Category: Covid-19 Vaccine

Novavax Inc. NVAX, +17.46% is still waiting for U.S. regulators to decide whether to authorize its COVID-19 vaccine, which some experts believe could serve as an alternative option for people who are hesitant to get a mRNA vaccine.

Novavaxs vaccine, called Nuvaxovid, is a recombinant protein-based shot that is similar in design to a flu shot thats been available in the U.S. since 2013.

This type of vaccine has a different makeup than the mRNA vaccines developed by Moderna Inc. MRNA, +8.73%, BioNTech SE BNTX, +5.57% and Pfizer Inc. PFE, -0.15% as well as the adenovirus shot from Johnson & Johnson JNJ, +0.91%.

I do think there is a minority group who would take a protein vaccine over an mRNA vaccine, Dr. Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland, told Kaiser Health News. (Nuezil is a researcher for one of the Novavax vaccine trials.)

The Food and Drug Administration is expected to make a decision after the regulators vaccines advisory committee meets June 7 to discuss the risks and benefits of the investigational two-dose shot.

Nuvaxovid has been authorized as a vaccine or booster in several countries, including Australia, Europe, Japan, the U.K., and Singapore, where a rollout of the shot is currently underway. The company said Wednesday it is participating in a new Phase 2 trial in the U.K. that gives a Novavax booster to teens who were vaccinated with the BioNTech SE BNTX, +5.57% and Pfizer Inc. PFE, -0.15% vaccine. The company also applied for authorization of a booster for teens in the U.K. earlier this month.

That said, investor interest in Novavax has largely waned at the same time that the intensity of the pandemic has lessened. The stock hit an all-time high of $319.93 on Feb. 8, 2021, but has since tumbled 86% since through Wednesdays closing price of $46.13.

We see a difficult commercial setup for Nuvaxovidbased on decreasing C-19 booster use, unclear benefit as a heterologous option, and waning immunity against new variants, BofA Securities analyst Alec Stranahan said in a research note to clients last week.

The shot is expected to generate $4.2 billion in revenue this year, according to a FactSet consensus.

Other COVID-19 news to know:

Heres what the numbers say:

The U.S. is averaging 110,614 cases a day, up 31% from two weeks ago, according to a New York Times tracker. The country is averaging 25,755 hospitalizations a day, up 29% from two weeks ago. The average daily death toll of 361 is up 10% from two weeks ago. Ciara Linnane

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The FDA's decision on the Novavax COVID-19 vaccine could come in weeks - MarketWatch

Misinformation and confusion about the COVID-19 vaccines and pregnancy remains widespread, with most people including women who are pregnant or trying to get pregnant either believing or being uncertain about at least one of three false claims theyve heard, a new KFF COVID-19 Vaccine Monitor shows.

Among women who are pregnant or trying to get pregnant the group for whom accurate information about the vaccines safety before, during and after pregnancy is most important 72% either believe or are unsure about at least one of the myths. Specifically:

More than two years into the pandemic, theres a surprising amount of confusion about the vaccines safety for pregnant women, said Mollyann Brodie, a KFF Executive Vice President and Executive Director of the Public Opinion and Survey Research Program. The fact that so many younger women incorrectly believe the vaccines can cause infertility or that theyre not safe for pregnant women highlights the real challenges facing public health officials.

The widespread reach of this misinformation may contribute to the publics lower level of confidence in the safety and effectiveness of the COVID-19 vaccines for pregnant woman. For instance, about half (53%) of adults say they are confident in the vaccines safety for pregnant women and those trying to conceive, well below the 72% share who express confidence in its use for adults generally.

About 4 in 10 (42%) women who are or planning to become pregnant express confidence in the vaccines safety for pregnant women and those trying to conceive.

As part of KFFs THE CONVERSATION / LA CONVERSACIN campaign, OB-GYNs, a nurse and midwife affirm the safety of the COVID-19 vaccine during pregnancy and debunk myths about the impact on fertility in 40+ FAQ videos. Tailored media messages and community tools address information needs about the vaccines.

