#moderna booster dose

[queenvlion]

[mariacallous]

Updated vaccines against Covid-19 are coming, just as hospitalizations and deaths due to the virus are steadily ticking up again.

Today, the US Food and Drug Administration authorized new mRNA booster shots from Moderna and Pfizer, and a panel of outside experts that advises the Centers for Disease Control and Prevention voted to recommend the shots to everyone in the United States ages 6 months and older. Once Centers for Disease Control and Prevention director Mandy Cohen signs off on the recommendations and the vaccines are shipped, people can start getting the boosters.

The recommendation is projected to prevent about 400,000 hospitalizations and 40,000 deaths over the next two years, according to data presented at the meeting by CDC epidemiologist Megan Wallace.

This year’s mRNA vaccines are different from the 2022 booster in a key way. Last year’s shot was a bivalent vaccine, meaning it covered two variants: the original one that emerged in China in 2019, plus the Omicron subvariant BA.5, which was circulating during much of 2022. This fall’s booster drops the original variant, which is no longer circulating and is unlikely to return. It targets just the Omicron subvariant XBB.1.5, which was dominant throughout much of 2023.

Pfizer and Moderna’s vaccines work by introducing a tiny piece of genetic material called messenger RNA, or mRNA, that carries instructions for making SARS-CoV-2’s characteristic spike protein. Once it is injected, cells in the body use those instructions to temporarily make the spike protein. The immune system recognizes the protein as foreign and generates antibodies against it. Those antibodies stick around so that if they encounter that foreign invader again, they will mount a response against it.

Since the start of the Covid-19 pandemic, the virus has acquired new mutations in its spike protein and elsewhere. These mutations result in new variants and subvariants that diverge from the original virus. When enough mutations accumulate, these new versions can more easily evade the antibodies created by previous vaccine doses or infections.

The constantly evolving nature of the virus is the reason health regulators decided last year to update the original mRNA vaccines, which were designed against the version of the virus that first appeared in 2019. This year, once again, the virus has changed enough to warrant an updated booster.

In June, an advisory committee to the FDA recommended that this fall’s booster be a monovalent vaccine—targeting only the then-dominant XBB.1.5 subvariant.

At that meeting, committee members reviewed evidence suggesting that the inclusion of the original variant may hamper the booster’s effectiveness against newer offshoots. “The previous bivalent vaccine contained the ancestral spike and thus skewed immune responses to the old spike,” says David Ho, a professor of microbiology at Columbia University whose research, which is not yet peer-reviewed, was among the evidence the FDA panel reviewed. “This is what we call immunological imprinting, and it results in lack of immune responses to the new spike.” He thinks taking out the old variant should optimize the immune response.

But over the past few months, even newer Omicron offshoots have arrived. Currently, EG.5.1, or Eris, is the dominant one in the United States, United Kingdom, and China. Meanwhile, a variant called BA.2.86, or Pirola, has been detected in several countries. Pirola has raised alarm bells because it has more than 30 new mutations compared to XBB.1.5.

Even though the new boosters were formulated against XBB.1.5, they’re still expected to provide protection against these new variants. “The reason is, while antibodies are important in protection against mild disease, the critical part of the immune response that’s important for protecting against severe disease is T cells,” says Paul Offit, a professor of vaccinology at the University of Pennsylvania and member of the FDA’s vaccine advisory committee.

These cells are a different part of the immune response. Unlike antibodies, which neutralize a pathogen by preventing it from infecting cells, T cells work by eliminating the cells that have already been invaded and boosting creation of more antibodies. Both the Moderna and Pfizer-BioNTech Covid vaccines produce long-lasting T cells in addition to antibodies.

It’s why, Offit says, when the Omicron wave hit in late 2021 and peaked in January 2022, the US didn’t see a dramatic increase in hospitalizations and deaths even as cases rose significantly: People’s T cells kicked into gear, even when their antibodies didn’t recognize the Omicron variant.

“In some ways,” says Offit, when it comes to vaccine booster development, “it almost doesn’t matter what we pick to target” because the coronavirus has yet to evolve away from T cell recognition. “Everything works.”

Scientists think T cells are able to protect against severe Covid because they’re recognizing parts of the virus that have remained unchanged throughout the pandemic. “I suspect that as we continue to vaccinate, there are some conserved regions [of the virus],” says Jacqueline Miller, Moderna’s head of infectious diseases. “So even with the accumulation of mutations, we’re still building on previous immunity.”

