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First coronavirus vaccines roll out as officials share months-long timeline for immunization effort (nationthailand.com)

First coronavirus vaccines roll out as officials share months-long timeline for immunization effort

Health & BeautyDec 14. 2020

By The Washington Post · Paulina Firozi, Meryl Kornfield, Josh Dawsey

WASHINGTON – The first vials of the coronavirus vaccine were shipped Sunday, paving the way for inoculations to begin across the country this week.

Nearly 3 million doses of the Pfizer-BioNTech vaccine are expected to arrive at 145 facilities Monday, marking the beginning of a massive logistical effort to stop the rampant spread of the disease covid-19, which has so far killed more than 298,000 Americans. The vaccine against the virus it causes will arrive at nearly 500 additional sites Tuesday and Wednesday.

But even as state officials scrambled to distribute the first doses, they criticized the federal government for a lack of transparency and limited financial help, warning that both could hamper efforts to quickly vaccinate the most vulnerable populations, including health-care workers and the elderly.

As the vaccine doses made their way to hospitals Sunday, Centers for Disease Control and Prevention Director Robert Redfield gave the final nod, approving the decision to recommend Pfizer’s vaccine for people 16 and older.

Additionally, the governors of California, Washington, Oregon and Nevada announced Sunday that an independent review of the Pfizer vaccine found it safe for public use. They said the vaccine was on the way but did not give a specific estimate for when the first shots would be given.

As the vaccine arrived at a Louisville, Ky., hub for distribution across the East Coast on Sunday, Democratic Gov. Andy Beshear moved up his timeline, announcing that immunizations could begin as early as Monday. New Jersey Gov. Phil Murphy, a Democrat, said Sunday that the first vaccines are expected to be administered Tuesday at University Hospital in Newark.

Amid questions about when people can get their shots, a Sunday report said people in President Donald Trump’s White House circle were told to expect to be vaccinated shortly.

“Senior officials across all three branches of government will receive vaccinations pursuant to continuity of government protocols established in executive policy,” National Security Council spokesman John Ullyot said in a statement. The administration has not mentioned when Trump will get a dose. Since contracting the virus, Trump has repeated false claims that he is “immune,” though experts are not yet certain about how long immunity lasts.

Despite the rapid rollout of the Pfizer vaccine, it will be months before immunizations have any effect on the pandemic in the United States, where case numbers are surging. As of Saturday, more than 16 million people in the United States have tested positive, and an average of 2,415 people died of the virus every day for the past week, a pandemic record.

Officials stressed that a large proportion of the nation’s population – about 70% to 80% – will need to get the vaccine before herd immunity is achieved.

Moncef Slaoui, chief science adviser to the White House’s effort to develop a vaccine, said officials hope to “reach that point between the month of May and the month of June.”

“All in all, we hope to have immunized 100 million people, which would be the long-term-care-facility people, the elderly people with co-morbidities, the first-line workers, the health-care workers,” he said in an interview on “Fox News Sunday. “It’s about 120 million people – we would have immunized 100 million people by the first quarter of 2021 with two doses of vaccines.”

Health and Human Services Secretary Alex Azar detailed what could come in the weeks and months following the initial vaccine shipments. He said the plan is to have 20 million people vaccinated by the end of December, up to 50 million by the end of January and 100 million by the end of February. That includes plans for a second vaccine, developed by Moderna, which is expected to gain emergency authorization from the Food and Drug Administration soon.

The FDA gave emergency use authorization for Pfizer and BioNTech’s vaccine on Friday for people 16 and older, and Moderna’s vaccine is expected to be authorized following a review scheduled for this Thursday by the agency’s independent advisers.

“We’ll be getting more and more Pfizer product, and we’ve got 12 1/2 million Moderna product, assuming that we get approval at the end of this week on Moderna, that we’ll ship out very soon thereafter,” Azar said during an interview with CBS News’s “Face the Nation.”