Designed and analyzed by public opinion researchers at KFF, the Vaccine Monitor survey was conducted from May 10-19, 2022, among a nationally representative random digit dial telephone sample of 1,537 adults, including 306 Hispanic adults and 248 non-Hispanic Black adults. Interviews were conducted in English and Spanish online (1,246) and by phone (39). The margin of sampling error is plus or minus 3 percentage points for the full sample. For results based on subgroups, the margin of sampling error may be higher.

The KFF COVID-19 Vaccine Monitoris an ongoing research project tracking the publics attitudes and experiences with COVID-19 vaccinations. Using a combination of surveys and qualitative research, this project tracks the dynamic nature of public opinion as vaccine development and distribution unfold, including vaccine confidence and acceptance, information needs, trusted messengers and messages, as well as the publics experiences with vaccination.

Read more from the original source:

Misinformation About COVID-19 Vaccines and Pregnancy is Widespread, Including Among Women Who are Pregnant or Planning to Get Pregnant - Kaiser Family...

While coronavirus cases are rising across the nation and in Alabama, vaccination rates have slowed.

According to data from the Centers for Disease Control and Prevention, 221.2 million people in the United States are fully vaccinated, or about 66.6% of the countrys population. About 46.7% of fully vaccinated people have received a first booster dose.

COVID cases are rising slowly in Alabama and hospitalizations are inching upwards as the state closed out the week by adding more than 1,000 cases on Friday. That marks the first time the state has added at least 1,000 cases in a single day since March 2, according to data from the Alabama Department of Public Health. Fridays total brought the states weekly case count to 4,554..

The United States as of May 27 reached over 1 million COVID-19-related deaths and nearly 83.8 million COVID-19 cases, according to Johns Hopkins University. Stacker.com compiled a list of the counties with highest COVID-19 vaccination rates in Alabama using data from the U.S. Department of Health& Human Services and Covid Act Now.

Counties are ranked by the highest vaccination rate as of May 26, 2022. Due to inconsistencies in reporting, some counties do not have vaccination data available. See the top 10 below, and check out the full list here.

10. Lowndes County

- Population that is fully vaccinated: 51.4% (4,997 fully vaccinated)

--- 0.2% higher vaccination rate than Alabama

- Cumulative deaths per 100k: 792 (77 total deaths)

--- 97.5% more deaths per 100k residents than Alabama

- Cumulative cases per 100k: 27,082 (2,634 total cases)

--- 1.3% more cases per 100k residents than Alabama

9. Sumter County

- Population that is fully vaccinated: 51.9% (6,447 fully vaccinated)

--- 1.2% higher vaccination rate than Alabama

- Cumulative deaths per 100k: 418 (52 total deaths)

--- 4.2% more deaths per 100k residents than Alabama

- Cumulative cases per 100k: 21,027 (2,613 total cases)

--- 21.4% less cases per 100k residents than Alabama

8. Montgomery County

- Population that is fully vaccinated: 52.6% (119,231 fully vaccinated)

--- 2.5% higher vaccination rate than Alabama

- Cumulative deaths per 100k: 420 (952 total deaths)

--- 4.7% more deaths per 100k residents than Alabama

- Cumulative cases per 100k: 24,587 (55,687 total cases)

--- 8.1% less cases per 100k residents than Alabama

7. Bullock County

- Population that is fully vaccinated: 53.9% (5,449 fully vaccinated)

--- 5.1% higher vaccination rate than Alabama

- Cumulative deaths per 100k: 535 (54 total deaths)

--- 33.4% more deaths per 100k residents than Alabama

- Cumulative cases per 100k: 23,097 (2,333 total cases)

--- 13.6% less cases per 100k residents than Alabama

6. Wilcox County

- Population that is fully vaccinated: 54.1% (5,607 fully vaccinated)

