Concerns over AstraZeneca vaccine

Monica Naguib, Wednesday 29 May 2024

There have been widespread concerns regarding the potential side effects of the AstraZeneca Covid-19 vaccine, with reports suggesting that these could lead to serious health conditions or even death.

Concerns over AstraZeneca vaccine
Concerns over AstraZeneca vaccine

 

In recent months, the conversation surrounding the AstraZeneca Covid-19 vaccine has shifted somewhat. While initially hailed for its rapid development and efficacy, there has been renewed focus on the rare side effects associated with the vaccine.

The AstraZeneca vaccine has been shown to be highly effective in reducing the risk of severe illness, hospitalisation, and death from Covid-19. Studies have found a significant decrease in the number of people who are hospitalised or die after being vaccinated. A specific UK study estimated that the vaccination programme had prevented over 105,000 deaths, with a large portion of these being in the most vulnerable elderly population (over 80 years old).

Although the vaccine’s effectiveness against getting sick with Covid-19 can vary depending on the specific variant of the virus circulating, research suggests a strong protective effect. There is also evidence that the AstraZeneca vaccine may help reduce transmission of the virus to others. In adults over 70, a single dose offered 73 per cent protection against symptomatic illness, and this protection increased to 89 per cent after the second dose.

Another UK study showed that a single dose reduced the chance of a new infection by 65 per cent compared to unvaccinated individuals.

The AstraZeneca vaccine is widely used across over 170 countries, especially in regions with limited healthcare infrastructure. Unlike some other vaccines, the AstraZeneca formulation does not require ultra-cold storage, making it a more viable option in these settings.

When compared to mRNA vaccines like those developed by Pfizer-BioNTech and Moderna, the AstraZeneca version offers distinct advantages in terms of cost and storage. However, it generally shows a slightly lower efficacy rate against symptomatic infection, which has influenced policy decisions regarding its use in various demographic groups.

Back in April 2020, the fight against Covid-19 entered a new phase when the University of Oxford and AstraZeneca joined forces to develop a vaccine. This marked the beginning of a rapid development process driven by the urgency of the global pandemic. By December 2020, the urgency had paid off as the UK became the first country to authorise the AstraZeneca vaccine for emergency use. This was a significant step forward, offering a new weapon in the fight against the virus.

However, the story did not end there. As the virus continued to evolve, concerns emerged in February 2021 about the vaccine’s efficacy against a South African variant. This highlighted the need for constant adaptation in the face of a rapidly changing situation, underscoring the importance of ongoing research and development efforts.

Just a month later, in March 2021, reports of rare blood clots in some vaccinated individuals led several European countries to pause their AstraZeneca vaccination campaigns. This raised critical safety concerns that demanded a thorough investigation.

In April 2021, the European Medicines Agency (EMA) confirmed a link between the vaccine and rare blood clots, but importantly it emphasised that the benefits of protection against severe Covid-19 still outweighed the risks. This announcement helped to reassure many hesitant individuals about the safety of the vaccine, allowing for continued vaccination efforts.

Global organisations like the World Health Organisation (WHO) and the EMA have consistently supported the AstraZeneca vaccine’s use. They point to its effectiveness in reducing hospitalisations and deaths from Covid-19. Experts also acknowledge its contribution to fighting the pandemic overall.

Meanwhile, the Oxford-AstraZeneca Covid vaccine, once hailed as a triumph in the fight against the pandemic, is being phased out globally. This decision by AstraZeneca comes despite the vaccine’s role in saving millions of lives, according to the company.

AstraZeneca says the withdrawal is purely commercial. Newer vaccines targeting Covid-19 variants have rendered AstraZeneca’s vaccine less necessary, and the emergence of more effective vaccines and new Covid-19 variants requires updated formulations. The vaccines need to adapt to the new challenges posed by the evolving virus, and variant strains can partially evade protection from initial vaccines.

This ongoing evolution necessitates the development and preference for newer vaccines that target these variants more effectively. The withdrawal of the AstraZeneca vaccine in some regions reflects this ongoing adaptation in vaccine technology and strategy. Hence, the company has ceased manufacturing and supplying the vaccine.

The situation highlights the dynamic nature of the pandemic response. Vaccine strategies need to adapt to new scientific data and the ever-changing face of the virus. The global effort relies heavily on the continuous adaptation and optimisation of vaccines to ensure they provide the most effective protection.

