Bharat Biotech seeks nod for booster trials among children


Bharat Biotech has sought approval to conduct a Phase 2/3 study of Covaxin as a booster dose for the 2 to 18 years population….reports Asian Lite News

Hyderabad-based vaccine manufacturer Bharat Biotech has sought permission to conduct booster dose trials of its Covid vaccine Covaxin for below 18 population.

According to a source, Bharat Biotech has sought approval from apex drug regulator Drug Controller General of India to conduct a Phase 2/3 study of Covaxin as a booster dose for the 2 to 18 years population.

The study is likely to be conducted at six placed which also includes AIIMS Delhi and Patna, the source said.

Under the national vaccination drive, vaccines Covaxin and Covishield are being administered as precaution doses to above 18 plus population.

India began administering precaution doses of vaccines to the healthcare and frontline workers and for above 60 from January 10 this year. Later, all those aged above 18 were also included.

As per the Health Ninistry report on Wednesday evening, so far 2,88,62,660 precaution doses have been administered among the eligible beneficiaries.

Meanwhile, India’s Covid-19 vaccination coverage has crossed 189.60 crore with over 12 lakh doses being administered by Wednesday evening as per the ministry report.

No individual can be forced for vaccination: SC

The Supreme Court on Monday said that no individual can be forced to get vaccinated and added that the current Covid-19 vaccine policy of the government is not arbitrary.

A bench comprising Justices L. Nageswara Rao and B.R. Gavai said that restrictions imposed on the unvaccinated people by different organisations, institutions, and governments is not proportional. The bench suggested till numbers are low, state governments must remove such restrictions.

The bench noted that bodily autonomy/bodily integrity is a constitutional right, therefore no individual can be forced to get vaccinated. It also said that the current Covid-19 policy of the government is not arbitrary.

The top court further directed the Centre to make public the data on adverse events of Covid-19 vaccination.

The top court noted that the governments did not bring on record any data to establish that unvaccinated people spread virus more than vaccinated people, and also people who have not been vaccinated should not be barred from accessing public places. The detailed judgment will be uploaded later.

The top court’s judgment came on a petition filed by Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation, seeking the data of clinical trials and adverse effects of Covid vaccines and also challenging the vaccine mandates issued by some state governments. Puliyel was represented by advocate Prashant Bhushan.

During the hearing, the Centre had told the top court that as on March 13, over 180 crore doses of Covid-19 vaccines have been administered and “adverse incidents”, which were periodically recorded, were 77,314 as on March 12, which is 0.004 per cent of the total vaccination. The Centre emphasised that segregated clinical data cannot be demanded by anyone under the garb of filing of public interest litigation

Solicitor General Tushar Mehta and Additional Solicitor General Aishwarya Bhati made submissions on behalf of the Centre.

Bharat Biotech International Ltd, represented by advocate Vipin Nair, had told the Supreme Court that Covaxin has undergone all necessary clinical trials and the phase 3 efficacy trials revealed it is 77.8 per cent effective against Covid. The vaccine manufacturer said it has extensively published the findings of clinical trials in publicly available reputed peer reviewed journals and on its website.

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