Category: Covid-19 Vaccine

MOH said it would also roll out bivalent vaccines for booster jabs later this month.

"This updated bivalent vaccine will provide better protection against newer COVID-19 variants," it said.

"MOH will therefore replace the original Moderna/Spikevax vaccines with the updated bivalent version from Oct 17, 2022, for all vaccinations using the Moderna/Spikevax vaccine, for all adults aged 18 years and above.

"Hence, for persons aged 50 and above, or for persons yet to achieve minimum protection, as they are at higher risk of severe illness from COVID-19 infection, they should take the bivalent vaccines."

The Pfizer/Comirnaty bivalent vaccine is undergoing evaluation and is expected to be available by the end of this year, the ministry added.

It also announced a transition away from the current system of counting jabs.

"Instead of counting the number of shots and boosters we receive, we will transit to a new definition of up-to-date vaccination," the ministry said.

"This is similar to influenza vaccination, where individuals are advised to take them periodically, so as to protect ourselves against new strains of the endemic influenza virus as they arise."

Under this regime, MOH said it would recommend that those aged five years and above complete three mRNA or Novavax/Nuvaxovid doses, or four Sinovac-CoronaVac doses, to achieve minimum protection.

"After achieving minimum protection, persons aged 50 years and above should receive an additional booster dose between five months to one year from their last dose, to keep up-to-date with their COVID-19 vaccination," said the ministry, adding that it recommended taking the bivalent vaccine for this booster.

"Individuals will be considered up-to-date with their COVID-19 vaccination if they have received at least the minimum protection and their last vaccine dose was received within the past one year."

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COVID-19 vaccination for children aged 6 months to 4 years to start from Oct 25 - CNA

The Countermeasures Injury Compensation Program (CICP) provides some benefits to Americans who have experienced injuries or deaths as a result of a COVID-19 shot and other countermeasures recommended to prevent, diagnose, or treat the disease.

But without the development of a vaccine injury table by the Health Resources and Services Administration (HRSA), the burden of proof lies with the petitioner and not the government to prove causation in order to establish eligibility.

Thats because an injury table is the standard of proof in determining compensation, according to Wayne Rohde, an author who has written extensively on the National Vaccine Injury Compensation Program (NVICP) that covers injuries from the recommended vaccines routinely administered to children and/or pregnant women.

The standard of proof is a way to determine whether the petition measures up to a certain standard to award compensation, Rohde told The Epoch Times.

HRSA, an agency under the Department of Health & Human Services (HHS), is in charge of the CICP.

A vaccine injury table lists the injuries and conditions caused by the vaccine and the time periods in which the first symptom of these injuries and conditions must occur after receiving the vaccine, the Centers for Disease and Prevention (CDC) explains (pdf). If both the injury or condition and the specified timeframe are met, it is presumed that the vaccine was the cause and compensation would be awarded.

However, if an individual does not meet the requirements listed on the injury table, it then falls on the person filing the claim to prove that the vaccine caused the injury or condition.

Such a table eliminates the extra burden put on petitioners who are already suffering severe adverse reactions or have lost a loved one, according to Mark Sadaka, a vaccine lawyer whos helped more than 60 people file a COVID-19 injury claim.

If theres a vaccine injury table, that burden shifts from the person to the other side, Sadaka, told The Epoch Times, adding that the purpose of the table is thegovernment acknowledging that this vaccine can cause the injury and then puts the burden on the other party to disprove it.

All four COVID-19 injections administered in the United States under emergency use authorization, and the federally approved Pfizer (Comirnaty) and Moderna (Spikevax) shots, are covered under the CICP.

The federal agency did not reply to queries about the injury table. But in August and December 2021,HRSA spokespersons told The Epoch Times in an email that the CICP has not yet developed an injury table for COVID-19 countermeasures and that an injury table for COVID-19 medical countermeasures will be developed when there is sufficient data to meet the compelling, reliable, valid, medical, and scientific evidence standard.

The compensation program has received over 9,000 complaints in the two years since COVID-19 appeared compared to the 500 claims filed between 2010 and 2020, where 30 claims were compensated, totaling over $6 million.

Yet none of the 7,084 claims alleging injury or death from the vaccines or the 2,804 claims related to drugs and devices have been paid compensation. Three claims have been found eligible for compensation but are still awaiting a medical benefits review, according to HRSA.

One eligible claim is the result of anaphylaxis, and two claims are the result of myocarditis, the federal agency wroteon Sept. 1.

Sadaka said that many of the claims hes helped file have still not been assigned to someone in the agency although its been over a year since the necessary paperwork was submitted.

So far, theyve gone nowhere. Theyre not even assigned to anybody. Theres some sort of procedural hellhole and that no one knows whats happening with it, Sadaka said.

Rohde said he began submitting Freedom of Information Act (FOIA) requests to HHS and HRSA at the beginning of the year to find out whether the agency had developed or planned to develop a COVID-19 vaccine injury table.

