Category: Side Effects

COVID-19 live updates: Vaccine protection against hospitalization is dropping slightly, CDC says

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The CDC initially said 97% of people hospitalized with COVID-19 are unvaccinated

Authors: By Julia Jacobo and Ivan Pereira Last Updated: August 30, 2021, 5:18 PM ET

The COVID-19 vaccines’ ability to keep people out of the hospital appears to be dropping slightly, particularly for those 75 and older, the Centers for Disease Control and Prevention announced Monday during an advisory panel.

The CDC has previously estimated that 97% of people in the hospital being treated for COVID-19 are unvaccinated, but that data was collected before the spread of delta, a hyper-transmissible variant that many doctors have warned appears to be making people sicker.

The latest CDC analysis estimates that the ability of the COVID vaccines to keep a person out of the hospital is now between 75% to 95%.

For people older than 75 in particular, vaccine effectiveness against hospitalization experienced the steepest decline, from more than 90% to 80% between June and July.

Health experts are also concerned that a person’s immunity could be waning over time, particularly among older people whose bodies are less likely than younger people to develop a strong immune response to the vaccines.

However, the vaccine still remain highly effective at preventing serious illness, according to the briefing.

FDA Issues Warning About Increased Risk Of Heart Inflammation Caused By Moderna Jab

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Authors: BY TYLER DURDENMONDAY, AUG 30, 2021 – 02:14 P

Earlier this month, we reported on leaked data from a Canadian study which arrived at a disturbing conclusion: the risk of rare side effects like myocarditis and pericarditis – types of heart inflammation that are potentially deadly in some patients – was at least 2.5x higher in the Moderna jab than in its main competitor, produced by Pfizer-BioNTech.

The leaking of the data to the press was an embarrassment for the FDA and CDC, and so they pledged to investigate. Now, less than two weeks later, the FDA has just announced that it has updated its “fact sheet” to reflect the higher risk of heart inflammation in male patients under the age of 40.

For all patients, the “post-marketing” data examined by the FDA show that the risk of experiencing these side effects is highest within 7 days of receiving the second dose.

Only Pfizer has received full approval from the FDA; the Moderna jab is still technically under the emergency authorization. Whether this will delay or in any way impact the FDA’s approval of the Moderna jab remains unclear.

Here’s the full updated text:

Myocarditis and Pericarditis Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis

Questions about the link between the mRNA jabs and heart inflammation have been circulating since these side effects were first uncovered in a group of American soldiers reporting acute chest pain after their vaccinations.

The news is weighing on Moderna’s share price, which has fallen substantially since its Aug. 9 peak. It was down more than 3% on Monday afternoon.

First case of postmortem study in a patient vaccinated against SARS-CoV-2

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Author:TorstenHansenaUlfTitzeaNidhi Su AnnKulamadayil-HeidenreichbSabineGlombitzacJohannes, et. al.

Highlights

• We report on a patient with a single dose of vaccine against SARS-CoV-2.

• He developed relevant serum titer levels but died 4 weeks later.

• By postmortem molecular mapping, we found viral RNA in nearly all organs examined.

• However, we did not observe any characteristic morphological features of COVID-19.

• Immunogenicity might be elicited, while sterile immunity was not established.

Abstract

A previously symptomless 86-year-old man received the first dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks later from acute renal and respiratory failure. Although he did not present with any COVID-19-specific symptoms, he tested positive for SARS-CoV-2 before he died. Spike protein (S1) antigen-binding showed significant levels for immunoglobulin (Ig) G, while nucleocapsid IgG/IgM was not elicited. Acute bronchopneumonia and tubular failure were assigned as the cause of death at autopsy; however, we did not observe any characteristic morphological features of COVID-19. Postmortem molecular mapping by real-time polymerase chain reaction revealed relevant SARS-CoV-2 cycle threshold values in all organs examined (oropharynx, olfactory mucosa, trachea, lungs, heart, kidney and cerebrum) except for the liver and olfactory bulb. These results might suggest that the first vaccination induces immunogenicity but not sterile immunity.

