The pharmaceutical giant AstraZeneca has reportedly withdrawn its COVID-19 vaccine Vaxzevria, also known as Covishield, worldwide,citing commercial reasons for the decision.
"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," various media outlets quoted the company was quoted as saying.
A document hosted by the EU's European Medicines Agency website confirmedthatVaxzevriawas no longer authorized in the region.
In an email to DW, virologistWolfgang Preiser said"the demand for SARS-CoV-2 vaccines is very low and unlikely to pick up significantly in the foreseeable future, so I understand the reasoning."
AstraZeneca, who developed the vaccine with Oxford University,said it was "incredibly proud of the role Vaxzevria played in ending the global pandemic."
More than three billion doses were supplied globally. Independent studies estimate that more than 6.5 million lives were saved in the first year that itwas used.
The Oxford-AstraZenecavaccine was developed within the first months of the pandemic in 2020. It was first approved in the UK on December 30, 2020, with other countries granting the vaccine conditional marketing authorization later in 2020 due to the urgency of the pandemic.
Vaxzevria was effective against initial ancestral variants of COVID-19 virus the alpha variant but was less effective against newer variants of COVID-19, such as the omicron variant.
Many governments, including in the UK, Germany and Australia, had stopped using the Oxford-AstraZeneca vaccine before its withdrawal from the market.
"We are still distributing COVID-19 vaccines, but none of them are AstraZeneca any more. They were the first manufacturer with which we concluded our arrangement in 2022,"Olly Cann, director of communications at the international organization Gavi, the Vaccine Alliance, told DW.
Thelatest COVID-19 vaccine advice issuedby the World Health Organisation in April advised that COVID-19 vaccines should target the JN.1 lineage of the virus, which is now the most dominant variant.
However,at the time of writing,Preiser saidrelatively few severe infections were being observed"due to a high level of population immunity stemming from past vaccination,and often also past infection."
Although the vaccine was found to be safe and effective overall, it carried a very small risk of developingblood clotsas a side effect. The condition is known as "thrombosis with thrombocytopenia syndrome(TTS)."
The rare syndrome occurred in two to three people per 100,000 who were vaccinated with the Vaxzevria vaccine.
While studies found the vaccine did not increase the risk of heart attacks or strokes, it has been under intense scrutinydue to TTS.
"The side effects are real and may have serious consequences for those affected, but as with all interventions, a careful risk-benefit analysis [was]needed. During the pandemic, the balance was definitely in favor of using the vaccine," saidPreiser, who is based atStellenbosch University in South Africa.
In a UK High Court case, AstraZeneca isbeing sued by more than 50 people, who claim to have been affected by side effects.
The BritishTelegraph newspaper, quoted as the first to break the news of Vaxzevria's withdrawal from the market, reportedthat AstraZeneca had admitted in the court case in February 2024 that the vaccine "can, in very rare cases, cause TTS."
AstraZeneca said the decision to withdraw the vaccine was not linked to the court case or any risks associated withTTS.
Edited by: Zulfikar Abbany
UK health officials today announced a new 5-year national action plan on antimicrobial resistance (AMR).
The 2024 to 2029 national action plan replaces the United Kingdom's previous 5-year plan (2019 to 2024), under which the country saw reductions in the use of antimicrobials in people and food-producing animals, development of improved surveillance systems, and the piloting of a new, subscription-style antibiotic payment scheme within the National Health System. UK officials say the new plan will build on those achievements and contribute to meeting the goals of the country's 20-year vision for AMR.
The plan is organized under four themes: Reducing the need for, and unintentional exposure to, antimicrobials; optimizing the use of antimicrobials; investing in innovation, supply, and access; and being a good global partner. The themes apply to human health and social care, animal health, agriculture, food production, and the environment.
"AMRis not just a matter for cliniciansit is important to work across sectors to help preserve these vital medicines to minimise the impact ofAMR," UK Chief Medical Officer Chris Whitty, CB, DSc, said in a government press release.
Strategic outcomes within the four themes include developing a "whole systems approach" to infection prevention and control and management; increasing public education and engagement on AMR; strengthening surveillance and antimicrobial and diagnostic stewardship; prioritizing development of new antimicrobials, diagnostics, and vaccines; and maintaining Britain's role as a global leader on AMR.