People who have hybrid immunity—that is, have had a Covid infection and have also been vaccinated—seem to have the best immune responses to new variants, she says, which suggests that previous exposure shapes and improves immune responses to new variants. Preliminary studies show that antibodies generated by previous infections and vaccinations should be capable of neutralizing Pirola.

Earlier this month, Moderna issued a press release saying that clinical trial data showed that its updated booster generated a strong immune response against Pirola, as well as the more prevalent Eris variant.

In a statement to WIRED, Pfizer spokesperson Jerica Pitts said the company continues to closely monitor emerging variants and conduct tests of its updated monovalent booster against them. Data presented at Tuesday’s CDC meeting showed that Pfizer-BioNTech’s updated booster elicited a strong neutralizing antibody response against both Eris and Pirola.

The FDA expects that Covid-19 vaccines will continue to be updated on an annual basis, unless a completely new variant emerges that requires a different approach. “We will always be a little behind the virus,” says Ho. “In this instance, we won’t suffer too much, but that might not be the case going forward. Surveillance is imperative.”

[covid-safer-hotties]

Reference preserved in our archive

A preprint from the latest vaccine study in the Prevent-19 trial. Novavax elicits broader, longer lasting, and sequentially increasing protection from past and present strains of covid than Pfizer and Moderna's mRNA vaccines. This is the fourth study in a row showing Novavax's increasing efficacy with additional boosters, something not seen with mRNA covid vaccines. If you can, you should try and get started on a Novavax series. The more doses you can get, the better lasting protection you'll have.

Abstract Background NVX-CoV2373, a recombinant SARS-CoV-2 spike (rS) protein vaccine with Matrix-M™ adjuvant, has been authorized for use in adults and adolescents. PREVENT-19 (NCT04611802/2019nCoV-301), a pivotal phase 3, randomized, placebo-controlled trial demonstrated robust efficacy of a primary, 2-dose series of NVX-CoV2373 against COVID-19. Methods Protocol expansions to PREVENT-19 included enrollment of adolescents (aged 12 to <18 years) and administration of 3rd and 4th doses of NVX-CoV2373 to adults and adolescents. Participants randomized 2:1 received NVX-CoV2373 or placebo 21 days apart; 3rd and 4th doses were administered ≥6 months after the preceding dose. Secondary and additional assessments included post-3rd- and 4th-dose immune responses (neutralizing antibody [nAb], anti-rS IgG, human angiotensin-converting enzyme-2-receptor binding inhibition [hACE2-RBI]) and response durability (post-3rd dose) to ancestral virus; cross-reactivity to Omicron subvariants; safety; and reactogenicity. Results Immune responses were observed against ancestral virus after two doses of NVX-CoV2373 but not after placebo. In both adults and adolescents, additional doses of NVX-CoV2373 increased nAb titers, anti-rS IgG levels, and hACE2-RBI; durable responses were recorded 8 months post 3rd dose. nAb responses post 3rd dose were noninferior to those post primary series. Cross-reactivity to BA.5 and BQ.1.1 variants was also observed, with anti-rS IgG levels post 3rd or 4th dose exceeding previously reported correlates of protection. Additional doses of NVX-CoV2373 were well tolerated, with no new safety signals. Conclusions NVX-CoV2373 elicited robust and durable humoral immune responses to ancestral SARS-CoV 2 as a 3rd and 4th dose after the primary series in adults and adolescents. Cross-reactivity to relevant variants provides insight into potential protection against antigenically related, but shifted, viral strains. Additional doses of NVX-CoV2373 were well tolerated with no new safety signals. These results support the utility of this vaccine platform and continued updates, based on currently circulating strains, to help effectively combat SARS-CoV-2 infection.

[darkmaga-returns]

Are Particulates to Blame?

Washed Up Pharmacist Nov 08, 2024

Update Eagle-eyed Jessica Rose noted that the Moderna batch 052D22A is NOT included in the batches identified by the FDA and released. However, batches 050D22A and 051D22A are mentioned so it is possible 052D22A wasn’t actually tested but I would expect to have the same issues as the other batches.

This also gives background as to these early booster bivalent doses Moderna's new booster launch tripped up by production issues at Catalent plant: reports

Evidence supporting early lots of the Pfizer vaccine were toxic than later lots. Dr Peter McCullough just recently summarized the data supporting the increased toxicity of the early lots in the US.