He also was asked by host Margaret Brennan whether he believes President-elect Joe Biden’s team will be able to meet the goals, and Azar appeared to acknowledge that the incoming Biden administration will take over the process.

“If they carry forward with the plans that we’ve put in place, 100 million shots in arms by the end of February is very much in scope,” Azar said.

Officials hoping to bolster confidence in the vaccine worry that such a large immunization effort could be hindered by skepticism.Francis Collins, director of the National Institutes of Health, said the level of potential vaccine hesitancy in the nation is of “great concern for all of us.”

During an interview on NBC News’s “Meet the Press,” he urged viewers to “hit the reset button on whatever they think they knew about this vaccine that might cause them to be so skeptical.”

“The data is out there now. It’s been discussed in a public meeting, all the details of the safety and the efficacy for anybody who wants to look,” he said, adding: “I think all reasonable people, if they had the chance to sort of put the noise aside and disregard all those terrible conspiracy theories, would look at this and say, ‘I want this for my family. I want it for myself.’ People are dying right now. How could you possibly say? ‘Let’s wait and see’ if that might mean some terrible tragedy is going to befall?”

There’s also particular concern about addressing any vaccine hesitancy in communities of color, especially because they have been disproportionately affected by the pandemic.

NBC’s Chuck Todd asked Collins to respond to concerns from a health-care worker who said she hopes people who look like her and other Black doctors in the community also will help generate trust in the vaccines.

“She’s absolutely right. For somebody like me to say, ‘You should be signing up for this vaccine,’ OK, a White guy who works for the government. Sure, that isn’t necessarily going to be the voice that people need to hear if they’re skeptical,” Collins said. “We are working closely with health-care providers, especially those in communities of color, and trying to make sure that all of those messages are ready to go.”

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CDC advisory group recommends Pfizer vaccine for use (nationthailand.com)

CDC advisory group recommends Pfizer vaccine for use

Health & BeautyDec 13. 2020

By The Washington Post · Lena H. Sun, Isaac Stanley-Becker · NATIONAL, WORLD, HEALTH, SCIENCE-ENVIRONMENT, HEALTH-NEWS 

WASHINGTON – A federal advisory panel voted overwhelmingly Saturday to recommend the nation’s first coronavirus vaccine for people 16 and older, paving the way for inoculations to begin as shipments of vaccine arrive at hospitals and state health departments Monday.

The advisory panel to the Centers for Disease Control and Prevention found the benefits of the vaccine from Pfizer and BioNTech, which has been shown to be 95% effective at preventing illness after two shots, far outweighed side effects, including sore arms, fatigue, headaches, muscle pain and chills that resolved within a few days. The action follows the Food and Drug Administration’s action late Friday authorizing the vaccine for emergency use for people 16 and older.

The vote was 11 in favor, with three members not voting because of conflicts of interest.

“I know we’re going to have very tough and sad times ahead because of the surge and a limited vaccine supply, but I am really hopeful that this is the beginning of the end of the coronavirus pandemic,” said Peter Szilagyi, a professor of pediatrics at the University of California at Los Angeles.

The panel’s recommendation is “a hugely important step,” said Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases.

Beth Bell, a global health expert at the University of Washington who chairs the panel’s coronavirus vaccine work group, referred to public concerns about the new vaccine and said she would get a shot when it is her turn and would recommend it for her family. Several members said they would do the same.

While Bell applauded the huge scientific achievement of developing a vaccine, she and others noted the stark imbalance between the $10 billion of taxpayer money used to fund vaccine development and the lack of funding – only “hundreds of millions” – for the enormously complicated and challenging distribution and vaccination effort rolling out across the country during the next year.

“The imbalance between that kind of money and funding provided for the vaccination program is really shocking and needs to be corrected,” Bell said. “We are not going to be able to protect Americans if we don’t have a way to deliver the vaccine to them.”

Jeffrey Duchin, a top health official for Seattle and King County, Wash., noted that the funding necessary for state and local health departments “has been put in the deep freeze with the vaccine,” referring to the vaccine’s ultracold storage and handling requirements.

