Category: Covid-19 Vaccine

The protocol was approved by the ethics committee (EC) of each of the 16 study centers and the Vietnam National EC in Biomedical Research and Ministry of Health. All participants provided informed consent before enrolment, and the study was conducted in accordance with the ethical principles of Good Clinical Practice, the Declaration of Helsinki and International Council for Harmonisation (ICH E6R2), and applicable local regulatory and bioethics requirements. Primary objectives of phase 1, 2, and 3a studies were to assess in comparison with placebo the safety and reactogenicity of two ARCT-154 doses administered four weeks apart, and the immunogenicity four weeks after the second dose. Primary objectives of the phase 3b study were to assess the safety and reactogenicity of two doses of ARCT-154 and their efficacy against COVID-19 disease from 7 (Day 36) to 63 (Day 92) days after the second vaccination. An exploratory assessment of efficacy from Day 1 to Day 92 was done in all participants who had received at least one dose of ARCT-154 in any phase of the study. An independent data and safety monitoring board (DSMB) had full oversight over the study, including assessment of blinded data on safety and confirmed COVID-19 cases, and made recommendations to continue enrolment or the study.

Study designs for individual study phases are illustrated in Fig.1. In phase 1 eligible participants were healthy adults > 18 to <60 years of age; in phases 2/3a/3b eligible participants were adults > 18 years of age. Enrolled volunteers in phases 1/2/3a were randomized 3:1 and those in phase 3b 1:1 to receive ARCT-154 or placebo. Phase 3b included volunteers at increased risk of severe COVID-19 due to their comorbidity status31 or being 60 years old, and randomization included stratification of these at-risk participants. Phase 1 participants were recruited and treated first, parallel enrolment for phases 2 and 3a was only allowed after the DSMB and Vietnam MoH had reviewed all safety data collected up to 7 days after the second vaccination (Day 36) in phase 1. Similarly, enrolment for phase 3b was only approved following review of all safety data collected through Day 7 following the first dose in phases 2 and 3a.

Other than the above age restrictions, eligible participants were male or female adults who could consent to participate, agreed to comply with all required study visits and procedures, and were willing to provide required blood and nasal swab samples. Major exclusion criteria were evidence of an acute infection at the time of enrolment, pregnancy or breastfeeding, previous COVID-19 infection (including a positive result of RT-PCR), close contact with a person known to be infected with SARS-CoV-2 or any known history of anaphylactic reactions to vaccines. Detailed exclusion criteria are shown in Supplementary Table2.

At enrolment volunteers were allocated to ARCT-154 or placebo groups using an interactive response technology (IRT) system which provided a unique identifying study code and the allocated study intervention for each participant. Codes were accessible only to unblinded study personnel who prepared and administered the vaccine/placebo but played no other role in the study. All other study personnel and participants were blinded to study allocation. A nasal swab was collected for SARS-CoV-2 testing by RT-PCR at screening on or within 5 days of Day 1. On Day 1, after a baseline blood draw for testing for SARS-CoV-2 nucleocapsid-specific antibodies and negative urine or blood pregnancy test for females of child-bearing potential, the first assigned vaccine or placebo injection was administered; a second dose was given in the same manner on Day 29. To ensure all participants received immunization against COVID-19 there was as switchover at Day 92 when placebo recipients from all phases were offered ARCT-154 as two doses four weeks apart. Vaccinees from the different phases received either a third dose of ARCT-154 or two doses of placebo. This report only presents data acquired up to Day 92, data from the switchover will be presented separately.

ARCT-154 consists of a replicon based upon Venezuela equine encephalitis virus in which RNA coding for the virus structural proteins has been replaced with RNA coding for the full-length spike (S) glycoprotein of the SARS-CoV-2 D614G variant, encapsulated in lipid nanoparticles. 100g active ingredient, stored in vials at -20C or lower, was dissolved in 10mL sterile saline immediately before use and 0.5mL doses containing 5g were administered by intramuscular injection in the deltoid. Placebo was sterile saline.