--- 5.5% higher vaccination rate than Alabama

- Cumulative deaths per 100k: 443 (46 total deaths)

--- 10.5% more deaths per 100k residents than Alabama

- Cumulative cases per 100k: 27,948 (2,899 total cases)

--- 4.5% more cases per 100k residents than Alabama

5. Marengo County

- Population that is fully vaccinated: 54.7% (10,312 fully vaccinated)

--- 6.6% higher vaccination rate than Alabama

- Cumulative deaths per 100k: 573 (108 total deaths)

--- 42.9% more deaths per 100k residents than Alabama

- Cumulative cases per 100k: 27,610 (5,208 total cases)

--- 3.2% more cases per 100k residents than Alabama

4. Jefferson County

- Population that is fully vaccinated: 58.6% (386,233 fully vaccinated)

--- 14.2% higher vaccination rate than Alabama

- Cumulative deaths per 100k: 360 (2,374 total deaths)

--- 10.2% less deaths per 100k residents than Alabama

- Cumulative cases per 100k: 28,422 (187,177 total cases)

--- 6.3% more cases per 100k residents than Alabama

3. Hale County

- Population that is fully vaccinated: 61.6% (9,024 fully vaccinated)

--- 20.1% higher vaccination rate than Alabama

- Cumulative deaths per 100k: 724 (106 total deaths)

--- 80.5% more deaths per 100k residents than Alabama

- Cumulative cases per 100k: 32,523 (4,765 total cases)

--- 21.6% more cases per 100k residents than Alabama

2. Madison County

- Population that is fully vaccinated: 62.6% (233,584 fully vaccinated)

--- 22.0% higher vaccination rate than Alabama

- Cumulative deaths per 100k: 260 (970 total deaths)

--- 35.2% less deaths per 100k residents than Alabama

- Cumulative cases per 100k: 24,449 (91,174 total cases)

--- 8.6% less cases per 100k residents than Alabama

1. Choctaw County

- Population that is fully vaccinated: 66.7% (8,397 fully vaccinated)

--- 30.0% higher vaccination rate than Alabama

- Cumulative deaths per 100k: 294 (37 total deaths)

--- 26.7% less deaths per 100k residents than Alabama

- Cumulative cases per 100k: 16,300 (2,052 total cases)

--- 39.1% less cases per 100k residents than Alabama

See more here:

Top 10 Alabama counties with the highest COVID-19 vaccination rate - AL.com

Heres the latest news from the pandemic.

In this week's editionof theCovid Q&A, we look at long Covid and viral variants.Inhopes of making this very confusing time just a little less so, each week Bloomberg Prognosispicksone reader question and puts it toexperts in the field. This weeks question comes to us from Laura in St. Louis Park, Minnesota. Sheasks:

Are people experiencing long Covid at the same rates with the new variants as they were at thebeginning of the pandemic?

Read more here:

Is Omicron Creating More Cases of Long Covid? - Bloomberg

FALLS CHURCH, Va. Are you continuing to protect yourself against COVID-19? Scientific evidence shows that the COVID-19 vaccines and booster doses are effective in protecting people. They protect people both from infection and especially from severe outcomes of the virus. The Centers for Disease Control and Prevention (CDC) is now recommending a second COVID-19 booster for people in certain groups, and a first booster for children ages 5 through 11.As of now, a second booster dose is recommended for people who are at higher risk of severe outcomes of COVID-19, said Dr. Jay Montgomery, Immunization Healthcare Divisions medical director of the North Atlantic Region Vaccine Safety Hub. We know that the protection of previous dosages does diminish somewhat over time and, for some, a second booster dose could help increase protection. TRICARE beneficiaries are encouraged to stay up to date with their COVID-19 vaccines, which includes a booster for many people.Who is eligible for the second booster?This varies based on your age, your health status, what vaccine you first received, and when you first got vaccinated. According to the CDC, an additional booster is available for certain people who got their first booster at least four months ago.Right now, the eligibility rules for the second booster are as follows:

Continue reading here:

Get the Latest COVID-19 Info on Boosters and Treatment - TRICARE Newsroom

COVID-19 cases are increasing again and health officials are giving some worrisome predictions for the fall season.

