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LI hospitals are preparing for distribution and four vaccines are used in final clinical trials

 


Hospitals, state and federal governments in Long Island are preparing for the arrival of the COVID-19 vaccine, which could occur as early as the end of the year, experts say.

The plan pledges that four potential vaccines are in a large final-stage clinical trial in the United States, and Governor Andrew M. Cuomo pledges that the state will independently evaluate vaccine research data due to distrust of the Trump administration. Because it is.

Northwell Health is planning a vaccine for several weeks, said Dr. Mark Jarrett, Chief Quality Officer for the healthcare system that operates 11 Long Island hospitals.

“What we’re doing is coming up with multiple scenarios, so we’re planning for the first vaccine to come out,” he said.

Each vaccine candidate has unique characteristics. Catholic Health Services has purchased six new sub-zero freezers and Jason, Chief Quality Officer and Senior Vice President of CHS, which operates six Long Island hospitals, as some require storage at very low temperatures. Dr. Gorbin said.

According to officials from these hospitals, Oceanside’s Sinai Sannan Nassau and East Meadow’s Nassau University Medical Center are preparing distribution plans based on how influenza vaccines are administered.

According to Jarrett, Northwell is developing a way to track everyone who is vaccinated and ensure that a second dose is available to those who need a second dose. Some major vaccine candidates require two injections every few weeks.

Northwell will also monitor people who may get sick with COVID-19 despite the vaccine, as it is not 100% effective despite the vaccine, Jarrett said.

Dr. William Schaffner, director of medicine at the National Foundation, says it’s hard to convince most people to get the flu shot, for example, if it only works for 70% of people, which is the upper limit of the flu shot. maybe. Professor of Infectious Diseases and Infectious Diseases at Vanderbilt University Medical Center.

“People are really frustrated and surprised to learn that after being vaccinated, they will have to stay socially distant from the masks and go to large group events. “I will.” He said. “All of this needs to be done for months and months.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, made a similar statement.

However, “we are not going to eliminate the virus,” Schaffner said, but high-dose vaccination is important to control the spread of the coronavirus.

“The better the vaccine and the more people who receive it, the faster it can return to a normal, new normal state.” It was common to wear a mask, for example, in winter. Some Asian countries have said over the years to fight the flu.

Still, many Americans say they can’t be vaccinated because of safety concerns. In a Kaiser Family Fund poll released on September 10, 62% of Americans are approved before the vaccine is shown to be safe and effective due to political pressure from the Trump administration. I found that I was worried about that.

Long Island’s physician, who plays an important role in vaccine approval, has vowed that he and the other 14 voting members of the US Centers for Disease Control and Prevention’s Independent Advisory Board on Vaccines will scrutinize study data.

“Our group does not recommend anything until we become accustomed to science. Immunization practices, which are the recommendations that CDC directors usually follow.” We are not going to cut the corner. “

Dr. Paul Spearman, director and professor of infectious diseases at the Cincinnati Children’s Hospital Medical Center, said Americans can trust the recommendations of a committee of medical and public health experts.

“They will make independent decisions that are not related to political pressure,” he said.

Bernstein, the attending physician at the Cohen Children’s Medical Center in New Hyde Park, said the vaccine could be launched at the end of the year, in line with expectations from other key experts.

But he expressed suspicion that the vaccine would be ready before the election day of November 3, President Trump said it might happen.

“It will accelerate the vaccine development process in my mind too fast,” Bernstein said.

He has four of the largest and final stage clinical trials in the United States, even if some vaccine candidates are promising-there aren’t enough data to predict how effective or safe the vaccine will be. He said it would take months to provide the vaccine to all Americans who want it.

Bernstein’s remark came as Cuomo Announced the establishment of the committee on Thursday Review vaccines for safety.

Mr. Trump said yesterday that the White House could revoke the U.S. Food and Drug Administration’s plans to independently oversee the U.S. Food and Drug Administration’s review of vaccine safety and efficacy.

Dr. Anthony Boutin, CEO and Chief Medical Officer of Nu Health, a public interest corporation that operates the Nassau University Medical Center, said state recommendations are key to convincing patients that the vaccine is safe.

“I’m not going to sell what I don’t believe in,” he said.

Northwell will carry out its own assessment, Jarrett said.

On Thursday, Cuomo also appointed a committee to develop a vaccine distribution and implementation plan.

The US Department of Health and Human Services reported on September 16 that the federal government is developing a distribution plan with the state. When asked if Kuomo’s new committee would circumvent the process, State Department spokeswoman Erinsilk said in an email that the CDC had asked each state to submit a vaccination plan that the committee would put together. ..

“As always, I think a competent federal government in partnership with the state is ideal, but as we’ve learned from the last six months, expect the best and be prepared for the worst. We need to, “said Silk.

The federal government spends billions of dollars on the development, purchase, and production of vaccines, and clinical trials are beginning.

NYU Winthrop Hospital in Mineola was selected as the final site for a Phase 3 trial of vaccine candidates developed by UK-based AstraZeneca and Oxford University and was announced on September 8. The company has withheld testing in the United States for safety reasons. The Mount Sinai Hospital System, including Mount Sinai South Nassau, is discussing potential clinical trial collaboration with vaccine producers, said Dr. Arlongrat, director of infectious diseases at the hospital.

Johnson & Johnson announced on Wednesday that it has begun Phase 3 trials of a vaccine that, unlike other candidates, requires only a single dose.

“When trying to vaccinate hundreds of millions of people, getting them back for a second dose is a logistical challenge,” Forch said during an online discussion Thursday.

The FDA will not grant an emergency license for the vaccine, rather than waiting for full approval after the clinical trial is completed, Spearman said. He said it could be justified if multiple experts determined that there was sufficient data to demonstrate its safety and effectiveness.

Bernstein’s committee is discussing recommendations for vaccine-first populations, he said.

Children will be the last to be vaccinated, as clinical trials in the United States have not yet begun.

Forch said Thursday that safety data is still accumulating and there are “good ethical reasons” for not testing children with the vaccine while they are less likely to get sick with the coronavirus. Stated.

However, Dr. Sharon Nackman, director of pediatric infectious diseases at Stony Brook Children’s Hospital, said, “Delaying children’s studies puts them at risk of getting sick and dying from COVID.”

Nachman is a co-author of a new paper published in Clinical Infectious Diseases that calls for the start of clinical trials in children.

Nackman said it is appropriate to start smaller Phase 1 and 2 trials in children, as the vaccines in the Phase 3 trial have already shown some safety and immune response.

The children are not vaccinated, but she said they could infect others with the virus.

“Because so many households contain children, you never really stop the pandemic, and they will continue to be the source of new COVID infections in the community,” she said.

Vaccine priority

The National Academy of Science, Engineering and Medicine published a draft report on vaccine distribution on September 1. The Academy is an independent body authorized by Parliament that advises the federal government.

The academy has proposed to distribute vaccines in this priority:

1a: High-risk workers and first responders in medical facilities.

1b: People in health at high risk of severe or fatal COVID-19 cases, and elderly people in special nursing homes and other “aggregated or overcrowded environments”.

2. All seniors, teachers and school staff, homeless shelter and group home residents, imprisoned and detained people, people in good health leading to a moderate risk of severe or fatal COVID-19 cases, and People at high risk of worker infections that appear to be essential to the functioning of society.

3. Young adults, children, and mandatory workers at moderate risk of infection.

Four. Those who do not belong to the first three categories. The academy estimates that the first three categories make up 85% to 95% of Americans.

Source: National Sciences of Sciences, Engineering and Medicine, Draft Preliminary Framework for Equity Allocation of COVID-19 Vaccines

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