver them to the hospitals, doctors' offices and pharmacies where they will be injected. , twice, on people's arms.

If Pfizer receives clearance from the Food and Drug Administration (FDA) for its vaccine in the coming weeks, as expected, in theory the company could vaccinate

millions of Americans by the end of the year

, taking advantage of months of planning and decades of experience.

“I am very confident.

I live for this, ”said Tanya Alcorn, a Pfizer executive who is in charge of the vaccine supply chain, in an interview on Wednesday.

"We have developed a system that does not allow any of this precious vaccine to go to waste."

But Pfizer - like other manufacturers that may soon be allowed to launch their vaccines - is

not in full control of its own destiny

.

The initiative will depend on the collaboration between a network of companies, federal and state agencies and health workers on the battlefield, amid a pandemic that is spreading faster than ever in the United States.

Before Pfizer can begin shipping vaccine shipments, the federal government and state governments must tell you

where to send doses and in what quantities

.

McKesson, a major medical provider, will have to supply hospitals and other distribution sites with syringes, needles and other supplies needed to administer the vaccine.

Pfizer's vaccine requires strict cold chain care.

Photo Bloomberg.

Employees at these locations will need to be trained to store and administer the vaccine.

They will also need to make sure that four weeks after they get the first dose of the vaccine, people return for the second dose.

And first of all, you

have to convince millions of Americans to get the injection

.

"There is a

lot of confusion

at the level of state and municipal Health departments and a lot of concern about the practicality of deployment," said Saad Omer, director of the Yale Institute for Global Health.

And he detailed: "What places, where to vaccinate, how to get the vaccine there, how to identify people from the various risk groups, how to summon people for the second dose."

Even in normal times, mass vaccination campaigns comprise many gears within a huge network of

providers, carriers, and intermediaries

.

The unique characteristics of Pfizer's vaccine will make this effort even more complex.

The vaccine, developed with the German company BioNTech, has to be stored at about

70 degrees Celsius below zero

until shortly before being injected.

That temperature is similar to that of the South Pole on a winter day and lower than that required by other major vaccines in development.

The results obtained by other laboratories in the race for the vaccine could change the rules of the game.

Moderna Therapeutics

reported Wednesday that it had seen enough COVID-19 cases in its late-stage study to conduct a first analysis of its vaccine, which uses the same "messenger RNA" technology as Pfizer's.

This technology

has never produced an approved vaccine

.

There are nine other candidates in the final testing phase.

If any of them get FDA approval, it will reduce the importance of Pfizer's vaccine, but it will also raise

new questions

, such as which hospitals and people will receive the different vaccines.

But for now, Pfizer is the front-runner.

Getting from the processing plants to the arms of the people: a challenge for laboratories and for States.

Photo AP.

If the analysis planned for next week confirms the safety of the vaccine, the company will likely ask the FDA this month for an

emergency clearance

to distribute it.

In that case, it is likely that a limited number of doses will be sent to large hospitals and pharmacies to apply to health workers and other vulnerable groups.

But the specifics of how that will work, at best, are fuzzy.

Pfizer still doesn't know where the government wants the vaccine

shipped

or

who will be the first to receive it

, said Alcorn, the supply chain executive.

"We are working very closely, particularly in the US, with 'Operation Speed ​​of Light' to identify those distribution points," Alcorn explained, referring to the federal initiative to produce and distribute covid-19 vaccines.

"Today we do not have them," he added.

Pfizer is making the vaccine at its Kalamazoo, Michigan facility;

and Puurs, Belgium.

The doses distributed in the US for the most part will come from Kalamazoo.

In Kalamazoo, the vaccines will be placed in vials (five doses per vial).

The ampoules will go in trays (195 ampoules per tray).

The trays will go in specially designed thermal boxes (up to five trays per box).

Pfizer plans to have about

100,000 insulated boxes

by the end of this month and more than double that total by March.

The reusable boxes, each loaded with between 1,000 and 5,000 doses and stocked with dry ice, are equipped with GPS sensors.

Pfizer employees will be able to monitor the location and temperature of the boxes as FedEx and UPS transport them to hospitals and clinics across the country.

The boxes "will have eyes that will be looking at them at all times," Alcorn said.

An adequate supply of syringes and other items is crucial when it comes to vaccinating tens of millions of people in a short time.

AFP photo.

Representatives for UPS and FedEx said they have already made planning for a role in the distribution of the vaccines and

are ready to go

.

Once the Pfizer insulated boxes reach their destination, hospitals or pharmacies will have different options for storing the vaccine.

The easiest option is to use

ultra-cold freezers

, but not many places have them.

Otherwise, centers can store trays in

conventional freezers for up to five days

.

Or they can keep the vials in the cooler for up to 15 days, as long as they replenish the dry ice and open it no more than twice a day.

Then there's the thorny question of who will be the first to get vaccinated.

That will depend on the state governments.

Pfizer expects to be able to produce

50 million doses this year

.

The CEOs of Pfizer and BioNTech have hinted that half of those doses could go to the US. Since each person needs two doses, they could potentially vaccinate 12.5 million Americans.

"If we're talking about 12.5 million people, we're going to have to make some tough decisions about who will get this," said J. Stephen Morrison, senior vice president of the Center for Strategic and International Studies, a research firm.

"It is a

fairly small amount of dose

that is going to be distributed."

One of the biggest challenges initially may be to

distribute the vaccine in rural areas

, which may not be able to deliver the doses quickly enough before they deteriorate.

It is unclear how states with large rural populations will address this.

Industry executives acknowledge another potential hurdle:

Will Americans reject the vaccine?

There has long been a noisy minority of people in the country who are opposed to vaccination.

Safety concerns are likely only heightened by the speed with which coronavirus vaccines have been produced.

The whole effort would be frustrated if people resist getting the vaccine.

Photo Reuters.

"Obviously, the challenge that will be presented is: are people going to get vaccinated?"

Alcorn said.

"It would be a shame if we did all this work and then the public does not trust that the vaccine is safe."

When it comes to the difficulties of making and distributing the vaccine, public health experts say the most difficult part of the process may soon be over.

Having designed and tested a seemingly effective vaccine, solving the logistics involves more than

applying

existing

know-how

, said Omer of the Yale Institute for Global Health.

"The good news," he said, "is that

these problems are not insurmountable

."

Translation: Elisa Carnelli.

Look also

Trump slows down the fight against the coronavirus and is furious that the vaccine was announced after the US elections.

Another vaccine against the coronavirus: a clinic in La Matanza signs up volunteers for Johnson and Johnson's

Source: clarin

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