For many people, that raises the question: What will COVID-19 vaccines look like after the summer ends?

The answer is that the vaccines may eventually become more targeted and perhaps more regularly scheduled.

We are clearly transitioning from pandemic to what we call endemic, Dr. William Schaffner, a professor of infectious diseases at Vanderbilt University in Tennessee, told Healthline. That means it will continue to live with us and smolder around us and we are all learning how to contend with it.

That learning includes the somewhat formidable task, he said, of knowing and understanding when and why we might need a vaccine booster.

Schaffner pointed out that hospitalizations are relatively stable even with the current rise in cases. So, he explained, the virus is doing exactly what infectious disease experts predicted at the start if not enough people were vaccinated quickly.

It seeks out the previously unvaccinated, the older population, and the immune-compromised, he said. The question is: how do we manage this?

Will there eventually be an annual vaccination and could it come soon?

Dr. Monica Gandhi, the director of the University of California San Francisco Center for AIDS Research, told Healthline that someday a once-a-year inoculation could exist. For now, though, it does not.

Its important, she said, to understand how the current COVID-19 vaccines work and why boosters are necessary for the time being.

The mRNA vaccines are powerful in terms of preventing severe disease with COVID-19 across populations because of the multifaceted immune response they generate, she said.

While those antibodies will wane over time and perhaps become less effective against variants, Gandhi explained, they do more than produce antibodies.

The vaccines also generate something called cellular immunity, which is much longer-lasting, and protect against severe disease in a more enduring fashion, she said.

That, she said, gives her hope.

Although we do not know how long memory B cells from the vaccine will [to kick in], survivors of the 1918 influenza pandemic were able to produce antibodies from memory B cells when their blood was exposed to the same strain nine decades later, she said.

Gandhi believes an annual shot could come along at some point, mainly because it takes up to four days for vaccines to kick in which could be too long for someone with serious underlying conditions.

A plan to boost the vulnerable every year is compatible within terms of vaccinations moving forward, she said.

Another question is whether more targeted vaccines will be necessary to deal with new COVID-19 variants.

Schaffner said the Food and Drug Administration is hinting that they will have what he calls vaccine 2.0 available this fall.

That would be a vaccine thats modified much the same way as an annual influenza vaccine.

Scientists would prepare a vaccine each year thats the same basic vaccine but with adjusted compositions to ward off the variants that are anticipated.

Right now, influenza vaccines are quadrivalent; meaning they can protect from up to four flu variants.

The COVID-19 vaccines now protect from one. A 2.0 version, if it comes out this fall, will be bivalent, protecting against two strains.

Schaffner says there are scientists also working on 3.0 and 4.0 versions, but he has no information on a timeline.

In the meantime, Schaffner is worried about hesitation on boosters as we move into fall.

Only half (of those eligible) have had the third (booster), and the third solidifies your protection against hospitalization, he said.

That leads him to believe people wont be flocking to get boosted any time soon.

I think were all going to continue to struggle with this, he said.

Susan, a Colorado mother of two teens who believes in vaccines, said shes confused over what they really need and when.

I mean, I want to be vaccinated and I am, she told Healthline. But boosters? I kind of feel like theyre throwing them at me willy-nilly.

How does someone know what the right choice is for them, given the variations in guidance from person to person?

Schaffner suggests reaching out to your healthcare professional, who knows details about your health history and can help you understand and decide.

For those who are older or immune-compromised, he says boosters are strongly advised.

Gandhi hopes for a clearer system of vaccines down the road.