HRSA states that they do not have any records or documents of any existing injury table specific to the COVID-19 jab nor have any plans to develop one, Rohde wrote in an article.

In a Sept. 14 email reply to Rohdes FOIA request for copies of discussions regarding the COVID-19 vaccine table, or development of the table, the HHS said, Upon receipt, your request was sent to HRSAs Division of Injury Compensation Programs who informed our office that they do not have records responsive to your request.

Without a specific injury table, then how will the petitions be measured regarding if the jab could have induced or created a specific medical condition? Rohde asked, adding that is what is called a standard of proof.

John Howie, a trial lawyer focused on vaccine and personal injuries, told The Epoch Times in anearlier interview that the compensation program is only a feel good program where there is no transparency like a true judicial process nor a provision for attorneys fees, thus making it difficult for any injured individual to even retain a lawyer. Furthermore, any appeals are handled by [three] people hand-selected by HHS to review the claim.

The CICP is the payer of last resort, meaning only medical expenses that have not been paid by insurance, lost wages, and a death benefit for people whove died are compensated. The program doesnt allow payment for pain and suffering, or attorneys fees like in a traditional compensation program, regardless if an individual is severely disabled following the administration of a vaccine or other countermeasures.

Unlike a traditional program, people only have one year from the date that the covered countermeasure was received to file and there is no public disclosure of decisions, according to Rohde.

On Aug. 16, 2021, it was announced in the Federal Register (pdf) that the HHS had established and adopted a smallpox countermeasures injury table even though the last naturally occurring case of smallpox was reported in 1977 and monkeypox was not declared a public health emergencyuntil August 2022.

The injury table includes a list of covered smallpox countermeasures, required time intervals for the first symptom or manifestation of onset of injuries, and the accompanying Qualifications and Aids to Interpretation (QAI), which set forth definitions and other requirements necessary to establish Table injuries, the HHS wrote.

The Table informs the public about serious physical injuries known to be directly caused by covered countermeasures and creates a rebuttable presumption of causation for eligible individuals whose injuries are listed on the Table and meet the Tables requirements, the agency added.

Rohde said that HRSA sent him the smallpox injury table in a response to a FOIA requesting true and accurate copies of the records, documents relating to the definition and decision-making process for the standard of proof on all countermeasures injury petitions.

In a Sept. 21, 2022,email reply, HRSA said its Division of Injury Compensation Programs (DICP) hadlocated 34 pages containing a copy of The Federal Registry Countermeasures Injury Compensation Program, Final Rule, that explains the standard of proof that DICP uses, released in its entirety.

The federal government had quietly snuck the table in without letting the public know, Rohde said.

There was no announcement, he added. I looked everywhere, if there was an announcement in August of 2021. There was no press, no press release, theres nothing in the HRSA website, the CICP website, nothing!

The injuries and conditions listed on the smallpox injury table, according to Sadaka have similarities between this document and whats seen in the literature for COVID-19 adverse events.

Some of the conditions listed on the table include anaphylaxis, syncope, and myocarditis, pericarditis, or myopericarditis.

Emails to HRSA inquiring about the reason for adopting the smallpox countermeasure injury table went unanswered, so The Epoch Times could not verify whether the table is being used to measure and decide on claims related to the COVID-19 injection.

The CICP was set up in 2010 to provide compensation for any injuries and deaths that resulted from the use of a covered countermeasure under the 2005 Public Readiness and Emergency Preparedness (PREP) Act (pdf).

Under the PREP Act, COVID-19 vaccine manufacturers, providers, distributors, and program planners are immune from lawsuits related to vaccine injuries and death, unless it can be shown that there was willful misconduct in the production of the vaccine by the company.

The CICP was not really designed as a national compensation program, Rohde said, as it was more of a regional program focused on disasters such as from hurricanes the avian flu scare, anthrax, and regional emergencies.

Rohde said the compensation program lacks adequate funding to pay all of the claims filed so far. It doesnt have a funding mechanism or a trust fund like the traditional compensation program that is funded by anexcise tax of $0.75 per dose or disease that is prevented. For example, the measles, mumps, and rubella (MMR) vaccine is taxed at $2.25 because it prevents three diseases. The excise tax thengoes into a trust fund that is managed by the Department of Treasury.

In a response to a different FOIA that Rohde submitted asking for the total compensation budget for fiscal year 2020 to 2024, HRSA revealed how underfunded the CICP is.

In 2021 and 2022, over $931,000 was budgeted for compensation under the CICP, with the budget increasing to $5 million for 2023. No estimate has been completed for 2024. Whereas, the traditional compensation program has $3.9 billion in the vaccine injury trust fund.

The 2021 and 2022 budget would only be able to pay out two claims of death each year before running out of funds since the CICP pays a one-time maximum death benefit of over $370,000 (pdf). For lost wages, the annual compensation is capped at $50,000 per year.