Keywords

SARS-CoV-2VaccineAutopsyHistologyRT-PCR

We report on an 86-year-old male resident of a retirement home who received vaccine against SARS-CoV-2. Past medical history included systemic arterial hypertension, chronic venous insufficiency, dementia and prostate carcinoma. On January 9, 2021, the man received lipid nanoparticle-formulated, nucleoside-modified RNA vaccine BNT162b2 in a 30 μg dose. On that day and in the following 2 weeks, he presented with no clinical symptoms (Table 1). On day 18, he was admitted to hospital for worsening diarrhea. Since he did not present with any clinical signs of COVID-19, isolation in a specific setting did not occur. Laboratory testing revealed hypochromic anemia and increased creatinine serum levels. Antigen test and polymerase chain reaction (PCR) for SARS-CoV-2 were negative.

For More Information: https://www.sciencedirect.com/science/article/pii/S1201971221003647

Covid-19 Vaccine Analysis: The most common adverse events reported so far

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Authors: DATED: AUGUST 6, 2021 BY SHARYL ATTKISSON 

As of July 19, 2021 there were 419,513 adverse event reports associated with Covid-19 vaccination in the U.S., with a total of 1,814,326 symptoms reported. That’s according to the federal Vaccine Adverse Event Reporting System (VAERS) database.

Report an adverse event after vaccination online here.

Each symptom reported does not necessarily equal one patient. Adverse event reports often include multiple symptoms for a single patient.

Reporting of illnesses and symptoms that occur after Covid-19 vaccination does not necessarily mean they were caused by the vaccine. The system is designed to collect adverse events that occur after vaccination to uncover any patterns of illnesses that were not captured during vaccine studies.

Read CDC info on Covid-19 vaccine here.

Scientists have estimated that adverse events occur at a rate many fold higher than what is reported in VAERS, since it is assumed that most adverse events are not reported through the tracking system. Reports can be made by doctors, patients or family members and/or acquaintances, or vaccine industry representatives. 

Read: Exclusive summary: Covid-19 vaccine concerns.

Some observers claim Covid-19 vaccine adverse events are not as likely to be underreported as those associated with other medicine, due to close monitoring and widespread publicity surrounding Covid-19 vaccination.

Approximately 340 million doses of Covid-19 vaccine have been given in the U.S. Slightly less than half of the U.S. population is fully vaccinated.

According to the Centers for Disease Control (CDC) and Food and Drug Administration (FDA), the benefits of Covid-19 vaccine outweigh the risks for all groups and age categories authorized to receive it.

Watch: CDC disinformation re: studies on Covid-19 vaccine effectiveness in people who have had Covid-19.

The following is a summary of some of the most frequent adverse events reported to VAERS after Covid-19 vaccination. (It is not the entire list.)

Most common Covid-19 vaccine adverse events reported as of July 19, 2021

Yellow highlighted adverse events are subjects of investigations, warnings or stated concerns by public health officials. For details, click here.

128,370 Muscle, bone, joint pain and swelling including:

  • 39,902 Pain in extremity
  • 37,819 Myalgia, muscle pain, weakness, fatigue, spasms, disorders, related
  • 30,138 Arthralgia, joint pain or arthritis, swelling, joint disease, bone pain, spinal osteoarthritis
  • 14,682 Back pain, neck pain
  • 5,829 Muscle and skeletal pain, stiffness, weakness

119,866 Injection site pain, bleeding, hardening, bruising, etc.

105,332 Skin reddening, at injection site or elsewhere, rash, hives

100,564 Fatigue, lethargy, malaise, asthenia, abnormal weakness, loss of energy

89,302 Headache, incl. migraine, sinus

68,252 Vomiting, nausea

68,064 Fever

63,133 Chills

60,913 Pain

49,574 Dizziness

34,076 Flushing, hot flush, feeling hot, abnormally warm skin

31,785 Lung pain or abnormalities, fluid in lung, respiratory tract or lung congestion or infection, wheezing, acute respiratory failure including:

  • 23,005 Dyspnoea, difficulty breathing
  • 1,398 Pneumonia
  • 1,128 Respiratory arrest, failure, stopped or inefficient breathing, abnormal breathing
  • 563 Covid-19 pneumonia
  • 265 Mechanical ventilation
  • 217 Bronchitis

