British drugmaker AstraZeneca has admitted that its COVID-19 vaccine can cause a rare side effect of blood clotting and low platelet count after immunisation. The announcement caused panic among the people who took the COVID-19 jab.
The development has also sparked a political furor, as the opposition is now accusing the government of administering ‘wrong’ vaccine to the people of the country. In India, the global pharma giant partnered with the Serum Institute of India (SII) to supply the vaccine to the government. The vaccine in India was called Covishield.
The vaccine, developed by researchers from Oxford University, can cause Thrombosis with Thrombocytopenia Syndrome (TTS), and the company has admitted this in court amid a slew of lawsuits alleging severe harm and deaths caused by the vaccine.
Amid concerns over potential side effects, AstraZeneca issued a statement reiterating its commitment to patient safety. “Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines,” the company said in a statement.
The company also said that “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.”
Is there a need to panic?
In India, Covishield has been administered through 175 crore doses. Understandably, the company’s admission has raised questions about the safety of the jab. However, the occurrence of TTS was well-documented the cases first came to light within months of the vaccination drives beginning in Europe. Consequently, the vaccine drive was also halted for a while in some countries.
Regulatory agencies and health experts worldwide continue to maintain that the benefits of vaccination far outweigh the risks posed by exceedingly rare side effects.
“It is important not to panic about Covishield’s side effects related to thrombosis with thrombocytopenia syndrome (TTS) for many reasons: TTS is an extremely rare side effect occurring in a very small number of cases compared to the millions who have received the vaccine worldwide. This side effect occurs within the first few days of vaccination and is not observed thereafter. It is not a concern for most of us who had taken this vaccine a few years ago. The benefits of vaccination against COVID-19, including reducing severe illness, hospitalization, and death far outweigh the risk of this rare side effect,” Dr. Navin Kumar, Consultant, Clinical Microbiology & Infection Prevention, Manipal Hospital, New Delhi told Financial Express.com.
Experts also maintained that the side-effects are mentioned on the vaccines since the beginning. They also emphasised that any adverse event associated with the vaccine would have occurred within 21 days to a month of the first dose.
Dr Tushar Tayal, Lead Consultant, Department of Internal Medicine, CK Birla Hospital, Gurugram explained that TTS is a rare side effect of messenger RNA-based Covid vaccines such as Covishield characterised by venous or arterial thrombosis.
“The symptoms generally occur 4 to 42 days following COVID-19 vaccination and can include headache, abdominal pain, back pain, nausea and vomiting, vision changes, shortness of breath, leg pain and swelling, and bleeding. TTS is a known complication of vaccination with non-replicating adenovirus vector (AV) vaccines and has been seen previously with other non-Covid vaccines too. Although TTS is a serious complication but we have to look at the larger picture of the number of deaths prevented by Covid vaccination,” Dr. Tayal told Financial Express.com.
He also highlighted that the incidence of TTS is around 10 per million vaccinated individuals.
“The important thing to remember is to be aware of the side effects of the vaccine and report to your nearest hospital in case of untoward symptoms. Also, follow government directives regarding the vaccination schedule,” he added.
Dr. Varun Bansal, Consultant, Cardiology and Cardio Thoracic surgery, Indraprastha Apollo Hospitals explained that a vaccine instigates a very small minute effect of the overall disease in the body and prepares the body for illness if and when it occurs, the body generated immune reaction has a fighting mechanism inside once it is vaccinated.
“…the remote possibility is there, but, very rare. So in the same manner, what a vaccine does is like to understand about the side effect, we have to see, we have to understand what a does vaccine. It’s just like taking a flight. So do you think there’s a risk in taking a flight? The answer is yes, there is a risk of the flight crashing. But day in and day out there 1000s and 10s of 1000s airplanes flying in and around and doing benefit to the people who are traveling. So in the same manner every vaccine which is given to the patient be it polio vaccine be it measles be it any vaccine, has a potential side effect of causing some immune reaction inside the body,” Dr. Bansal told Financial Express.com.
He also emphasised that the side-effects depends on the reaction of the body to the vaccine.
“So, it is not a cause to worry, because it is extremely rare and it is not due to the vaccine itself, it is due to the immune reaction of the body because of which this complication occurs. And even if it occurs, it can be treated. It just has to be identified in time in case the patient is having any weakness in any part of the body,” he said.
The recipient should consult their doctor in case they have any bleeding spots or discolorations over the body because of low platelet count. “…most of these problems are easily treatable without any morbidity or any problem in the immediate or the long term aspect of life,” he added.
Last year, the World Health Organization (WHO), said in its report that TTS emerged as a new adverse event following immunisation in individuals vaccinated with COVID-19 non-replicant adenovirus vector-based vaccines which include AstraZeneca COVID-19 ChAdOx-1 vaccine and the Johnson & Johnson Janssen COVID-19 Ad26.COV2-S vaccines.
It is noteworthy that SII made AstraZeneca’s COVID-19 vaccine using a viral vector platform rather than mRNA technology.
What is the status of TTS globally?
A 2022 study published in The Lancet Global Health journal found that AstraZeneca had reported rates of 8.1 TTS cases per million receiving the first dose and 2.3 TTS cases per million receiving the second dose.
According to the study, there was a geographic variation in the reporting of TTS, with the highest cases coming from Nordic countries (17.6 per million doses) and the lowest from Asian countries (0.2 per million doses).
According to a report by The Indian Express, the Government committee on Adverse Events Following Immunisation (AEFI), vetted at least 36 cases of TTS and confirmed 18 deaths from it in 2021, the first year of Covid-19 vaccination in India.
More legal trouble for AstraZeneca?
After the reports of AstaZeneca’s admission, a lawyer has moved the Supreme Court seeking the constitution of a Medical Expert Panel to examine side-effects and risk factors of the said vaccine as well as compensation of those who were severely disabled or died due to the vaccination drive.
In another case, the parents of a woman who died after receiving the Covishield vaccine will also file a case against the SII. Venugopalan Govindan, father of Karunya, who died post-vaccination, said AstraZeneca’s admission was “too late,” following numerous casualties.