How can this be? Our government, more precisely, HRSA is planning to compensate only one possibly up to three petitions this year, Rohde wrote in August 2022.In the NVICP, the estimated dollar amount for compensation in FY 2022 could be around $225 million for a projected 850 damage awards.

Authors of a study published in the Journal of Law and the Biosciences calling for a reform to the CICP, said that the program lacks accountability, transparency, and cost-effectiveness efficiency, with 94% of its total costs spent on administration rather than compensation. CICPs ability to compensate is also questionable.

They added, If COVID-19 claims were compensated at its historical rate, CICP would face around $21.16 million in compensation outlays and $317.94 million in total outlays, 72.1 times its current balance.

To ensure just compensation for injured petitioners during COVID-19 and future public health emergencies, we recommend Congress (1) initiate a major reform by relocating CICP from DHHS to the Claims Court or (2) keep CICP within DHHS and make incremental changes by permitting judicial review of DHHS administrative adjudication of CICP claims. We further recommend Congress audit and adjust budgets for CICP and DHHS promptly propose an injury table for COVID-19 claims.

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Americans Injured by the COVID-19 Vaccine Have to Prove Causation to Receive Compensation - The Epoch Times

People pose with syringe with needle in front of displayed Pfizer logo in this illustration taken, December 11, 2021. REUTERS/Dado Ruvic/Illustration

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BERLIN, Sept 22 (Reuters) - Pfizer said on Thursday it had submitted an application to Swissmedic for authorisation of a further bivalent COVID-19 vaccine.

The ready-to-use dispersion for injection contained both messenger RNA (mRNA) from the original Pfizer/BioNTech COVID-19 vaccine and mRNA coding for the spike protein of Omicron variants BA.4 and BA.5, Pfizer said.

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Reporting by Kirsti KnolleEditing by Paul Carrel

Our Standards: The Thomson Reuters Trust Principles.

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Pfizer applies to Swissmedic for authorisation of another COVID-19 vaccine - Reuters.com

As Texas families head into the busy fall season, the best way to keep our communities protected against COVID-19 is for everyone to be fully vaccinated and boosted. More than 220 million Americans have been fully vaccinated. My recommendation is that if you or a family member have not been vaccinated, get vaccinated as soon as you can to keep yourselfand your communityhealthy.

Is the COVID-19 vaccine safe? Yes. COVID-19 vaccines have undergoneand continue to undergothe most intensive safety monitoring in U.S. history. And 96% of all practicing U.S. physicians have received the COVID-19 vaccine.

Can you get the virus from the vaccine? No. The vaccine does not contain the live virus, so you cannot get COVID-19 from the vaccine.

Did they rush the testing to get the vaccine approved quickly? No. Researchers have been studying and working with mRNA vaccines for decades. This includes studies for vaccines like the flu. This work made it possible for scientists to create the COVID-19 vaccine. Also, typically testing and manufacturing of vaccines are done in sequence, or sequentially. But for COVID-19 vaccines, testing and manufacturing were done in parallel, which saved a lot of time, thereby allowing much quicker availability.

What do I need to know about the updated COVID-19 boosters? The updated COVID-19 vaccine boosters are different from earlier COVID-19 vaccines because they are designed to protect against the original strain of COVID-19 plus the omicron variant.

The boosters are a single dose that uses the same mRNA technology as the original Pfizer and Moderna COVID-19 vaccines. People can get the updated booster as long as it has been at least two months since they completed any primary COVID-19 vaccine series or gotten a previous booster. Pfizers updated COVID-19 vaccine booster is available for people 12 years and older; Modernas is available for people 18 and older.

Should you get vaccinated if you already had COVID-19? Yes. Evidence shows that people can have added protection by getting vaccinated after having COVID-19. Evidence also shows that people who have already had COVID-19 and do not get vaccinated after their recovery are more likely to get COVID-19 again than those who get vaccinated after their recovery are. Talk to your doctor or pharmacist about when you should get the vaccine.

Should you get vaccinated if you are trying to get pregnant? Yes. It is recommended for people who

are trying to get pregnant now or might become pregnant in the future. COVID-19 can make pregnant people very sick and lead to an increased risk of complications that can affect pregnancy. There is currently no evidence that the COVID-19 vaccine causes fertility problems. Recent studies show that antibodies produced after COVID-19 vaccination during pregnancy are transferred to the newborn, thereby reducing the risk of COVID-19 hospitalization in infants younger than 6 months.

What are the short-term vaccine side effects? As with other vaccines, some people have experienced pain at the injection site, fever, chills, tiredness, headache, and joint and muscle pain. These typically last one to three days. The risks of serious long-term health problems from getting COVID-19 are much greater than the rare risks of serious side effects of the vaccine.

What are the long-term vaccine side effects? Vaccines have been safely given to billions of people worldwide for decades with no long-term side effects, saving countless lives.

