APWU HEALTH PLAN WILL COVER COVID-19 BOOSTER SHOTS AT 100% FOR MEMBERS

COVID-19 Vaccine Booster

When can I get a COVID-19 vaccine booster? Not immediately. The goal is for people to start receiving a COVID-19 booster shot beginning in the fall, with individuals being eligible starting 8 months after they received their second dose of an mRNA vaccine (either Pfizer-BioNTech or Moderna). This is subject to authorization by the U.S. Food and Drug Administration and recommendation by CDC’s Advisory Committee on Immunization Practices (ACIP). FDA is conducting an independent evaluation to determine the safety and effectiveness of a booster dose of the mRNA vaccines. ACIP will decide whether to issue a booster dose recommendation based on a thorough review of the evidence. 

If we need a booster dose, does that mean that the vaccines aren’t working? No. COVID-19 vaccines are working very well to prevent severe illness, hospitalization, and death, even against the widely circulating Delta variant. However, with the Delta variant, public health experts are starting to see reduced protection against mild and moderate disease. For that reason, the U.S. Department of Health and Human Services (HHS) is planning for a booster shot so vaccinated people maintain protection over the coming months.

Source: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html

For more information see links below: 

High Option: Go here
Consumer Driven Option: Go here or our COVID-19 Resource Center

FDA Review Finds J&J COVID Vaccine Safe, Effective

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WEDNESDAY, Feb. 24, 2021 (HealthDay News) — A single-shot coronavirus vaccine made by Johnson & Johnson completely prevented hospitalizations and deaths in a large clinical trial, a new review released Wednesday by the U.S. Food and Drug Administration found.

What would be the third vaccine to be authorized in the United States for emergency use could be approved as soon as this weekend, the Washington Post reported. The J&J vaccine was more than 85 percent effective at preventing severe illness, including in a region dominated by a concerning variant, but only 66 percent protective overall when moderate cases were included.

FDA scientists found the “known benefits” of the vaccine included reducing the risk of symptomatic and severe cases of COVID-19, at least two weeks after vaccination. The review found its efficacy against severe illness “was similarly high across the United States, South Africa, and Brazil.”

“We know this vaccine prevents 85 percent of the severe disease. . . . It was 100 percent effective in preventing hospitalization and deaths, and that’s really what’s important,” Nancy Bennett, a professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry, told the Post. “Those facts are the most important thing to recognize.”

The vaccine was less effective in a subgroup of adults older than 60 who also had risk factors for severe illness, but regulators noted there were no deaths or cases requiring medical intervention a month after those older adults received vaccines. Overall, there were seven deaths in the trial, all in the group that received a placebo shot, the Post reported.

An FDA advisory panel is set to meet Friday to recommend whether the FDA should authorize the shot for emergency use. 

Public health officials have eagerly awaited the arrival of the J&J vaccine because it can be stored in a refrigerator for several months, which should ease the challenges of distributing vaccines in sub-zero temperatures, and it doesn’t require a follow-up booster shot, the Post said.

Pfizer, Moderna say big jump in vaccine supply coming.

Officials from both Pfizer and Moderna delivered reassuring news about their COVID-19 vaccines to Congress on Tuesday: There will be a sharp rise in the delivery of doses in the coming month, and they will be able to provide enough doses to vaccinate most Americans by summer.

By the end of March, Pfizer and Moderna expect to have delivered a total of 220 million vaccine doses to the U.S. government, a significant uptick from the roughly 82 million doses that the U.S. Centers for Disease Control and Prevention says have shipped so far.

“We do believe we’re on track,” Moderna President Stephen Hoge told a House subcommittee after describing how the company has ramped up production. “We think we’re at a very good spot.”

That encouraging news comes as federal regulators plan to weigh the emergency use of a third COVID-19 vaccine, from Johnson & Johnson, later this week. The Biden administration said Tuesday that it expects about 2 million doses of that vaccine to be shipped in the first week after approval, and the company told lawmakers it should provide enough of the single-dose option for 20 million people by the end of March, the Associated Press reported.

By summer, Pfizer and Moderna said they expect to complete delivery of 300 million doses each, while J&J aims to provide an additional 100 million doses. That would be more than enough to vaccinate every American adult, the AP reported.

Two other manufacturers, Novavax and AstraZeneca, have vaccines in the pipeline and anticipate eventually adding to those totals, the AP said.

When asked whether they face shortages of raw materials, equipment or funding that would delay vaccine deliveries, all of the companies testified that they had enough supplies and had already addressed some early bottlenecks in production.

“At this point, I can confirm we are not seeing any shortages of raw materials,” said Pfizer’s John Young.

The U.S. vaccination campaign continues to accelerate after a sluggish start and recent disruptions caused by a series of brutal winter storms. But state health officials say demand for shots still outstrips the weekly shipments they are given by the federal government.

