Who shouldn't take COVAXIN? Maker Bharat Biotech issues fact-sheet
Two days after India started its coronavirus vaccination program, Hyderabad-based Bharat Biotech released guidelines revealing who should receive shots of COVAXIN. On Monday, the company said people who have weaker immunity or are taking medicines that affect their immune system or have allergies must not take COVAXIN. Those having fever, a bleeding disorder, pregnant/breastfeeding women were also advised to not take the antidote.
The fact-sheet is in contrast to statements issued by the government. The latter said those on immuno-suppressants or suffering from immune deficiency can take the vaccine but underscored that the efficiency could be reduced. Cancer patients on chemotherapy, HIV positive people, and those on steroids fall in this category. However yesterday, Bharat Biotech cleared the air amid rising concerns over its vaccine.
The company said that getting vaccinated doesn't mean coronavirus-linked precautions can be discarded. "The Central Licensing Authority has granted permission for the sale/distribution of the antidote for restricted use in emergency situations in the public interest as an abundant precaution, in clinical trial mode," the fact-sheet said. Those who received a dose of any other coronavirus vaccine mustn't get COVAXIN, declared the company.
In the document, Bharat Biotech listed the common and rare adverse reactions of COVAXIN. Itching, pain, swelling, redness at the injection site as well as body ache, fever, rashes, headache, nausea, and vomiting were labeled as common side-effects. In rare cases, a beneficiary can experience difficulty in breathing, swelling in the face/throat, faster heartbeats, rashes all over the body, dizziness, and weakness.
In a bid to remain transparent, the document also disclosed the ingredients of COVAXIN. The vaccine has been made using an inactivated/killed virus and some chemicals. "COVAXIN contains 6μg of whole-virion inactivated SARS-CoV-2 antigen (Strain: NIV-2020-770), and other inactive ingredients such as aluminum hydroxide gel (250μg), TLR 7/8 against (imidazoquinolinone) 15μg," the company said. Bharat Biotech reiterated that COVAXIN's clinical trials are underway.
The fact-sheet also said the two-dose series has to be administered four weeks apart into the deltoid muscle of the upper arm. "Informing the individuals about the offer for vaccination with COVAXIN will rest with the respective Government Program Officials. Those offered COVAXIN at pre-specified booths will have the options to receive or reject administration of the vaccine," the company went on.
Besides COVAXIN, the Drugs Controller General of India (DCGI) also approved Covishield for emergency use. As per the latest data of the Ministry Of Health, 4,54,049 have been inoculated. A top official from the government said yesterday that 580 AEFI (adverse events following immunization) were reported and of them, seven had to be hospitalized. Two reported deaths weren't linked to vaccination, he added.
