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Covaxin and Covishield not approved by the government for use by under 18, pregnant or lactating women

Tabish Neyaz

Government didn't approve Covaxin and Covishield to be used on those under 18, pregnant or lactating women

'Covaxin and Covishield not approved by the government for use by under 18, pregnant or lactating women'. It is to be noted that the government approved Covishield by Serum Institute of India (SII) to be used for people aged 18 or above.. Earlier, the government has disapproved the authorisation of Bharat Biotech’s Covid Vaccine to people below 18 years of age.

The ministry highlighted in a letter to all states and UTs, that under the emergency use authorisation, coronavirus vaccination is indicated only for 18 years and above.

The health ministry said on Thursday, Interchangeability of COVID-19 vaccines is not permitted and pregnant and lactating women should not be administered the shots as they have not been part of any anti-coronavirus vaccine clinical trial so far. COVID-19 and other vaccines has to be separated by an interval of at least 14 days, if required.

“Interchangeability of COVID-19 vaccines is not permitted. Second dose should also be of the same COVID-19 vaccine which was administered as the first dose,” the letter written by Manohar Agnani, Additional Secretary, Union health ministry said.

The ministry has provided in a list, the precautions and contraindications for COVID-19 vaccination along with a comparative factsheet for both the vaccines (Covishield and Covaxin) which contains information on vaccine platform, physical specifications, dosage, cold-chain storage requirements, contraindications and minor AEFIs (adverse event following immunization).

It further said that this information must be circulated amongst programme managers across all levels and through them to cold-chain handlers and vaccinators for ready reference. Intimating the contraindications, the healthy ministry cautioned against administration of the vaccine in persons with a history of anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine, and in those with immediate or delayed onset anaphylaxis or allergic reaction to vaccines or injectable therapies, pharmaceutical products, food items, among others.

As per the letter, in case of persons having active symptoms of SARS-CoV-2 infection, coronavirus infected patients who have been given anti-SARS-Cov-2 monoclonal antibodies or convalescent plasma and acutely unwell and hospitalised patients due to any illness, the COVID-19 vaccination is to be delayed for four to eight weeks after recovery.

The letter stated, “Pregnant and lactating women have not been a part of any COVID-19 vaccine clinical trial so far. Therefore, women who are pregnant or not sure of their pregnancy and lactating women should not receive COVID-19 vaccine at this time.”

The vaccine dose should be taken with caution in persons with a history of any bleeding or coagulation disorder (like clotting factor deficiency, coagulopathy or platelet disorder), it said.

“Following conditions are not contraindicated for COVID-19 vaccines –persons with past history of SARS-CoV-2 infection and or RT-PCR positive illness, history of chronic diseases and morbidities and immune-deficiency, HIV, patients on immune suppression due to any condition,” the letter stated.

The massive vaccination drive will be launched by the Prime Minister, Narendra Modi on January 16 via video conferencing. Adequate doses of Bharat Biotech’s ‘Covaxin’ and Serum Institute’s ‘Covishield’ vaccines have been delivered across the country to all states and Union territories. The letter also mentions mild AEFIs following vaccination for both the vaccines.

As for Covishield, some mild AEFI may occur like injection site tenderness, injection site pain, headache, fatigue, myalgia, malaise, pyrexia, chills and arthralgia and nausea. And for Covaxin, some mild AEFIs include injection site pain, headache, fatigue, fever, body ache, abdominal pain, nausea and vomiting, dizziness-giddiness, tremor, sweating, cold, cough and injection site swelling.

Paracetamol may be used to provide symptomatic relief from post vaccination adverse reactions, the letter added.

Also Read: 109 Cases Of UK Variant Reported in India

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