While AstraZeneca and the Serum Institute of India continue to face criticism over their handling of the side effects of the Covishield vaccine, many companies are lining up to begin fresh trials for a next-generation Covid jab. This move comes in the wake of rising cases in some parts of the world, particularly Singapore. For instance, Hyderabad-based Biological E has begun clinical trials for a vaccine to combat the XBB1.5 variant of the SARS-CoV-2 virus and expects preliminary results in June. Currently, India does not have any vaccines specifically targeting the XBB 1.5 variant.
Last month, a Subject Expert Committee recommended granting permission to the Pune-based Serum Institute of India (SII), which had partnered with AstraZeneca to develop the Covishield vaccine. SII will now develop a vaccine for the Omicron XBB1.5 variant, with a local clinical trial waiver for emergency use.
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Covishield: A vaccine controversy
AstraZeneca is one of the prominent companies that manufactured COVID-19 vaccines. Once the dust around the pandemic settled, many in the scientific community started questioning the rushed rollout of vaccines, leading to increased scrutiny of these manufacturers. It is true that vaccines were rolled out by overruling major safety guidelines due to the urgent need to find a cure for the virus amid mounting deaths.
Amid this heightened scrutiny, Covishield’s makers admitted for the first time in court documents that their COVID-19 vaccines—Covishield and Vaxzevria, among others—may lead to a rare, deadly side effect: Thrombosis with Thrombocytopenia Syndrome (TTS). TTS is a rare condition in which blood clots form in unusual places in the body, and the number of platelets in the blood drops. Besides Vaxzevriaand Covishield (AstraZeneca), TTS was also observed in people who received the Johnson & Johnson/Janssen COVID-19 vaccine.
Impact and response in India
Covishield was administered to millions in India. While AstraZeneca is a British-Swedish pharmaceutical company, India’s Serum Institute partnered with AstraZeneca and the University of Oxford in January 2021 to manufacture the Covishield vaccine for India and other low- and middle-income countries. Covishield was widely administered in collaboration with the government. As of April 30, 2024, over 1.7 billion doses of Covishield had been given in India as part of the world’s largest vaccination programme.
Facing heat after the company admitted to rare side effects from the vaccine, AstraZeneca withdrew the shots, renamed Vaxzevriain 2021, from the global market. The vaccine maker cited a surplus of available updated vaccines effective against new variants of the virus as the reason for its decision.
The public response to the revelations about the Covishield vaccine has been mixed. While some individuals remain confident in the benefits of vaccination, others have expressed concerns about transparency and trust in pharmaceutical companies. This trust deficit has been exacerbated by misinformation and the rapid spread of unverified claims on social media. Public health officials are working tirelessly to address these concerns through awareness campaigns and by providing clear, evidence-based information about the safety and efficacy of vaccines. Restoring public trust is essential for the success of current and future vaccination programs.
The World Health Organisation has documented the side effects of the AstraZeneca vaccine, which are typically mild and short-lived. These common reactions include soreness at the injection site, fatigue, fever, headache, nausea, muscle aches, swelling and redness near the injection point, dizziness, drowsiness, sweating, abdominal pain, and even fainting. These side effects usually go away on their own and don’t require hospitalisation.
Balancing safety and progress
The furore that AstraZeneca faced does not mean scientific progress must be entirely banned. While the company acknowledged that the vaccine comes with rare side effects, this holds true for every medicine in the world. In fact, both Covishield and Covaxin were the bulwark of the country’s fight against the virus and played a crucial role in vaccination campaigns worldwide.
At the height of the pandemic, dire times required rapid development of vaccines, sometimes achieved by bypassing rules and regulations. While the compressed timeline raised concerns, it also led to exceptional collaboration between scientists, healthcare professionals, and policymakers. The widespread vaccination success significantly reduced the severity of COVID-19 after the fatal second wave in 2021. It was only because of the available vaccines that the pandemic could be brought under control.
Despite the controversy, it is crucial to acknowledge the effectiveness of the Covishield vaccine during the pandemic. Numerous studies have shown that the vaccine significantly reduced the severity of COVID-19 cases, hospitalisations, and deaths. The ability of the vaccine to adapt to new variants has been a focal point of ongoing research. Scientists are continuously working on updating vaccines to enhance their effectiveness against emerging strains like the Omicron XBB1.5 variant. This adaptability is a testament to the advancements in vaccine technology, highlighting the importance of ongoing research and development in combating future outbreaks.
The recent panic over the Covishield vaccine emphasises that while drug makers must maintain the highest standards, hiccups like these must not derail scientific progress. In an Indian Express editorial, the writer maintains that ongoing research into COVID-19 vaccinations is essential. These studies, with much larger sample sizes than initial trials, provide nuanced information on safety and efficacy. With the retrospective knowledge and database at hand, scientists must understand how vaccines work across diverse populations and increase their potency. The technologies used in COVID-19 vaccines, like viral vectors and mRNA, are weapons in a larger war against infectious diseases.
However, situations like the pandemic do not entirely absolve drug makers from responsible behavior. AstraZeneca’s recent admission casts a shadow on the company’s transparency. Going forward, companies, government, and regulators must conduct a more thorough approach to trials, even if it means a slight delay in vaccine rollout. Pharmaceutical companies must prioritise complete safety, especially when dealing with the health of millions.
In response to the controversies and challenges faced during the COVID-19 vaccination drive, governments and regulatory bodies have implemented stricter measures to ensure vaccine safety and efficacy. These measures include more rigorous clinical trial protocols, enhanced surveillance of adverse effects, and transparent reporting mechanisms. Additionally, collaboration between international health organisations and national regulatory agencies has been strengthened to streamline vaccine approval processes while maintaining high safety standards. These steps are vital in preparing for future pandemics and ensuring that public health responses are both swift and safe.