Four California universities missed out on $47 million more in coronavirus aid. Heres why – CalMatters

Four California universities missed out on $47 million more in coronavirus aid. Heres why – CalMatters

Coding for COVID-19 Vaccine Shots | CMS

Coding for COVID-19 Vaccine Shots | CMS

December 16, 2021

After the FDA issues an emergency use authorization (EUA) or approveslicensure of each COVID-19 vaccine product, CMS will identify the following for Medicare payment:

CMS and the American Medical Association (AMA) collaborated on a new approach to report use of COVID-19 vaccines.If you planto administer the COVID-19 vaccinesor the monoclonal antibody infusions, especially if you plan to roster bill these codes,download and install the newest release of PC-ACE (PDF). This release includes the coding structure, currently comprised of both of these:

Together, these codes support the administration of the COVID-19 vaccines and the monoclonal antibody infusions, as they become available. CMS and the AMA developed this code structureto make claims processingfor COVID-19 vaccines and monoclonal antibody infusions that get FDA EUA or FDA approval more efficient. Most of these codes aren't currently effective and we won't use all codes.We'll issue specific code descriptors in the future.Medicare effective dates for the codeswill match with the date of the FDA EUA or FDA approval.

Get the most current list of billing codes, payment allowances and effective dates.

Use HCPCS Level II code M0201 for the additional payment for administering the COVID-19 vaccine to certain Medicare patients in their homes.


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Coding for COVID-19 Vaccine Shots | CMS
Nurse reflects on being first to receive COVID-19 vaccine in El Paso one year ago – cbs4local.com
Explaining the New COVID-19 Vaccination Requirement for Health Care Provider Staff – Kaiser Family Foundation

Explaining the New COVID-19 Vaccination Requirement for Health Care Provider Staff – Kaiser Family Foundation

December 16, 2021

On November 5, 2021, the Centers for Medicare and Medicaid Services (CMS) published regulations that established the first ever federal vaccination requirements for health care provider staff. Drawing on its authority to establish patient health and safety standards, CMSs regulations require health care providers that participate in the Medicare and/or Medicaid programs to ensure that their staff are fully vaccinated against COVID-19. The new rule applies to staff who provide any care, treatment, or other services for providers or patients, including contractors and volunteers. The first phase of the new regulations was to take effect on December 6, 2021, with staff required to have received their first vaccine dose or requested an exemption by that date. However, the new regulations have been put on hold by federal courts, and the pending lawsuits create uncertainty about whether the new requirements ultimately will be implemented. This issue brief examines the new regulations, explains the status of the pending litigation, and identifies issues to watch.

CMS says it decided to require health care staff to be vaccinated because its earlier efforts to simply encourage vaccination have been insufficient to protect patient health and safety. For example, CMS cites data showing that COVID-19 cases in nursing homes surged with the rise of the Delta variant. The nursing home staff vaccination rate is nearly 76% nationally as of November 2021, with substantial variation by region. CMS concluded that standard federal requirements across provider types are needed because the existing patchwork of state and employer requirements has not been enough to bring the pandemic under control in health care settings. CMS notes that the vaccines are safe and highly effective at preventing severe illness and death, and unvaccinated staff can strain the health care system by transmitting COVID-19 to patients and having to miss work if they are recovering from COVID-19 or quarantining after exposure. CMS acknowledges that some staff may leave their jobs because they do not want to receive the vaccine but cites examples of vaccine mandates adopted by health systems in Texas and Detroit and a long-term care parent corporation with 250 facilities as well as the New York state health care worker mandate, all of which resulted in high rates of compliance and few employee resignations.

In response to the new regulations, 26 states led by Republican officials filed four federal lawsuits challenging the new rules (Table 1). While the specific legal claims vary somewhat among the different cases, the states essentially raise four major arguments. First, the states challenge the process that CMS used to adopt the new rules, arguing that CMS did not have good cause to forgo public notice and comment under the Administrative Procedure Act (APA). The states also argue that CMSs authority to establish health and safety regulations for Medicare and Medicaid providers does not allow it to adopt a broad vaccine requirement. And, they assert that CMSs new rule is arbitrary and capricious under the APA because CMS did not appropriately consider factors such as potential staffing disruptions, the limitations of vaccines, and the benefits of natural immunity. Finally, the states contend that the new rules violate Constitutional principles about the appropriate balance between federal and state government power. For example, the states argue that the rules place new conditions on state receipt of federal funds in violation of the Constitutions Spending Clause. The states also argue that the new rules improperly force states to administer federal regulations and unconstitutionally infringe on the states police powers to regulate for public health and safety.