After 30minutes monitoring for any immediate reactions, all participants completed electronic or paper study diaries for 7 days starting on the day of each study injection. Diaries solicited local reactions (injection site erythema, pain, induration/swelling, and tenderness) and systemic adverse events (AEs; arthralgia, chills, diarrhea, dizziness, fatigue, headache, myalgia, nausea/vomiting and fever). Unsolicited AEs were recorded up to 28 days after each vaccination. Any adverse event leading to discontinuation or withdrawal from the study, any medically attended adverse event (MAAE) or serious adverse event (SAE) was to be documented for one year of follow-up after the completion of the initial vaccination series. Here we present general safety data including MAAEs, SAES and withdrawals up to six months (Day 210). Participants were contacted through weekly telephone calls to ensure compliance with completing the study diaries, which were collected on Days 8 and 36, 7 days after each vaccination, and at a follow-visit on Day 57. Adverse event data was entered into the case report form, and the causal relationship of events was established by the reporting investigator.

Sera for immunogenicity analyses were collected on Days 1, 29 and 57. The primary immunogenicity objective was the response at Day 57 in all sera available from eligible phase 1/2/3a participants as measured at the Vietnamese National Institute of Hygiene and Epidemiology Laboratory using the SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT) kit (GenScript, Piscataway, NJ, USA). This kit is a functional enzyme-linked immunosorbent assay for qualitative or semiquantitative detection of antibodies (Nabs) that block the binding of SARS-CoV-2 to the human ACE2 receptor of host cells. Antibodies were expressed as group geometric mean concentrations (GMC), seroconversion rates (SCR), and geometric mean fold rises (GMFR) from Day 1. Results were expressed in units per mL (U/mL) calibrated with the WHO standard serum.

To confirm observations from the exploratory assay, immunogenicity was also assessed in a validated 293T-ACE2 cell-based microneutralization assay by the Pharmaceutical Product Development Bioanalytical Laboratory (PPD, Richmond, VA, USA). This measured neutralizing antibodies against SARS-CoV-2 in sera from Days 1 and 57 from all phase 1 participants, the first 150 samples from phase 2, and randomly selected samples from the other participants in phase 2, and all available samples from phase 3a.

For efficacy assessments, participants with suspected COVID-19 were evaluated for the presence of potential symptoms and clinical signs of COVID-19 including fever, chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting or diarrhea. Any of these symptoms occurring after 3 days post-vaccination triggered COVID-19 diagnostic testing. Where possible, participants visited their respective study clinic where nasal swabs were taken for RT-PCR, with documentation of medical history and medications taken. A protocol-defined COVID-19 case had to have virological confirmation (by RT-PCR) of SARS-CoV-2 and at least one of the symptoms or clinical findings listed above.

Case definitions for evaluations of COVID-19 and severe COVID-19 were based on US FDA recommendations in line with similar clinical trials, which for severe COVID-19 included any of the following: acute pulmonary, cardiac, renal, hepatic, or neurologic dysfunction; shock; death; or admission to an intensive care unit (Supplementary table3). All suspected COVID-19 cases underwent blinded tiered review by an independent Event Adjudication Committee (EAC) composed of clinical experts experienced in the diagnosis, care, and treatment of COVID-19. The EAC reviewed blinded data from each case and concluded on whether the case met the protocol-defined COVID-19 case criteria, and severity according to the US FDA and WHO classifications. Only virologically confirmed, protocol-defined cases adjudicated by the EAC are included in the primary vaccine efficacy (VE).

Primary safety endpoints were evaluated in the Safety Analysis Set (SAS; all participants who received any study injection) and Reactogenicity Analysis Set (RAS; all participants who received any study injection and provide at least one diary report). Statistical analysis of safety and reactogenicity data was descriptive with frequency and percentage for participants analyzed according to study group.

Primary immunogenicity analysis in the Immunogenicity Analysis Set (IAS) included all participants who received both assigned study injections by the evaluated timepoint with no evidence of prior SARS-CoV-2 infection at Day 1 (i.e., were seronegative for N-antibody) and at least one valid post-vaccination immunogenicity assay result. GMCs were calculated as the mean of log-transformed results and then exponentiating the mean (in order to present the results on the original scale). GMFR was calculated as the mean of the difference after log-transformed results (post baseline minus baseline) and exponentiating the mean. Two-sided 95% CI for GMCs and GMFRs were obtained by taking log-transformation of the antibody results; the 95% CI was calculated based on Students t-distribution for the mean difference, then exponentiating the confidence limits. Seroconversion was defined as 4-fold increase in titer from baseline and its two-sided 95% CI was calculated using the Clopper-Pearson method.