I have noticed in my practice that nearly all of those with serious COVID-19 vaccine syndromes including myocarditis, blood clots, and other live-threatening problems received their first shots either in December 2020 or early 2021. Pfizer’s lots or batches have been evaluated and studied for variation in risk by Schmeling, Manniche, and Jablonowski. All three studies have concluded the earlier batches were more lethal and the variation in risk was considerable from lot to lot. Now Jablonowski and Hooker report:

Here is the paper. Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine in the United States. The conclusion states:

So batches allocated in the first 2 months, sent out to hospitals and universities first. Here are the batches mention in the Jablonowski and Hooker report:

Death: EL0140, EL9261, EL3248, EN9581, EJ1686

Serious AEs: EC4176, EK5730, EH9899, EJ1685

All AE’s: EK5730, EH9888, EK9231, EJ1685

All of these are the purple topped vials formulated in the PBS buffer.

[pandemic-info]

https://twitter.com/jeffgilchrist/status/1700854098755563660

#Novavax vs mRNA vaccine This thread explains how @Novavax is different from the #Moderna and #Pfizer #mRNA #vaccines and describes some of the benefits such as broadened #variant recognition, more durable #immunity, and fewer side effects.

This is an awesome thread explaining all of the above + recommendations for primary layers of protection like ventilation, filtration, and masking.

Notable:

What about people who had mRNA doses previously but want to consider Novavax? There have been several studies now that found mixing the two, getting mRNA and then Novavax actually gave better results than just mRNA on its own.

One study found that getting Novavax as a booster after mRNA "may enhance the persistence and durability of vaccine-mediated immunity compared to mRNA options" ...with slower decay rate compared to an mRNA booster dose and less side effects than mRNA boosters

While vaccines are important, they should be the last layer of protection to rely on in case all the other layers fail and you get exposed. Vaccines should not be the one and only layer governments all seem to be currently relying on.

This link may be easier to read:

[allthebrazilianpolitics]

Brazilian-developed vaccine against Covid-19 registered by Anvisa

The new vaccine against Covid-19 developed by the Brazilian company Zalika Farmacêutica has been entered into the National Health Surveillance Agency (Anvisa) this week, Agencia Brasil reported. The drug can be used in people aged 12 and over and is to be administered in two doses, 21 days apart, with boosters after 6 months for those over 18 years of age.

The technology used in the Zalika vaccine is called “recombinant” because its molecules are formed by combining two different sources. In this case, the protein S antigen (spike) -capable of promoting a response from the immune system- and the saponin-based adjuvant allow the mixture to enhance the production of antibodies. This form of production brings greater safety to the pharmaceutical industry, Anvisa explained in a statement.

The new immunizer is the sixth to receive definitive individual registration from Anvisa, in addition to Comirnaty Ipfizer/Wyeth, Comirnaty bivalent (Pfizer), Janssen Vaccine (Janssen-Cila), Oxford/Covishield (Fiocruz and Astra-Zeneca) and Spikevax bivalent vaccines have received this type of authorization. Pfizer/Biontech, Astra-Zeneca, Janssen, Moderna, Sinopharm, and Sinovac also have definitive registration in the form of the Covax Facility consortium.

Continue reading.

[nowstomorrow]

"What about people who had mRNA doses previously but want to consider Novavax? There have been several studies now that found mixing the two, getting mRNA and then Novavax actually gave better results than just mRNA on its own.

One study found that getting Novavax as a booster after mRNA "may enhance the persistence and durability of vaccine-mediated immunity compared to mRNA options" with slower decay rate compared to an mRNA booster dose and less side effects than mRNA boosters.

A randomized controlled trial found that getting a Novavax dose after Pfizer mRNA elicited the highest humoral and peak cellular immune responses.

The mRNA + Novavax combination also had the lowest rate of breakthrough infections and the study also found fewer moderate and severe systemic adverse effects for Novavax than Pfizer mRNA.

Neutralising antibodies against Omicron BA.1 and BA.2 were higher with Novavax after mRNA compared to two mRNA doses."

- sources and graphs at the link:

[xxkawaiibatmanxx]

Seeking answers for unbiased opinions and experiences to a particular question related to COVID vaccination symptoms, as internet searches do not provide adequate information to these specifics.