Once we get whole virus vaccines, there will be a lot less nuance as I think then that booster will be used across populations every time a new variant emerges, she said.

But Schaffner wonders if we need more for the majority of the population to come on board with COVID-19 vaccines.

He does see one solution that might gain acceptance though it does not exist as of yet. A vaccine that prevents infection.

What could change all this? A brand new vaccine that is also capable of cutting off transmission, he said. That will get peoples attention.

Read more:

COVID-19 Vaccines: Fall Version May Be Different - Healthline

When we look back at global COVID-19 vaccination in a few years time, how will it be considered in terms of public-private cooperation?

We are still in the thick of the pandemic, of course, as the United States tragic milestone of 1 million deaths reminds us. Nevertheless, its possible to make an early assessment, and most importantly, consider how the private sector can further support efforts to bring an end to the acute phase of the pandemic.

Lets start with supply. Two years ago, few people would have dared hope we would have as many safe and effective vaccines available as we do today. We didnt even know for sure there would be any. Getting to this stage reflects not only a triumph of science but also industry, whose efforts to scale up production from zero to 12 billion vaccines in a year resembles something of a moonshot.

Its important to note that for too long these doses were not equitably distributed. COVAX, the multilateral initiative co-led by Gavi, experienced severe shortfalls in supply in 2021 as it contended with vaccine hoarding and export controls. Nevertheless, with around 1.3 billion doses delivered to 92 lower-income economies, a turning point has now been reached, with supply for some months exceeding demand.

Which brings us to the other vital area where private sector activation can help end this pandemic: delivery. Despite lower-income economies having protected on average 46% of their population with two doses, the global vaccine equity gap persists and too many of the most vulnerable people in lower-income societies are still not protected.

More than 1 billion doses have already been delivered, but many countries are still waiting for COVAX doses.

Image: Statista/Unicef

So how to turn vaccines into vaccinations? COVAX with the help of sovereign and private sector backers and its partners are stepping in with much-needed delivery funding to help countries tackle key bottlenecks, such as trained vaccinators, lack of cold chain infrastructure or other equipment.

This country delivery support will be critical in helping countries grow capacity and keep up with other life-saving immunization or other public health activities. It also provides a platform for businesses to make interventions of their own.

One way to do this is through investment in health systems. Recent years have seen an uptick in investments from private equity in African healthcare, for example. These investments, generally focused on private healthcare companies, seem a million miles away from the primary health care clinics that form the backbone of national vaccination programmes. But with resources so stretched in a time of crisis, private operators are incredibly well placed help fill the gap.

Demand is another key area where the private sector could play a transformational role. If there is one thing the private sector is good at, its selling things and there could be fewer more valuable interventions than helping consumers understand the benefits of vaccination. Gavis work with Unilever and Google demonstrate how effective public-private collaboration can be and there is room for plenty more.

Finance businesses, too, can help Gavi continue its traditional of innovative financing, making scarce donor resources go as far as possible. Again we have seen in recent years how much appetite there is among investors for investments that deliver solid societal as well as financial returns.

Innovation elsewhere is welcome, too. Through Gavis Infuse programme which seeks to identify and scale up technology that can support our goal of vaccine equity launched in Davos in 2016 and has since helped accelerate the use of drones for vaccine delivery and biometrics for tracking vaccinations, among other applications.

Public-private cooperation has played a major role in Gavis and its partners efforts to protect half the worlds children from preventable disease. It can play a similar role in getting countries the tools they need to control the COVID-19 pandemic for good.

Written by

Seth Berkley, Chief Executive Officer, Gavi, the Vaccine Alliance

The views expressed in this article are those of the author alone and not the World Economic Forum.

Original post:

COVID-19 is far from over. How can the private sector continue to help fight it? - World Economic Forum

In a recent article posted to themedRxiv* preprint server, researchers demonstrated the short-term protection conferred by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) BNT162b2 vaccination in adolescents and children.

