UK’s approval to Oxford shot clears India’s vaccine path

LONDON/NEW DELHI: Britain became the first country in the world to approve AstraZeneca and Oxford University’s lowcost Covid vaccine, raising hope that the Indian drug regulator – which held a meeting on Wednesday – eventually approving the shot for emergency use in the country as well.

The independent Medicines and Healthcare products and Regulatory Agency (MHRA) said the vaccine “met its strict standards of safety, quality and effectiveness”, and a roll-out was set for January 4 in the UK.

UK Prime Minister Boris Johnson, who spent several days in intensive care with Covid earlier this year, called it “truly fantastic news” and “a triumph for British science”.

Britain has already approved the Pfizer/BioNTech vaccine for general use, and some 800,000 people have received a first dose in the country’s biggest ever vaccination drive.

But as daily Covid infection rates hit record highs, the British government is pinning its hopes on the Oxford/AstraZeneca jab, which is cheaper to produce, and easier to store and transport.

Unlike the Pfizer-BioNTech vaccine, it does not require ultra-low freezing temperatures and can use normal refrigerated supply chains, making it a more attractive proposition globally.

The partners, who have billed it as a “vaccine for the world”, have also promised to provide it not-for-profit to developing nations, and hope to make up to three billion doses in 2021.

Indian officials in a huddle

India too is likely to rely on the same.

Experts at India’s drug regulator met on Wednesday to consider approving an AstraZeneca/Oxford coronavirus vaccine for emergency use after Britain’s annoncement, two sources with knowledge of the matter said.

A representative of the Central Drugs Standard Control Organization (CDSCO) declined to reveal the agenda of the meeting but said its minutes would be uploaded on its website within hours.

Sources had earlier told news agency Reuters that the CDSCO was likely to approve the vaccine this week after its local manufacturer, Serum Institute of India (SII), submitted additional trial data.

SII, the world’s biggest producer of vaccines, has already

stockpiled about 50 million doses, enough for 25 million people.

SII welcomed the UK approval. “This is great and encouraging news,” chief executive Adar Poonawalla said in a statement. “We will wait for the final approval from Indian regulators.”

India wants to start administering the shots starting next month and is also considering emergency use authorisation applications for vaccines made by Pfizer Inc with Germany’s BioNTech and by India’s Bharat Biotech.

India, which has the world’s second highest number of Covid-19 infections in the world after the United States, plans to inoculate 300 million people in the next six to eight months and the affordable Oxford vaccine is its biggest hope.

Though the Indian government has not yet signed a purchase agreement with SII, the company says it will focus on its home market first, and then exports, mainly to South Asian countries and Africa.

Protection

The Oxford/AstraZeneca vaccine is based on a weakened version of a common cold virus (adenovirus) in chimpanzees which has been genetically changed to stop Covid-19 replicating in humans.

It delivers genetic cargo into cells, giving them instructions how to fight Sars-CoV-2, the virus that causes Covid-19.

The vaccine will be priced at $4-5 per vial -- a fraction of the price of the Moderna and Pfizer/BioNTech drugs.

On Sunday, AstraZeneca chief executive Pascal Soriot said the vaccine would provide “100% protection” against severe Covid disease requiring hospitalisation.

He predicted trials would show his firm had achieved a vaccine efficacy equal to Pfizer/ BioNTech at 95% and Moderna at 94.5%.

While the approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) is a vindication for a shot seen as essential for mass immunisations in the developing world as well as in Britain, it does not eliminate questions about trial data that make it unlikely to be approved so rapidly in the European Union or the United States.

Uncertainty has swirled over the most effective dosing pattern for the vaccine since it released data last month showing a 90% success rate for a half-dose followed by a full dose, but only 62% -- still usually more than enough for regulators -- for two full doses.

The MHRA said that the results for the half-dose regimen had not been borne out by analysis. Instead, it approved the regimen of two full doses.

An official involved in the MHRA decision, said that the vaccine’s effectiveness had risen when the doses were given three months apart.

“Effectiveness was high, up to 80%, when there was a threemonth interval between first and second doses, which is the reason for our recommendation,” Munir Pirmohamed, chair of the Commission on Human medicines expert Working Group on Covid-19 vaccines, told reporters on Wednesday.