Vaccine development against Covid-19 requires continuous surveillance for side effects and subsequent regulatory actions. Public health authorities and manufacturers are constantly monitoring and studying all vaccines to detect and understand potential adverse effects. This vigilance ensures that vaccines remain safe and effective against evolving viral threats.

The global response to Covid-19 highlights the complexities of managing a pandemic. It involves balancing the rapid development and deployment of life-saving vaccines with the need to monitor their effects and make necessary adjustments. This process is vital not only for addressing the immediate crisis but also for preparing for future public-health challenges.

Nevertheless, the withdrawal also coincides with recent legal challenges against AstraZeneca. The company has admitted in court documents that the vaccine can cause a rare blood-clotting side effect called TTS (thrombosis with thrombocytopenia syndrome). This has led some to question whether safety concerns, not just market forces, influenced the decision.

Lawyers representing those who suffered serious side effects from it argue that the vaccine was not as safe as people were led to believe. Families of those who died after receiving the vaccine are seeking compensation.

LEGAL CASES

Kam Miller, a resident of Kibworth in Leicestershire, England, is suing AstraZeneca after her husband Neil died from a blood-clot complication following his Covid-19 vaccination in March 2021.

Neil Miller, a 50-year-old father of two and a coach of a youth football team, was fit and healthy before the vaccination. Afterwards, he started experiencing flu-like symptoms that worsened over time, leading to multiple hospital visits. He tragically passed away at home two months after receiving the vaccine.

Miller says that she is not against vaccination and that her husband was eager to get vaccinated to protect himself and others. She believes that he would have survived a Covid-19 infection if he had not got the vaccine, however. She argues that the compensation she received through the UK government’s Vaccine Damage Payment Scheme (VDPS) is not enough, especially considering the financial and emotional impact of losing her husband, who was the main breadwinner in their family.

Miller is one of 80 claimants suing AstraZeneca. They argue that the company’s Covid-19 vaccine was less safe than people were led to believe. Their lawyer, Sarah Moore, emphasises that these are not anti-vaccine cases. They acknowledge the importance of vaccination in fighting the pandemic, but they believe this small group of people suffered severe consequences and deserve fair compensation.

AstraZeneca says patient safety is its top priority and that regulatory authorities have strict standards for vaccine safety. They point to clinical trial data suggesting an acceptable safety profile for their vaccine and that regulators worldwide acknowledge the benefits outweigh the risks of rare side effects. The company emphasises that it provided the vaccine on a not-for-profit basis and that Covid-19 vaccines have saved millions of lives.

The UK Government has transitioned its national vaccination programme to primarily use mRNA vaccines since September 2021. It stopped ordering the AstraZeneca vaccine in 2022. The UK Department of Health and Social Care declined to comment on the ongoing litigation but confirmed that the supply agreement with AstraZeneca was completed in 2022.

Another case is related to a 42-year-old American woman named Brianne Dressen, who is also suing AstraZeneca. She alleges that participating in a Covid-19 vaccine trial organised by the company in 2020 left her with permanent disabilities. The lawsuit is the first of its kind in the US as the AstraZeneca vaccine was never widely approved for use there.

Dressen, a former teacher from Utah, claims she developed a neurological condition called post-vaccine neuropathy after taking part in the trial. This condition causes nerve damage, leading to symptoms like pain, numbness, tingling, and burning sensations. The exact mechanism linking vaccines to neuropathy is unclear, yet some believe it might be triggered by an autoimmune response. Cases are rare, but this lawsuit highlights the importance of continued research into vaccine side effects.

Estimates suggest that less than one in 100,000 doses of vaccines lead to serious neurological complications like post-vaccine neuropathy. Several factors might contribute to its occurrence, including genetic predisposition, pre-existing autoimmune disorders, and individual immune responses.

In February 2024, AstraZeneca acknowledged a possible link between their vaccine and vaccine-induced immune thrombotic thrombocytopenia (VITT) in a legal document submitted to the UK High Court. The acknowledgment emphasises the extreme rarity of this side effect.
The scrutiny around safety intensified following the cases of blood clots in vaccinated individuals. These rare events involve clotting combined with low blood platelet levels. Importantly, this risk is significantly lower than the risk of blood clots associated with the Covid-19 infection itself.