“The most pressing challenge now is the lack of supply of vaccine doses,” Rep. Diana DeGette, a Colorado Democrat, said as she opened the subcommittee hearing. “Some of the companies here today are still short of the number of doses they promised to initially deliver when they last testified before this subcommittee in July.”

Even with no further interruptions, other issues could still delay or block the United States from vaccinating 70% to 80% of its population — the critical threshold needed to neutralize the spread of coronavirus — by summer.

As of Wednesday, more than 65 million people had received at least one dose of a COVID-19 vaccine, including 19.8 million people who have received both doses, according to the CDC.

U.S. Sees 500,000 COVID deaths

President Joe Biden marked the once unthinkable milestone of half a million Americans lost to coronavirus with a somber, candlelit ceremony at the White House on Monday night.

“The people we lost were extraordinary,” Biden said. “They span generations. Born in America, immigrated to America. But just like that, so many of them took their final breath alone in America.”

The nation’s coronavirus death toll is now higher than in any other country in the world. It has surpassed early predictions of loss by some federal experts, and more Americans have died from COVID-19 than did on the battlefields of World War I, World War II and the Vietnam War combined, The New York Times reported.

The United States now accounts for about 20 percent of the world’s known coronavirus-related deaths, but makes up just 4.25 percent of the global population, the Times reported.

About 1 in 670 Americans has died of COVID-19, and it has become a leading cause of death in the country, along with heart disease and cancer, the Times said. The pandemic has also driven down life expectancy more drastically than seen in decades.

During the early days of the pandemic, Dr. Anthony Fauci, the nation’s top infectious disease expert, and Dr. Deborah Birx, the official coordinating the coronavirus response at the time, projected that even with strict stay-at-home orders, the virus might eventually kill as many as 240,000 Americans — a number that seemed unimaginable at the time.

Less than a year later, the virus has killed more than twice that number. It has spread to every corner of America, decimating both densely populated cities and rural counties.

In New York City, more than 28,000 people have died of the virus — or roughly 1 in 295 people. In Los Angeles County, the toll is about 1 in 500 people, the Times reported. In Lamb County, Texas, where 13,000 people live scattered across 1,000 square miles, the loss is 1 in 163 people.

The virus has torn through nursing homes and other long-term care facilities, which account for over 163,000 deaths, roughly one-third of the country’s death count.

Minorities have suffered far more than others during the pandemic: the coronavirus death rate for Black Americans has been almost two times higher than it is for white Americans, 2.3 times higher for Hispanics than for white Americans; and 2.4 times higher for Native Americans, the Times reported.

More information The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.     SOURCES: Associated Press; Washington Post; The New York Times; CBS News; CNN

COVID-19 Vaccines: Experts Answer Your Questions

WEDNESDAY, Dec. 9, 2020 (HealthDay News) — Two new COVID-19 vaccines, developed at record-setting speed, are soon to be assessed by U.S. agencies for emergency use in combating the ongoing pandemic.

Advisory panels of infectious disease experts this week will assess a vaccine developed by pharmaceutical company Pfizer and German biotech firm BioNTech — a vaccine that Britain began administering to its most vulnerable citizens on Tuesday. The committees will then turn their attention next week to a second vaccine developed by Moderna. Approval of either or both vaccines will begin the largest vaccination effort ever undertaken. The transition from hazy lab science to a very real vaccine-laden needle raises many questions for Americans. But experts have some answers:

When will the first Americans get their vaccines?
U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention advisory committees will review the Pfizer-BioNTech vaccine this week, and if the nod is given then the vaccine rollout could commence at startling speed, said Dr. William Schaffner, a professor of infectious disease with the Vanderbilt University Medical Center in Nashville, Tenn. “It could well be that the first people to get the vaccine could be within the next week or week and a half,” Schaffner said. Because Operation Warp Speed paid manufacturers to start producing doses even as their vaccine candidates underwent clinical trials, there will be stockpiles of both the Pfizer-BioNTech and Moderna vaccines that are ready to ship the second the green light is given, Schaffner said. Warp Speed paid Pfizer nearly $2 billion to manufacture and deliver 100 million doses, and Moderna received about $1.5 billion for 100 million doses of its vaccine. “We’ve stored a lot of vaccine already. It’s one of the reasons we were able to move so quickly. We didn’t wait until the trials were completed to start making and storing the vaccine,” Schaffner said.

