Dr. Umair Shah remembers the last mass vaccination campaign conducted by the United States.
The H1N1 “swine” flu broke out in April, at the end of the normal flu season, in 2009.
“It was very difficult,” Shah, who heads the Department of Health in Harris County, Texas, told CNN.
“There were a lot of moving parts. It took weeks or months to not only organize, but to implement and run safely and effectively. And it was a mild pandemic.”
This is not a gentle pandemic. And vaccine manufacturers, public health professionals, and the federal government are all confident that one or more coronavirus vaccines currently being tested will work safely by the end of the year, but in the United States. And the world will still have a long way to go, ending the pandemic.
“I’m entering the beginning of 2021, so I’m cautiously optimistic that the vaccine will be available by the end of this year,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, with the virus. The medical battle spoke on CNN’s Wolf Blitzer Friday.
“But that doesn’t mean turning it off and turning it on. It’s going to be gradual,” Forch added.
“Having” a vaccine does not mean approving, distributing, or putting it in the weapons of more than 300 million Americans.
First, the vaccine must be approved or approved by the US Food and Drug Administration. This is a process that normally takes months or years. The FDA promises a faster process for the Covid-19 vaccine, but it must pass a committee known as the Vaccine and Related Biologics Advisory Board (VRBAC).
The FDA will almost certainly allow an emergency use permit or a shortcut process known as the EUA, but authorities say it will require “EUA Plus” to add at least some tier scrutiny.
“It is unlikely that the Covid-19 vaccine will soon be fully approved and widely distributed. Instead, the FDA is probably the people in the target group who are at high risk for Covid and are most likely to benefit from the vaccine. “I approve the use of the vaccine in Japan,” said former FDA members Dr. Mark McClellan and Dr. Scott Gottlieb, Wall Street Journal Monday. “This all means that, at least initially, the Covid vaccine does not provide swarm immunity to help eliminate the infectious disease.”
It will take some time — most experts who spoke to CNN predicted, perhaps even if the vaccine was approved in January.
“People can’t settle for false relief just because they know the vaccine is coming,” Dr. Marcus Precia, chief health officer for state and community health, told CNN. ..
The manufacturer has already given the vaccine, but it will take some time. And the United States will probably need more than 600 million doses — enough for everyone to get two vaccines.
A new vaccine and a plan to release it
“At the end of the year … let’s say millions to tens of millions of doses will be available,” Forch said in a CNN interview on Friday.
“For the first time in 2021, hundreds of millions of doses will be given, creating logistical constraints on vaccination of large numbers of people. Sufficient people will be vaccinated and immune umbrellas. It will take several months to get it. To the community. “
Public health experts agreed that the United States is simply not ready for large-scale vaccination campaigns such as those needed to control the coronavirus.
“I don’t think it will be seamless,” Precia said.
The largest mass vaccination program that the United States implements each year is the annual influenza vaccine. Only about half of Americans receive the flu vaccine, and manufacturers manufacture and distribute it in less than 150 million doses.
Still, each flu season takes a year from start to finish to create, manufacture, and distribute the flu vaccine.
“We will start planning influenza vaccines in January or February,” said Michael Einhorn, president of Dealmed, an independent medical supplies distributor covering New York, New Jersey, Connecticut, and Pennsylvania. Influenza vaccines will generally be available in August — 7 to 8 months later.
And it’s about vaccines dispensed in the way people are used to, in pediatrician offices, pharmacies, grocery stores, and clinics.
“I have a flu notebook,” Shah said. “This is not the same.”
All coronavirus vaccines require new technologies and entirely new processes for distribution, administration, and payment.
And while anyone can, for example, step into a pharmacy, get a flu shot, and leave without thinking about it again, the coronavirus vaccine comes with far more problems and paperwork. People will probably need at least two doses at intervals of about one month. Someone needs to track it down and follow up.
“We need to know who has been vaccinated and who has not been vaccinated,” said Dr. Ngozi Ezike, director of the Illinois Public Health Service, at the National Academy of Sciences and Medicine.
Documents and red tape
“Two doses mean providing the first dose. You need to give the second dose a month later,” said Dr. Jinlene Chan, Assistant Secretary of Public Health, Maryland. Told CNN.
And it is very likely that vaccines made by several different companies will be used by next year.
“We need to make sure they are given the same vaccine that we got for their first dose for their second dose,” Chan said.
The vaccination program cannot be started until you have a plan to manage it.
In addition, the coronavirus vaccine is still experimental, so everyone who gets the vaccine should be tracked to make sure there are no side effects.
There are no plans for this yet.