Because the vaccine initially will be in extremely limited supply, the CDC recommended last week that about 21 million health-care workers and about 3 million residents of long-term care facilities be first to get the vaccine.

Health-care personnel are a priority because of their potential exposure to the virus and their critical role keeping the nation’s hospitals and clinics functioning. Residents and employees of long-term care facilities were prioritized because they account for nearly 40% of deaths from covid-19, the disease caused by the coronavirus.

The recommendations from the Advisory Committee on Immunization Practices were sent to CDC Director Robert Redfield, who is expected to approve them imminently. Once approved, they become the official CDC recommendation on immunization in the United States. Authorization from the FDA means the Pfizer vaccine is permitted to be administered, but an endorsement by the CDC immunization panel signals that the vaccine should be administered to the populations included in its guidance.

Recommendations from the group, an independent body of experts, have been the gold standard for evidence-based guidance on vaccine use in the United States for decades. Health-care providers rely on the group’s recommendations because of the committee’s reputation for rigor and attention to detail, said Jason L. Schwartz, a professor of health policy at the Yale School of Public Health. The committee has been planning for its recommendations for coronavirus vaccines since the spring.

The committee’s review of safety and efficacy data Friday and Saturday reached the same conclusions as the FDA and its advisory committee, including appropriateness of use in 16- and 17-year-olds. One member noted that teenagers can actively spread the virus to family members.

Committee members said pregnant women who are part of a group recommended to receive the shot may talk with their medical providers and choose to get vaccinated, even in the absence of data on the safety of coronavirus vaccines in pregnant women.

Many health-care personnel are women, and a significant percent are likely to become pregnant or to have recently had babies, noted physician Sandra Fryhofer, a liaison representative speaking on behalf of the American Medical Association.

Pregnant women have been excluded from coronavirus vaccine trials. A Pfizer official said Saturday the company plans to report to the FDA this month on a developmental and reproductive toxicity study in animals that could help elucidate any risks.

On Sunday, the CDC is expected to provide briefings for clinicians and provide additional detailed clinical considerations for health-care providers and patients on its website, including guidance on possible severe allergic reactions. Peter Marks, director of the FDA’s division that regulates vaccines, said Saturday that officials had looked carefully at such side effects and concluded that people should receive the vaccine unless they “have had a severe reaction to the vaccine or one of its components.”

Two health-care workers in Britain had severe anaphylactic reactions after getting the vaccine this week, according to authorities. Both had a history of serious allergic reactions and carry epinephrine auto-injectors, known as EpiPens, for such emergencies. A third health-care worker, with no history of allergies, developed a rapid heartbeat and skin reddening. The CDC is following up with British health officials on the cases and has convened experts in vaccine safety, immunology and allergy to investigate possible causes, officials said.

The weekend meeting was not devoted to deciding on allocation of finite vaccine supplies but whether to recommend its use.

But there was a preview of the jockeying certain to take place over who will gain preference following health-care workers and long-term care facility residents and staff, who constitute the first phase, known as phase 1a. Members of the advisory group heard from industry representatives and other advocates about why workers in certain sectors or particularly vulnerable people should have priority access.

John Allan III, vice president of regulatory affairs and international standards for the International Dairy Foods Association, warned that if food workers did not get immunized soon, “Our supply chains could eventually fall apart, creating widespread disruptions to our economy.”

Julie Russell, a representative of a school district in San Diego County, said teachers and other front-line education staff required attention because of “how many young lives each of them touch.”

And Charles Lee, president-elect of the American College of Correctional Physicians, said incarcerated people are of paramount concern because of the outbreaks that have torn through prisons.

There were also concerns about access in the first phase. A rural health advocate in Wisconsin said ultracold storage requirements and the batch size of the Pfizer vaccine, which is shipped in 975-dose allocations, threatens access beyond densely populated metropolitan areas.

Several members of the public warned about the pernicious effects of misinformation, asking the committee to develop a plan to combat false narratives about vaccination, particularly those targeting communities of color.