After about two years of having received both doses of the Moderna COVID vaccination (no after boosters nor the recent RSV vaccination) I'm randomly experiencing stab like pains within my right lung, and pin & needle like simulations within my heart.

As well as random palpitations within my chest and irregular heartbeats. This has been an occurrence beforehand as I've experienced anxiety and panic attacks, though my current state of mental health dictates otherwise.

*Edited to add information not to confuse future commenters: These feelings of symptoms have persisted for a couple months now. I'm experiencing no COVID like symptoms at the current moment and am COVID free. These symptoms of what I'm experiencing are not correlated to COVID, per medical diagnosis and treatments. These symptoms are in relation to others after having received vaccinations per testimonials online.*

To add, what I'm aware of and have tested, I was never diagnosed with COVID while the outbreak persisted.

Curious if anyone, of any age, if you're comfortable to share this information online, has had similar symptoms after receiving the vaccine and if medical treatment has been sought out, what were the diagnosis?

If so, thank you for sharing and helping.

Blessed be.

[gusty-wind]

Latest peer-reviewed study destroys any dignity left for these so-called “Covid experts”

July 29, 2023

Covid experts are likely scrambling for cover as a new peer-reviewed study has been released. If any of them had any remaining dignity after all the politics, lies, and cover-ups, this study would surely wipe it out. But in the end, it’s not the experts who suffer the most; it’s all the people they deceived. According to the findings, heart-related Injuries from a Moderna C•19 Booster Dose were 3000x higher than thought. Researchers found a staggering 1 in 35 healthcare workers at a Swiss hospital had signs of heart injury associated with the booster dose.

So, this study basically tells us that in order to treat a bad “cold,” governments around the world created heart conditions in millions of people. The kicker is that the booster appears to impact woman more.

NEW Peer-Reviewed Study Finds Heart-Related Injuries from a Moderna C•19 Booster Dose were 3000x higher than thought. Researchers found a staggering in 1 in 35 of healthcare workers at a Swiss hospital has signs of heart injury assoc. with booster dose. pic.twitter.com/dHnqLPKH2Q

--- TexasLindsay™ (@TexasLindsay_) July 27, 2023

Wiley:

Hospital employees scheduled to undergo mRNA-1273 booster vaccination were assessed for mRNA-1273 vaccination-associated myocardial injury, defined as acute dynamic increase in high-sensitivity cardiac troponin T (hs-cTnT) concentration above the sex-specific upper-limit of normal on day 3 (48-96 h) after vaccination without evidence of an alternative cause. To explore possible mechanisms, antibodies against IL-1RA, the SARS-CoV2-Nucleoprotein(NP) and -Spike(S1) proteins and an array of 14 inflammatory cytokines were quantified. Among 777 participants, median age 37 years, 69.5% women, 40 participants (5.1% [95%CI, 3.7%--7.0%]) had elevated hs-cTnT concentration on day 3 and mRNA-1273 vaccine-associated myocardial injury was adjudicated in 22 participants (2.8% [95%CI, 1.7%–4.3%]). Twenty cases occurred in women (3.7% [95%CI, 2.3%–5.7%]), two in men (0.8% [95%CI, 0.1%–3.0%]). Hs-cTnT-elevations were mild and only temporary. No patient had ECG-changes, and none developed major adverse cardiac events within 30 days (0% [95%CI, 0%–0.4%]). In the overall booster cohort, hs-cTnT concentrations (day 3; median 5 [IQR, 4–6] ng/L) were significantly higher compared to matched controls (n = 777, median 3 [IQR, 3–5] ng/L, p < 0.001). Cases had comparable systemic reactogenicity, concentrations of anti-IL-1RA, anti-NP, anti-S1, and markers quantifying systemic inflammation, but lower concentrations of IFN-?1(IL-29) and GM-CSF versus persons without vaccine-associated myocardial injury.

Conclusion

mRNA-1273 vaccine-associated myocardial injury was more common than previously thought, being mild and transient, and more frequent in women versus men. The possible protective role of IFN-?1(IL-29) and GM-CSF warrant further studies.

This horrific news comes on the heels of several very high-profile and public “medical incidents” that occurred over the past week.

