How will the Oxford vaccine be produced in India?

Two of the leading coronavirus vaccine contenders in India have been granted approval for restricted use. Oxford-AstraZeneca's coronavirus vaccine Covishield, manufactured by Serum Institute of India and Bharat Biotech's COVID vaccine Covaxin have been approved for emergency use authorisation. Here's a glimpse of the Covishield factory:

How is the vaccine prepared and packaged?

SII CEO Adar Poonawalla took India Today TV inside the factory to show the packaging process, which is fully automated. The empty vials are first washed under a high-pressure water jet and sterilised in a high-temperature tunnel to make sure that the vaccine is not introduced to any contaminants.
After washing and sterilisation, the vials are filled with the vaccine. Then another machine puts on the rubbers seal and another seals the vials with aluminium caps.

What is Covishield vaccine's dosage?

Adar Poonawalla said that every person would need to get two doses of vaccine for effective results. He said that the results of various trials indicate that two to three months of gap between the two doses yields the best results. Poonawalla said that the institute has already prepared nearly 50 million doses of the vaccine which at a rate of two doses per person are enough to vaccinate 25 million people in India or abroad.

What is the distribution plan for Covidshield?

Speaking to Rahul Kanwal, Adar Poonawalla explained that initially, the institute has applied for an emergency use license, which only allows them to provide the vaccine vials to the government for distribution among essential workers and at-risk individuals who need to be immunised in the first phase. However, once phase 1 ends and they get a normal distribution license, the vaccine will also enter the private sector.

 

How is Covishield vaccine stored?

The Covishield vials need to be stored at temperatures between 2 degree Celsius to 8 degree Celsius. The institute has a large storage facility that is currently holding the manufactured vials worth Rs 2,000 crore, he said. The storage facility is heavily guarded to avoid any untoward incident and bar entry of unauthorised personnel.

What is the price of Covishield vaccine?

Adar Poonawalla said that the Serum Institute has set two separate rates of the vaccine - one for the Government of India and one for the private sector. "For the Government of India, it will be about USD 3 per dose, so USD 6 [Rs 440] per person but for the private market it will cost around Rs 700-800."

Are vaccines safe?

Serum Institute CEO Adar Poonwalla said that all vaccines are bound to have some side-effects which manifest in a small percentage of people who get the vaccine. "It is nothing to worry about," he said. "Whether it is a chaperone virus, killed virus or live attenuated virus - different technologies that different vaccine developers are using - there are bound to be some side-effects. It should not alarm us. A very small percentage of those who are vaccinated experience these side effects, which may include a slight fever, sore throat or maybe a slight headache that may last for two days. These side-effects will also go away with paracetamol," Adar Poonwalla said.

How do we know Covidsheiled is safe and effective?

Adar Poonawalla said that no severe side-effects have been noticed among thousands of people across the globe who participated in trials for Covishield. In terms of its effectiveness, Poonwalla said that there has been zero hospitalisation among people who were administered the Covishield vaccine, "which means it's working well."

Poonawalla explained that Covid-19 vaccine immunisation does not guarantee that a person will not get the disease; rather it ensures that the symptoms will not be severe enough to require hospitalisation. Adar Poonawalla further assured that the safety standards being followed by Serum Institute were at par with foreign vaccine makers like Moderna and Pfizer.

Is Covishield effective against the mutated virus?

The SII CEO said that mutations in the Covid-19 virus registered so far have all been minor which means that the developed vaccine is effective against them. "We have had a group of experts look at the available data on mutated strains and they have said that the vaccine is effective against them. However, we would wait for the final result to come in next week," he said.

Challenges faced during developing Covishield

Poonawalla revealed that the company took a massive risk by halting production and work on all other vaccines to speed up Covisheild.

"The first challenge we faced after we signed tech transfer agreements with our partners was to do this in a short span of time. To be able to scale up a process is very challenging, you need to have multiple runs, you need to show consistency, so the challenge was to do it at a speed never been done before. We had to stop production of other vaccines so that we can use those plants to do this high-scale level research and development which normally we would have done on a small scale," he said.

"And the huge risk we had to take in rejigging these facilities without even knowing if the Covid-19 vaccine would work. Traditionally, with other vaccines, you wait till phase 3 is over and then you invest in making the product but here we had to bet hundreds of millions of dollars early on so that we could be ready for dispatch even before the license has been issued," Poonawalla said