The Coronavirus disease 2019 (COVID-19) Pfizer-BioNTech (BNT162b2) vaccine has a lower efficiency against the SARS-CoV-2 Omicron variant than the Delta and other variants. Moreover, the BNT162b2 vaccine's real-world efficacy against Omicron infection in children and adolescents is limited.

Shortly before the SARS-CoV-2 Omicron outbreak, the BNT162b2 two-dose vaccination for children and the third BNT162b2 shot for adolescents were authorized in Israel. The BNT162b2 vaccination was approved in Israel on 2 June 2021 for adolescents aged 12 to 15, and a booster dosage was approved on 29 August 2021 for those who had received the second vaccine at least five months before. Starting 23 November 2021, children aged five to 11 received a two-dose BNT162b2 vaccination utilizing a third of the amount provided to children aged 12 and older. However, the impact of these vaccinations on Omicron-confirmed SARS-CoV-2 infection rates in these populations is still unknown.

In the current work, the researchers analyzed data from Israel to investigate the efficacy of the two-dose BNT162b2 schedule for children aged five to 11 years old and the booster shot for adolescents aged 12 to 15. The authors collected information for the Omicron BA.1 sublineage-dominated timeframe: between 26 December 2021 and 8 January 2022 in Israel. They noted that credible estimates of efficacy for the time following 8 January 2022 were hard to acquire due to substantial policy changes in COVID-19 testing, contact isolation, and quarantine in schools.

The scientists analyzed data from the Israeli Ministry of Health database, which contained information on all vaccinations and tests performed in Israel. The study cohort included children (aged five to 10) and adolescents (12 to 15) if they had received a COVID-19 vaccine or had taken at least one state-regulated antigen or polymerase chain reaction (PCR) test before 1 December 2021. The team omitted the 11-year-old age group because the current data only contained age in years, and vaccination eligibility dates varied for 11 and 12-year-olds.

The investigators evaluated rates of confirmed SARS-CoV-2 infection in children aged five to 10 years old 14 to 35 days after getting the second dose with an internal control cohort of children three to seven days following receiving the first shot when the vaccination was still ineffective. Likewise, they compared confirmed COVID-19 rates in adolescents aged 12 to 15 years old 14 to 60 days following getting a booster shot to a control cohort of adolescents three to seven days after getting the booster dose. The authors used Poisson regression controlling for sex, age, calendar week, exposure, and socioeconomic level.

Overall, the study results showed that the COVID-19 BNT162b2 vaccination offered an initial nearly two-fold improvement in immunity against SARS-CoV-2 infection in children aged five to 10. The estimated incidence of confirmed COVID-19 in the five to 10 age category was 2.3-times lower in the second dose cohort compared to the internal control population.

In addition, the current analysis found that a recent BNT162b2 booster dose in adolescents reduced SARS-CoV-2 infections by three- to four-time relative to the internal control. Specifically, the third dose decreased confirmed-COVID-19 rates over 3.3-time in adolescents.

The authors found that different testing habits did not explain the reduced confirmed-SARS-CoV-2 infection rates in the vaccinated groups relative to the non-vaccinated. In all age categories, the non-vaccinated cohorts tested less frequently than the vaccinated groups, implying that the predicted protection compared to non-vaccinated persons may be underestimated.

While the vaccine-naive cohorts had reduced testing rates than the vaccinated groups, the internal control subjects had a slightly higher testing rate than the second dose vaccination group in the five to 10 age range, which might contribute to an overestimation of the vaccine's protection. The internal control subjects had a decreased testing rate than the booster group in the vaccinated 12 to 15 age range, probably indicating that the booster shot confers a better degree of protection than anticipated in this study.