The primary efficacy objective was assessed in the modified Intention to Treat (mITT) set composed of all participants who received both assigned study injections and had no evidence of SARS-CoV-2 infection on Day 1 and up to Day 36, 7 days after the second study injection. The first primary endpoint was defined as the first occurrence of confirmed, protocol-defined COVID-19 with onset between Days 36 and 92 inclusive. For the overall primary efficacy objective of the study, the null hypothesis was that the vaccine efficacy (VE) of ARCT-154 to prevent COVID-19 was 30% (i.e., H0efficacy: VE 0.3). Vaccine efficacy was calculated from 1-hazard ratio, where the hazard ratio (HR) and 95% CI are estimated by Cox proportional hazard regression. The primary efficacy objective would be met if the lower limit of the 95% CI for VE exceeded 30%; a total of 372 COVID-19 cases were needed to provide approximately 90% power to detect a 50% reduction in hazard rate (50% VE). Factors used as covariates in Cox proportional hazard regression included: Risk group: 18 to <60 years and healthy, 18 and <60 years and at risk and 60 years and study site region. If the primary efficacy objective was met, following a hierarchical approach, the null hypothesis that the vaccine efficacy to prevent occurrence of confirmed severe COVID-19 was 0% (i.e., H0efficacy: VEsevere0) was also tested. A secondary efficacy assessment was done in the ITT set, comprising all participants who received at least one study injection, in which the secondary endpoint was the occurrence of confirmed, protocol-defined COVID-19 with onset at any time after the Dose 1 up to Day 92, inclusive.

Further information on research design is available in theNature Portfolio Reporting Summary linked to this article.

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Safety, immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine: pooled phase 1, 2, 3a ... - Nature.com

The number of children who received their routine vaccinations declined during the pandemic, so public health officials have been focusing on getting kids back up to date. They should also be paying attention to adults as a new, first-of-its-kind report quantifying the economic impact of adult immunizations makes clear.

Researchers at the nonprofit Office of Health Economics, based in London, analyzed four adult vaccine programs for the flu, pneumonia, respiratory syncytial virus (RSV), and shingles across 10 countries including Australia, France, Japan, and the United States. They found that adult vaccination programs paid for themselves many times over, returning up to 19 times the initial investment in societal benefits.

Vaccines are among the most effective public health inventions in human history. Yet despite the clear benefits, the most recent data from The Commonwealth Fund indicates that the 2021 flu vaccination rate for U.S. adults was just 42%. By contrast, in the 2022-2023 school year, 93% of kindergartners received all state-required vaccines.

This shows what a difference a concerted policy effort can make: providers administer childhood vaccines based on a schedule set by the U.S. Centers for Disease Control and Preventions Advisory Committee on Immunization Practices. The schedule for adult vaccines is much more complex.

I know the public health community can do better. During the pandemic, nearly 80% of U.S. adults completed their primary series of Covid-19 shots.

With that public health emergency in the rearview mirror, the U.S. has slipped into complacency, and demand for vaccines across the life course is falling. Fewer than half of adults received updated Covid-19 and flu shots last year. New vaccines offer adults protection against RSV and shingles, but most Americans eligible for these shots arent getting them: Nearly two in three people age 65 and older havent received the shingles vaccine, which the CDC recommends that people aged 50 and older get. Only 23% of people 65 and older have gotten the RSV shot, which is encouraged for every adult aged 60 and over.

Severe cases of flu, pneumonia, RSV, and even shingles can be deadly. Vaccines can prevent many of these deaths. A study by the Brown School of Public Health found that if Covid-19 vaccinations had stayed at their peak rate, the United States could have averted more than 300,000 deaths between January 2021 and April 2022.

Vaccines also offer protection against conditions beyond the ones for which theyre designed, because they reduce the risk of other health issues like heart attacks and certain cancers. A study cited in the Office of Health Economics report found that getting a flu shot can lower the risk of stroke and subsequent hospitalization among elderly people by as much as 16%.

As the U.S. population ages, the importance of boosting adult vaccination rates will only grow. Without a campaign to increase adult vaccination, experts estimate that rates of vaccine-preventable illnesses will rise over the next 30 years. That wont just lead to more human suffering. It will also impose staggering costs on major world economies.

How can the U.S. increase vaccination rates for adults? The process begins with encouraging doctors, biopharmaceutical companies, and government leaders to work together to build awareness of recommended vaccines and their impact and remove barriers to access. Studies show that when physicians and community leaders recommend vaccination, it has a positive impact on increasing rates.