On 12/13/21, the 8th Circuit in a 2:1 order denied CMSs motion to lift the preliminary injunction pending appeal.

On 12/6/21, the 11th Circuit in a 2:1 decision denied FLs motion for an injunction pending appeal.

Currently, CMS is unable to enforce the new rules nationwide, as a result of court orders, though circumstances may change as cases are appealed. To date, the 8th Circuit Court of Appeals has ruled that a Missouri federal courts decision preventing CMS from enforcing the new rules should remain in place while the appeal in that case is pending. Additionally, a federal court in Louisiana has blocked the new rules, while the 11th Circuit Court of Appeals has affirmed a Florida federal courts decision that the new regulations can be implemented while litigation is pending. (A fourth case in Texas federal court is on hold, pending further court action in the Louisiana case.) The Missouri courts preliminary injunction blocking the new rules applies in the 10 states that brought that case. However, the Louisiana court went further, applying its preliminary injunction not only to the 14 states in the case before it but also to all other states (except the 10 states in the Missouri case). This means that the new rules are now on hold even in states that did not challenge them. The Louisiana decision also put the new rules on hold in Florida, despite the Florida courts decision that the new rules should go into effect. However, as the 11th Circuit points out in its review of the Florida decision, the Louisiana decision could be changed when it is reviewed by the 5th Circuit on appeal. Specifically, the 11th Circuit found that it is reasonably likely that the 5th Circuit will conclude that the Louisiana court should not have applied its decision nationwide, even if the 5th Circuit ultimately upholds the Louisiana courts decision to block the new rules in the 14 states that brought the Louisiana case.

Court decisions in the lawsuits to date demonstrate opposing views about the scope of CMSs authority to respond to the pandemic and what constitutes the publics interest (Table 2). The 11th Circuits decision defers to the agencys expertise in the face of an unprecedented pandemic and notes that accepting Floridas arguments in opposition would amount to substituting the states views on epidemiology for the Secretarys judgment about the best way to protect the public from infection. By contrast, the Missouri and Louisiana courts fault the agency for not giving more credence to the arguments advanced by states that oppose CMSs rule. When articulating the publics interest in these issues, the 11th Circuit emphasizes the publics interest in slowing COVID-19 spread and protecting patients from preventable infection, while the Missouri and Louisiana decisions emphasize the publics interest in being free from vaccine requirements. The Louisiana courts characterization of the public interest is notable in light of its ultimate decision to block the rule in states that are not part of the litigation. The Louisiana court says that it entered a nationwide ruling because there are unvaccinated healthcare workers in other states who also need protection, though it does not discuss other aspects of the public interest, which may favor the rule.

The fate of CMSs new rules may ultimately be determined by the Supreme Court. The preliminary injunctions blocking implementation of the rules issued by Missouri and Louisiana courts currently are awaiting review on appeal by the 8th and 5th Circuits, respectively. If one or both appeals courts affirms the preliminary injunction, that decision would conflict with the 11th Circuits conclusion that the rule should not be blocked. A conflict among different appeals courts could increase the likelihood of the Supreme Court stepping in. As litigation to determine CMSs authority to mandate health care provider vaccines as part of its pandemic response continues to play out, the emergence of the Omicron variant is raising new questions about the pandemics future course. This development likely will further challenge CMS as it seeks to adopt policies to bring the pandemic under control which ultimately could prove successful but may never be implemented if courts decide to limit the agencys authority.

MO* and LA courts(granting preliminary injunction)

(A) Did CMS have good cause to issue the rule as interim final and bypass public notice and comment?

(B) Is CMSs rule within its authority to regulate Medicare and Medicaid as delegated by Congress?

(C) Is CMSs rule arbitrary and capricious?

(D) Does the new rule inappropriately infringe on state power?

(B) No. Though Congress has given CMS general authority to issue regulations about Medicare and Medicaid patient health and safety, CMS needs clear authorization to adopt a vaccine mandate because this involves powers of vast economic and political significance.