"We have to work together, across the world, with those countries that need action the most, to make progress and containAMR," said Dame Sally Davies, UK Special Envoy on AMR.
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There is no association between the SARS-CoV-2 vaccine and the risk for new-onset seizure, data from a new meta-analysis of six randomized, placebo-controlled clinical trials (RCTs) showed.
Results of the pooled analysis that included 63,500 individuals vaccinated with SARS-CoV-2 and 55,000 who received a placebo vaccine showed there was no significant difference between the two groups with respect to new-onset seizures at 28- or 43-day follow-up.
Regarding new-onset seizures in the general population, there was no statistically significant difference in risk for seizure incidence among vaccinated individuals vs placebo recipients, according to our meta-analysis, the investigators, led by Ali Rafati, MD, MPH, Iran University of Medical Sciences in Tehran, Iran, wrote.
The findings were published online on April 29 in JAMA Neurology.
Results from previous research have been mixed regarding the link between the SARS-CoV-2 vaccination and new-onset seizures, with some showing an association.
To learn more about the possible association between the vaccines and new-onset seizures, the researchers conducted a literature review and identified six RCTs that measured adverse events following SARS-CoV-2 vaccinations (including messenger RNA, viral vector, and inactivated virus) vs placebo or other vaccines.
While five of the studies defined new-onset seizures according to the Medical Dictionary for Regulatory Activities, trial investigators in the sixth RCT assessed and determined new-onset seizures in participants.
Participants received two vaccinations 28 days apart in five RCTs and only one vaccine in the sixth trial.
The research team searched the data for new-onset seizure in the 28 days following one or both COVID vaccinations.
After comparing the incidence of new-onset seizure between the 63,500 vaccine (nine new-onset seizures, 0.014%) and 55,000 placebo recipients (one new-onset seizure, 0.002%), investigators found no significant difference between the two groups (odds ratio [OR], 2.70; 95% CI, 0.76-9.57; P = .12)
Investigators also sliced the data several ways to see if it would yield different results. When they analyzed data by vaccine platform (viral vector) and age group (children), they didn't observe significant differences in new-onset data.
The researchers also searched for data beyond the month following the injection to encompass the entire blinded phase, so they analyzed the results of three RCTs that reported adverse events up to 162 days after the vaccine.
After pooling the results from the three studies, investigators found no statistical difference between the vaccine and placebo groups in terms of the new-onset seizure (OR, 2.31; 95% CI, 0.86%-3.23; P > .99)
Study limitations included the missing information on vaccine doses or risk factors for the development of seizures. Also, the RCTs included in the meta-analysis were conducted at different times, so the SARS-CoV-2 vaccines may have differed in their composition and efficacy.
"The global vaccination drive against SARS-CoV-2 has been a monumental effort in combating the pandemic. SARS-CoV-2 vaccinations that are now available appear safe and appropriate," the authors wrote.
There were no study funding sources or disclosures reported.
Lawyers for claimants in the High Court case argue that the drug caused vaccine-induced immune thrombocytopenia and thrombosis (VITT) a subset of TTS and that it was not as safe as individuals were entitled to expect. AstraZeneca has always insisted that patient safety is our highest priority.
The company has said: From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects.
But Kate Scott, whose husband Jamie was left with a permanent brain injury after having the vaccine and who was the first person in the UK to bring a legal action, said: AstraZenecas Covid vaccine no longer being used in the UK or Europe, and soon the rest of the world, means no one else will suffer from this awful adverse reaction.
They say it is for commercial reasons, but maybe its because it can no longer be seen as being within the acceptable safety parameters, with 445 confirmed cases of VITT, 81 of these fatal in the UK alone.
Mr Scott, 47, a father of two who has had to give up work, said: This is good news, but I will always wish they had, like they did in other countries, paused it in the UK after just one case. More lives could have been saved and I would not be suffering the way I am.
Pharmaceutical company AstraZeneca has announced its removing its Covid-19 vaccine worldwide.
But why is this coronavirus jab being discontinued?
FactCheck takes a look.