During the pandemic, a focus on community-based organizing helped ensure that vaccination rates for Covid-19 were high. The CDCs Covid-19 Vaccine Equity Community Education and Outreach Initiative, for example, provided federal funding to trusted community organizations during the pandemic. The outreach conducted by these organizations helped increase vaccine uptake in communities disproportionately impacted by the pandemic. Its why one of the policy priorities of BIO, the organization I work for, is to continue the CDC-funded, community-based outreach approach and transition the focus to routine vaccinations.

Every American, regardless of their insurance status, should have equitable access to all recommended vaccines with no out-of-pocket costs.

The federal government can guarantee that uninsured adults have access to routine vaccines with zero cost sharing, just like insured patients. And when insured patients try to get vaccinated, they shouldnt run into surprise charges from their insurance company. High vaccine coverage in adults would more than pay for itself by preventing healthy adults from getting sick and incurring taxpayer-funded healthcare expenses in the future.

Lawmakers at every level of government should also ensure that different types of medical providers including physician assistants and pharmacists can administer vaccines to adults, no matter what state they work in. Some states still impose restrictions on the ability of non-physician providers to administer vaccines, despite a lack of evidence that more relaxed policies pose any health risk to patients. This measure would prove especially valuable for underserved communities.

The public health community knows what works and knows how to get things done. Investing in life-course immunization will pay for itself in health and prosperity.

Phyllis Arthur is the senior vice president of infectious disease and emerging science policy at the Biotechnology Innovation Organization (BIO).

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Study: Adult vaccinations pay for themselves in societal benefits - STAT

Federal Court Rules University of Colorado Vaccine Policies Motivated by Religious Animus

Last week the United States Court of Appeals for the Tenth Circuit reversed a lower court decision, issuing a 55-page ruling holding that the University of Colorado Anschutz School of Medicines policies refusing religious exemptions to its COVID-19 vaccination mandate were motivated by religious animus and unconstitutional under the First Amendments Religion Clauses.

The original mandate had been rejected by some university staff and students after a vaccine was developed in response to the global COVID-19 pandemic. The court case was mounted by the conservative Thomas More Society, a not-for-profit law firm based in Chicago. In an appeal filed in March 2022, the firm represented 17 faculty and students who asserted that the university refused to accommodate their sincerely and deeply held religious objections that prevented them from taking the vaccine.

The University of Colorado Anschutz Medical Campus on the academic health sciences campus in Aurora, Colorado, houses the University of Colorados six health sciences-related schools and colleges. In September 2021, the university enacted and enforced a policy that all students, employees, and other individuals who currently or may in the future access any CU Anschutz facility or participate in any CU Anschutz program or otherwise interact with members of the Anschutz community regardless of location must become fully vaccinated against COVID-19 with a vaccine that has been approved by the World Health Organization.

COVID-19 vaccines. Photo by Daniel Schludi for unsplash

In addition to finding religious animus, the Court found that the vaccine mandates of the Universitys Anschutz Medical Campus granted exemptions for some religions, but not others, because of differences in their religious doctrines and granted secular exemptions on more favorable terms than religious exemptions, all of which was illegal.

The court also reaffirmed the First Amendment principle that the government may not test the sincerity of employees religious beliefs by judging the legitimacy of those doctrines. The Court also held that the Universitys mandates violated clearly established constitutional rights.

The University of Colorado ran roughshod over staff and students of faith during COVID, and the Court of Appeals has now declared plainly what weve fought to establish for almost three years: the University acted with religious animus and flagrantly violated the fundamental religious liberties of these brave healthcare providers and students, said Thomas More Society Executive Vice President & Head of Litigation Peter Breen.

These medical providers were hailed as heroes, as they served bravely on the front lines through the worst of the pandemic, but when their religious principles conflicted with the beliefs of the University of Colorado bureaucrats, these heroes were callously tossed aside. he added.

With this ruling in favor of our clients, the Court of Appeals has made clear that people of faith are not second-class citizens, he added. They are deserving of full respect and the protection of the United States Constitution in their free exercise of religion. By unlawfully and intrusively probing our staff and students religious beliefs, the university rendered value judgments that not only reeked of religious bigotry but violated our clients constitutional rights, as well as basic decency.