Where can I get vaccinated? At local pharmacies and your doctors office. You can also visit CovidVaccine.texas.gov or call 1-833-832-7067 to find a vaccine near you.

How much does it cost, and do I need insurance? The vaccine is free for everyone, and no insurance or ID is required.

Can you get the COVID-19 vaccine and other vaccines at the same time? Yes, you can get the COVID-19 vaccine with other vaccines, including the flu shot, without any gaps.

*CDC Data, June 2022

Dr. Farris Blount Jr. is a family medicine doctor in Houston, Texas, and is affiliated with Medical Associates of Houston. He has been in practice for more than 30 years.

Read more:

Why Doctors Recommend the COVID-19 Vaccine - Irving Weekly

In a recent study posted to the medRxiv* preprint server, a team of researchers explored the effect of immune checkpoint blockade (ICB)-induced expansion of age-associated B cells (ABCs) on coronavirus disease 2019 (COVID-19) vaccine-derived humoral immunity in patients with cancer and inborn errors of immunity (IEI).

Immune checkpoint blockade is a cancer therapy that improves anti-cancer and anti-viral immunity by targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and programmed death 1 (PD-1) checkpoints and consequently enhancing antibody responses by promoting T and B cell interactions. Observational studies have indicated better vaccine efficacy in cancer patients using ICB.

However, the benefits of using ICB to improve vaccine performance in cancer patients are confounded to a certain extent by the expansion of ABCs. Age-associated B cells are antigen-experienced B cells that expand and accumulate in healthy individuals, as the name suggests, with age. The natural accumulation of ABCs is beneficial for improved antibody responses because of their improved ability to present antigens to T cells. In people with immune disorders, infectious diseases, or autoimmunity, and sometimes as a response to the COVID-19 vaccine or infection, ABCs have been seen to accumulate prematurely.

In cancer patients, ICB therapy seems to cause the expansion of ABCs before either the antibody-mediated or the non-antibody-mediated immunity develops. Studies have found that this leads to a T cell deficit due to B-cell extrinsic functions in cancer patients and individuals with IEI. Therefore, understanding the effect of ICB-induced expansion of ABCs on the vaccine-related immune response is essential in decreasing the vulnerability of cancer and immune disorder patients to COVID-19.

In the present study, the researchers addressed two major questions 1) are ABC levels in patients receiving ICB therapy similar to those in individuals not under ICB therapy? and 2) what effect does the expansion of ABCs during ICB therapy have on vaccination-related humoral responses?

To answer these questions, the team selected patients based on the deficient genes of interest, such as CTLA-4, lipopolysaccharide-responsive beige-like anchor protein (LRBA), and nuclear factor kappa B subunit 1 (NFB1) and subunit 2 (NFB2), and clinical diagnostics such as ICB therapy. A control group of healthy individuals was also included in the study. Blood samples from the participants, collected at different time points corresponding to the time of vaccination, were used for the study.

The researchers first used single-cell RNA sequencing (scRNAseq) to understand whether different transcriptional profiles were involved in ABCs arising from different etiologies. They investigated whether ABCs from different diseases or conditions could be subdivided based on the expression of different immune function genes, such as the autoimmune regulator (AIRE).

The second part of the study was a comprehensive longitudinal profile examining the response to the COVID-19 vaccination in all the participants. The profile included a serological assay to quantify antibodies specific to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein trimer. A neutralization assay measured antibody titers at 50% inhibition against wild-type SARS-CoV-2. Additionally, B cells were analyzed using flow cytometry.

The study's results indicate that while several factors, such as ageing, obesity, and polygenic risk alleles, can contribute to ABC expansion in older patients, the disruption of specific genes is responsible for the expansion of ABCs in younger patients suffering from rare inherited monogenic diseases.

The study found the ABC differentiation states to be homogenous across different groups consisting of cancer patients receiving ICB therapy, patients with CTLA4 or NFB1 haploinsufficiency, systemic lupus erythematosus patients, as well as healthy individuals. These results suggest that it is the increased frequency of expanded ABCs which is responsible for its pathology and not inherent differences in the ABCs from patients with distinct diseases.

The most clinically relevant finding, however, was that patients with expanded ABCs exhibited a lower B cell response to the COVID-19 vaccine, which subsequently resulted in a decreased neutralization capacity and reduced formation of memory B cells. The memory B cell frequency indicates subsequent neutralization responses to booster vaccinations. Therefore, the results suggest that patients with cancers and immune dyscrasias will require frequent booster vaccines to maintain their B-cell-related immunity.

Overall, the study indicated that expansion of ABCs in IEI patients or cancer patients receiving ICB therapy results in a decrease in memory B cells, which reduces the duration and strength of vaccine-induced antibody responses. The authors believe that ABC expansion can be used as a biomarker for monitoring humoral immunity and administering booster doses of COVID-19 vaccinations in cancer patients.

