Category: Covid-19 Vaccine

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

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.

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

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.

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

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

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.

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

December 15, 2021

Physicians are reminded that the Centers for Medicare and Medicaid Services (CMS) will change the way physicians bill and are paid for COVID-19 vaccine administration services for Medicare Advantage enrollees effective January 1, 2022. For Medicare Advantage patients vaccinatedon or afterJanuary 1, 2022, COVID-19vaccine administration claims should be submittedto the patients Medicare Advantage plan.Fee-for-service (FFS) Medicare will no longer paythese claims.

Currently and for services provided through the end of 2021, Medicare Advantage claims must be submitted directly to Noridian, the Medicare FFS Administrative Contractor in order to be paid.

The California Medical Association (CMA) has published several resources includingCMAs COVID-19 Vaccine Reimbursement Quick GuideandCOVID-19 Vaccine Toolkit for Physician Practicesto provide answers to frequently asked physician questions about the COVID-19 vaccine rollout and billing guidance on administration of the vaccine. Both resources are updated frequently with the latest information regarding COVID-19 Vaccines.

If your practice has questions regarding COVID-19 vaccine billing or is experiencing reimbursement challenges, please contact CMA atEconomicServices@cmadocs.orgor (888) 401-5911.

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Avoid denials by submitting Medicare Advantage COVID-19 vaccine claims to the right place - California Medical Association

These Celebrities Are Getting the COVID-19 Vaccine to Protect Themselves and Others | PEOPLE.com Skip to content Top Navigation Close this dialog window Explore PEOPLE.com Close this dialog window Share & More Close this dialog window View image

These Celebrities Are Getting the COVID-19 Vaccine to Protect Themselves and Others

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These Celebrities Are Getting the COVID-19 Vaccine to Protect Themselves and Others - PEOPLE

A woman receiving the Johnson & Johnson Covid-19 vaccine in New York earlier this year.Credit...James Estrin/The New York Times

Expert advisers to the Centers for Disease Control and Prevention are meeting on Thursday for discussion on what federal health officials see as a concerning increase in the rates of a rare but serious blood clotting disorder linked to Johnson & Johnsons coronavirus vaccine.

The Advisory Committee on Immunization Practices will see new data at the meeting that shows elevated risks of the condition in men and women, according to one federal official, setting the stage for the experts to possibly recommend new restrictions on the use of the vaccine.

The F.D.A. on Tuesday said that although problems arose in men and women, the highest rate was in about 1 in 100,000 in women aged 30-49.

Among the women who were diagnosed with the syndrome, which can impair clotting and cause internal bleeding, about one in seven of them died, the F.D.A. said. The federal official who described the planning for Thursdays meeting said that updated figures showed roughly nine deaths from the disorder.

The panel on Thursday may advise that the vaccine only be given to people who cannot access a different brand or who want it despite the risk, or restrict it to certain groups.

The Washington Post first reported the plans for Thursdays meeting and the new federal data.

Jake Sargent, a spokesman for Johnson & Johnson, said the company shares with regulators reports of side effects in people who have received the vaccine and strongly support raising awareness of the signs and symptoms of this rare event.

About 16 million people in the United States have received a single shot of the Johnson & Johnson vaccine as their primary immunization, compared to 73 million fully immunized with Modernas vaccine and 113 million with Pfizers. Among the people in the United States who have received a booster shot, just 1.5 percent have gotten the one from Johnson & Johnson.

The side effect, known as thrombosis with thrombocytopenia syndrome, can impair clotting and cause internal bleeding. An increased risk for the condition has been linked to the Johnson & Johnson vaccine and the shot from AstraZeneca, which is not authorized in the United States. It has not been linked to the vaccines from Moderna or Pfizer.

On Tuesday, the Food and Drug Administration announced that it added a warning to the vaccines fact sheets for patients and providers, saying the shot should not be given to anyone who has had a clotting problem after a first dose. The agency said that it continues to find that the benefits of the vaccine outweigh its risks.

As more cases of the clotting disorder were adjudicated by federal health officials in recent months, F.D.A. and C.D.C. officials grew increasingly alarmed by the numbers presented to them by the C.D.C.s immunization safety office, which monitors reports in the Vaccine Adverse Event Reporting System, or VAERS, a decades-old system that relies on self-reported cases from patients and health care providers.