To summarize, the current investigation illustrated an assessment of the COVID-19 BNT162b2 vaccine's transient protection against confirmed SARS-CoV-2 infection in adolescents and children. Relative to the corresponding internal control cohorts, the recent two-dose vaccination of the BNT162b2 vaccine in children and the latest booster shot in adolescents lowered the risk of confirmed SARS-CoV-2 infection. The authors mentioned that future research was needed to determine how long this protection lasts and how well it protects against other COVID-19 outcomes, including long-COVID and pediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS).

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

Read the original here:

Short-term immunity imparted by COVID-19 BNT162b2 vaccination in adolescents and children - News-Medical.Net

A 35-year-old Asian female with a pertinent past medical history of autoimmune hepatitis presented with an acute recurrence of autoimmune hepatitis two weeks after receiving the second dose of the Pfizer-BioNTech messenger RNA (mRNA) coronavirus disease 2019 (COVID-19) vaccine. Nine cases of autoimmune hepatitis after the administration of the COVID-19 vaccine have been reported, but this is the first documented case of a reactivation of autoimmune hepatitis in remission. As recommendations for COVID-19 vaccinations and booster shots continue to evolve, all adverse events should be reported to better educate and monitor patients.

The coronavirus disease 2019 (COVID-19) pandemic has ushered in the first use of messenger RNA (mRNA) vaccines. On December 11, 2020, the Food and Drug Administration granted emergency use authorization (EUA) to the Pfizer-BioNTech mRNA COVID-19 vaccine. Subsequently, EUA was granted to the Moderna COVID-19 vaccine on December 18, 2020. Messenger RNA directs cells to build foreign proteins leading to the desired immunologic response. It is a versatile technology that will likely continue to be a very prominent part of vaccine development in the future. After millions of mRNA vaccines had been administered, the Centers for Disease Control and Prevention granted full approval to the Pfizer-BioNTech vaccine on August 23, 2021. As must be expected with all medical interventions, cases of adverse events from the vaccine are slowly being reported. Prior to this publication, there were nine cases reported of autoimmune hepatitis that developed after the administration of the COVID-19 vaccine [1-9].

Autoimmune hepatitis is characterized by a cell-mediated attack against liver cells resulting in chronic hepatocellular necrosis, inflammation, and fibrosis, which can result in cirrhosis and liver failure. It is typically responsive to glucocorticoid and immunosuppressive therapy. The onset of autoimmune hepatitis can be abrupt or insidious, and recurrent attacks are not uncommon. The 10-year survival for autoimmune hepatitis is 80-98% with treatmentand approximately 67% without treatment [10].

A 35-year-old Asian female was originally diagnosed with autoimmune hepatitis in 2016 after her liver enzymes were noted to be elevated on routine labs: aspartate transferase (AST): 255 U/L, alanine transferase (ALT): 433 U/L, alkaline phosphatase: 74 U/L, and total bilirubin: 0.82 mg/dL. Her only past medical history included chronic sinusitis and insomnia. She had no family history of liver disease. Hepatitis A, B, and C viruses were negative. Cytomegalovirus was negative. Ferritin was elevated at 256 ng/ml. Smooth muscle antibody was elevated at 1:640 with IgG at 2382 mg/dL and antinuclear antibody (ANA) at 1:640 in a homogenous pattern. Liver biopsy was consistent with grade 2 stage II chronic hepatitis with lymphocytic infiltrate, piecemeal necrosis, and interface hepatitis. The patient was started on prednisone 60 mg followed by a taper and azathioprine 50 mg. Her liver enzymes normalized after treatment and she stopped taking azathioprine in November 2018. Her only complaint when treatment was discontinued was intermittent epigastric pain that had occurred for years. In December 2020, her AST level was 28 U/L, ALT was 29 U/L, and smooth muscle, mitochondrial, and parietal cell antibodies were all negative, indicating continued remission off therapy.