AstraZeneca said on 7 May that it has started to withdraw its Covid vaccine worldwide.
This comes after applying to withdraw its European Union marketing authorisation which is the approval to market a medicine in member states on 5 March.
On 7 May, the European Medicines Agency issued a notice that the vaccine is no longer authorised for use.
The pharmaceutical company said: As multiple, variant Covid-19 vaccines have since been developed there is a surplus of available updated vaccines. Basically, other vaccines are more effective against the versions of Covid that are most common now and demand for Covid jabs overall has fallen.
The statement also said: According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over 3bn doses were supplied globally.
Some countries have already stopped supplying the vaccine, including Australia, where it has not been available for use since March 2023.
The AstraZeneca vaccine which was renamed as Vaxzevria in 2021 had, like all vaccines, side effects.
As well as common side effects such as nausea and joint pain, it was linked to a rare but serious side effect called thrombosis with thrombocytopenia, or TTS.
TTS is a very rare syndrome which occurs when a person has blood clots (thrombosis) together with a low platelet count (thrombocytopenia).
Blood clots can reduce normal blood flow in an affected blood vessel, and thrombocytopenia is a condition where there arent enough platelets in the blood.
Platelets help the blood to clot which then stops you from bleeding excessively, for example, if you cut yourself.
The side effect was found to have occurred in about two to three people per 100,000 who were vaccinated with the Vaxzevria vaccine.
The UK governments Medicines and Healthcare products Regulatory Agency (MHRA) said in November 2023 that TTS has been observed very rarely following vaccination with Vaxzevria.
Up to 23 November 2022, the MHRA had received Yellow Card reports from doctors of 445 cases of blood clots with low platelet counts in the UK following an AstraZeneca Covid vaccine.
The overall case fatality rate was 18 per cent with 81 deaths, six of which occurred after the second dose.
The Pfizer jab is also associated with a very rare side effect (reported in 1 out of every 10,000 people) of inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis).
Like almost any medical intervention, vaccines carry the risk of side effects. The question for scientists and clinicians is whether the benefits of the treatment outweigh the risks.
At the start of the pandemic, Covid was so widespread and immunity so low that the benefits of vaccination outweighed the risk of rare side effects for almost every age group. As we reported in 2021, the chances of developing severe complications from Covid itself are much higher than that of potential complications from a Covid vaccination.
As Covid rates have fallen and more people have acquired immunity through vaccination and exposure to infection, the calculation has changed.
The Joint Committee on Vaccination and Immunisation (JCVI), which advises the government on vaccine use, now says that a booster Covid jab (made by Pfizer or Moderna) should be offered to adults over 75, residents in a care home for older adults, and anyone aged six months or over who is immunocompromised.
(Image Credit:Mustasinur Rahman Alvi/Shutterstock)
AstraZeneca said on Tuesday it had initiated the worldwide withdrawal of its COVID-19 vaccine due to a "surplus of available updated vaccines" since the pandemic.
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The company also said it would proceed to withdraw the vaccine Vaxzevria's marketing authorisations within Europe.
ALSO READ | AstraZenecas submission in U.K. court nothing new, say doctors over Covishields potential to cause blood clots
"As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines," the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.
According to media reports, the Anglo-Swedish drugmaker has previously admitted in court documents that the vaccine causes side-effects such as blood clots and low blood platelet counts.
The firm's application to withdraw the vaccine was made on March 5 and came into effect on May 7, according to the Telegraph, which first reported the development.
London-listed AstraZeneca began moving into respiratory syncytial virus vaccines and obesity drugs through several deals last year after a slowdown in growth as COVID-19 medicine sales declined.
8 May 2024
Image source, Getty Images
After more than three billion doses, the Oxford-AstraZeneca Covid vaccine is being withdrawn.
AstraZeneca said it was "incredibly proud" of the vaccine, but it had made a commercial decision.
It said the rise of new coronavirus variants meant demand had shifted to the newer updated vaccines.
Its vaccine was estimated to have saved millions of lives during the pandemic, but also caused rare, and sometimes fatal, blood clots.
In the race to lift the world out of pandemic lockdowns, the Covid vaccine was developed by scientists at the University of Oxford in record time. A process that normally takes 10 years was accelerated down to about 10 months.