More:

[heartmarierose]

i got my covid booster wish me luck re: migraines

i’ve never had less than 50 hours worth of migraine after a covid shot - over 100 hours after the first dose of moderna

got novavax this time though, hoping that means less migraine

[infosnack]

Did the government get a bad deal on the Covid-19 boosters?

Did the government get a bad deal on the Covid-19 boosters? https://www.statnews.com/2023/09/28/covid-vaccines-higher-price/?utm_campaign=rss WASHINGTON — After Pfizer and Moderna hiked the prices of their Covid-19 vaccines this year, the federal government will now pay nearly three times more than it did previously for each dose. And it’s paying more than countries that did far less to support vaccine development. Health and Human Services Secretary Xavier Becerra glossed over the dramatic increase in the amount the government is paying for vaccines in a public appearance last week, when he got vaccinated at a CVS pharmacy in D.C. Read the rest… via STAT Health - Science, medicine and healthcare news https://www.statnews.com/category/health/ September 28, 2023 at 04:30AM

[covid-safer-hotties]

Also preserved on our archive (Daily updates!)

Like I was saying earlier: mRNA vaccines have poor effect on long term immune memory, but keeping up to date with your shots improves its general efficacy.

By Mary Van Beusekom, MS

A team led by US Food and Drug Administration (FDA) researchers studying Medicare claims data during the early Omicron SARS-CoV-2 variant months conclude that a third dose of mRNA COVID-19 vaccine provides significant protection against hospitalization and death compared with two doses but wanes substantially after 4 months.

The research, published today in the Journal of Infectious Diseases, was based on data from 8.1 million community-dwelling Medicare Fee-for-Service beneficiaries ages 65 years and older who received a second or third dose of the Moderna or Pfizer/BioNTech vaccine from December 2021 to March 2022. Of all eligible beneficiaries, 73.3% received a third dose of the original mRNA COVID-19 vaccine by the end of the study period.

77%, 73% effective 14 to 60 days postvaccination Fourteen to 60 days postvaccination, third-dose Moderna relative vaccine effectiveness (RVE, compared with two doses) against hospitalization was 77.2% (95% confidence interval [CI], 76.0% to 78.4%), and Pfizer/BioNTech RVE was 72.5% (95% CI, 70.8% to 74.0%). The added benefit was high for 61 days to 4 months (Moderna RVE, 42.1% [95% CI, 37.5% to 46.3%]; Pfizer RVE, 51.0% [95% CI, 48.0% to 53.7%) but waned substantially thereafter.

Participants with a previous medically attended COVID-19 diagnosis derived substantial protection against hospitalization after a third vaccine dose for 14 to 60 days (Moderna RVE, 71.1%; 95% CI, 62.6% to 77.6% and Pfizer RVE, 65.5%; 95% CI, 55.1%, 73.5%). Both vaccines still provided a benefit—albeit waning—for up to 120 days in these patients.

A third dose of Pfizer was only 5.4% effective against hospitalization after 120 days for those with a previous medically attended COVID-19 diagnosis, while Moderna provided a greater benefit for this group at that timepoint (RVE, 43.1%). The benefits were similar across all age-groups and both sexes and were observed more in participants with weakened immunity than in those with healthy immune systems.

Moderna more effective against hospitalization A three-dose Moderna vaccine regimen was more effective against COVID-19 hospitalization than the Pfizer regimen at 14 to 60 days (RVE, 35.2%; 95% CI, 30.2% to 39.9%), 61 to 90 days (RVE, 40.6%; 95% CI, 36.5% to 44.6%), and 91 to 120 days (RVE, 34.8%; 95% CI, 29.0% to 40.2%).

"Our observed differences between brands could be partly due to the higher dosage of Moderna (100 µg [microgram] for the third-dose primary series for certain immunocompromised individuals and 50 µg for the first booster dose for the general population) compared to Pfizer-BioNTech (30 µg) vaccines," the study authors wrote.

There were no significant differences in effectiveness against COVID-19 hospitalization between brands after 120 days following a third dose (RVE, 7.5%; 95% CI, 0.9% to 15.2%). But more severe outcomes such as death and in-hospital death showed significant differences in effectiveness between brands 14 to 90 days after a third dose.

"With more recent formulations of COVID-19 vaccines and new dominating SARS-CoV-2 variants, additional studies that investigate waning effectiveness of COVID-19 vaccines are needed to inform the design of future vaccination programs, especially for high-risk individuals," the researchers wrote.

