Friends, you must have read/heard about the news related to Covid Vaccine which Pharmaceutical giant AstraZeneca developed in partnership with Oxford University. In India, AstraZeneca issued the licence to manufacture the same vaccine to The Serum Institute of India (SII), and in India this vaccine is known as COVIDSHIELD, and this vaccine was administrated to the majority of Indians, approx 80%
Recently, AstraZeneca had admitted in a UK court that its Covid-19 vaccine could cause a rare side effect known as Thrombosis with Thrombocytopenia Syndrome (TTS).
What is TTS
TTS is characterised by blood clots (thrombosis) combined with low levels of platelets (thrombocytopenia), which are necessary for blood clotting. It often involves unusual blood clot locations, such as in the brain (cerebral venous sinus thrombosis) or abdomen.
Symptoms of TTS
It may include
- Severe or persistent headaches
- Blurred vision
- Shortness of breath
- Chest pain
- Leg swelling
- Persistent abdominal pain
- Easy bruising or tiny blood spots under the skin beyond the injection site.
A blood clot is essential a gel-like clump of blood. Small blood clots form naturally whenever you cut or scrape your skin to stop bleeding. However, they become dangerous when they develop within blood vessel, causing thrombosis (where they block blood flow). These type of clots typically occur in individuals who are bedridden, hospitalized, or other medical issues related to inflammation, infection, or cancer.
First report came from World Health Organisation (WHO) that TTS emerged as a new adverse event following immunization in individuals vaccinated with Covid-19 non-replicant adenovirus vector based vaccines. This included AstraZaneca Covid-19 vaccine and Johnson & Johnson Covid-19 vaccine.
As in India, General election is going on, this issue of side effects of Covidshield vaccine is snowballing into a political issue. The opposition Congress party alleged that the BJP government at the centre did not follow the guidelines of WHO, and demanded that the relatives of those who died due to heart attack or similar reasons after taking Covidshield vaccine should be paid compensation. The fact is that as per the expert panel of doctors ‘there is no direct link between Covid-19 vaccines and blood clotting which can lead to heart attacks.’
Three years back, the same opposition parties were demanding that why government is delaying approval of Covidshield vaccine of SII, as this vaccine is licenced from AstraZeneca, many developed countries in the world have already approved this vaccine.
In reality, benefits of Covid vaccines far outweigh the risks. Diverging views emerged between the position of vaccine safety experts and public health administration. The Pharmacovigilance Risk Assessment Committee (PRAC) in 2012, had concluded that the benefits of the vaccine in combating continuing threat of Covid outweigh the risk of rare side effects. The disease itself also caused clotting problems that could result in death. The WHO’s Global Advisory Committee on Vaccine Safety (GACVS) had reviewed, in March 2021, available data from 20 million doses administrated in Europe and another 27 million doses administrated in India and concluded in favour of positive benefit-risk profile.
Friends, you will recall that by Mid 2020 Covid-19 pandemic was spread all over the world and some countries were affected very badly. There was huge hue and cry in general public that vaccine for this pandemic should be developed immediately and administrated to all. That time most of the vaccine manufacturing companies requested the concerned governments to give them indemnity against any future compensations/litigations for the side effects etc. The reason being that Covid-19 vaccines may not enough trial time.
As per the reports available, the risk of TTR is about 5-7 in one million people, who are administrated with vaccines manufactured by AstraZeneca, J&J, and SII, and other similar vaccines manufactured by other Pharma companies.
In the western world there is common practice to sue Pharma companies or governments on vaccine’s or any other medicines’ side effects.
The accusation by various opposition party leaders that all Indians, who have been administrated Covidshield vaccine, face imminent dangers/perils from TTS and attributing it to governmental failure are grossly exaggerated and misleading. The reality is that all the vaccines have few side effects, government sees that benefits of vaccines should outweigh the risk factors by huge percentage.
Waiting for your feedback on this blog.
Anil Malik
Mumbai, India
6th May 2024