Astrazeneca’s Covid Vaccine: India’s Serum Institute seeks urgent approval

Serum Institute of India, the world's largest producer of vaccines by volume and India's main hope of large-scale supplies, said yesterday it had lodged the first formal application for emergency use approval for AstraZeneca Plc's Covid-19 vaccine.

The UK pharmaceutical giant is chasing rivals Pfizer Inc and Moderna Inc with a vaccine that has less stringent storage requirements and is expected to be easier to distribute and faster to scale up in production than others.

But it is also facing queries from scientists over its trial data, which showed a 1.5 dose regimen delivered more than 90% efficacy and a full two-dose regimen just 62%, both administered over two stages.

Astra said two weeks ago that it could launch an additional trial to evaluate the lower dose regimen, but Serum Institute has said it would continue to test only the two full doses as it would delay trials.

Serum Institute, seeking to deliver supplies for a domestic coronavirus outbreak that is the world's second biggest, has said an emergency use approval could preface a full rollout by February or March.

Serum Institute CEO Adar Poonawalla tweeted that the move to apply for emergency use "will save countless lives," but did not give any other details.

The company declined to reply to Reuters' follow-up questions about the process.

AstraZeneca's vaccine, called "Covishield" by Serum Institute, can be stored at two to eight degrees Celsius and distributed more easily in India, which lacks cold chain capabilities that the vaccine developed by Pfizer requires.

Poonawalla has said the company will first focus on supplying the vaccine in India before distributing it to other countries, pricing it at 1,000 rupees per dose ($13.50) for private markets.

Governments signing large supply deals will likely buy it at lower prices. In Europe, AstraZeneca has pledged to supply 300 million doses of the vaccine for 750 million euros, pointing to a per-dose price of 2.50 euros.

Meanwhile, Britain yesterday prepared to start its biggest ever immunisation campaign but health officials warned the drive to inoculate millions against Covid-19 would be a "marathon" stretching well into next year.

The world-first rollout of the Pfizer-BioNTech vaccine is due to start today -- dubbed "V-Day" by Health Secretary Matt Hancock, who has volunteered to take it live on television to assuage any public doubts over the rapid approval.

Croydon University Hospital in south London is one of 50 clinical hubs that started receiving the country's initial consignment of 800,000 doses over the weekend, from a Pfizer plant in Belgium.

The vaccine rollout coincides with the end-game of Brexit talks on Britain's future trading relationship with the European Union, reports AFP.

In China, Sinovac Biotech has secured $515 million in funding from a local firm to double production capacity of its coronavirus vaccine, the companies said yesterday, as it expects efficacy data of its experimental shot this month.

The investment deal also comes as Sinovac expands supply deals and trials of its experimental Covid-19 vaccine CoronaVac with more countries following positive results from early to mid-stage clinical trials.

China's Sino Biopharmaceutical Limited said yesterday a business unit will invest $515 million in Sinovac Life Sciences, a subsidiary of Sinovac, to help development and production of CoronaVac.

The investment will give Sino Biopharmaceutical a 15.03% interest in Sinovac Life Sciences, Sino Biopharmaceutical said in a filing to the Hong Kong Stock Exchange.

Sinovac said in a separate statement that it would be able to manufacture 300 million vaccine doses annually and aims to complete construction of a second production facility by the end of 2020 to increase annual Covid-19 vaccine production capacity to 600 million doses.

Depending on market conditions and the availability of financing, it may seek to further expand its production capacity, Sinovac said.

Sinovac has secured CoronaVac supply deals with several countries including Indonesia, Turkey, Brazil and Chile, and is holding talks with the Philippines for a potential sale.

CoronaVac is also one of three experimental Covid-19 vaccines China has been using to inoculate around 1 million people under an emergency use programme.