[darkmaga-returns]

Dr Campbell analyses this stufdy:

Behavioral and Health Outcomes of mRNA COVID-19 Vaccination: A Case-Control Study in Japanese Small and Medium-Sized Enterprises | Cureus

Which has these findings:

“The adjusted ORs for COVID-19 infection among vaccinated individuals compared to unvaccinated individuals were:

Overall - 1.85 (95% CI: 1.33-2.57, p < 0.001).

Which means that for the whole study those vaxxed were 85% more likely to get infected with C19.

Dose dependent breakdown:

one to two doses (OR: 1.63, 95% CI: 1.08-2.46, p = 0.020),

three to four doses (OR: 2.04, 95% CI: 1.35-3.08, p = 0.001),

five to seven doses (OR: 2.21, 95% CI: 1.07-4.56, p = 0.033).

Japanese people employed in small to medium size enterprises who received more than two doses were twice as likely to get infected as the unvaxxed – the very low “p” values indicate a low probability of these results being pure chance.

Bottom line: Exceeding the initial course of two doses with boosters make you twice as likely to get C19 AND you are exposed to all the potential side effects of the experimental, adulterated and contaminated, modified mRNA C19 injections that enter and alter your DNA.

Even if you stuck to the initial owe or two dose regimens, you were around 70% more likely to get C19.

What’s not to like? A complete and lethally dangerous failure.

Here’s the link to Dr Campbell’s 14-minute YouTube video:

Negative efficacy

Oddly, the study includes this statement:

“Messenger RNA (mRNA) vaccines developed by Pfizer-BioNTech and Moderna have demonstrated high efficacy in preventing symptomatic infection, hospitalization, and death [3,4].”

Seems to fly in the face of the actual study results!

[myrawjcsmicasereports]

Rapid progression of angioimmunoblastic t cell lymphoma after Covid-19 vaccination by Iryna Abramenko, MD in Journal of Clinical Case Reports Medical Images and Health Sciences

Abstract

We present the case of a 57-year-old male patient from Ukraine who developed tonsillitis and generalized lymphadenopathy approximately one week after receiving the first dose of the ChAdOx1 (AstraZeneca) anti-SARS-CoV-2 vaccine. A total body computerized tomography scan revealed pronounced lymphadenopathy above and below the diaphragm, and enlargement of the spleen. Histologic examination of the left inguinal lymph node revealed revealed lack of a clear separation of the cortical and paracortical areas. Expanded proliferation of vessels (postcapillary venules) around which atypical lymphoid cells of small and medium size were located. The most of atypical lymphoid cells expressed CD3, CD4, PD1, blc-6, and Ki-67 antigens, some cells also CD10-, CD30-positive. Diagnosis of angioimmunoblastic T-cell lymphoma (AITL), IVB Ann Arbor stage, was established. The patient received six courses of therapy CHOEP regimen. According to the results of treatment clinical and hematological remission is achieved. Thus, this article describes the second case of the development of AITL after vaccination. The accumulation of such data and their analysis will allow to make appropriate conclusions about the relationship of anti-SARS-CoV-2 vaccination with development of oncohematological diseases.

Introduction

SARS-Cov-2 virus infection is widespread throughout the world. By May 2023, the number of infected cases raised to 765,903,278 persons and a total 13,350,530,518 vaccine doses have been administered [1]. Vaccination is an effective mean of preventing infection and the development of severe forms of the disease. Eleven vaccines were recommended by World Health Organization for vaccination: Pfizer-BioNTech, Oxford-AstraZeneca, Sinopharm BIBP, Moderna, Janssen, CoronaVac, Covaxin, Novavax, CovoVax (Novavax formulation), Convidecia, Sanofi-GSK; a number of vaccines are under consideration [2]. Oxford-AstraZeneca, CoronaVac, Pfizer-BioNTech, and Moderna were used for vaccination against SARS-CoV-2 in Ukraine [3].