(C) Yes. CMS acknowledges that the extent to which vaccines prevent COVID-19 spread and their long-term effectiveness are unknown. CMS should not have used evidence about COVID-19s impact on long-term care facilities to extrapolate about effects on other providers that do not care for vulnerable patients. CMSs rule is too broad because it acknowledges that children are less affected by COVID-19 but subjects pediatric facilities to the new rule. CMS did not appropriately consider alternatives such as testing or natural immunity or the harm the rule will cause by exacerbating worker shortages.

(D) The preliminary injunction decisions do separately analyze this issue in detail, though the LA court notes that the rule infringes on state power because it specifically preempts state law.

(B) Yes. Federal law expressly authorizes CMS to establish Medicare and Medicaid provider health and safety standards. Congress did not need to be more specific because until now, vaccination has not been a political issue and instead has been regarded as a common-sense measure designed to prevent healthcare workers, whose job it is to improve patients health, from making them sicker.

(C) No. The court should defer to CMSs decision about how to best protect patients, which is supported by ample evidence. CMS cites evidence showing that health care workers respond to mandates by getting vaccinated instead of leaving their jobs.

(D) While not separately analyzed by the 11th Circuit, the court notes that federal law preempts conflicting state law.


Read more here: Explaining the New COVID-19 Vaccination Requirement for Health Care Provider Staff - Kaiser Family Foundation
Wisconsin hospitals are holding off on requiring COVID-19 vaccine boosters, even facilities with vaccine mandates – Wisconsin Public Radio News

Wisconsin hospitals are holding off on requiring COVID-19 vaccine boosters, even facilities with vaccine mandates – Wisconsin Public Radio News

December 16, 2021

As hospitals fill up, public health officials in Wisconsin have renewed their pleas for people to get vaccinated against COVID-19 and also receive a booster shot.

Whether additional shots are voluntary or mandatory is something hospitals are now deciding for their employees,as research begins to show boosters increase protection against the new omicron variant.

Some large national organizations have already mandated boosters.

On Monday, the National Football League announced some team staff who work closely with players will have to get a booster.

This summer, as the delta variant pushed COVID-19 cases upward, hospitals around the state started requiring staff to get vaccinated to protect their workforce and vulnerable patients.

In June, SSM Health, a regional health care system with hospitals in Wisconsin and three other states, was the first in the state to announce itwould require its employees to be vaccinated.

SSM Health does not currently require booster shots for staff.

"Our Infectious Disease and Employee Health teams continue to monitor the situation, but at this time no changes have been made to our policy or definition of fully vaccinated," Lisa Adams, a spokesperson with SSM Health, told Wisconsin Public Radio.

UW Health has hospitals and clinics across the state and northern Illinois. It has a COVID-19 vaccine mandate, but does not require staff to get a booster.

Stay informed with WPR's email newsletter.

"We do not currently require staff to get boosters as part of our vaccine mandate. We do however, strongly encourage it and thousands of our employees have already received a booster of the COVID-19 vaccine," Emily Kumlien, UW Health press secretary, said.

Marshfield Clinic, which operates in northern, western and central Wisconsin, is also not requiring boosters at this time, said John Gardner, director of communications.

While some hospitals in the state had high vaccination rates among staff before mandating COVID-19 shots, the requirement has not been accepted as readily at other health care facilities, especially nursing homes.

Theres concern a booster requirement could prompt staff to leave or be fired at a time worker shortages are widespread. Rural hospitals in Wisconsin that havent required employees to be vaccinated against COVID-19 say they expect mandates will require many workers to quit.

But a recent survey by the Wisconsin Office of Rural Health found very little attrition. As WPR reported, hospitals that had not required workers to get vaccinated estimated they would lose more than 20 percent of their staff if they did so. But those with a COVID-19 vaccine requirement reported between zero and 4 percent of staff had actually resigned as a result of the mandate.

State and local health officials have recommended everyone over age 16 and older get a COVID-19 booster shot. As of Wednesday, 1.3 million people in Wisconsin had received a booster or additional dose.

A study out of Israel published in the New England Journal of Medicine last week compared those whove had two doses of vaccine to those who also got a booster. The latter were 10 times less likely to get COVID-19 than those who were vaccinated but not boosted. And the boosted group was also 18 times less likely to get severe infection.

