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Vaccine Makers Publish ‘Fact Sheets’ on Benefits and Risks of Candidates – The Wire Science



Covaxin and Covishield vaccine candidates in vials. Photos: bharatbiotech.com/Reuters/PTI

New Delhi: With many people who have received the Covaxin and Covishield vaccine candidates reporting allergies and other side effects, their manufacturers Bharat Biotech and Serum Institute of India (SII) have published ‘fact sheets’ that inform potential beneficiaries of risks and benefits of immunisation.

The Union health ministry said that as of 5 pm on Monday, over 3.80 lakh beneficiaries have received the first dose of the two COVID-19 vaccine candidates. Of these, 580 adverse events following immunisation (AEFI) were reported. However, as The Wire Science has reported, most of these are allergy-like reactions that are expected.

SII said that people who are severely allergic to any ingredient of its COVID-19 vaccine candidate Covishield are advised not to take it. According to the fact sheet for the vaccine recipient published by SII, a person who had a severe allergic reaction after a previous dose of this vaccine should not receive the second dose.

“The ingredients of Covishield vaccine are L-Histidine, L-Histidine hydrochloride monohydrate, Magnesium chloride hexahydrate, Polysorbate 80, Ethanol, Sucrose, Sodium chloride, Disodium edetate dihydrate (EDTA), Water for injection,” the company said.

The vaccine maker also said that the recipient should tell the healthcare provider about all the medical conditions before getting its vaccine candidate, including, “if you have ever had a severe allergic reaction (anaphylaxis) after any drug, food, any vaccine or any ingredients of Covishield vaccine”.

Recipients should also inform the healthcare provider if they have fever, bleeding disorder or are on a blood thinner and also if they are immuno-compromised or are on a medicine that affects their immune system.

The fact sheet also says that if a person is pregnant or plans to become pregnant or is breastfeeding, she should tell the healthcare provider before taking the jab.

The recipient should also inform the healthcare provider if they have received another COVID-19 vaccine, Serum Institute said.

Bharat Biotech also said that those with any history of allergies, fever and bleeding disorder, those who are on blood thinners and who are immunity compromised or on medication should not take Covaxin.

The company had earlier asked pregnant/lactating women, those using other COVID-19 vaccines and people with any other serious health-related issues as determined by the vaccinator/officer supervising vaccination to not receive the jab.

Bharat Biotech has now released a fact sheet that lists possible adverse events that could follow immunisation and those who are eligible and ineligible for its vaccine candidate.

The manufacturer said side-effects such as body aches, headache, fever, rashes, nausea and vomiting are to be expected after taking the jab.

It said, “There is remote chance that Covaxin could cause severe allergic reaction including difficulty in breathing, swelling of face/throat/fast heart beat, rash all over the body and dizziness and weakness.’’

The company highlighted that Covaxin’s clinical efficacy has not yet been established. “Hence it is important to appreciate that receiving the vaccine did not mean that other precautions related to COVOD-19 need not be followed,” it added.

IMA advocate ‘aggressive’ awareness campaign

According to The Hindu, the Indian Medical Association (IMA) is pushing for an aggressive awareness campaign in light of the reports of AEFI – three of which needed hospitalisation. It asked its members to reach out to people using public forums, media, social media to raise awareness about the vaccine candidates.

“The IMA lost its 732 expert doctors during the past one year and now we have a vaccine. It stands with the government during this phase where healthcare and front line workers would be vaccinated,’’ said the body’s honorary secretary general Dr Jayesh Lele.

As a modern medicine professional body, the IMA considers fighting the menace of misinformation against COVID-19 its responsibility, Lele said.

“[Vacccines] help develop immunity and decrease the chances of contracting the illness. These basic facts should be brought in public awareness. This scientific and evidence based preventive medicine should be taught to the people of our country,’’ IMA said, according to The Hindu.

In many states, there has been a ‘sluggish’ response to the vaccination drive. Apart from the Co-WIN app – used to coordinate the campaign – facing glitches, officials have also admitted that there are some reports of vaccine hesitancy among health and frontline workers, who are the first in line to receive the two vaccine candidates.

“The hesitation if any will be addressed through the ongoing awareness campaign and correct information released by the [health] ministry,’’ an official told The Hindu.



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