The reports of the condition grew worrisome enough in recent weeks that federal officials determined they needed to call an emergency meeting of the C.D.C. advisers.

In April, soon after Johnson & Johnsons vaccine started being administered in the United States, federal officials briefly recommended halting use of the shot because of concerns about the risk of blood clots. At the time, the condition had emerged in six women, all of whom developed the illness within one to three weeks of vaccination. One of the women had died. By May, 28 cases had been confirmed.

The updated F.D.A. fact sheet for providers says that currently available evidence supports a causal relationship between the condition and Johnson & Johnsons vaccine.

The new data come during a surge in virus cases driven by the Delta coronavirus variant and Omicron, the version of the virus that has already become dominant in some countries and is spreading fast in the United States.

Several laboratory experiments suggest that a single dose of Johnson & Johnsons shot may offer little defense against infection with Omicron. The company said late last month that it is testing blood samples from clinical trial participants who have received its shot as a booster to see how their vaccine-induced antibodies fare against Omicron.

The shot has largely fallen out of favor in the United States, despite early hopes that its one-and-done format would be easy to deploy in more isolated communities, and among people skittish about receiving two doses.

Federal health officials in October authorized booster shots for people who had received a single shot of Johnson & Johnson vaccine at least two months earlier. They allowed for a mix and match approach, allowing people to get a second shot of a Pfizer or Moderna vaccine. Among people in the United States who originally received a single Johnson & Johnson shot and then got a second shot, fewer than 28 percent have gotten Johnson & Johnson as their booster.

Christina Jewett contributed reporting.

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Covid-19 Live Updates: Cases, Vaccines, and Omicron News - The New York Times

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Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers.

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U.S. study suggests vaccines may be ineffective against Omicron without booster - Reuters

The US Centers for Disease Control and Preventions vaccine advisers will meet on Thursday to revisit the benefits and risks for the Johnson & Johnson Covid-19 vaccine. The Advisory Committee on Immunization Practices is scheduled to vote on the vaccines recommendation for use.

According to an agenda posted online on Wednesday, the group will hear presentations about thrombosis and thrombocytopenia syndrome known as TTS a rare but serious type of blood clot that has been linked to the vaccine, as well as the benefits and risks assessment of the vaccine.

The CDC has said for months that the J&J vaccines known and potential benefits outweighed the known and potential risks. However, it says, women younger than 50 years old should be aware of the rare but increased risk of TTS, which involves blood clots with low platelets. Safety monitoring has been ongoing since the adverse event was first identified in April.

The advisory committee is scheduled to meet from noon to 4 p.m. ET Thursday. It is scheduled to vote at 2:30 p.m. ET. Its not clear what the voting question will be.

The single-dose Johnson & Johnson vaccine is authorized for use in people age 18 and older, and can be used as a booster shot for adults fully vaccinated with the J&J, Pfizer or Moderna vaccines.

The vaccine advisers will also hear a presentation on vaccine safety in children ages 5 to 11.

During a White House Covid-19 briefing on Wednesday, CDC Director Dr. Rochelle Walensky did not say why the committee was meeting about the Johnson & Johnson vaccine or whether she believes the benefits of the vaccine still outweigh the risks.

A source close to the situation told CNN the CDC has been "coy" about what the vote will be about, but it mayinvolvelimiting who's recommended to get the vaccine.

"I think a fair amount of the discussion will be about J&J do we need to use this one at all since we have so much of the others, or, if it's used, should it be focused on certain populations?" the source said. "J&J hasn't lived up to its billing as one and done."

"We could just take J&J off the table and do fine in this country," the source said.

The source added that its possible the CDC could recommend against the use of Johnson & Johnsons vaccine in women under age 50. While women 30-49 have seen the highest rates of the TTS blood clot, the source noted that it has also occurred in older women and in men.

J&J did not address the ACIP meeting in a response to CNN on Wednesday. It acknowledged that the US Food and Drug Administration updated its fact sheets for the vaccine on Tuesday to say people with a history of TTS should not get the Johnson & Johnson's Janssen Covid-19 vaccine.

Johnson & Johnson said "the safety and well-being of the people who use our products is our number one priority" and that it "strongly support raising awareness of the signs and symptoms of this rare event."

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Latest on the coronavirus pandemic and the Omicron variant - CNN