The Court of Appeals decision highlighted specific instances of what it referenced as religious discrimination, including the following:

. . . the Administration decided that it is morally acceptable for Roman Catholics to take vaccines against COVID-19, and that any Roman Catholic objections to the COVID-19 vaccine are personal beliefs, not religious beliefs. Id. at 116263. As a result, the Administration would not grant exemptions to Roman Catholic applicants under the September 1 Policy. (Slip Opinion, p. 5.)

. . . the Administration refused to approve any exemptions for Buddhist applicants under the September 1 Policy. Nor would the Administration approve any exemptions for members of the Roman Catholic Church or the Eastern Orthodox Church. At the same time, the Administration admitted it would approve applications from practitioners of select, favored religions, such as Christian Scientists. (Slip Opinion, p. 30.)

a government policy that grants an exemption for medical reasons but denies the same exemption for religious reasons is not generally applicable, as it devalues religious reasons . . . by judging them to be of lesser import than nonreligious reasons. The September 24 Policy on its face makes a value judgment in favor of secular motivations because it has a lower bar for denying religious exemptions.

Under its September 1, 2021 policy, the university declared that it would only accept requests for religious exemptions from those whose religions taught that all vaccines are forbidden. In addition, those seeking exemptions were required to justify their religious beliefs under questioning. Under its September 24, 2021 policy, the University entirely excluded students from religious exemptions and provided for medical exemptions on more generous terms than religious exemptions.

Read the May 7, 2024 decision by the United States Court of Appeals for the Tenth Circuit in Jane Does 1-11 and John Does 1, 3-7 v. The Board of Regents of the University of Colorado, et. al. here [https://uploads-ssl.webflow.com/63d954d4e4ad424df7819d46/663bd07a66d645d57f832e4a_010111045465.pdf].

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United States Court of Appeals for the Tenth Circuit Reverses a Lower Court Decision Regarding COVID-19 Vaccine ... - The Ark Valley Voice

AstraZeneca developed the first vaccine for COVID-19, beating the competition, but this week theyve announced theyre withdrawing the jab worldwide following a drop in demand.

More than 3 billion doses of the vaccine, called Vaxzevria, have been administered globally, and AstraZeneca said it is incredibly proud of it.

Vaxzevria was developed in conjunction with scientists at the University of Oxford, UK, who stunned the world by producing a vaccine in just 10 months, a process that would generally take a decade The team was awarded the worlds oldest prize in science, the Copley Medal, by the UKs Royal Society in recognition of their achievements in 2022.

Experts contacted by the UK Science Media Centre (SMC) said that, while the vaccine was dogged by rare but serious side effects, not to mention more than its fair share of misinformation, its important to remember that its rapid development saved millions of lives.

We seem to forget how desperate the global population was for an effective COVID-19 vaccine, Professor Jonathan Ball, Deputy Director of the Liverpool School of Tropical Medicine, told the UK SMC.

And Adam Finn, Professor of Paediatrics at the UKs University of Bristol, said the speed of development and low cost of the vaccine meant it could be used in many of the poorer countries in the world.

Dr Michael Head, a Senior Research Fellow in Global Health at the University of Southampton, UK, said the vaccine played a vital role in tackling the emerging Delta variant of COVID-19 in India, which he described as a humanitarian crisis.

India was the main producer of the AstraZeneca vaccine at that time, amid global shortages and very high COVID-19 burdens. It will have saved so many lives in India alone across 2021 and 2022.

The vaccine cost only US$4-8 a shot, compared with between US$20 and US$30 per shot for the mRNA vaccines later developed by Pfizer and Moderna, added Peter Openshaw, a Professor of Experimental Medicine at Imperial College London.

And those mRNA vaccines needed a full cold chain, making them unavailable in resource-poor setting, he added.

But, the lives saved have to be balanced against the rare but potentially serious side effects, specifically vaccine-induced thrombocytopenia and thrombosis (VITT) that were reported in about one in 500,000 AstraZeneca vaccine recipients, he acknowledged.

However, its not just the side effects that have killed off the vaccine, said Finn: Global demand for all COVID-19 vaccines is now much lower and overall supply exceeds demand.

And the AstraZeneca vaccine has not kept up with changes in the SARS-CoV-2 virus as new variants have emerged, he added.

[It] expresses the original Wuhan Spike protein, and has not been updated, [so] is probably now much less effective than it was to begin with because the Spike protein on the SARS-CoV-2 variants now circulating has changed a good deal over time as the virus has evolved.

Meanwhile, other vaccines, particularly those capable of giving protection against newly emerging variants of concern have come to the fore, says Ball.