“We don’t have much information about how this will be deployed,” said Shah of Harris County. “It makes planning even more difficult.”
One of the potential obstacles is what is called a cold chain. The two most distant vaccines under development should both be stored frozen. The Moderna vaccine should be kept at -4 degrees Fahrenheit (-20 degrees Celsius), while the Pfizer vaccine should be kept at -94 F (-70 C). -4 isn’t as cold as the optimal home freezer setting of 0 degrees (F), but -94 is more difficult.
“Throughout-from every point the vaccine must pass-we need to keep it at that temperature, otherwise there is some risk of deterioration and the vaccine may be less effective. There is, “said Mr. Chan. “You need to make sure that you have the ability to save properly until you can use it.”
Otherwise, thawed batches can mean that hundreds or thousands of people are vaccinated.
Dr. Carlos Del Rio, a vaccine expert at Emory University, said this could be a challenge. “Most clinics don’t have a freezer that reaches minus 70 degrees Celsius,” he said at the National Academies Conference.
In order to reach a sufficient number of people, mass vaccination efforts must go beyond clinics, hospitals and pharmacies. “You will have to go to the community. You will have to go to work,” Del Rio said. It makes it more difficult to keep the vaccine cold enough.
Pfizer said it plans to help keep the vaccine cool, Pfizer said. “Pfizer will have a special box to ship vaccines filled with dry ice,” he said. “Once you get the box, keep the ingredients at minus 80 degrees for 10 days.”
But it’s unclear if it’s safe to open the box and take out several doses of the vaccine, Precia said. “Even if these boxes work very well, they will still add an overall level of challenge,” he said.
Remove population from mass vaccination
That was exactly what the large-scale vaccination efforts of the past were — in large numbers. But coronavirus is a respiratory illness, and the last thing everyone has to do is line up people or stuff them into school gyms, for example to get vaccinated, Chan said. ..
“In a mass vaccination clinic, we need to bring a large group of people to the scene and vaccinate as many people as possible,” said Chan. “How do you do that in a way that reduces the risk of transmitting the very disease you are trying to vaccinate?”
Ezike, Illinois, said some of his experience at the test site could be helpful. “We had these strike teams,” she said. “We were able to convert many different sites into sites that people can drive. Can you vaccinate? [car] window? “She asked.
But to accommodate that, cities and states need to be busy quickly. “We will need additional providers,” she told the NASEM conference. “We need a mass vaccination clinic and site, so we really want to recruit a lot of important partners,” she added-a pandemic, especially including meat processing facilities and remote rural areas. For the most devastated community in.
This means policy and legal changes — another potentially time-consuming process. Medical practice is legislated by the state, not the federal government. “We know that we need some extended range of practice for different groups of experts,” she said. For example, the state may want to allow people to be vaccinated by dentists, dental hygienists, and even medical students and veterinarians.
And it requires some other level of law so that providers can be paid for their time. Health insurance law changes may be required, including billing codes that provide a system for people to be vaccinated free of charge.
People are vaccinated in groups because deployment is not immediate. The National Academy is considering this, as is the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention. Together with private sector advocacy groups, they have already released their own blueprints that put healthcare professionals, first-line responders, and the most vulnerable people at the forefront. But that’s another management layer that the government takes over.
Many states have old and cumbersome systems to manage all of this, and Ezike said the necessary upgrades can take some time.
Immunization takes time
Adding to the timeline is simple biology. Pfizer and Modern vaccines should be given at least twice a month. After that, it takes about 2 weeks to get immunity. This is the six weeks between when someone is first vaccinated and when they feel safe from the infection.
In addition to this, many Americans are afraid of vaccines. In particular, new vaccines introduced during the era of intense politics of the process, especially new vaccines, are feared.
“There is general distrust of vaccination, then there is distrust of the government,” Ejike said.
Mr. Shah of Harris County added that the current atmosphere of mask use was useless.
“We made it a political battle,” he said.
“Ultimately, people are on their side if they are political in nature, not because of health and medical concerns.”
The virus will continue to spread unless the majority of the population is vaccinated. Most estimates suggest that 60% to 70% of the population must be immune to provide sufficient herd immunity to stop the spread of the virus. According to polls, we are confident that only half of Americans are currently vaccinated.
And if the vaccine is not effective enough, it may mean that it needs to be vaccinated to further affect the population.
Then there is the unknown.
“The tests weren’t seamless at all. There will be some glitches,” Precia said.
“I think the vaccine works and has a good chance of saving us, but given all that can happen, it’s hard to believe that the vaccine will go really smoothly.”
Shah is ready for an unpleasant surprise. “This is a very smooth virus that broke all the rules of the book,” he said.
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