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

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Study explores the effect of age-associated B cells on COVID-19 vaccine-induced immunity - News-Medical.Net

On CNBCs "Mad Money Lightning Round," Jim Cramer said he wants to buy Moderna, Inc. MRNA. "I know it can go lower, but I think its a really well-run company," he added.

When asked about Crown Castle Inc. CCI, he said, "I say, keep your powder dry."

The "Mad Money" host said The Trade Desk, Inc. TTD is selling at a very high price-to-earnings multiple. He added, "It can go lower, and then I would buy it."

When asked about Texas Instruments Incorporated TXN, Cramer said, "I think that itll make the quarter and I think you can start buying."

Cramer said ON Semiconductor Corporation ON is "doing well, but all semiconductor stocks are vulnerable."

When asked about Carnival Corporation CCL, he said, "I think it can stave off that bankruptcy, but I dont think that makes it a good stock."

Cramer said Micron Technology, Inc. MU might go to "$48, $47 before I ever think about buying it."

Link:

Cramer On COVID-19 Vaccine Stock: 'I Know It Can Go Lower, But I Think It's A Really Well-Run Company' - - Benzinga

About 30 people are working on monitoring data from theVaccine Adverse Event Reporting System (VAERS), the U.S. Centers for Disease Control and Prevention (CDC) revealed to The Epoch Times.

The disclosure came in response to a Freedom of Information Act request.

The Epoch Times sought details on the U.S. governments COVID-19 vaccine safety monitoring, which officials have repeatedly described as the most intensive in U.S. history. The CDC previously declined to name any of the employees working on VAERS, and falsely said it was performing a type of analysis on the data from the system starting in early 2021. The agency and its director later acknowledged the method, calledProportional Reporting Ratio, was not performed until March 2022.

The U.S. Food and Drug Administration, meanwhile, which co-manages VAERS with the CDC, says that it has performed a different type of analysis calledempirical Bayesian data mining, but refused to share any of the results.

Approximately nine full-time CDC workers are on the VAERS team, which is led by Dr. John Su, the CDC told The Epoch Times in a letter. Another 20 contractors are on the team.

The staffing numbers vary depending on the agency needs and has been larger and smaller in the past, the team said in a statement conveyed through the CDCs records office.

The Epoch Times asked for all documents concerning the creation of the team and two associated efforts, which focus on post-vaccination heart inflammation, or myocarditis, and blood clotting with low blood platelets, orthrombosis with thrombocytopenia syndrome (TTS)two known serious side effects for COVID-19 vaccines.

That included all materials outlining the mission for each team, documents sent for recruiting purposes, and the number of employees on each team.

The CDC provided no materials about the mission for each team. It said the VAERS team is understood to mean the team tasked with administering and monitoring VAERS and pointed to theNational Childhood Vaccine Injury Act, which led to the establishment of VAERS in 1990.

The teams focusing on heart inflammation and blood clotting are basically ad hoc groups that are formed to address needs but are not part of any formal organizational structure, the CDC said, adding that the sizes of the groups have varied between approximately 2 to over 20, depending on workload.

There is no documentation with regard to formal authorization and chronology of creating these teams, when they started their work, or their size, the CDC added.

The only actual document provided was a four-page recruitment missive sent in November 2020 to members of theU.S. Public Health Service Commissioned Corps, which includes more than 6,500 employees of the CDC, the National Institutes of Health, and other agencies.

The VAERS team asked for workers with clinical backgrounds, including expertise in medicine, dentistry, and veterinary services.

Potential members were told that controlling the COVID-19 pandemic hinge[s] upon safe, effective COVID-19 vaccines and that the vaccines were expected to be available soon.

As more people receive COVID-19 vaccines, side effects or adverse events will occur. The VAERS Team will monitor adverse events reported after COVID-19 vaccines for unusual adverse events or patterns of reporting that might indicate the need for further safety analysis. For selected adverse events, medical record abstraction will be performed to learn more about the reported patient, Additionally, the VAERS Team will respond to public inquiries about COVID-19 vaccine safety- including from healthcare providers. The VAERS Team will coordinate with CDCs Clinical Immunization Safety Assessment Project on particularly complex and/or medically urgent inquiries, the missive said.

It told prospective applicants that the work offers a unique opportunity to contribute to the COVID-19 vaccination campaign, and to learn about COVID-19 vaccines.

Knowledge of and experience with vaccine safety was not required, nor was a background in infectious diseases.

Accepted applicants would work 100 percent remotelythe CDC has shifted drastically to offsite work during the pandemicand were not expected to have to work nights or weekends.

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Zachary Stieber covers U.S. and world news. He is based in Maryland.

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EXCLUSIVE: CDC Reveals Details of COVID-19 Vaccine Safety Monitoring Teams - The Epoch Times

The study showed significant respiratory protection against Omicron subvariants of the SARS-CoV-2 virus lasting at least six months. Illustration by iStock.