That means there is probably no commercial case for continuing to manufacture and distribute the vaccine. I think this is likely to be the main reason the company has decided to discontinue making and selling it, concluded Finn.

You can read the UK EXPERT REACTION in full here

First published in Science Deadline, the weekly newsletter of the Australian Science Media Centre.

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Expert reaction: AstraZeneca withdraws its COVID-19 vaccine - Cosmos

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Heart failure patients who are vaccinated against COVID-19 have an 82% greater likelihood of living longer than those who are not vaccinated, according to research presented at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC), held 1114 May in Lisbon, Portugal. Heart Failure is a life-threatening syndrome affecting more than 64 million people worldwide.

"Patients with heart failure should be vaccinated against COVID-19 to protect their health," said study author Dr. Kyeong-Hyeon Chun of the National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea.

"In this large study of patients with heart failure, COVID-19 vaccination was associated with a lower likelihood of contracting the infection, being admitted to hospital because of heart failure, or dying from any cause during a six-month period compared with remaining unvaccinated."

Previous studies have shown the safety of COVID-19 vaccination in patients with cardiovascular diseases including heart failure, and that COVID-19 outcomes are worse in patients with heart failure compared to those without heart failure. However, there has been little research on how vaccines work specifically in patients with heart failure. This nationwide, retrospective study examined the prognosis of heart failure patients according to COVID-19 vaccination status.

This study used the Korean National Health Insurance Service database, which covers nearly all residents of the Republic of Korea, to obtain information on vaccinations and clinical outcomes. Participants who received two or more doses of COVID-19 vaccine were defined as "vaccinated," and those who were not vaccinated or had received just one dose were defined as "unvaccinated."

The study included 651,127 patients aged 18 years or older with heart failure. The average age was 69.5 years and 50% were women. Of the total study population, 538,434 (83%) were defined as vaccinated and 112,693 (17%) as unvaccinated.

To control for factors that could influence the relationship between vaccination status and outcomes, the researchers performed 1:1 matching of vaccinated and unvaccinated patients according to age, sex, other health conditions (e.g. high blood pressure, diabetes, high cholesterol, etc.), income, and region of residence. This resulted in 73,559 vaccinated patients and 73,559 unvaccinated patients for the comparative analyses.

The median follow-up was six months. Vaccination was associated with an 82% lower risk of all-cause mortality, 47% lower risk of hospitalization for heart failure, and 13% reduced risk of COVID-19 infection compared with no vaccination. Regarding cardiovascular complications, vaccination was associated with significantly lower risks of stroke, heart attack, myocarditis/pericarditis, and venous thromboembolism compared to no vaccination.

Dr. Chun said, "This was the first analysis of COVID-19 vaccine effectiveness in a large population of heart failure patients, and the first to show a clear benefit from vaccination. The study provides strong evidence to support vaccination in patients with heart failure. However, this evidence may not be applicable to all patients with heart failure, and the risks of vaccination should be considered in patients with unstable conditions."

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Study finds COVID-19 vaccine can help people with heart failure live longer - Medical Xpress

Considering reduced global demand for COVID vaccines, AstraZeneca has deemed there is no long-term value in investing in manufacturing the adenovirus-based vaccine.

Withdrawal of the marketing authorisation for the COVID-19 vaccine (ChAdOx1-S [recombinant]) Vaxzevria (SRD) by the European Medicines Agency on 7 May, follows a request by AstraZeneca.

Global demand for all COVID vaccines is now much lower and overall supply exceeds demand. This is in marked contrast to the early part of the pandemic when supply was limited and distribution very limited, especially in poorer countries.

there is probably no commercial case for continuing to manufacture and distribute the vaccine and I think this is likely to be the main reason the company have decided to discontinue making and selling it

Accordingly, there is probably no commercial case for continuing to manufacture and distribute the vaccine and I think this is likely to be the main reason the company have decided to discontinue making and selling it. [The treatment] saved very large numbers of lives in many countries around the world particularly in 2021 and 2022, both because it was developed and tested so rapidly and because AstraZeneca made it available at very low cost so that it could be used in many of the poorer countries in the world, Professor Adam Finn, Professor of Paediatrics, University of Bristol shared.

