Status check on COVID-19 vaccines in pipeline for India over next six months

In the initial phase, India will inoculate about one crore healthcare workers, to be followed by two crore front-line workers, police, armed forces, municipal workers, revenue staff and others. In the third phase, 27 crore people above 50 years of age and those with co-morbidities like diabetes, hypertension, and organ transplant patients will get the vaccine.

Clearly the Indian government is looking at more options in terms of COVID-19 vaccines, which means more volumes and better pricing. India is also eligible to get free COVID-19 vaccines to vaccinate 20 percent of the population from COVAX - a global initiative led by the World Health Organisation (WHO), Gavi and the Coalition for Epidemic Preparedness Innovations (CEPI) to ensure speedy development, production and equitable access of COVID vaccines to low- and middle-income countries.

Here is a list of COVID-19 vaccines that are available and likely to be available in the first half of 2021.

Pfizer-BioNtech Pfizer and BioNTech is the most widely used COVID-19 vaccine. The vaccine based on genetic material or mRNA has been approved for emergency use in more than 45 countries including the US and the UK. With efficacy of 95 percent, the vaccine is sought after despite requiring cold storage temperature of minus 70 degrees Centigrade. Pfizer-BioNTech are ramping up capacities. They have committed to supply more than one billion doses for 2021.

India availability: Pfizer has sought more time to present data before the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO). It is still not known when this vaccine will be available in India. The two possible sticky points for the availability of the vaccine in India are cold storage requirement and price. The vaccine is priced at $19.5 per dose. There is a possibility of the Pfizer vaccine being available through COVAX.

Moderna
Moderna COVID-19 vaccine like Pfizer-BioNTech is based on genetic material or mRNA and has been approved for emergency use in the US, EU, UK, Canada and Israel. With efficacy of 94 percent, and cold storage requirement of between -25°C and -15°C, the vaccine is being sought by many countries. The US-based firm aims to produce 600 million to up to 1 billion doses in 2021.

India availability: It is still not known when this vaccine will be available in India. Officially, Moderna hasn't made any request for emergency use in the country. The major sticky point for the availability of the vaccine in India through public procurement is the price. The vaccine is priced at $32-$37 per dose, according to the government. There is a possibility of the Moderna vaccine availability through COVAX, if the global collaboration enters into procurement of Moderna vaccine.

Sputnik V
The COVID-19 vaccine, developed by Moscow’s Gamaleya Institute, Russian Defence Ministry and the sovereign Russian Direct Investment Fund, became the first vaccine to be cleared for public use. The vaccine is based on a modified human adenovirus as a vector. The vaccine’s efficacy is said to be about 91.4 percent based on data analysis of the final control point of clinical trials in Russia. Currently, the vaccine’s clinical trials are underway in the UAE, Egypt, Venezuela and Belarus, while it has been registered in Algeria, Argentina, Belarus, Bolivia and Serbia for inoculation. So far over 1 million Russians and 3,00,000 Argentinians have got the vaccine.

India availability: In India, Dr Reddy's is doing a bridge trial for the vaccine. Dr Reddy's expects the data to be ready by March. The vaccine has to be given in two doses. The vaccine's storage temperature requirement is 2-8 degrees Celsius. The vaccine will also be available in freeze-dried formulation making it much more stable to use in mass vaccination. Dr Reddy's and Hetero will produce up to 200 million doses of the vaccine. The vaccine will be priced less than $10 per dose.

Chinese vaccines
Three vaccines from Chinese companies Sinopharm, Sinovac and CanSinoBio are now available in several countries. There are now firm orders for these vaccines from 18 countries: Indonesia, Brazil, Chile, Turkey, the Philippines, Malaysia, Thailand, Ukraine, Senegal, Hungary, Peru, Serbia, Pakistan, Saudi Arabia, Morocco, Argentina, Egypt, and the UAE.

While the Sinopharm and Sinovac are inactivated vaccines similar to Bharat Biotech's Covaxin, CanSinoBio vaccine is based on human adenovirus vector. Chinese companies have created huge capacities, and are aggressively pushing their vaccines.

India availability: There is no clarity when these vaccines will be available in India. Chinese vaccine manufacturers have applied for COVAX, so there is a possibility of these vaccines being made available through that mechanism.

Johnson & Johnson
Johnson & Johnson's COVID-19 vaccine Phase-3 efficacy data is expected to be announced before the end of January 2021. The vaccine is based on a modified human adenovirus as a vector. Depending on the outcome of Phase-3 readout, the company plans to apply for emergency use in the US and other countries.

Unlike other COVID-19 vaccines, which require two doses, the J&J vaccine is a single-shot vaccine, adding a lot of convenience for people taking the shot and government bodies struggling to scale-up the mass rollout. It also greatly simplifies logistics and scalability. The vaccine's storage temperature requirement is 2-8 degrees Celsius.

India availability: It's too early, but J&J vaccine may be available in India in the first half of 2021. Indian vaccine maker Biological E has entered into an agreement with J&J to manufacture the drug substance and finished product of the vaccine. J&J had earlier said the partnership with Biological E, allows for production of 400-500 million doses per year.

The government, in its recent presentation, said the J&J vaccine is expected to be around $10 per dose. There is a possibility of the vaccine being made available through COVAX.

Novavax
The US-based biotech Novavax is developing a protein sub-unit vaccine that uses part of the virus and combines with adjuvant, or booster. Novavax vaccine is in Phase-3 trial. The company announced that it has completed its 15,000-participant enrolment target in the UK. The interim data from the trial is expected anytime.

On December 28, Novavax initiated a second Phase III trial with sites in the US and Mexico, and plans to recruit up to 30,000 volunteers. The vaccine's storage temperature requirement is 2-8 degrees Celsius.

India availability: The vaccine would be manufactured and distributed by its partner SII, with which Novavax has an agreement to produce around 2 billion doses a year. SII said it plans to begin a bridge trial in India in February 2021. The vaccine has to be given in two doses. The government, in its recent presentation, said the Novavax vaccine is expected to cost around $16 per dose.

Zydus Cadila Zydus Cadila has taken a novel approach to its potential COVID-19 vaccine. Called plasmid DNA, the vaccine consists of genetic material of SARS-CoV-2 proteins that instruct human cells to make SARS-CoV2 antigen, eliciting an immune response. The company has initiated a Phase-3 trial in which it plans to recruit around 30,000 volunteers. ZyCoV-D vaccine can be stored at 2-8 degrees temperature.

India availability: The company expects to have final data by March-April 2021. The launch of the vaccine is expected in the first half of 2021. The pricing is not known at the moment.

Other COVID-19 vaccines
There are other COVID-19 vaccines in clinical trials in India that may be available towards the end of 2021. These include SII-SpyBiotech vaccine, Biological E-Baylor College of Medicine-Dynavax vaccine, Genova Pharmaceutical's mRNA vaccine and Bharat Biotech intranasal vaccine.