30,909 Skin swelling, pain, tightness, face swelling, swelling under skin, hives, angioedema including:

  • 7,579 Skin pain, sensitivity, burning, discoloration, tenderness

25,319 Heart failure, heart rhythm and rate abnormalities, atrial fibrillation, palpitations, flutter, murmur, pacemaker added, fluid in heart, abnormal echocardiogram including:

  • 3,105 Heart attack or cardiac arrest, sudden loss of blood flow from failure to pump to heart effectively, cardiac failure, disorder

22,085 Itchiness

29,861 Sensory disturbance including:

  • 8,236 Tinnitus, hearing noise
  • 7,951 Abnormal vision, blindness
  • 6,349 Ageusia, loss of taste, altered taste, disorders
  • 2,249 Anosmia, loss of smell, parosmia (rotten smell)
  • 2,075 Hypersensitivity
  • 1,560 Sensitivity or reaction to light 
  • 890 Hearing loss, deafness

CDC Study: Side Effects Of Covid Far More Dangerous Than Any Of Vaccines

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The possibility of experiencing a serious adverse effect from the covid shots approved in the U.S. is significantly lower than the chances of severe illness, hospitalization or death from contracting covid, new research from the Centers for Disease Control and Prevention shows. Other studies show covid’s pregnancy impact and vaccine protection against the delta variant.

Bay Area News Group: COVID-19 Far Riskier Than Vaccines, New CDC Study SaysHow risky are the COVID-19 vaccines? A new study by the U.S. Centers for Disease Control and Prevention found that the risk of illness, hospitalization and death following the shots is far lower than the danger from becoming infected with the highly contagious and often deadly virus. Three health threats have surfaced among some vaccinated people: Blood clots and the Guillain-Barre Syndrome neurologic disorder after the Johnson & Johnson shot, and heart inflammation after the Pfizer or Moderna shots, which use a messenger-RNA technology. But the CDC analysis found that the risk in adults from the vaccines to be minimal compared to the virus that causes COVID-19, which has infected 35 million Americans and killed more than 614,000. (Woolfolk, 8/10)

San Francisco Chronicle: Devastating Impact Of COVID On Pregnancy Highlighted By Large UCSF StudyPregnant women infected with the coronavirus are at significantly higher risk for adverse complications, including preterm birth, according to a University of California San Francisco analysis of all documented births in the state between July 2020 and January 2021. In the largest study of its kind, researchers found the risk of very preterm birth, which occurs at less than 32 weeks of gestation, was 60% higher for people infected with the coronavirus during their pregnancy. The risk of giving birth at less than 37 weeks — which is any preterm birth — was 40% higher. (Vaziri, 8/10)

USA Today: Study Showing Antibody Levels Protecting Against COVID-19 Could Speed Creation Of New Vaccines, BoostersEagerly anticipated new research pinpoints antibodies scientists can test for to see if a COVID-19 vaccine is effective. These “correlates of protection” could speed the development of new vaccines or boosters without requiring the enormous clinical trials used to create the first COVID-19 vaccines. Instead, researchers could vaccinate people with a new vaccine or booster, measure their antibodies over the course of several months, and know if it worked. This is “the Holy Grail” in terms of vaccines, and one that hasn’t yet been set for the virus that causes COVID-19, said Peter Gilbert, co-author of the study posted Tuesday to medRxiv, a preprint site where scientific articles can be published prior to being accepted by peer-reviewed journals. (Weise, 8/10)

Reuters: Moderna May Be Superior To Pfizer Against Delta; Breakthrough Odds Rise With TimeThe mRNA vaccine from Pfizer and BioNTech may be less effective than Moderna’s against the Delta variant of the coronavirus, according to two reports posted on medRxiv on Sunday ahead of peer review. In a study of more than 50,000 patients in the Mayo Clinic Health System, researchers found the effectiveness of Moderna’s vaccine against infection had dropped to 76% in July – when the Delta variant was predominant – from 86% in early 2021. Over the same period, the effectiveness of the Pfizer/BioNTech vaccine had fallen to 42% from 76%, researchers said. While both vaccines remain effective at preventing COVID hospitalization, a Moderna booster shot may be necessary soon for anyone who got the Pfizer or Moderna vaccines earlier this year, said Dr. Venky Soundararajan of Massachusetts data analytics company nference, who led the Mayo study. (Aug. 9)

