India Grants Emergency Approval to Astra-Oxford Covid Shot
Bloomberg 2hrs ago

(Bloomberg) -- India has followed the U.K. and granted emergency approval for the coronavirus vaccine developed by AstraZeneca Plc and the University of Oxford, the first step in its plan to inoculate citizens in the country that’s home to the world’s second-largest Covid-19 outbreak.

a group of people standing next to a person: A vaccine delivery testing process in Delhi, India, on Jan. 2. © Bloomberg A vaccine delivery testing process in Delhi, India, on Jan. 2.

In a brief statement on Sunday, the Drugs Controller General of India V.G. Somani, confirmed the approval of the AstraZeneca shot being produced locally by the Serum Institute of India Ltd. -- the world’s largest vaccine maker by volume.

Somani also said the locally developed Bharat Biotech’s Covaxin -- which has yet to complete vital phase three trials -- had been granted permission “for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.”

Serum has an agreement with AstraZeneca to roll out at least one billion doses and has already made millions of shots. The move came just days after the U.K. regulator gave clearance to the vaccine, which is to roll out to Britain’s most vulnerable groups from Monday.

Astra-Oxford Covid Shot Gains First Clearance With U.K. Nod

The approval means India can begin to vaccinate its population of about 1.3 billion. That’s a daunting task given the country’s vast territory, limited infrastructure and patchy health networks. The South Asian nation already has more than 10.3 million confirmed infections and as many as 149,400 deaths.

AstraZeneca’s vaccine, which has the most supply deals globally, has been pegged as a more suitable shot for reaching people in the remotes areas of India’s hinterlands than one developed by Pfizer Inc. and BioNTech SE that’s also being considered.

Cold Storage

Video: India approves two Covid-19 vaccines for emergency use (AFP)

Pfizer’s vaccine requires subzero conditions for transportation and storage, while AstraZeneca’s can be stored at refrigerator temperatures and is also expected to be cheaper.

Yet clinical trial data indicates the Astra shot may be less effective than Pfizer’s and another similar vaccine from Moderna Inc., which each showed 95% efficacy in trials.

Initial data from Astra and Oxford in November raised concern over how much protection the vaccine would offer. The trials produced two different results from two dosing regimens. The partners said their vaccine was 90% effective when a half-dose was given before a full-dose booster, and that two full doses showed an efficacy of 62%.

Astra-Oxford Vaccine Study Leaves Key Questions Unanswered

While trial results published in The Lancet found the vaccine is safe and effective, more analysis will be needed to see how well it works in people over 55, among those at higher risk from the pandemic. A U.S. trial that aims to evaluate the shot in 40,000 people is ongoing and should clarify some of these questions, with results expected early in 2021.

Local Doses

Human trials conducted by Serum in India have also been dogged by allegations from a volunteer who claimed serious side effects from the vaccine and is seeking compensation. Pune-based Serum has denied the claims and said the volunteer’s illness had nothing to do with the shot.

Serum has said half of any vaccine it produces will stay in India, with 100 million doses manufactured in December for the local inoculation drive, Chief Executive Officer Adar Poonawalla in an interview in November.

The Astra vaccine accounts for more than 40% of supplies going to low- and middle-income countries, based on agreements tracked by London-based research firm Airfinity Ltd.

(Updates with Drug Controller approval in second and third paragraph)

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©2021 Bloomberg L.P.

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