Who’s in charge of distributing the vaccine?
Operation Warp Speed and the CDC will oversee national distribution of the vaccine, working in conjunction with the pharmaceutical companies, Schaffner said. However, each state’s health department will identify the specific locations that will receive the vaccine prior to individuals receiving their inoculation, Schaffner said. Because the first two vaccines are based on highly fragile messenger RNA (mRNA), they need to be kept frozen at extremely low temperatures. “The Pfizer vaccine has to be kept so cold, almost minus 100 degrees Fahrenheit, in really deep freeze, otherwise it begins to degrade,” Schaffner said. “It will be going to a relatively small number of institutions, usually hospitals, where they have the facilities to deal with that and they have personnel who can be trained to administer the vaccine.” Upcoming vaccine candidates produced using more traditional methods are expected to be more hardy, and those likely will be distributed directly to pharmacies and the offices of participating physicians, Schaffner said.

How quickly can the vaccine be produced?
One advantage of the mRNA vaccines produced by Pfizer-BioNTech and Moderna is that they are fully lab-manufactured, said Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “It’s a synthetic molecule. You just make it in the lab. You don’t have to worry about growing it up in cells, as is true for more classic vaccines,” Offit said. Because of this, Offit is hopeful that large amounts of these vaccines can be quickly churned out. “The Pfizer vaccine is a 30-microgram dose. A microgram is a millionth of a gram. You can make kilograms of this stuff,” Offit said.

However, there are 7.8 billion people in the world. Even with manufacturers working at a fast clip, it will take months to produce two doses for every adult on the planet. And the United States will have to wait in line with other nations competing for the same resource. Pfizer has told the Trump administration that, because other countries have rushed to buy up most of its supply, substantial additional doses above the 100 million the U.S. government purchased earlier this year will not be available to the United States until late June or July, the Washington Post reported Tuesday. Other vaccine candidates receiving approval in subsequent months could speed up efforts to immunize everyone, but at this point it’s not clear how soon those will receive their turn at bat. U.S. officials expect to have about 40 million doses of vaccines from Pfizer-BioNTech and Moderna distributed by the end of the year — just enough to immunize 20 million people with the two-dose vaccine, the Post said.

Who will get the vaccine first, and in what order?
The CDC has decided that health care workers and people working or living in long-term care facilities will be the first folks to get the COVID-19 vaccine. There are about 21 million health care workers and about 3 million people at long-term care facilities, so their inoculations will account for the first 48 million doses of the two-dose vaccine. It’s not clear who will be next in line. The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet in the coming weeks to make recommendations for the groups to be included in subsequent waves. The next phase of priority vaccinations could focus on essential workers such as educators, food and agriculture workers, utility workers, police, firefighters, corrections officers and transportation employees, according to a slideshow presented at the Dec. 1 meeting of the ACIP.

This represents about 87 million people, and also would promote vaccination among minority communities that have been hit hard by the pandemic, the Post reported. After that, people aged 65 and older (about 53 million) and adults with high-risk medical conditions (about 100 million) could be next in line for vaccination, the presentation noted. The CDC likely will decide as part of its rollout strategy which high-risk conditions should be placed at higher priority than others, Schaffner said. For example, health officials will have to weigh placing people with compromised immune systems like cancer patients and transplant recipients in line ahead of people with heart or lung ailments, diabetics or folks who are obese.

How will I know when it’s my turn and where I should go to get my shot?
Average folks probably will learn it’s their turn for the COVID-19 vaccine from their local media, Schaffner said. “State and local health departments will communicate that through TV, newspapers, radio and the like,” Schaffner explained. Health care workers are being advised by their employers that they will constitute the first wave of immunization, said Susan Mashni, chief pharmacy officer for the Mount Sinai Health System in New York City. “We’ve already started internally town halls and huddles and manager meetings with staff to let them know they’re going to be in the first wave of folks who are eligible,” Mashni said of Mount Sinai. Doctors who care for high-risk patients also are likely to promote outreach to those people when their turn comes, Mashni added. “We will be doing outreach to our patient population, to let them know they’re in that category and that we’ve received vaccine and are ready to accept the patients,” Mashni said. “Physician groups within Mount Sinai have been advocating for their patients, to make certain that when we’re getting the allocations that we’re aware who the highest risk patients are.”

Will I get some proof that I got the vaccine, like a vaccine certificate?
It’s expected that people who receive the COVID-19 vaccine will receive some sort of paperwork. The form of that documentation will be described in the emergency use authorization that each vaccine receives from the FDA, Mashni said. “I believe we’ll be giving people a card that shows the lot number of the vaccine they received,” Mashni said. “Then we’ll make certain at the time they get their first vaccine that they are also scheduled for their second vaccine.”  One important reason for this paperwork is that a person must get the same vaccine from the same manufacturer for their first and second doses, Mashni and Schaffner explained. The paperwork also will help health officials track vaccine distribution and make sure all doses are being efficiently disbursed, Schaffner added. “Every dose of vaccine will have to be accounted for,” Schaffner said. “The state health departments are going to be very tough about that. They will want to know that vaccine is not remaining unused in a refrigerator and they will want to know who received the vaccine, and which vaccine they received so that you can plan rigorously the second dose.”