"These numbers are really quite staggering. The vaccine is very effective. But the protection thats added from that booster is really critical," said Dr. Ben Weston, an associate professor at the Medical College of Wisconsin and health policy advisor for Milwaukee County.


Continued here:
Wisconsin hospitals are holding off on requiring COVID-19 vaccine boosters, even facilities with vaccine mandates - Wisconsin Public Radio News
Opinion: With a year of data, it’s clear the COVID-19 vaccine is safe – Detroit Free Press

Opinion: With a year of data, it’s clear the COVID-19 vaccine is safe – Detroit Free Press

December 16, 2021

Susan Grant| Detroit Free Press

Ive been vaccinated against COVID-19 now for one full year. I recently obtained my booster shot. There is a lot of misinformation out there about the side effects, and consequences of getting vaccinated. As the Executive Vice President and Chief Nursing Officer of Beaumont Health, let me set the record straight.

Myth: You will become magnetic or microchipped if you get vaccinated.

Fact: I was one of the very Michigan residents to receive the first authorized COVID-19 vaccine last December 2020. For a full year now, Ive navigated my life, and there is absolutely no truth to the idea that these vaccines contain any form of tracking devices.

Myth: The vaccines dont work. Look at how many cases there are today.

Fact: Vaccines are not meant to completely prevent transmission. Vaccines reduce your risk of getting ill if you come in contact with a virus, and in the event that you do become ill, the hope is that you have a very mild case, rather than a debilitating long infection or death. If you look at our current COVID patients, the vast majority of those 76% are unvaccinated. Of those cases, the majority of those who are hospitalized with a severe illness are also unvaccinated 87% of COVID ICU patients and 88% of COVID ventilator patients are unvaccinated.

Myth: The vaccines cause a virus to mutate leading to new variants.

Fact: Vaccines do not cause variants. In fact, the truth is almost completely opposite. Not vaccinating allows a virus to spread in the unvaccinated population. Viruses naturally undergo an ongoing mutation process. The more opportunities a virus has to spread, the more opportunities it has to mutate or change. The higher we can get our vaccination rate, the more coverage will exist in our communities preventing spread and ultimately preventing mutation. Omicron is the latest result of this spread and mutation and will not be our last.

For every myth that exists about these vaccines, there are mountains of data to the contrary. It seems almost impossible to ask residents to cut through the clutter on their own. So as a health care professional with 38 years of clinical patient care experience, please believe me when I tell you this: The COVID-19 vaccine is safe and its effective. It is keeping people out of the hospital, preventing serious illness, and reducing spread between vaccinated residents. And as someone who is fully vaccinated along with more than 6 million Michiganders and 198 million Americans I can confidently tell you that its safe.

It is exhausting and discouraging to watch people fight for their lives against a disease that is now largely preventable. Our resources as health care professionals are finite and maxed out. Our hospitals are overwhelmed, and our workforce is exhausted and burned out so much so, that we have requested the support of the military to help in our hospitals. Please, go get your COVID vaccine as soon as possible. Your health and the lives of others depend on it.

Susan Grant is executive vice president and chief nursing officerat Beaumont Health.


See the original post: Opinion: With a year of data, it's clear the COVID-19 vaccine is safe - Detroit Free Press
Next steps a year after first COVID-19 vaccine, a spacecraft touches the sun: 5 Things podcast – USA TODAY

Next steps a year after first COVID-19 vaccine, a spacecraft touches the sun: 5 Things podcast – USA TODAY

December 16, 2021

On today's episode of the 5 Things podcast:A year after first COVID-19 vaccine, here's what's next for researchers

Patient safety reporter Karen Weintraubexplains. Plus, the EPA is warning about a cancerouschemicalfound in water, a spacecraft touches thesun, money reporter Terry Collins recommends giving stocks as a holiday gift to kids and 'Spider-Man: No Way Home' hits theaters.

Podcasts: True crime, in-depth interviews and more USA TODAY podcasts right here.

Hit play on the player above to hear the podcast and follow along with the transcript below. This transcript was automatically generated, and then edited for clarity in its current form. There may be some differences between the audio and the text.