Also —

The Washington Post: Johnson & Johnson Coronavirus Vaccine Recipients Worry They Chose The Wrong Brand New research offers encouraging evidence about how the Johnson & Johnson vaccine stacks up against its competitors — and the delta variant — according to infectious-disease specialists. However, there are still lingering questions about booster shots. Earlier clinical trials showed the Johnson & Johnson vaccine was 66 percent effective overall in preventing moderate to severe disease four weeks after the shot, with effectiveness varying depending on location. Its competitors from Pfizer and Moderna, on the other hand, recorded 90 percent-plus effectiveness against the coronavirus. Anthony S. Fauci, the nation’s leading infectious-disease expert, has said all three vaccines are effective. (Beachum, Bever and Iati, 8/10)

CIDRAP: Viral COVID-19 Detected In Singing, Talking, Breathing Between breathing, singing, and talking, researchers detected SARS-CoV-2 RNA copies mostly from talking and singing (94%), and 85% of all viral particles were detected in fine aerosols, according to a small study late last week in Clinical Infectious Diseases. The researchers had 22 COVID-19 patients at Singapore’s National Centre for Infectious Diseases breathe for 30 minutes, talk for 15 minutes, or sing for 15 minutes into a G-II exhaled breath collector. Thirteen patients (59%) had detectable SARS-CoV-2 levels, of whom three were asymptomatic and one was presymptomatic. Variables such as age, sex, virus variant, and clinical symptoms were not significantly associated with detectable viral RNA in aerosols, but median day of illness was, with a higher likelihood earlier on in a patient’s illness (median, 3 vs 5 days after illness onset). (8/9)

The potential neurological effect of the COVID-19 vaccines: A review

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Authors: Lu Lu 1 2, Weixi Xiong 1 2, Jie Mu 1 2, Qi Zhang 1 2, Hesheng Zhang 1 2, Ling Zou 3, Weimin Li 4, Li He 1 2, Josemir W Sander 1 2 5 6, Dong Zhou 1 2

Abstract

The coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a pandemic with people infected in almost all countries. The most efficient solution to end this pandemic is a safe and efficient vaccine. Classic platforms are used to develop vaccines including live-attenuated vaccine, inactivated vaccine, protein subunit vaccine, and viral vector. Nucleic acid vaccine uses next-generation platforms for their development. Vaccines are now rushing to the market. Eleven candidates are in advance development. These comprise inactivated vaccines, viral vector vaccine, nucleic acid vaccine, and the protein subunit vaccine platform, which are now quite advanced in trials in various geographic and ethnic populations. The reported severe adverse effects raised the worries about their safety. It becomes critical to know whether these vaccines will cause neurologic disorders like previously recognized vaccine-related demyelinating diseases, fever-induced seizure, and other possible deficits. We reviewed the most promising COVID-2 vaccines with a particular interest in mechanism(s) and adverse effect(s). We exemplify potential neurological problems these vaccines could cause by looking at previous studies. The current evidence indicated a minor risk of the acute neurological disorders after the application. The observation of the long-time effect is still needed.

For More Information: https://pubmed.ncbi.nlm.nih.gov/33779985/

An Update: Is hydroxychloroquine effective for COVID-19?

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Authors: Medically reviewed by Drugs.com. Last updated on Feb 2, 2021.

Multiple studies provide data that hydroxychloroquine (brand name: Plaquenil) does not provide a medical benefit for hospitalized patients with COVID-19. Hydroxychloroquine, an FDA-approved prescription drug used for malaria, rheumatoid arthritis and lupus erythematosus, has been suggested as a possible treatment or preventive for COVID-19 based on demonstrated antiviral or immune system activity.

In June 2020, the FDA revoked the emergency use authorization (EUA) of oral hydroxychloroquine and chloroquine phosphate for the treatment of COVID-19. An EUA can allow quicker access to critical medical products when there are no approved alternative options.