The patient received her first dose of the Pfizer-BioNTech mRNA COVID-19 vaccine on May 20, 2021, and her second dose on June 10, 2021. Two weeks after her second dose, her liver enzymes were elevated for the first time since her initial diagnosis in 2016; her AST was 129.5 U/L, ALT was 217 U/L, alkaline phosphatase was 72 U/L, and total bilirubin was 0.9 mg/dL. Smooth muscle antibody was positive at 1:20with negative mitochondrial antibody and parietal cell antibody. She denied any abdominal pain, nausea, vomiting, weight loss, fevers, chills, malaise, fatigue, decreased appetite, or changes in bowel movements. There were no other changes in her medical history, and she had not started any new medications. Fibroscan in June of 2021 (one week prior to the elevation of liver enzymes) was F0-F1, showing no steatosis. These findings were consistent with the recurrence of her autoimmune hepatitis. She was monitored off treatment and repeat liver enzymes two weeks later showed improvement. Three months later in September 2021, her liver enzymes normalized near her previous baseline (AST: 31 U/L; ALT: 34 U/L).

A patient with autoimmune hepatitis in remission and off of treatment presented with recurrence of autoimmune hepatitis with elevated liver enzymes and positive smooth muscle antibodies. She had previously been treated with prednisone and azathioprinebut had been off of treatment since 2018. The only change in her medical management prior to the recurrence was the administration of the Pfizer-BioNTech mRNA COVID-19 vaccine. Nine previous cases of new-onset autoimmune hepatitis associated with COVID-19 vaccines have been reported, but our patient is the first case of recurrence of autoimmune hepatitis that was previously in remission.

There is debate within the medical literature on whether these associations are due to causality or coincidence. Whether the occurrence/recurrence in these 10 cases was due to the COVID-19 spike protein contained in the vaccine, the mechanism of mRNA vaccines, or simply a flare of autoimmune hepatitis unrelated to the vaccine is unclear. Multiple pathways of autoimmune dysregulation following COVID-19 vaccinations have been proposed, including cross-reactivity of spike protein and autoimmune liver cellsand mRNA-specific pathways including RNA activation of the type I interferon pathway, but findings are inconclusive [5]. The first mechanism involves molecular mimicry and the idea that molecular similarities between the viral proteins (such as the spike protein used in the vaccine)and proteins in human tissueare similar enough in structure that the immune system is activated against both. There is thought that some of the lung damage seen in severe COVID-19 infections is due to this immune response [11]. Another possible way that the vaccines may be inducing an autoimmune response has to do with the inherent nature of mRNA and the immunogenicity of nucleic acids. The primary goal of the mRNA in these vaccines is to be translated into immunogenic proteins that the body will respond to. Butprior to translation into these proteins, the mRNA is able to bind to pattern recognition receptors (PRRs) in the cell, which leads to the recognition of the mRNA by Toll-like receptors, retinoic acid-derived gene-I (RIG-I), melanoma differentiation-associated protein 5 (MDA5), and other proteins leading to activation of inflammatory cascades [12]. The activation of thetype 1 interferon pathway and nuclear factor kappa B pathway, among others, may then lead to autoimmune responses seen in these cases.Overall, these 10 cases raise the possibility of autoimmune dysregulation caused by the COVID-19 vaccine.

The COVID-19 pandemic has ushered in the era of mRNA vaccines. These vaccines, along with COVID-19 itself, have the potential to cause autoimmune dysregulation. While it is unclear if the vaccine caused the autoimmune dysregulation seen in our patient and others, the possibility exists. As COVID-19 policies continue to change and new vaccination guidelines are implemented, possible complications of vaccination should be part of our education and monitoring of patients. Further research is needed to investigate the possibility of autoimmune dysregulation with mRNA vaccines.

Excerpt from:

Recurrence of Autoimmune Hepatitis After COVID-19 Vaccination - Cureus

Nasal COVID-19 vaccines help the body prepare for infection right where it starts in your nose and throat  Kiowa County Press

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Nasal COVID-19 vaccines help the body prepare for infection right where it starts in your nose and throat - Kiowa County Press