Taylor Wilson:

Good morning, I'm Taylor Wilson. And this is 5 Things you need to know Thursday, the 16th of December, 2021. Today, what's next a year after the first COVID-19 vaccine. Plus, a spacecraft touches the sun and more.

Here are some of the top headlines:

We're just past the one year mark since the first COVID-19 vaccine. In the month since, tons of progress has been made, including promising research on boosters to add protection to initial doses. So as the omicron variant continues to worry, people want to know what's next. Patient safety reporter Karen Weintraub is here to answer some of those questions.

Karen Weintraub:

So a couple of things, the first is they're going to come up with some variant specific vaccines. And that means a vaccine that can fight is targeted directly at omicron, for instance. It's not clear yet whether we need one. The vaccines do seem to be holding up we think, at least in lab studies. But if not omicron, there's going to be another one down the road. So they're trying to make sure that they can fight a specific variant if necessary. After that, then they're going to try to come up with a vaccine that combats all the variants or a wide range of variants. And then after that, they're going to try to fight all coronaviruses or all in a certain class. So we've had three different pandemics from coronaviruses since 2003. There was the original SARS, MERS, which is mostly in the Middle East, and then this one. And so the concern is that there may be another. And so they want to come up with a vaccine first that can prevent all of those possibilities.

The biggest challenge is going to be to go after a variety of different types of viruses, provide effective and durable protection against a wide range of viruses. And there's just a ton of scientific challenges there. The other challenge of course that they're facing is acceptance. As we've seen with the COVID vaccine, not everybody is willing to take them, and vaccines are useless unless people take them.

So right now, our only option is a needle in the arm, which a lot of people don't like. So at some point, not entirely clear when these are coming, but there was a study that started this week of a vaccine that's delivered by air. It's like shot into your arm with a puff of air. And then there are going to be potentially some nasal vaccines where you just like a nasal spray that coats the inside, the mucosal lining of your nose and sinuses. And then there may be something that goes on almost like a bandaid where you push into your skin and these tiny, tiny needles, so small you can't even feel them, will inject the vaccine into your arm. So hopefully, that'll help for people who are uncomfortable with needles.

Taylor Wilson:

The US passed 800,000 COVID-19 deaths this week, part of more than 5.3 million COVID deaths around the world.

The Environmental Protection Agency is moving to update health advisories after new documents show a chemical found in drinking water is likely a carcinogen. The chemical called PFOA has essentially no safe level of exposure. PFOA and similar chemicals are in the blood of 98% of Americans and small amounts are in drinking water across the country. New EPA documents also affirm findings that the chemicals are driving up kidney cancer rates and weakening immune systems. The EPA may require water utilities to filter out detectable amounts of PFOA or could decide that the cost of doing so outweigh the benefits. The agency will hold its first public hearing on the process later today.

For the first time in history, a spacecraft has touched the sun. NASA announced this week that its Parker Solar Probe has flown through the sun's upper atmosphere or corona, and sampled particles and magnetic fields there that happened in April during the craft's eighth close approach to the sun. But scientists said it took a few months to get the data back and several more months to confirm it. At its closest approach, the front of the probe's solar shield endured temperatures approaching 2,500 degrees Fahrenheit. The $1.6 billion mission aims to bring more information about our solar system and could also help learn more about other stars, too. Plus it can help improve space weather forecasts that impact life on earth. The probe initially launched in 2018.

Popular gifts for kids every holiday season range from the latest video game console to Legos and Barbies, but there's one present that's a bit out of the box. Money and Tech reporter Terry Collins explains how giving stocks to your kids is not just for the wealthy and it's one gift that supply chain issues cannot ruin.

Terry Collins:

Well, I think it's better probably maybe some ways, according toexperts, better for over the long haul instead of getting the latest thing, whether it be a smartphone, gaming console or some other electronic device. In terms of stocks, they mature as the child matures. They can grow over time. It has the ability to maybe make something as a good gift to use for educational purposes, maybe paying for a private school tuition or college tuition. Or if proper planning goes, maybe it could be something that's a pre-retirement fund that can just age as they are. It's in some ways seemingly a viable alternative. It's smart. After talking to some of the experts, I think it's something that, wow, it feels like the younger the child is, the earlier the better.