The Oxford/AstraZeneca adenovirus-based vaccine was designed for rapid global deployment and was the least expensive of all the [options] that were available in the early stages of the pandemic, coming in at only $4-8 dollars a shot. This meant that it had a huge global reach, 100 million doses being commissioned by the UK Vaccine Taskforce in July 2020. This overshadowed the mRNA vaccines from BioNTech/Pfizer and Moderna vaccines (90 and 17 million doses respectively at that time). The mRNA vaccines cost between $20 and $30 per shot and needed a full cold chain, making them unavailable in resource-poor setting. In the face of alternative vaccines that can be rapidly updated the decision to cease issuing this type of vaccine is logical, Professor Peter Openshaw, Professor of Experimental Medicine, Imperial College London explained.

In the companys other recent developments, earlier this month AstraZeneca released promising data for a novel BTK inhibitor indicated to treat mantle cell lymphoma.

Excerpt from:

Oxford/AZ Covid-19 vaccine to be discontinued - European Pharmaceutical Review

AstraZeneca's withdrawal of its vaccine has left many asking questions. Reuters

Its been another week of big developments.

AstraZeneca in a shocking move announced it was withdrawing its COVID-19 vaccine from across the world.

This, just weeks after admitting its jab caused a rare side effect.

Meanwhile, in the US, Indian students are seemingly staying away from campus protests in Columbia.

Closer to home, the Maldives is begging Indian tourists to return after a significant drop in travellers to the archipelago.

China is on a gold buying spree and inflating the pricing of the precious metal.

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All this and more in our weekly roundup of explainers from the world.

1. The headline alone, AstraZeneca withdraws COVID vaccine, was eye catching.

That the news came just week after the company said its jab caused a rare side effect left many second guessing the decision to take the vaccine.

But do you really need to worry?

Is your country one of those that used AstraZenecas jab?

And why did the company withdraw the vaccine?

2. Campuses in the US remain in an uproar.

Students have set up encampments, teachers have joined in, in-person classes have been cancelled and university bosses have been summoned before the US House to testify about anti-semitism on campuses.

However, Indian students, the second-largest group of international scholars in the US, seem to have little to no presence among the demonstrations.

But why is that? Are Indian students concerned about somehow being swept up in the tumult? And if so, what are they worried about?

This article gives you an up close look.

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3. Indians come back.

That was the message this week from the Maldives tourism minister.

The island nation has seen its flow of Indian tourists slow immensely after a boycott following three government ministers making derogatory remarks about Prime Minister Narendra Modi.

But what did Ibrahim Faisal say?

How many Indian tourists actually visited Maldives?

And what has been the fallout of the boycott?

Click here to know more.

4. For the past few years, China has been having a love affair with gold.

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Not only is the country the worlds largest producer of gold, it is also the biggest consumer.

And it is powering the yellow metal to brand new highs.

While gold was the provenance of middle-aged women, experts say thats no more the case and many customers are now in their 20s.

Meanwhile, the Peoples Bank of China (PBC) is also increasing its exposure to gold.

But whats behind this affinity? And where does gold go from here?

5. Supporters of Donald Trump are taking their devotion to a new level.

Admirers of the former president are turning up to rallies in nappies.

Thats not all they are also wearing T-shirts that say Real men wear diapers.

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But what prompted this bizarre turn of events amid Trumps hush money trial in New York?

6. Over the years, Japan has made headlines for its somewhat strange attitude towards sex and romance.

Now, the youth are pioneering a new trend marriage without sex and love.

This so-called friendship marriage is replacing the more traditional union.

So what is it all about? How does it work? How many people are taking it to heart?

This piece gives you an insight into the latest trend in Japan.

7. For many people, a nice cold beer at the end of a long workday is just the ticket.

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But have you ever considered why that is the case?

Researchers at the Chinese Academy of Sciences say there is actually a science behind what makes a child pint taste so good.

So why do we like cold beer? And what possible impact could this research have in real life?

You are all caught up on world affairs for this week. If you want to read and support more of our work, you can bookmark this page .

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This Week in Explainers: Why AstraZeneca withdrew its COVID-19 vaccine from across the world - Firstpost

Pharmaceutical company AstraZeneca has initiated a global withdrawal of its COVID-19 vaccine just months after it admitted it could cause a rare side effect.

The news sparked speculation on social media that the vaccine was being withdrawn because of concerns about associated health risks.

Read more: Compare Top Health Savings Accounts

However, the British-Swedish company said that the decision was made purely for commercial reasons after a decline in demand because of a "surplus of available updated vaccines."

