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India approves AstraZeneca and local Covid vaccines, rollout in weeks | Dawn / Reuters |

India's drugs regulator on Sunday gave final approval for the emergency use of two coronavirus vaccines, one developed by AstraZeneca and Oxford University and the other by local company Bharat Biotech.

The world's second most populous country is now expected to start a massive immunisation programme within weeks, with the AstraZeneca/Oxford shot taking the lead and Bharat Biotech's Covaxin administered under stricter conditions given that no efficacy data has been released for it.

The overall efficacy of the AstraZeneca/Oxford vaccine was 70.42 per cent, while Bharat Biotech's Covaxin was "safe and provides a robust immune response", said Drugs Controller General of India VG Somani.

The British-developed AstraZeneca/Oxford shot is being made locally by the Serum Institute of India (SII) and will be branded Covishield, while Bharat Biotech has teamed up with the government run Indian Council of Medical Research.

Both vaccines will be produced in India ...

Oxford/AstraZeneca Covid vaccine has 70% efficacy, full trial data shows | The Guardian |

It is possible the Healtcare Authority (MHRA) in the UK, the European Medicines Agency (EMA) and the FDA in the US will come to different conclusions.

...
Both the Pfizer/BioNTech and the Moderna vaccines have reported 95% efficacy in their trials, but Gilbert said it was important to see how well the vaccines did after six months or a year.

..,
"We will be submitting the data to the FDA, but our best assumption is that we will need the study readout from the US before we are likely to get approval in the US," said Mene Pangalos, executive vice-president of biopharmaceuticals R&D at AstraZeneca.

Oxford AstraZeneca's is seen as the most globally important vaccine because it is easy to manufacture and distribute at fridge temperature, and the cost is low. AstraZeneca has undertaken to manufacture 3bn doses and is part of Covax, the UN programme to distribute vaccines to all countries in the world.

UK and Russian scientists are teaming up to trial a combination of the Oxford-AstraZeneca and Sputnik V vaccines.

Conclusion: decisions on approval of COVID-19 vaccines has been become highly politicised for domestic consumption.

by Oui on Sun Jan 3rd, 2021 at 07:22:37 PM EST

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