And it just seems like one of the more smarter gifts you can get if you're thinking of not messing up, getting a child something for Christmas beyond a gift card. It seems like it's a wise, long term investment. And for those who give, it's a bit tax benefit as well. You can give up to $15,000 and not pay taxes on it. So I just find it to be one of the more smart options to consider giving kids for Christmas. Theymay not appreciate it now, but give a few years, I think they'd have a different perspective on it.

If you consider giving stock, talk to someone ahead of time like a planner. I know we only have about 10 days left before Christmas, but you can actually do this through December 31st. So you have a little more time. Make sure that it's something that is planable and feasible for both you and the young person you're giving it to. There's exclusions you can take advantage of, but it's got to be all given and made before December 31st.

Taylor Wilson:

For more, search "stocks gift" on USATODAY.com.

Spider-Man: No Way Home is here.

Tom Holland as Peter Parker:

Ever since I got bit by that spider, I've only had one week where my life has felt normal. That was when you found out.

Taylor Wilson:

The movie picks up where 2019's Far from Home left off. Peter Parker played by Tom Holland has to deal with the fallout after his secret identity as Spider-Man gets leaked to the world. Benedict Cumberbatch is also back as Dr. Strange to help him out and some familiar villains from past Spider-Man franchises make appearances. Spoiler alert:Willem Dafoe as Green Goblin and Alfred Molina as Doc Ock. Our movie critic Brian Truitt was a big fan of the new movie, giving it three and a half out of four stars.

And we ask for a five star review if you're listening to 5 Things on Apple Podcasts. You can also find the show wherever you like to find your pods, seven mornings a week. Thanks as always to PJ Elliott for his great work on the show. And I'm back tomorrow with more of 5 Things from USA TODAY.


View original post here: Next steps a year after first COVID-19 vaccine, a spacecraft touches the sun: 5 Things podcast - USA TODAY
COVID-19 vaccine requirements: Why U.S. doctors are fighting for them – American Medical Association

COVID-19 vaccine requirements: Why U.S. doctors are fighting for them – American Medical Association

December 16, 2021

With federal health officials warning that the SARS-CoV-2 Omicron variant is already spreading quickly in the U.S. and is likely to peak with a huge caseload in January, American doctors are redoubling their support for COVID-19 vaccinationand vaccine requirementsas the best way to save lives and keep patients out of the hospital.

The scientific experts at the Centers for Disease Control and Prevention say that booster doses can effectively fight the Omicron variant, which now has joined the SARS-CoV-2 Delta variant in a kind of tag team of viral attack.

That is just one huge reason why the AMA is continuing its legal efforts in support of policies that require widespread COVID-19 vaccination. In a newly filed set of amicus briefs, the AMA urged the 6th and 11th U.S. Circuit Courts of Appeals to stay lower-court orders denying enforcement of theSafer Federal Workforce Task Forces Guidance for Federal Contractors and Subcontractors.

The AMA-led amicus briefs inKentucky v. BidenandGeorgia v. Bidenwere joined by more than a dozen leading medical organizations representing family doctors, pediatricians, allergists and immunologists, clinical pathologists, and more. They all recognize COVID-19 as a grave danger to public health and support widespread vaccination requirements as the most effective strategy to end the COVID-19 pandemic.

Halting enforcement of the guidance requiring federal contractor vaccination would severely and irreparably harm workers and undermine the public interest, the briefs noted. Vaccines provide a safe and effective way to protect against transmission of COVID-19 in the workplace and across the nation, as shown by a body of well-regarded scientific evidence from rigorous clinical trials.

The AMA has alsofiled several briefsin courts around the country in support of theemergency temporary standardissued by the Occupational Safety and Health Administration (OSHA) to protect the health and safety of U.S. workers, families and communities across the nation.

The AMA has been tracking the need for COVID-19 vaccine requirements since the three safe and effective vaccines that have been authorized or approved in the U.S. became widely and easily accessible across the country at no cost to patients. Find below a few of the AMAs best news articles supporting the case for COVID-19 vaccination requirements.

The AMA recognizes the critical importance of scientific integrity, transparency and public trust in the fight to contain the global spread of COVID-19. Stay updated with the AMA on COVID-19 and vaccine development.


