A lot has changed since the last blog post. Pfizer, Moderna and AstraZeneca have declared preliminary results for their ongoing Phase III trials while the UK has rushed to grant approval to the Pfizer vaccine and aims to begin vaccinations by next week.
The Union Health Minister was quick to point out that India will not need the Pfizer vaccine and will concentrate on indigenously developed vaccines. This approach was backed further by the Prime Minister’s visit to vaccine manufacturing centres last week.
Three major changes have happened since.
- Sputnik V trials begin
After rejecting the proposal for only Phase III trials, the DCGI has now allowed Dr Reddy Laboratories to begin Phase II trials of the Sputnik V vaccine. Developed by the Gamaleya Research Institute of Epidemiology and Microbiology, the Sputnik V first made news when approved by Russia without a Phase III trial.
The vaccine is quite similar to the one that Oxford University has developed along with AstraZeneca. Except that for the two doses, it uses two different viral vectors and claims better efficacy than the AstraZeneca variant.
Hetero Biopharma has signed an agreement with Sputnik for production of this vaccine and has the capacity to produce ten crore doses a year. So far, we know that Dr Reddy’s arrangement with Sputnik is only for distribution of the vaccine and not production.
So, considering this, our previous graph for production capacity changes to this.
To determine how this marginally increased capacity changes the timeline for vaccination, we divide the total requirement of 240 crore doses by the current production capacity of 18.43 crore doses a month which gives us a period of 13 months.
This would mean that vaccinations can be completed only by
Which is still a very long time to go. We need to do more to complete vaccinations by December 2021.
Luckily, help seems to be on the way.
- Biological E and Gennova Pharmaceuticals
While the focus of COVID-19 vaccine has largely been Serum Institute of India, recent discussions have featured other vaccine manufacturers as well.
Hyderabad based Biological E has begun its Phase I/II trial of a vaccine candidate developed in association with Baylor College of Medicine and DynaVax. Currently, Biological E has a capacity to 83 lakh doses a month and has worked on further expanding its capacity.
The other vaccine manufacturer that made the news recently was Pune based, Gennova Biopharmaceuticals. The company’s candidate is also a mRNA based vaccine which it claims will be stable between 2-8 degrees Celsius. Seed funding for this vaccine development was provided by the Department of Biotechnology in July. Human clinical trials are expected to begin before the end of the year and complete before March 2021.
mRNA vaccine candidates are preferable because large dose quantities can be made in very short times.
- One Billion doses from Novavax
A recent update from Duke Univeristy’s Global Health Innovation Centre shows that India leads the global vaccine procurement table.
Bulk of the doses will be sourced from Novavax, whose vaccine candidate is registered for a Phase III trial in the UK but not in India. Novavax has signed an agreement with the Serum Institute of India to manufacture two billion doses by mid-2021. The doses will be sourced from Serum directly, says the update.
The question is, why is this not made public?