How long will I have to wait between doses?
The good news is that Pfizer’s vaccine offers strong protection after the first dose, The New York Times reported. The efficacy of the vaccine after the first dose is about 52%, and after the second dose, that rises to about 95%. But you will have to wait three to four weeks between your first and second dose, depending on whether you get the Pfizer or Moderna vaccine. “If you miss and you come in later, no problem, you don’t have to repeat the first dose,” Schaffner said. “We just don’t want you to get the dose too soon. That’s not optimal for your immune system.”

If I’ve already had COVID-19, do I need to get the vaccine?
People who’ve had COVID-19 will need to receive the vaccine same as everyone else, Schaffner said. “They will be asked to stand in line and get a vaccine also,” Schaffner said. “There will be no distinction made, in part because we think there’s no adverse event that will occur, and also the protection from the vaccine actually may be more long-lived, of longer duration than that you get from the natural infection.” Coronaviruses are notorious for promoting short-lived immunity in humans, explained Dr. Greg Poland, director of the Vaccine Research Group at the Mayo Clinic, in Rochester, Minn. “With the four seasonal beta coronaviruses that circulate and cause all the upper respiratory infections you see in your practice, those people lose immunity in months to a year or two,” Poland said. That’s why people fall prey to the common cold again and again.

This happens because the body uses a relatively simple strategy to fight off common cold coronaviruses, and this strategy does not appear to make a lasting impression on immune system memory, Poland said. There’s a chance people who had asymptomatic or mild cases of COVID-19 did not build up any lasting immunity; at this point it is unclear what sort of immunity is conferred even by severe cases. More threatening coronavirus diseases like SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) appear to produce immunity that potentially lasts longer, but the data is limited because both viruses have infected far fewer people than COVID-19, experts said. “This virus is so new that we don’t know very much about levels of protection and their duration. We’re all together on this, learning as we go along,” Schaffner said.

How should I expect to feel after I get the vaccine?
The two-dose Pfizer-BioNTech and Moderna vaccines use what’s called a “prime/boost” strategy, Schaffner said. “The first inoculation kind of alerts the immune system, and it’s the second inoculation that really gets the immune system worked up,” Schaffner said. People should not be surprised if they feel under the weather after receiving either dose, but especially the booster, Schaffner and Offit said. “When your immune response is activated you have certain symptoms, which can be things like low-grade fever, headache, muscle ache and fatigue, enough so that you could actually miss a day of work,” Offit said. “I wish the immune system had a better public relations team working for it. This is just a natural consequence of having an activated immune system.” When it’s your turn to get either dose, make sure you don’t make any plans for the next day, Schaffner advises. “This is not COVID. This is merely the immune system revving up and responding to the vaccine. But it is sufficient that some people might not want to go to work that next day,” Schaffner said. Hospitals are taking this into account when scheduling vaccinations for their employees, Offit said. “You’re not going to vaccinate your whole emergency department and have them potentially be out the next day,” Offit said.

Do I get to resume normal life after receiving the vaccine?
Vaccination might produce delightful thoughts of throwing your mask away and hugging dear friends, but you will have to resist the urge. People will still need to maintain infection control habits even after they’ve received their shots. “The trials have shown us that the vaccine prevents the occurrence of disease and severe disease. They were not designed to tell us whether it prevents infection,” Schaffner said. Given that, a person who received the vaccine might well be able to spread the novel coronavirus even though their risk of falling seriously ill with COVID-19 is low. “You could be infected and you could be contagious even though you had the vaccine,” Schaffner said. “We don’t know that, but we don’t know it’s not true. We are going to ask everyone to keep masking and observing social distancing until we are complete.”

How many Americans will need to be immunized before we achieve herd immunity?
The COVID-19 coronavirus has a transmission rate greater than three, meaning that every infected person can be expected to spread the virus to three other folks unless infection control measures are maintained. “The goalpost for herd immunity has to be fairly high because this is a highly contagious virus,” Schaffner said. “I would anticipate around 70%. That is a very high goal post, trying to get 70% of the United States population vaccinated to really flatten the curve of transmission.”

More information
The U.S. Food and Drug Administration has more about COVID-19 vaccines https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines

SOURCES: William Schaffner, MD, professor, infectious disease, Vanderbilt University Medical Center, Nashville, Tenn.; Paul Offit, MD, director, Vaccine Education Center, Children’s Hospital of Philadelphia; Susan Mashni, PharmD, chief pharmacy officer, Mount Sinai Health System, New York City; Greg Poland, MD, director, Vaccine Research Group, Mayo Clinic, Rochester, Minn.