Here is the original post: COVID-19 vaccine requirements: Why U.S. doctors are fighting for them - American Medical Association
How effective are COVID-19 vaccines against omicron? – PBS NewsHour

How effective are COVID-19 vaccines against omicron? – PBS NewsHour

December 16, 2021

The pandemic has brought many tricky terms and ideas from epidemiology into everyones lives. Two particularly complicated concepts are vaccine efficacy and effectiveness. These are not the same thing. And as time goes on and new variants like omicron emerge, they are changing, too.

Melissa Hawkins is an epidemiologist and public health researcher at American University. She explains the way researchers calculate how well a vaccine prevents disease, what influences these numbers and how omicron is changing things.

A vaccine activates the immune system to produce antibodies that remain in your body to fight against exposure to a virus in the future. All three vaccines currently approved for use in the U.S. the Pfizer-BioNTech, Moderna and Johnson & Johnson vaccines showed impressive success in clinical trials.

All new vaccines must undergo clinical trials in which researchers test the vaccines on thousands of people to examine how well they work and whether they are safe.

Efficacy is the measure of how well a vaccine works in clinical trials. Researchers design the trials to include two groups of people: those who receive the vaccine and those who receive a placebo. They calculate the vaccines efficacy by comparing how many cases of the illness occur in each group, vaccinated versus placebo.

Effectiveness, on the other hand, describes how well a vaccine performs in the real world. It is calculated the same way, by comparing illness among vaccinated and unvaccinated people.

Efficacy and effectiveness are usually close to each other but wont necessarily be the same. How the vaccines work will vary a bit from the trial results once millions of people are getting vaccinated.

Many factors influence how a vaccine performs in the real world. New variants like delta and omicron may change things. The number and age of people enrolled in the trials matter. And the health of those receiving the vaccine is also important.

Vaccine uptake the proportion of a population that gets vaccinated can also influence vaccine effectiveness. When a large enough proportion of the population is vaccinated, herd immunity begins to come into play. Vaccines with moderate or even low efficacy can work very well at a population level. Likewise, vaccines with high efficacy in clinical trials, like coronavirus vaccines, may have lower effectiveness and a small impact if there isnt high vaccine uptake in the population.

The distinction between efficacy and effectiveness is important, because one describes the risk reduction achieved by the vaccines under trial conditions and the other describes how this may vary in populations with different exposures and transmission levels. Researchers can calculate both, but they cant design a study that will measure both simultaneously.

Both Pfizer and Moderna reported that their vaccines demonstrated more than 90% efficacy in preventing symptomatic COVID-19 infection. Stated another way, among those individuals who received the vaccine in the clinical trials, the risk of getting COVID-19 was reduced by 90% compared with those who did not receive the vaccine.

Imagine conducting a vaccine trial. You randomize 1,000 people to receive the vaccine in one group. You randomize another 1,000 to be given a placebo in the other group. Say 2.5% of people in the vaccinated group get COVID-19 compared with 50% in the unvaccinated group. That means the vaccine has 95% efficacy. We determine that because (50% 2.5%)/50% = .95. So 95% indicates the reduction in the proportion of disease among the vaccinated group. However, a vaccine with 95% efficacy does not mean 5% of vaccinated people will get COVID-19. Its even better news: Your risk of illness is reduced by 95%.

Vaccine effectiveness is calculated the exact same way but is determined through observational studies. Early on, vaccines were well over 90% effective at preventing severe illness in the real world. But, by their very nature, viruses change, and this can change effectiveness. For example, a study found that by August 2021, when delta was surging, the Pfizer vaccine was 53% effective at preventing severe illness in nursing home residents who had been vaccinated in early 2021. Age, health issues, waning immunity and the new strain all lowered effectiveness in this case.

New variants of the coronavirus are all slightly different from the original strain that vaccines were based on, so immunity to variants may be different. Alexey Solodovnikov, Valeria Arkhipova/WikimediaCommons, CC BY-SA

The preliminary data about omicron and vaccines is coming in quickly and is revealing lower vaccine effectiveness. Best estimates suggest vaccines are around 30%-40% effective at preventing infections and 70% effective at preventing severe disease.