  • Based on an evaluation of the scientific data to date, the FDA concluded that chloroquine and hydroxychloroquine are not likely to be effective in the treatment of COVID-19 for the authorized uses in the EUA.
  • In addition, the risk for serious side effects with hydroxychloroquine and chloroquine phosphate are a concern. This includes the possibility of adverse cardiovascular (heart) events such as an abnormal heart rhythm which could be fatal.
  • Additional worldwide studies are still ongoing to assess the use of these agents for the treatment or prevention or COVID-19, including early-stage outpatient and use with supplements such as zinc or vitamin D or with azithromycin. However, the FDA states hydroxychloroquine should not be used outside of clinical trials in the U.S.

The World Health Organization (WHO) and the U.S. National Institutes of Health (NIH) have also stopped studies evaluating hydroxychloroquine for the treatment of COVID-19 due to a lack of benefit. Current NIH and US treatment guidelines do not recommend use of hydroxychloroquine and chloroquine phosphate for COVID-19 treatment outside of clinical studies.

Although earlier studies suggested that hydroxychloroquine could inhibit the SARs-CoV-2 virus and was more potent than chloroquine, recent studies do not support the use of hydroxychloroquine or chloroquine phosphate. The FDA stated on June 15, 2020 that the suggested dosing regimens for chloroquine and hydroxychloroquine are unlikely to kill or inhibit the virus that causes COVID-19.

Do studies show hydroxychloroquine is not effective for COVID-19?

Yes, multiple studies provide data that hydroxychloroquine is ineffective in the treatment of SARS-CoV-2, the virus that causes COVID-19 disease.

The RECOVERY Trial from the University of Oxford is a large, randomized, controlled, open-label study evaluating a number of potential treatments for patients hospitalized with COVID-19. The study is being conducted by researchers at the University of Oxford in the UK (the hydroxychloroquine arm is now halted).

  • In the RECOVERY Trial, investigators reported that there was no beneficial effect or reduction of death in hospitalized patients with COVID-19 receiving hydroxychloroquine.
  • In this study, 1561 patients received hydroxychloroquine and were compared to 3155 patients receiving standard care only. No difference was found in the primary endpoint, which was the incidence of death at 28 days (26.8% hydroxychloroquine vs. 25% usual care, 95% CI 0.96-1.23; p=0.18).
  • In addition, hydroxychloroquine treatment was associated with an increased length of stay in the hospital and increased need for invasive mechanical ventilation.
  • Based on this data, investigators stopped enrollment in the RECOVERY hydroxychloroquine arm on June 5th, 2020.

For More Information: https://www.drugs.com/medical-answers/hydroxychloroquine-effective-covid-19-3536024/

Worse Than the Disease? Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19

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Authors: Stephanie Seneff1and Greg Nigh21Computer Science and Artificial Intelligence Laboratory, MIT, Cambridge MA, 02139, USA, E-mail: seneff@csail.mit.edu

ABSTRACT

Operation Warp Speed brought to market in the United States two mRNA vaccines, produced by Pfizer and Moderna. Interim data suggested high efficacy for both of these vaccines, which helped legitimize Emergency Use Authorization (EUA) by the FDA. However, the exceptionally rapid movement of these vaccines through controlled trials and into mass deployment raises multiple safety concerns. In this review we first describe the technology underlying these vaccines in detail. We then review both components of and the intended biological response to these vaccines, including production of the spike protein itself, and their potential relationship to a wide range of both acute and long-term induced pathologies, such as blood disorders, neurodegenerative diseases and autoimmune diseases. Among these potential induced pathologies, we discuss the relevance of prion-protein-related amino acid sequences within the spike protein. We also present a brief review of studies supporting the potential for spike protein “shedding”, transmission of the protein from a vaccinated to an unvaccinated person, resulting in symptoms induced in the latter. We finish by addressing a common point of debate, namely, whether or not these vaccines could modify the DNA of those receiving the vaccination. While there are no studies demonstrating definitively that this is happening, we provide a plausible scenario, supported by previously established pathways for transformation and transport of genetic material, whereby injected mRNA could ultimately be incorporated into germ cell DNA for transgenerational transmission. We conclude with our recommendations regarding surveillance that will help to clarify the long-term effects of these experimental drugs and allow us to better assess the true risk/benefit ratio of these novel technologies.