Initially, it was the cornerstone of the UK's plans to vaccinate our way out of lockdown.
"The truth is it made an enormous difference, it was what lifted us out of the catastrophe that was unfolding at the time, combined with the other vaccine from Pfizer," said Prof Adam Finn, from the University of Bristol.
However, its reputation was dented as unusual blood clots emerged as a rare side effect of the vaccine, and the UK turned to alternatives.
In a statement, AstraZeneca said: "According to independent estimates, over 6.5 million lives were saved in the first year of use alone.
"Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic."
It said the development of new vaccines that more closely match the mutated forms of Covid that are now circulating meant there was a "surplus of available updated vaccines", leading to a "decline in demand" for its vaccine which is "no longer being manufactured or supplied".
Prof Finn added: "I think the withdrawal of the vaccine simply reflects it's no longer useful.
"It's turned out that this virus is very agile and it's evolved away from the original vaccines, so they have in a sense become irrelevant and only the reformulated vaccines are likely to be being used now."
The Oxford-AstraZeneca vaccine was a critical part of the COVID-19 pandemic response. However, on May 7 2024, the European Commission announced the vaccine is no longer authorised for use.
This EU announcement was preceded by an application from AstraZeneca on March 27 2024 to withdraw the EU marketing authorisation.
This development has been covered in various media outlets as primarily related to the known "adverse events", namely a very small risk of blood clots. However, other factors are far more likely to be driving this decision.
The first AstraZeneca vaccine dose, outside of clinical trials, was administered on January 4 2021. In that year, about 2.5 billion doses were administered, and an estimated 6.3 million lives saved.
It was a key product at the peak of the pandemic. This includes during the emergence of the delta variant in India, across the first half of 2021 where, amid significant global supply issues, the AstraZeneca vaccine was one of the few tools available during that humanitarian crisis.
This COVID vaccine, like those from Pfizer, Moderna, Novavax and others, went through the appropriate levels of testing. The phase 3 trials (where the vaccine is tested on thousands of people) showed the AstraZeneca product was safe and effective. It was distributed in many countries in Europe in early 2021, including the UK.
The potential adverse events related to blood clots were publicly reported in February 2021, with, for example, the UK government and the drugs regulator (the MHRA) then publishing a statement about its continued use on March 18 2021.
Amid speculation and investigation, the European Medicines Agency and the World Health Organization both highlighted how the benefits of the vaccine greatly outweighed any possible risks.
This was a time when COVID levels were extremely high, and getting higher, with around 4 million confirmed new cases globally per week.
It is well established that COVID itself caused a significantly increased risk of these related blood clots (thrombocytopenia). An August 2021, analysis of 30 million vaccinated people in the UK showed that the risks of thrombocytopenic events were much higher following a COVID infection, compared with any COVID-related vaccine.
From that study, the British Heart Foundation describes how for every 10 million people who are vaccinated with AstraZeneca, there are 66 extra cases of blood clots in the veins and seven extra cases of a rare type of blood clot in the brain. By comparison, infection with COVID is estimated to cause 12,614 extra cases of blood clots in the veins and 20 cases of rare blood clots in the brain.
To put this into some perspective, these vaccine-associated blood clot rates are much lower than many widely prescribed medicines. For example, the combined contraception pill, prescribed widely to women, has blood clot-related risks of around one in 1,000. With women taking postmenopausal hormone therapy, around one in 300 per year are likely to develop a blood clot.
The AstraZeneca vaccine did suffer from a poor public profile, arguably much of it undeserved. There was some poor quality reporting in Germany in January 2021, with claims that the vaccine was only "8% effective in the elderly". This claim was widely repeated, but it turns out that 8% figure referred to the percentage of people aged over 65 years in the study and not the efficacy measure.
The anti-vaccine lobby had a field day with fuelling the "infodemic", including other false claims such as fabricated links between the vaccine and female infertility. As with the blood clots, COVID infection is known to increase the risks of infertility, but there is no link between infertility and the vaccine.
For individuals and families likely to have been injured by any medicine, including any of the COVID vaccines, compensation schemes are available. Many claimants report difficulties and frustrations with accessing the compensation.