A recent study co-authored by Tulane University researchers shows a new COVID-19 vaccine offers longer-lasting protection against Omicron variants of SARS-CoV-2.

The study, led by principal investigator Bali Pulendran, PhD, of Stanford University and published inScience Translational Medicine, evaluated the vaccines performance over time in nonhuman primates. The trial, performed at the Tulane National Primate Research Center, tested a vaccine that is currently in use in South Korea, but not yet available outside the country.

While U.S. regulators recently issued emergency use authorizations for new bivalent boosters for the Moderna and Pfizer Covid-19 vaccines to protect against the Omicron subvariants of the virus, scientists are still working to test different COVID-19 vaccines to see if they can deliver more durable and longer-lasting protection.

The nanoparticle vaccine tested at Tulanecontains spike proteins from the virus to help the immune system recognize and defend against SARS-CoV-2. By using spike proteins from a specific site or receptor binding domain of the virus, scientists have homed in on the site that may prove especially protective against the Omicron variant.

The study showed significant respiratory protection against Omicron subvariants of the virus lasting at least six months, even though the vaccine targeted the original and Beta variants of the virus. Current vaccines provide a similar level of protection against Omicron subvariants six weeks after vaccination, but that protection drops significantly just 10 weeks later.

The booster also elicited an antibody response against the virus that remained high over a 10-month period, the highest reported for COVID-19 vaccines in people.

The vaccine was tested against the BA.1 and BA.2 subvariants. However, scientists are encouraged by results that indicate it may also prove effective against subsequent subvariants including BA.5, the strain currently circulating throughout the U.S.

Jay Rappaport, PhD, director and chief academic officer of the Tulane National Primate Research Center, said that the finding is significant.

So far, the virus has been outpacing scientists in its ability to adapt in ways that can evade the immune system, even a short time after vaccination. Vaccines that protect against Omicron subvariants for a longer period will give us a real chance at achieving enough immunity to greatly reduce the spread of the virus, Rappaport said.

See original here:

New COVID-19 vaccine shows promise against Omicron variants - Tulane University

CLAIM

there is an international medical crisis due to the diseases and deaths co-related to the administration of products known as COVID-19 vaccines

DETAILS

Inadequate support: The claim that the vaccines have caused an international medical crisis due to millions of adverse effects, miscarriages, and over 70,000 deaths is unsupported. There is no evidence that the COVID-19 vaccines are causing a rise in mortality or miscarriages.Factually inaccurate: Large-scale studies show that the COVID-19 vaccines dont increase the risk of negative pregnancy outcomes.Misleading: Adverse event reports in databases like VAERS and EudraVigilance are important tools for monitoring vaccine safety. But reports in these databases alone arent sufficient evidence that the COVID-19 vaccines caused an adverse event, and reports need to be further analyzed to establish causality. Claims that excess deaths are due to COVID-19 vaccines are due to misleading interpretations of data.

KEY TAKE AWAY

Scientific evidence from clinical trials and safety monitoring indicate that the COVID-19 vaccines are safe and effective. In the first year of the COVID-19 vaccine campaign, these vaccines were estimated to have prevented 19.8 million deaths due to COVID-19. There is no evidence that these vaccines have caused a rise in mortality or sudden deaths, and studies have shown that the vaccines dont increase the risk of negative pregnancy outcomes. The claim that the COVID-19 vaccines have caused an international medical crisis is baseless.

REVIEW On 1 September 2022, a team of researchers at the MRC Center for Global Infectious Disease Analysis at the Imperial College London, published a study in The Lancet where they estimated that the COVID-19 vaccines prevented 19.8 million deaths due to COVID-19 during the first year of the vaccination campaign[1]. The COVID-19 vaccines are safe and effective, significantly reducing the risk of serious illness and death due to COVID-19.

Despite overwhelming evidence of the COVID-19 vaccines success, misinformation about these vaccines continues to spread online. Recently, a group of doctors and scientists signed a declaration where they called for a worldwide stop to the COVID-19 vaccination campaigns. The declaration also claimed that there is an international medical crisis due to the diseases and deaths co-related to the administration of products known as COVID-19 vaccines, and that a high incidence of miscarriages and a large number of adverse side effects were occurring in people who received the COVID-19 vaccines.

The declaration is supported by COVID-19 denialist groups that have created and spread misinformation about COVID-19 and the COVID-19 vaccines, including Mdicos por La Verdad, which is active in a number of Spanish-speaking countries, and Mdicos pela Vida, a Brazilian group that became famous for promoting ineffective COVID-19 treatments. Signatories of the declaration include individuals like Natalia Prego, a member of Mdicos por La Verdad (whose name appears three times on the list of signatories, see here).

