Oxford Covid vaccine approved, three more awaiting nod, confirms Javadekar

Oxford Covid vaccine approved, three more awaiting nod, confirms Javadekar”

These include Covishield which is the Oxford vaccine being developed by AstraZeneca and Serum Institute of India and Covaxin developed by Bharat Biotech and Indian Council of Medical Research (ICMR).

The AstraZeneca-Oxford vaccine is now undergoing a "rolling review" which allows the EMA to examine safety and efficacy data as they are released, even before a formal application for authorisation is filed by the manufacturer.

The committee meeting, which is ongoing is also now reviewing an application by Bharat Biotech for its vaccine candidate Covaxin.

British drugmaker AstraZeneca says it will boost production of the coronavirus vaccine it developed with Oxford University to two million doses a week by the middle of January. Meanwhile, a nationwide dry run to assess the preparedness on field for the vaccination process was conduced on Saturday.

It had also asked for details of the product that would be included in the package insert, as well as the specific conditions that the UK Medicines and Healthcare products Regulatory Agency (MHRA) had imposed on AstraZeneca while granting emergency authorisation for its candidate, known as AZD1222. The fact sheet sought by the committee on Wednesday is also to be made available for those being vaccinated, according to the source.

The EU regulator approved the Pfizer-BioNTech vaccine on 21 December and is expected to approve Moderna's vaccine on 6 January.

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"The phase 3 trial is ongoing and we will continuously keep reviewing the data", the source added, "Other than the case from Chennai of a reported severe adverse event from the vaccine, no other safety events have been reported".

Different efficacy results for a Chinese COVID-19 vaccine released separately in China and in United Arab Emirates are both real and valid, an executive at China National Biotec Group (CNBG) told state media.

Bharat Biotech is presenting its case for similar approval for Covaxin, as it too, has not finished late stage human trials on over 25,000 participants across the country.

V.G. Somani, DCGI, at a webinar on Thursday indicated that India was close to approving a COVID-19 vaccine.

India will now require the World Health Organization prequalification to export the vaccine to other countries that may take at least a month.

The Serum Institute has indicated it has stockpiled around 50 million doses and could increase production capacity to around 100 million doses per month by February or March.

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