Unmasking "Covishield"

Covishield had been developed by the University of Oxford in collaboration British pharmaceutical major AstraZeneca. Pune-based Serum Institute of India (SII), the world’s largest vaccine manufacturer in terms of numbers, partnered with the Oxford University to manufacture their Covid-19 vaccine in India. The SII produced 5,000 doses of the vaccine per minute in their assembly lines during peak vaccination period.

Key events in the journey of Covishield:

April 2020: SII announced its partnership with Oxford University to manufacture their Covid-19 vaccine. "We have partnered with the Oxford University vaccine project as one of the seven global institutions manufacturing the vaccine," Adar Poonawalla had said in a statement.

May 2020: A 1ml vial with the cellular material for the much-anticipated vaccine arrives at SII from Oxford, England.

August 2020: Phase-III clinical trials of Covishield began in India.

September 2020: AstraZeneca observed a severe adverse reaction in one of the participants in their trial program and paused clinical trials in other countries. Drugs Controller General of India (DCGI) issued a show-cause notice to SII citing the failure of the company to inform about the same. The company responded saying no such effects were observed in India and the program was allowed to resume in the same month.

November 2020: AstraZeneca declared their vaccine candidate was observed to be 70 per cent efficient based on data from trial results. It also said efficacy increased when a different dosage regimen was followed. SII announced that the company is moving to apply for an emergency use license within two weeks.

December 2020: A trial volunteer from Chennai, TN reported severe adverse reaction to Covishield. SII denied any correlation between the vaccine and the condition of the volunteer.

January 2021: DCGI granted an emergency use approval (EUA) for Covishield vaccine in India. Doses of the vaccines were transported from Pune to multiple hubs in India.

January 16, 2021: The first dose of the vaccine was administered to recipients based on a priority list prepared by the government.

A brief about Clinical Trials:

Most vaccines, drugs available in the market go through all four phases of clinical trials throughout their lifespan in the practical use. Clinical trials utilize multiple methods of tracking, categorizing, and assessing any side effects at each trial stage. 

A negative side effect during clinical trials, whether expected as a potential outcome or more spontaneous, is known as an adverse event, which is initially graded on a 1-5 scale, where grade 1 is mild and non-bothersome, while grade 5 adverse events are fatal.

THE CONTROVERSY: TTS

Thrombosis with Thrombocytopenia Syndrome (TTS) is a serious health condition that causes low platelet count (thrombocytopenia) and clots blood (thrombosis) within the body. The condition is linked to adenovirus vector vaccines launched during Covid-19.

The noted symptoms of the condition range from shortness of breath, chest pain, leg swelling, severe and continuous headaches, and stomach aches. Affected persons suffer from easy bruising.

In the court documents, AstraZeneca said, "It is admitted that the AZ vaccine can, in very rare cases, cause TTS. The causal mechanism is not known...Further, TTS can also occur in the absence of the AZ vaccine (or any vaccine). Causation in any individual case will be a matter for expert evidence."

The company is now facing a class action lawsuit in the UK over claims that its vaccine caused deaths and severe injuries. At total of 51 victims have moved the UK High Court seeking damages up to 100 million pounds (Rs 1,047 crore).

WILL WE DIE DUE TO THE VACCINE? NOOO!

The AstraZeneca Covid vaccine- Covishield does cause Thrombosis with Thrombocytopenia Syndrome (TTS), but note: it is a rare side effect. It is important to understand that as stated by the company and proven by earlier research, not everyone who was administered Astra Zeneca Covid vaccines will be affected with TTS.

The company has mentioned in its legal papers that though there is a chance for TTS to occur, it is "rare" and "uncommon".

Should you be concerned if you are vaccinated with Covishield?

Not at all.

Dr. Jayadevan, Co-Chairman of the National Indian Medical Association (IMA) Covid Task Force in Kerala, told ANI, "It's a rare occurrence following specific types of vaccines and other causes." 

Also, in rare cases when TTS is reported, it is mostly within a few weeks of vaccinations. So, be aware, eat healthy and consult a doctor in case you face any of the symptoms of TTS.

IMAGES SOURCED FROM THE INTERNET. Credits to respective owners. 

News Information sourced from NDTV and Economic Times.