"As multiple, variant Covid-19 vaccines have since been developed, there is a surplus of available updated vaccines. This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied," the company said in a statement, according to The Telegraph, which first reported the news. AstraZeneca changed the name of its COVID vaccine to Vaxzevria in 2021.

Despite media reports and social media speculation, AstraZeneca has withdrawn the vaccine, but not recalled it.

A recall, which would mean the medication was removed from shelves, typically takes place when there are safety concerns, defects, or regulatory issues posing risks to public health. A withdrawal means that the vaccine is no longer being actively manufactured or supplied by the company.

AstraZeneca noted that independent estimates say that over 6.5 million lives were saved in the first year of the vaccine's use and that over three billion doses were supplied globally.

The company said it had withdrawn its marketing authorizations for the vaccine in the European Union on March 5, which came into effect on May 7.

AstraZeneca will make similar applications in the coming months in the U.K. and other countries that had approved the use of the vaccine, the Telegraph reported. The vaccine was never approved for use in the United States.

Other countries have already stopped using the vaccine; it has not been available in Australia since March 2023.

Newsweek reached out to AstraZeneca for comment via email.

The withdrawal comes as the company faces a class-action lawsuit in the U.K. over allegations of side effects associated with the vaccine.

The company is contesting the claims, but admitted in a February legal document that its COVID vaccine "can, in very rare cases, cause TTS," according to the Telegraph.

TTS, or Thrombosis with Thrombocytopenia Syndrome, is a rare side effect linked to certain COVID-19 vaccines, which can manifest in the form of blood clots and a low blood platelet count.

The AstraZeneca COVID-19 vaccine was the first to be rolled out in the U.K. in early 2021.

However, the government reduced its use of the vaccine after emerging reports about the rare risk of blood clots and replaced it with Pfizer and Moderna vaccines.

Sarah Moore, a partner at law firm Leigh Day, which is bringing the legal claims against AstraZeneca, said that the withdrawal will come as welcome news to those who have suffered side effects.

"It will be seen as a decision linked with AstraZeneca's recent admission that the vaccine can cause TTS, and the fact that regulators across the world suspended or stopped usage of the vaccine following concerns regarding TTS," she told the Telegraph.

"This is an important regulatory step, but still our clients remain without fair compensation," she said. "We will continue to fight for the compensation our clients need and campaign for reform of the vaccine damage payment scheme."

Professor Catherine Bennett, the chair of epidemiology at Deakin University in Australia, told The Guardian that it was important to note that the vaccine played a crucial role in the early days of the pandemic.

"It has saved millions of lives and that should not be forgotten," she said. "It was a really important part of the initial global response. However, it targeted the initial ancestral variants. We've now moved into a vaccine chain where we have products available that are chasing the variants that are emerging."

Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.

Newsweek is committed to challenging conventional wisdom and finding connections in the search for common ground.

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Was COVID Vaccine Recalled Over Health Danger Fears? What We Know - Newsweek

AstraZeneca is withdrawing its COVID-19 vaccine from worldwide circulation and marketing authorizations.

The British-Swedish company recently acknowledged side effects such as blood clots and low platelet counts in court papers, Reuters news agency reported Tuesday.

But AstraZeneca said in a statement that the slipping COVID-19 market has become saturated with newer vaccines, hurting Vaxzevrias sales.

As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines, the company said. Vaxzevria is no longer being manufactured or supplied, Reuters reported.

The multinational companys application to withdraw Vaxzevria was made March 5 and took effect Tuesday, according to the first reports on the matter from the Telegraph.

For more information, visit The Washington Times COVID-19 resource page.

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AstraZeneca withdraws COVID-19 vaccine from worldwide circulation - Washington Times

LONDON Novavax, the beleaguered maker of a Covid-19 vaccine, just got a boost of its own.

The French pharma company Sanofi on Friday said it had reached a licensing deal to sell Novavaxs Covid shot going forward as well as to try to combine the vaccine with Sanofis own flu shot. The pact includes a $500 million upfront payment, with up to $700 million more on the table if certain regulatory and launch milestones are reached.

While Novavaxs stock soared during the pandemic as the vaccine race was underway, the company failed to get its shot authorized in the U.S. market until July 2022, long after the makers of mRNA vaccines had reaped billions in sales. Sales have sputtered along since then, and last year, the Maryland-based company warned that that it may not be able to stay in business.

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Sanofi strikes deal with Novavax, boosting the vaccine maker - STAT