This is an area where the government-led schemes should be more transparent, and also where the misinformation from the anti-vaccine lobby hinders those groups they are claiming to support.
So, why would AstraZeneca withdraw this high-profile product? One reason for the withdrawal is likely to be that other COVID vaccines, such as Pfizer and Moderna, are essentially better products.
AstraZeneca is very good, but the mRNA versions have better effectiveness and safety levels.
The initial concerns around the difficulties of the specialist refrigeration needed to transport and store the Pfizer and Moderna vaccines have been overcome, including in low-income countries. The mRNA vaccines are also easier to update when new variants emerge.
With those factors, orders for the AstraZeneca vaccine are probably much lower now than they were in previous years. It is being overlooked in favour of better-performing vaccines.
For the Oxford AstraZeneca vaccine, perhaps its time has indeed passed. But it has been a safe and effective vaccine and a key part of the pandemic response for most countries around the world.
Michael Head, Senior Research Fellow in Global Health, University of Southampton
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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AstraZeneca has announced it initiated a worldwide withdrawal of its Covid-19 vaccine, months after the pharma giant admitted the drug could causerare but life-threatening injuries.
The vaccine, initially known as Covishield, was developed by the pharmaceutical giant in collaboration with Oxford University, and produced by theSerum Institute of India.
The Anglo-Swedish company also said it would proceed to withdraw the vaccine Vaxzevrias marketing authorisations within Europe.
On Tuesday, the European Medicines Agency issued a notice that the vaccine is no longer authorised for use.
The Covid jab was widely administered in over 150 countries, including Britain and throughout the EU.
The withdrawal of the vaccine has been attributed to a "surplus of available updated vaccines" since the pandemic, the company said.
Some studies conducted during the pandemic found the vaccine was60 to 80 per centeffective in protecting against Covid.
What are the side effects of the vaccine?
Recent research has found that Covishield can cause some people to develop blood clots, which may prove fatal.
AstraZeneca admitted in court documents lodged with the High Court in February that the vaccine can, in very rare cases, cause TTS (Thrombosis with Thrombocytopenia Syndrome) though the cause is unknown, according to The Telegraph.
Further, TTS can also occur in the absence of the AZ vaccine (or any vaccine). Causation in any individual case will be a matter for expert evidence, it added.
TTS is characterised by blood clots and a low blood platelet count in humans.
The complaint claimed the vaccine led to deaths and severe injuries and sought damages up to 100m for about 50 victims.
One of the complainants also alleged that the vaccine caused him a permanent brain injury after he developed a blood clot, preventing him from working.
The rare syndrome occurred in about two to three people per 100,000 who were vaccinated with the Vaxzevria vaccine.
The World Health Organization also confirmed that the vaccine could have fatal side effects.
A very rare adverse event called Thrombosis with Thrombocytopenia Syndrome, involving unusual and severe blood clotting events associated with low platelet counts, has been reported after vaccination with this vaccine, WHO said.
According to the Council for International Organizations of Medical Sciences, very rare side effects are those reported in less than 1 in 10,000 cases.
In countries with ongoing SARS-CoV-2 transmission, the benefit of vaccination in protecting againstCovid-19far outweighs the risks, the WHO added.
How widespread was use of the vaccine in the UK?
Around 50 million doses of the the Oxford-AstraZeneca were administered in the UK by autumn 2021.
However, the government largely stopped using the jab and it was replaced in the UK with Pfizer and Moderna jabs in time for the winter booster campaign at the end of 2021.
The pharmaceutical company said the decision to withdraw the vaccine is not linked to the court case.
In a statement, AstraZeneca said: We are incredibly proud of the role Vaxzevria played in ending the global pandemic. According to independent estimates,over 6.5 million lives were saved in the first year of use alone and over three billion doses were supplied globally.
Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic.
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 Vaxzervria, which is no longer being manufactured or supplied.AstraZeneca has therefore taken the decision to initiate withdrawal of the Marketing Authorisations for Vaxzevria within Europe.
We will now work with regulators and our partners to align on a clear path forward to conclude this chapter and significant contribution to the Covid-19 pandemic.