Vaccination leads to the development of protective antiviral immunity [4, 5]. In oncological patients, this may have ambivalent influence on tumor growth. Two cases of spontaneous tumor regression after SARS-Cov-2 vaccination have been described: shrinking of the cervical lymph node and resolution of the diffuse lung lesions in patient with a recurrent primary cutaneous anaplastic large-cell lymphoma one week after having received the first COVID-19 vaccination (BioNTech/Pfizer) [6]; and spontaneous regression of metastatic salivary gland myoepithelial carcinoma in patient one month after vaccination of mRNA-1273 COVID-19 (Moderna) vaccine [7]. Anti-cancer effect of COVID-19 vaccines (a decrease in tumor size, a decrease in the expression of tumor markers (VEGF, Ki-67, MMP-2/9), CD4/CD8 ratio, and metastasis to the vital organs) has been shown in 4T1 mice models [8].

On the other hand, cases of progression of oncohematological diseases after vaccination have also been described. Goldman et al. described rapid progression of angioimmunoblastic T cell lymphoma following BNT162b2 mRNA vaccine booster shot [9]. Cavanna et al. presented a case of anaplastic large-cell lymphoma that developed in a patient approximately 10 days after receiving the third dose of the BNT162b2 vaccine and summarized eight additional cases identified in the available literature [10]. There were four cases of diffuse large-B-cell lymphoma [11-13], one case of extranodal NK/T-cell lymphoma [12], one patient with subcutaneous panniculitis-like T-cell lymphoma [14], one case of marginal zone B-cell lymphoma [15] and one primary cutaneous anaplastic large-cell lymphoma  (developed at the SARS-CoV2 vaccine injection site) [16].

In this article, we report a case of angioimmunoblastic T-cell lymphoma developed shortly after SARS-CoV2 vaccination.

Case report

The patient is a 57-year-old Caucasian man with no previous history of disease. On May 6, 2021, he received the first dose of the ChAdOx1 (AstraZeneca). A few days later, he noted a flu-like syndrome and a sore throat. A diagnosis of tonsillitis was established. Antibacterial therapy was ineffective and within two weeks patient noted rapid increase of cervical, axillary, and inguinal lymph nodes. On May, 28, 2021, trephine biopsy of the left inguinal lymph node was performed.

Pathological examination revealed lack of a clear separation of the cortical and paracortical areas. Expanded proliferation of vessels (postcapillary venules) around which atypical lymphoid cells of small and medium size were located. Mitotic figures, single plasma cells, macrophages, neutrophils and eosinophils were present. The most of atypical lymphoid cells expressed CD3, CD4, PD1, blc-6, and Ki-67 antigens, some cells also CD10-, CD30-positive. Small clusters of CD20-positive cells were found between tumor cells. CD21- and CD23-positive follicular dendritic cells wrapped around postcapillary venules. Conclusion (8.06.2021): morphological changes in the lymph node and the immunophenotype of tumor cells correspond to diagnosis of angioimmunoblastic T cell lymphoma.

CT scan (29.05.2021) revealed pronounced lymphadenopathy above and below the diaphragm (diameters of cervical lymph nodes 10-24 mm, paratracheal lymph nodes 8-18 mm, bifurcation lymph nodes 14-25 mm, right axillary lymph nodes up to 20 mm, left axillary lymph nodes up to 15 mm, inguinal lymph nodes 8-28 mm), enlargement of the spleen (5.8x12.0x11.3 cm).

On June, 11, 2021 patient referred to the hematological department of National Research Center for Radiation Medicine. Complaints of the patient upon admission: fever (up to 380C) in the second half of the day, weakness, severe fatigue, enlargement of tonsils and lymph nodes. At examination: ECOG2 performance status. Weight 72 kg. Height 174 cm. Skin is pale. Peripheral lymph nodes are palpable: submaxillary up to 6 cm, cervical 4-6 cm, axillary up to 4 cm, inguinal up to 4 cm in diameter. The liver is not enlarged. The spleen is not palpable. Breathing is vesicular. Systolic murmur over the cardiac apex. The heart rhythm is correct. Blood pressure is 115/75 mm Hg, heart rate is 80 per min. There are no edema.

Bone marrow aspiration (11.06.2021) showed hypercellular marrow, dysplasia in erythropoiesis and megakariocytopoiesis, absence of blast cells, 5.6% of lymphocytes, no cytological signs of leukemic involvement. Among all nuclear bone marrow cells 1.68% with phenotype CD45dim+CD34+CD7+CD5+CD1a-TdT- were quantified by flow cytometry.

Except high level of blood lactate dehydrogenase (1249 units/L), and C-reactive protein (29.8 mg|L) other results of laboratory test of blood and urine were unremarkable.

