Key Highlights:
- In March 2024 AstraZeneca initiated the removal of its vaccine from the global market
- In February 2024, AstraZeneca acknowledged to the courts the potential risk of thrombosis or thrombocytopenia (TTS) syndrome in rare instances associated with the vaccine’s usage
- For the vaccination drive, 7 million doses of Covishield vaccine were initially accumulated in Bangladesh, with 2 million doses provided as a goodwill gesture from India
AstraZeneca’s groundbreaking choice to globally retract its COVID-19 vaccine garnered praise from individuals affected by an exceedingly rare yet fatal side effect. They expressed relief, stating that it ‘ensures no one else will endure this dreadful adverse reaction’. In March 2024 AstraZeneca initiated the removal of its vaccine from the majority of European nations, a move sanctioned by the European Commission.
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Embarking on the monumental task on May 7, the British-Swedish corporation commenced the implementation of the withdrawal worldwide. By that time, over 3 billion vaccine doses had been administered globally, spanning countries like Bangladesh, India, and the UK, since the onset of the COVID-19 pandemic.
In February 2024 AstraZeneca acknowledged to the courts the potential risk of thrombosis or thrombocytopenia (TTS) syndrome in rare instances associated with the vaccine’s usage.
Throughout the Covid-19 crisis, the Covishield and Vaxzevria vaccines, developed collaboratively by AstraZeneca and Oxford University, were disseminated worldwide. The UK approved the vaccine for its immunization program on December 30, 2020, with inoculations commencing in January 2021.
Covishield, manufactured by India’s Serum Institute, is recognized as Vaxzevria in Europe, with India alone administering at least 175 million doses of the vaccine. Although distributed in over 170 nations, the majority of doses were administered in 2021, with no distribution in the United States outside of clinical trials.
AstraZeneca’s Statement
In legal proceedings in the United Kingdom, AstraZeneca addressed issues regarding thrombosis with TTS, following a lawsuit against the company.
According to recent reports by The Telegraph, the lawsuit was initiated by Jamie Scott, a father of two, who suffered a permanent brain injury after experiencing a blood clot and brain hemorrhage following his vaccination in April 2021.
The report states that a total of 51 cases have been filed in the UK High Court, with individuals and their families seeking damages amounting to an estimated £100 million. It has been linked to 81 deaths in the UK as well as hundreds of serious injuries.
AstraZeneca refuted any connection between the vaccine’s withdrawal and the ongoing court case, emphasizing that the decision is driven solely by commercial considerations. In court documents dated February, AstraZeneca admitted that the vaccine- AZD1222 universally causes TTS to occur in ‘very rare cases’ following vaccination.
Breaking Down TTS: Symptoms, Risks, and Insights
TTS is a grave medical condition characterized by low platelet count (thrombocytopenia) and the formation of blood clots (thrombosis) within the body. This syndrome has been associated with adenovirus vector vaccines. About 2 to 3 occurrences of this infrequent ailment have been noted per 100,000 vaccinated individuals.
Symptoms of TTS include shortness of breath, chest pain, leg swelling, severe and persistent headaches, and abdominal discomfort. Affected individuals also experience easy bruising.
According to a 2023 report by Yale Medicine hematologist Robert Bona, MD, these clots typically develop in individuals who are bedridden, hospitalized, or facing other medical conditions associated with inflammation, infection, or cancer.
Bangladesh to Monitor Vaccine Impact
Bangladesh’s Health and Family Welfare Minister, Dr. Samanta Lal Sen, has directed the Directorate General of Health Services (DGHS) to assess whether recipients of vaccines in Bangladesh have encountered any adverse effects. As there have been no reports of harmful symptoms in the country thus far, the AstraZeneca vaccination campaign will continue.
The vaccination initiative in Bangladesh commenced on February 8, 2021, initially employing AstraZeneca’s vaccine, followed by procurement of Sinopharm from China and Moderna from COVAX. Pfizer vaccine was administered as a fourth dose to the elderly.
Amidst the harrowing grip of the COVID-19 pandemic, the world faced a dire struggle for survival, with lockdowns, mourning, and death casting a grim shadow across nations. In this tumultuous time, the beacon of hope emerged in the form of life-saving vaccines against the virus. However, the journey to discover and deploy such a vaccine is a lengthy and meticulous process.
The initial phase of vaccine discovery involves rigorous Phase-1 trials, spanning at least 6 months, to assess the quality and short-term safety of the vaccine. Subsequently, Phase-II trials follow, lasting 1-2 years, wherein the vaccine’s clinical efficacy, safety, dosage, and response are scrutinized, along with its effectiveness across specific demographics.