Regulatory bodies like the US Centers for Disease Control and Prevention (CDC) and the EMA have thoroughly investigated these rare events and continue to emphasise the overwhelming benefit-to-risk profile of the vaccine. They have issued guidelines for monitoring potential VITT symptoms and strongly advocate vaccination, highlighting the significantly higher risks associated with unmitigated Covid-19 spread.

Furthermore, a large-scale study involving over 23 million vaccinations confirms that such serious side effects, including specific blood-clotting disorders and neurological conditions, are incredibly uncommon. For instance, a rare but serious reaction like acute inflammation of the brain and spine was estimated to occur in only about one out of every 1.75 million people who received the Moderna vaccine, demonstrating the rarity of such events.

Despite these rare occurrences, the overwhelming evidence points to the significant benefits of the AstraZeneca vaccine. The vast number of vaccinations administered has demonstrably saved lives and reduced the severity of Covid-19 cases. Continued use and study of the vaccine is an integral component of the global public health strategy to combat the virus.

Early intervention is crucial for managing post-vaccine neuropathy. Treatment typically starts with medications to manage pain. In severe cases, doctors might use corticosteroids to reduce inflammation. Rehabilitation through physical therapy can help maintain muscle strength and improve mobility. Regular follow-ups with a neurologist are essential to monitor progress and adjust treatment plans. Psychological support may be beneficial, as chronic pain and disability can significantly impact mental health.

Generally, the AstraZeneca vaccine is considered safe, with a very low risk of serious side effects.

EGYPT

Like many other countries, Egypt has been grappling with public anxieties surrounding the AstraZeneca Covid-19 vaccine.

In response, Egyptian health officials have reaffirmed their confidence in the vaccine’s ability to protect people from Covid-19. They acknowledge the rare possibility of blood clots as a side effect but have emphasised that this risk is significantly lower than developing blood clots from a Covid-19 infection itself.

Hossam Abdel-Ghaffar, spokesperson for the Ministry of Health, reports that blood clots occur in only three out of every million vaccinated individuals in Egypt — a rate comparable to those already at high risk for blood clots even without vaccination. He highlighted that the risk of blood clots is 10 times greater with a Covid-19 infection than with immunisation.

One Egyptian cardiologist, who asked to have his name withheld, has also talked about the issue in a series of videos. He mentioned that it is crucial for patients to monitor their general health through a series of medical tests. To ensure heart health, they should have an electrocardiogram (ECG) and cholesterol profile test. For diabetes monitoring, they should ask for a HbA1c test to check blood-sugar levels over the past three months, especially if there are suspicions of developing diabetes or being at risk.

Given that some individuals have reported thyroid issues post-vaccination, it is also advisable for patients to undergo TSH and FT4 tests to evaluate thyroid health. To rule out or confirm autoimmune conditions, ANA and ANCA tests should be considered. Some women have experienced miscarriages linked to antiphospholipid syndrome, a well-known immune disorder, so testing for anti-cardiolipin IgG and IgM is recommended.

Any new symptoms or unusual sensations should lead to a consultation with a healthcare professional. It is worth noting that the effectiveness of the Covid-19 vaccine tends to wane after six months.

“After a long period, for example exceeding a year, there cannot be any cases where we can definitively say there were health issues caused by the vaccine. This was a pandemic, and we were all scared, desperately looking for any glimmer of hope to get us through it,” Abdel-Ghaffar said.

The Egyptian Drug Authority approved the AstraZeneca vaccine for emergency use in January 2021. Egypt’s national vaccination programme continues to include the AstraZeneca vaccine alongside options from Johnson & Johnson, Pfizer, and Sinovac. This decision aligns with the WHO’s continued support for the safety and effectiveness of the vaccine.

While the pandemic is still a global concern, the WHO declared an end to the Covid-19 public health emergency in May 2023, attributing this success to the effectiveness of widely available vaccines, including that produced by AstraZeneca.
The global rollout of the AstraZeneca vaccine has cast a spotlight on the ethical considerations surrounding vaccine equity and access. Vaccine hesitancy, logistical hurdles in distribution, and intellectual property concerns can create disparities in access. Initiatives like the Covid-19 Vaccines Global Access (COVAX) campaign helped in addressing these disparities. Continued international cooperation and a commitment to knowledge sharing are vital.

Ongoing monitoring, research, and transparent communication are also essential. The ability of the various vaccines to adapt to challenges and meet global needs is a testament to the international scientific and health community’s resilience.

* A version of this article appears in print in the 29 May, 2024 edition of Al-Ahram Weekly

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