Diagnosis of angioimmunoblastic T-cell lymphoma (AITL), IVB Ann Arbor stage, was established, and CHOEP (cyclophosphamide, vincristine, doxorubicin, etoposide and prednisone) regimen was initiated. The patient received six courses of therapy CHOEP regimen. According to the results of treatment clinical and hematological remission is achieved: hemodynamic parameters are stable, peripheral lymph nodes are not palpable, the spleen is not enlarged, and the size of the tonsils has decreased significantly.  At the time of this report the patient continues to be in clinical and hematological remission.

Discussion

The most exciting, intriguing question is: can vaccines induce the development of tumors, in particular, lymphoproliferative diseases?

So far, only the development of fibrosarcomas in cats after vaccination is known. This has been proven for killed adjuvanted virus vaccines (vaccination against rabies and feline leukemia virus). An inflammatory process with the formation of granulomatous nodules, only 5% of which subsequently undergo transformation, preceded tumor development. The interval between vaccine administration and detection of sarcoma varied from 4 months to several years [17]. In human, we found three similar cases in the literature: the development of lymphoma and undifferentiated, pleiomorphic high-grade sarcoma at the site of anti-SARS-CoV-2 vaccine administration [16, 18], and peripheral T-cell lymphoma at the injection site of influenza vaccination [19]. However, the interval between vaccine administration and tumor development was short, which does not fit into the classical scheme for the development of the oncological process (initiation, promotion, progression). Thus, it is unclear whether there is a true association between vaccination and the development of malignancy.

For the case described in this article, progression of preceding lymphoma under the influence of the vaccine seems more likely. Anti-SARS-CoV-2 vaccines cause a powerful immune response and stimulation of T- and B-lymphocytes, as well as the production of numerous cytokines [20]. Cases of post vaccine benign lymphadenopathy are described [21]. Today, AITL is recognized as a neoplasm derived from T-follicular helper cells [22, 23]. Up to 75% of AITL patients had a mutation RHOA G17V that facilitates proliferation and activation of several signaling pathways [24]. Since T-follicular helper cells are one of the main targets of mRNA vaccines [25], the Goldman et al. suggested that their stimulation under the influence of the vaccine can accelerate the development of AITL. In their case the malignant cells of patient had a mutation RHOA G17V that could make them especially sensitive to anti-SARS-CoV-2 vaccines [9]. Unfortunately, molecular genetic studies have not been performed in our patient.

Thus, this article describes the second case of the development of AITL after vaccination. The accumulation of such data and their analysis will allow to make appropriate conclusions about the relationship of anti-SARS-CoV-2 vaccination with development of oncohematological diseases. It will contribute to our better understanding of the possible negative consequences of anti-SARS-CoV-2 vaccination and their prevention as well.

[archibaldtuttle]

Ok so I actually want to type out my answer in case people are wondering about the *most dire* side effects that you can possibly get (outside of outright allergic reactions).

For my first dose I was sore, I had headaches and a high fever, which was expected - however, for my second dose, almost exactly 24 hours after my injection, I started feeling a sharp pain in my chest, difficulty breathing, heart palpitations, sweating. I immediately rushed to the ER and was quickly diagnosed with pericarditis (an inflammation of the pericardium, which is the meat sack containing your heart).

I was given an aspirin IV and felt better within thirty minutes, then was sent home with a prescription of aspirin for three weeks with instructions to rest and stay home. Within two to three days, I barely felt any symptoms, and they were completely gone by the second week (I still took my treatment until the end). That was almost two years ago and I have done several heart check ups and ultrasounds since then and my heart is in great condition.

That is possibly one of the worst side effects someone can get from this. Of course I am young and healthy and I had access to medical help quickly, but most people who got that side effect were around 30 and recovered quickly like I did.

And that side effect occured in less than 20 people out of a million.

Just to give you an idea of what "the worst that could happen" is.

Even if I knew in advance that this would happen, I would still get vaccinated. In fact, I did, again, I got my third dose and it went great (I changed from Moderna to Pfizer on my doctor's advice).

Get vaccinated if you haven't. Get booster shots. Mask up. Stay safe.

Put in the tags how you felt if you did get side effects

For example all the times i got my vaccines the injection site was really sore and hurt to the touch for 2 days but my brother got knocked flat by the vaccine"

[samdelpapa]

Svatiamo veramente qualche leggenda del terzo millennio