Dr. Kaoser Alam
MBBS
FCPS (Medicine)
MD (Cardiologist)
Medicine specialist
Bangabandhu Sheikh Mujib Medical University
During the advent of the Covid-19 pandemic, the AstraZeneca vaccine achieved these milestones. Typically, a new drug or vaccine is brought to market post Phase-3 trials, ensuring a thorough evaluation of its safety and efficacy. However, due to the global emergency posed by the pandemic, the AstraZeneca vaccine was expedited to market without completing Phase-3 trials.
In our country, short-term side effects following the AstraZeneca vaccination have been documented. However, no comprehensive follow-up study has been conducted to assess its long-term effects among Bangladeshi recipients. Contrastingly, countries like the UK and India have implemented regular follow-up protocols for those vaccinated with AstraZeneca, aiming to monitor any emerging issues.
Around the world, evidence has surfaced regarding various long-term side effects among recipients of the AstraZeneca vaccine. Studies have indicated symptoms such as exertional wheezing, shortness of breath, inflammation of the heart muscle, peripheral neuropathy, kidney complications, physical weakness, lethargy, sleep disturbances, forgetfulness, and uncontrolled diabetes.
Despite the absence of systematic follow-up in our country, retrospective studies offer a glimmer of hope in understanding the nature of these side effects. However, discerning whether these effects stem from the AstraZeneca vaccine or other underlying health issues poses a challenge. Yet, through extensive research conducted at community and national levels, there remains a possibility of unraveling these complexities.
While the urgency of vaccine deployment during a global crisis is understandable, thorough monitoring of long-term effects is imperative. Through diligent research efforts, we strive to shed light on the impact of the AstraZeneca vaccine, ensuring the safety and well-being of our population.
For the vaccination drive, 7 million doses of Covishield vaccine were initially accumulated, with 2 million doses provided as a goodwill gesture from India. The remaining 5 million doses were procured from the Serum Institute. As of May 8 this year, 56.28 million doses of Covishield have been dispensed in the country.
Dr. Kaoser Alam
MBBS
FCPS (Medicine)
MD (Cardiologist)
Medicine specialist
Bangabandhu Sheikh Mujib Medical University
According to the Health Directorate, over 159 million first doses, more than 142 million second doses, over 68 million third doses, and over 5.14 million fourth doses have been administered. Among these, the highest number—207.676 million doses—comprised the AstraZeneca vaccine.
| Type of Vaccine | Total Doses Accumulated | Total Doses Administered |
|---|---|---|
| Covishield | 7 million | 56.28 million |
| AstraZeneca | – | 207.676 million |
India’s reaction to Covishield’s side-effects
As of April 2023, India has administered COVID-19 vaccines to over 1 billion people with nearly 88% of those doses being Covishield shots. In May 2021, the Indian government reported 26 potential thromboembolic events since the administration of Covishield began.
This translated to 0.61 cases per million doses or 0.000061%. Since January 16, 2021, when vaccinations commenced, the number of reported thromboembolic events was based on the total doses administered up to that point.
Recent data from the government’s Adverse Events Following Immunization (AEFI) committee indicates at least 36 vetted cases of thrombosis with thrombocytopenia syndrome (TTS). A previous report from the committee, released in June of the prior year, disclosed 18 deaths among these cases.
The Ministry also noted that scientific literature suggests a lower risk of blood clotting, approximately 70% less, among individuals of South and Southeast Asian descent compared to those of European descent.
| Date | Total Vaccinated | Covishield Doses | Thromboembolic Events | Thromboembolic Events (TTS) | Deaths (TTS) |
|---|---|---|---|---|---|
| May 2021 | 1 billion | 88% | 26 | – | – |
| April 2023 | 1 billion | 88% | – | 36 | 18 |
AstraZeneca’s move to globally withdraw its COVID-19 vaccine due to rare but fatal blood clotting risks has sent shockwaves across the world. While the decision garnered praise from affected individuals, it also raised concerns about vaccine hesitancy and the potential impact on immunization efforts, especially in developing nations like Bangladesh and India, where millions relied on AstraZeneca’s affordable shots.
As legal battles loom and nations monitor for adverse effects, the saga highlights the delicate balance between public health and pharmaceutical accountability. The aftermath of this groundbreaking retraction will undoubtedly shape future pandemic response strategies and highlight the paramount importance of rigorous safety protocols in the race to develop life-saving vaccines.