Outlets like One American News Network (OAN) and Daily Sceptic, two websites that have been previously factchecked by Health Feedback, reported on the declaration. Neither outlet acknowledged that the claims made in the declaration were previously fact-checked and found to be inaccurate, unsupported or misleading.

The outlets claim that 400 doctors signed the declarationlikely an attempt to suggest strong support by the general medical communityis suspect. Based on multiple signatures left on the declaration (see here, here, here, here, and here), some of which include fictitious names and locations, it becomes clear that any individual can sign it and no vetting of a signatorys qualifications is required.

The declaration made three main claims to support their statement that the COVID-19 vaccines have precipitated an international medical crisis. As well show below, these three claims are misleading, inaccurate and unsupported.

We are currently witnessing an excess in mortality in those countries where the majority of the population has received the so called COVID-19 vaccines

The declaration began by claiming that there was excess mortality in countries where the majority of the population had received the COVID-19 vaccines. This isnt a new claim. In 2022, Health Feedback and other organizations and news outlets fact-checked a number of claims about how the COVID-19 vaccines were to blame for the rise in excess deaths in 2021; fact-checks addressed claims about excess death in highly vaccinated European countries, in children in Europe, and among millennials in the U.S.

Previous fact-checks of these types of claims demonstrated that these claims are built on faulty analyses of data. For instance, in August 2022, Health Feedback pointed out that the claim that European countries with lower vaccination rates had lower excess deaths compared to countries with high vaccination rates was only true for June 2022 and only when compared to the average excess deaths for the years 2016 to 2019, which is before the COVID-19 pandemic and therefore doesnt reflect the current COVID-19 reality. Furthermore, these claims are built on correlations that are oversimplified and dont account for other variablessuch as age distribution and healthcare capacitythat also impact mortality.

Additionally, previous fact checks also pointed out that there are many possible explanations for excess death in 2021. In a fact-check about claims about excess death among millennials, experts told the Associated Press that COVID-19 itself is the obvious culprit for the deaths, especially as the rise in deaths coincided with the highly-contagious Delta and Omicron variants of SARS-CoV-2.

In a fact-check about the claims of excess death among European children, experts told the fact checking group RMIT FactLab that excess deaths in this age group could be due to COVID-19, the post-lockdown resurgence of respiratory diseases like influenza, and long-term consequences of the pandemic (postpones screenings and treatments, overloaded healthcare systems).

Finally, theres no evidence that the COVID-19 vaccines are causing a rise in mortality. To date, CDC has not detected any unusual or unexpected patterns for deaths following immunization that would indicate that COVID vaccines are causing or contributing to deaths, outside of the nine confirmed deaths following the Janssen vaccine, Martha Sharan, a spokesperson for the U.S. Centers for Disease Control and Prevention (CDC), told the Associated Press in March 2022.

The large number of sudden deaths in previously healthy young people who were inoculated with these vaccines, is particularly worrying, as is the high incidence of miscarriages and perinatal deaths

The authors of the declaration tied the COVID-19 vaccines to sudden deaths in previously healthy young people. As with the claim about excess death, this claim was previously shared on social media and fact-checked by Health Feedback and others and found to be unsupported. Some claims specifically implied that the COVID-19 vaccines are causing Sudden Arrhythmia Death Syndrome (SADS).

Sudden deaths are unexpected, fatal events that occur within one hour of the onset of symptoms in apparently healthy individuals; the majority of sudden deaths are cardiovascular and arrhythmic in origin, meaning most of these fatal events involve the heart, blood vessels or irregular heartbeats. SADS is a form of sudden death that occurs in people under the age of 40 who, due to a genetic problem, have an abnormal heart rhythm that leaves them at a higher risk of suffering a cardiac arrest; in the U.S., about 4,000 children and young adults die from a SADS condition every year.

The claim that the COVID-19 vaccines are implicated in the large number of sudden deaths in previously healthy young people is factually inaccurate in two ways. First, previous fact-checks of similar claims have shown that there is no evidence that there has been a rise in sudden deaths or SADS. Second, there is also no evidence that the COVID-19 vaccines are causing sudden deaths or SADS. As such, this part of the claim is unsupported.

The declaration also linked the COVID-19 vaccines to a high incidence of miscarriages and perinatal deaths. The American College of Obstetricians and Gynecologists (ACOG) defines miscarriages, also called early pregnancy loss or spontaneous abortion, as the loss of a pregnancy before 13 completed weeks. The Australian Institute of Health and Welfare defines perinatal deaths as a stillbirth (fetal death prior to the birth of the baby) or neonatal death (death of a live born baby) of a baby of 20 or more completed weeks of gestation or of 400 grams or more birth weight.