A preprint study one not formally reviewed by other scientists yet that was conducted in Germany found that antibodies in blood collected from people fully vaccinated with Moderna and Pfizer showed reduced efficacy in neutralizing the omicron variant. Other small preprint studies in South Africa and England showed a significant decrease in how well antibodies target the omicron variant. More breakthough infections are expected, with decreased immune system ability to recognize omicron compared with other variants.

Initial data reinforces that a third dose would help boost immune response and protection against omicron, with estimates of 70%-75% effectiveness.

Pfizer has reported that people who have received two doses of its vaccine are susceptible to infection from omicron, but that a third shot improves antibody activity against the virus. This was based on lab experiments using the blood of people who have received the vaccine.

Booster doses can increase the amount of antibodies and the ability of a persons immune system to protect against omicron. However, unlike the U.S., much of the world does not have access to booster doses.

Despite the lowered effectiveness of vaccines against omicron, it is clear that vaccines do work and are among the greatest public health achievements. Vaccines have varying levels of effectiveness and are still useful. The flu vaccine is usually 40%-60% effective and prevents illness in millions of people and hospitalizations in more than 100,000 people in the U.S. annually.

Finally, vaccines protect not only those who are vaccinated, but those who cant get vaccinated as well. Vaccinated people are less likely to spread COVID-19, which reduces new infections and offers protection to society overall.

This article is republished from The Conversation under a Creative Commons license. Read the original article.


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How effective are COVID-19 vaccines against omicron? - PBS NewsHour
Eagle COVID-19 vaccine clinics now offered Mondays and Thursdays – Vail Daily

Eagle COVID-19 vaccine clinics now offered Mondays and Thursdays – Vail Daily

December 16, 2021

Vail Health and its partner, Colorado Mountain Medical, are increasing the opportunities for community members to receive COVID-19 vaccines and vaccine boosters by offering two vaccine clinic days at the Colorado Mountain Medical location in Eagle (0377 Sylvan Lake Rd). COVID-19 vaccine clinics will be held on Mondays and Thursdays beginning Dec. 20, 2021, until further notice.

With the growing presence of the Omicron variant in our state and the country, it is more important than ever to get vaccinated and receive a booster shot, said Chris Lindley, chief population health officer at Vail Health. COVID-19 is here to stay, and we will continue to see variants emerge as winter continues. Receiving a COVID-19 vaccine is vital to us protecting our community as a whole and helps reduce the severity of COVID-19 if someone gets the virus.

All approved COVID-19 vaccines will be available, and the clinic will serve walk-in patients only. No appointments are required. Vaccine clinics will be for anyone age 5 or older. Patients seeking a booster shot are required to bring their COVID-19 vaccination card.

Our Thursday vaccine clinics have seen an increasingly high volume of people and adding a vaccine clinic weekly on Mondays allows us to more efficiently address the demand, specifically for booster shots, that we are experiencing in our community, said Shannatay Bergeron, director of specialty care services for Colorado Mountain Medical. This demand is welcome, and we are eager to vaccinate as many people in our community as possible.

In addition to the weekly vaccine clinics, the Pfizer vaccine for children between the ages of 5 and 11 is offered at the Colorado Mountain Medical Vail, Avon and Eagle locations within various child appointments available. Should a parent want a vaccine consultation appointment to ask their physician questions, they are welcome to schedule with a provider.

We cannot stress enough the importance of being fully vaccinated including a booster as we head into the peak of the winter season, said Dr. Brooks Bock, chief executive officer of Colorado Mountain Medical. Everyone over the age of 5 within our community should be vaccinated against COVID-19, and everyone over the age of 6 months should also be vaccinated against influenza. Colorado Mountain Medical providers are available to help our patients be prepared for the unknown months ahead.

Vail Health and Colorado Mountain Medical also offer six COVID-19 testing locations throughout the Eagle River Valley, in addition to tests conducted by a primary care physician at Colorado Mountain Medical. For a full list of testing locations and instructions visit: vailhealth.org/covid-19/covid-19-testing.


Read more:
Eagle COVID-19 vaccine clinics now offered Mondays and Thursdays - Vail Daily
COVID-19 vaccines may be less effective against Omicron – WHO – Reuters

COVID-19 vaccines may be less effective against Omicron – WHO – Reuters

December 16, 2021

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COVID-19 vaccines may be less effective against Omicron - WHO - Reuters