For More Information: https://ijvtpr.com/index.php/IJVTPR/article/view/23/51

From adenoviruses to RNA: the pros and cons of different COVID vaccine technologies

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Authors: Joel Abrams

The World Health Organisation lists about 180 COVID-19 vaccines being developed around the world.

Each vaccine aims to use a slightly different approach to prepare your immune system to recognise and fight SARS-CoV-2, the virus that causes COVID-19.

However, we can group these technologies into five main types. Some technology is tried and trusted. Some technology has never before been used in a commercial vaccine for humans.

As we outline in our recent paper, each technology has its pros and cons.

1. DNA/RNA-based

DNA and RNA vaccines use fragments of genetic material made in the lab. These fragments code for a part of the virus (such as its spike protein). After the vaccine is injected, your body uses instructions in the DNA/RNA to make copies of this virus part (or antigen). Your body recognises these and mounts an immune response, ready to protect you the next time you encounter the virus.

Pros

  • these vaccines can be quickly designed based on genetic sequencing alone
  • they can be easily manufactured, meaning they can potentially be produced cheaply
  • the DNA/RNA fragments do not cause COVID-19.

Cons

  • there are no approved DNA/RNA vaccines for medical use in humans, hence their alternative name: next-generation vaccines. So they are likely to face considerable regulatory hurdles before being approved for use
  • as they only allow a fragment of the virus to be made, they may prompt a poor protective immune response, meaning multiple boosters may be needed
  • there’s a theoretical probability vaccine DNA can integrate into your genome.

The speed at which these vaccines can be designed, needing only the genetic sequence of the virus, is why these vaccines were among the first to enter clinical trials.

An RNA vaccine, mRNA-1273, being developed by Moderna and the US National Institute of Allergy and Infectious Diseases, advanced to clinical testing just two months after the virus was sequenced.

2. Virus vectors

These vaccines use a virus, often weakened and incapable of causing disease itself, to deliver a virus antigen into the body. The virus’ ability to infect cells, express large amount of antigen and in turn trigger a strong immune response make these vaccines promising.

Examples of viruses used as vectors include vaccinia virus (used in the first ever vaccine, against smallpox) and adenovirus (a common cold virus).

Pros

  • highly specific delivery of antigens to target cells and high expression of antigen after vaccination
  • often a single dose is enough to stimulate long-term protection.

Cons

  • people may have existing levels of immune protection to the virus vector, reducing the effectiveness of the vaccine. In other words, the body raises an immune response to the vector rather than to the antigen.

For More Information: https://theconversation.com/from-adenoviruses-to-rna-the-pros-and-cons-of-different-covid-vaccine-technologies-145454

More Dangerous Side Effects Potentially Linked To mRNA Vaccines, EU Warns

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Authors: BY TYLER DURDEN

As shares of MRNA-vaccine purveyors Moderna and BioNTech tumbled on Wednesday, Reuters reported that the EMA, the EU’s medicines regulator, is looking into new potential side effects from the still-experimental MRNA jabs, including suspicious skin reactions and kidney ailments.

According to Reuters, three new conditions have been reported by a small number of people after vaccination with jabs from Pfizer and Moderna. The ailments include Erythema multiforme, a form of allergic skin reaction; glomerulonephritis, or kidney inflammation; and nephrotic syndrome, a renal disorder that leads to heavy urinary protein losses. All of the cases are being studied by the EMA to determine whether the vaccines might be linked to the conditions.

This isn’t the first time regulators have raised issues with an MRNA vaccine. As we reported a few months ago, the FDA determined that one side effect of the jabs in a small number of male patients with certain complications included heart inflammation. Still, the FDA, CDC and WHO have insisted that the risks posed by the jabs are far outweighed by their benefits to society.

The finding comes as Israeli health authorities have found that a small number of patients still managed to get infected with the virus even after their third dose of the vaccine.

For More Information: https://www.zerohedge.com/covid-19/new-side-effects-potentially-linked-mrna-vaccines-eu-warns