This is again a common piece of misinformation about the COVID-19 vaccines that has been debunked by vaccine clinical trial data and large-scale studies which show that the COVID-19 vaccines dont increase the rate of miscarriages and negative pregnancy outcomes. Moreover, because pregnant women are at a higher risk of developing severe COVID-19, which increases the risk of pregnancy complications, the vaccines actually reduce the risk of severe COVID-19 and of pregnancy complications. This is why medical associations like ACOG and government agencies like the CDC recommend that all pregnant women get vaccinated for COVID-19. As such, this part of the claim is inaccurate.

to date there have been more than 11 million reports of adverse effects and more than 70,000 deaths co-related to the inoculation of the products known as covid vaccines

To back their claims about the COVID-19 vaccines, the declaration referred to reports from the CDCs VAERS, the UKs Yellow Card System, the Australian Adverse Event Monitoring System, Europes EudraVigilance System and the WHOs VigiAccess Database claiming these showed over 11 million reports of adverse effects and more than 70,000 deaths. The declaration, however, failed to acknowledge a major limitation of these adverse event reporting databases: that reports arent confirmed, requiring further analysis to determine if the COVID-19 vaccines caused or contributed to the event reported.

VAERS, which stands for Vaccine Adverse Event Reporting System, is a database maintained by the CDC and the U.S. Food and Drug Administration where anyone can submit a report about an adverse event following inoculation with a US-licensed vaccine. On the CDCs About page for VAERS, a disclaimer states that VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness, adding that the number of reports alone cannot be interpreted as evidence of a causal association between a vaccine and an adverse event.

The Yellow Card scheme is run by the U.K.s Medicines and Healthcare products Regulatory Agency (MHRA) and it collects and monitors information on suspected safety concerns involving a [sic] healthcare products, including vaccines. The MHRA routinely publishes summaries of Yellow Card reporting for the COVID-19 vaccines. In a 1 September 2022 summary, the MHRA stated that many suspected ADRs [adverse drug reactions] reported on a Yellow Card do not have any relation to the vaccine or medicine and it is often coincidental that symptoms occurred around the same time as vaccination. Later in the same summary, the MHRA emphasized that it is therefore important that the suspected ADRs described in this report are not interpreted as being proven side effects of COVID-19 vaccines.

Australias Therapeutic Goods Administration (TGA) evaluates and monitors the safety of therapeutic goods, including collecting reports on adverse events to medicines and medical devices. TGA maintains a Database of Adverse Event Notifications (DAEN), and on the DAEN webpage TGA makes the limitations of this data clear. Specifically, TGA notes that adverse events are suspected of being related to a medicine or vaccine, but this relationship is usually not certain the symptom may be related to the underlying illness or to other factors, adding that there might be no relationship between the adverse event and the medicine or vaccine it may be a coincidence that the adverse event occurred when the medicine or vaccine was taken.

EudraVigilance is a database managed by the European Medicines Agency (EMA) that collects and analyzes reports of suspected adverse reactions to medicines in the European Economic Area. Similar to other databases, EudraVigilance facilitates the early detection of suspected safety issues with drugs. EudraVigilance also includes a disclaimer stating that the information on this website does not reflect any confirmation of a potential link between the medicine and the observed effect(s) and that the number of suspected side effects in EudraVigilance should not serve as a basis for determining the likelihood of a side effect occurring.

VigiAccess is the World Health Organizations (WHO) global database of reported suspected side effects to medicinal products, such as drugs and immunizations. As with the previously mentioned databases, the WHO makes clear that VigiAccess cannot be used to infer any confirmed link between a suspected side effect and any specific medicine and that the database cannot be used to determine the likelihood of a side effect occurring.

In short, while all five databases are important tools for monitoring vaccine safety, the existence of a report in any of these databases alone isnt sufficient proof that the COVID-19 vaccines caused or contributed to an adverse event. Reports need to be further analyzed to determine if vaccination played a role in the adverse event. As such, the claim made by the doctors and scientists in the declaration that there have been more than 11 million reports of adverse effects and more than 70,000 deaths co-related to the COVID-19 vaccines is misleading, for it doesnt consider that adverse event reports in these databases are unconfirmed.

Misinterpretation and misuse of these databases to claim that the COVID-19 vaccines are harmful have been rife since the beginning of COVID-19 vaccination campaigns. Such claims have primarily focused on VAERS, but have also been made about the Yellow Card scheme, TGAs reporting system, EudraVigilance and VigiAccess.

The declaration, which as of 16 September 2022 had been signed by nearly 11,000 individuals, made a series of inaccurate, unsupported and misleading claims claims about the safety of the COVID-19 vaccines and used these to urge for a worldwide stop to COVID-19 vaccinations. In reality, the COVID-19 vaccines are safe and effective and are estimated to have prevented nearly 20 million deaths from COVID-19 in the first year of the vaccine campaign.

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The COVID-19 vaccines are safe and effective; claim that they have caused an international medical crisis is baseless - Health Feedback

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BioNTech's COVID vaccine sales are poised to slip, but the shot will remain a 'cash cow' in the long term: analysts - FiercePharma