Serum Institute is optimistic that its pneumococcal vaccine will be available in India by June 2020. The vaccine is yet to be approved by the DCGI. But phase-3 trial data from Gambia has already been submitted to DCGI and the agency has looked into the data. The Indian phase-3 trial data has now been submitted.
The pneumococcal vaccine developed by the Pune-based Serum Institute of India is expected to become available in the private market by June this year. The vaccine has already been pre-qualified by the World Health Organisation (WHO) in December 2019.
Serum Institute had already submitted to the Drugs Controller General of India (DCGI) the data of a phase-3 trial carried out on 2,250 infants in Gambia. It has recently submitted the data of a smaller phase-3 trial carried out at multiple sites in India. Serum expects the approval from DCGI to come soon.
Serum has already patented the vaccine in India and other countries. In 2018, India granted patent to Pfizer’s Prevenar13, a pneumococcal conjugate vaccine.
While GSK’s vaccine, which contains 10 serotypes, is available for Rs.1,600 per dose in the private market, Pfizer’s vaccine, which has 13 serotypes, is priced at Rs.3,600 per dose. Each child has to be given four doses (6, 10 and 14 weeks and a booster dose at nine months) of the vaccine for full protection. The entry of Serum’s vaccine is likely to change the market dynamics.
Substantially lower price
“The price of our vaccine in the private market will be substantially lower than the existing vaccines in India,” says Dr. Rajeev Dhere, Executive Director of Serum Institute. He had earlier said that it will make the vaccine available to low- and middle-income countries for just $2 a dose, which is 30% cheaper than the GAVI price. Countries that get the vaccine through GAVI shell out nearly $3 per dose, while GAVI puts in an equal amount. Hence, the $2 per dose will be far cheaper for countries that do not get the vaccines through GAVI.
Despite the lower price, it might take some time for Serum’s pneumococcal vaccine to out sell its competitors in the private market. But Serum sees combined uptake of its vaccine in the private and public market to reach appreciable levels soon. “We expect to sell 100 million doses each year within the next three years. Of this, 40-50 million doses per year will be in India alone. The private market for the vaccine will be minuscule compared with the public market,” says Dr. Dhere.
But there are a few hurdles to cross before Serum can ever think of selling 40-50 million doses per year in India in the public market. The first hurdle will be the approval from the DCGI. But given that the phase-3 trial data from Gambia has already been submitted and the DCGI has already looked into the data, and Indian trial data of phase-3 has just been submitted, approval from DCGI might not take long. That probably is the reason why Serum if hopeful of making the vaccine available in the private Indian market by June 2020.
But it must be borne in mind that certain drugs manufactured in India were exported but patients in India did not have access to them as the drugs were not approved by the DCGI.
Inclusion in India’s immunisation programme
Since 2017, Pfizer’s 13-valent pneumococcal conjugate vaccine has been used in India’s Universal Immunisation Programme (UIP). The vaccine is being introduced in a phased manner; it has been introduced in Himachal Pradesh, and parts of Bihar, Uttar Pradesh, Madhya Pradesh and Rajasthan.
Serum’s vaccine has only 10 serotypes, with two serotypes found in the 13-valent vaccine included in the vaccine.
A vaccine can be used in the national immunisation programme only after the National Immunisation Technical Advisory Group (NITAG) approves it. “The WHO pre-qualification is the first welcome step but it’s a long way off before UIP adopts it and tender specifications allow for procurement of PCV 10 instead of PCV13,” says Leena Menghaney, South Asia Head of Médecins Sans Frontières’s Access Campaign, Delhi says in an email. “From the immunisation programme perspective there is a time lag between pre-qualification [by WHO] and a price being announced, the vaccine being registered, NITAG’s approving their substitution and tender specifications being worked out in a manner that cover two different PCV vaccines.”
GAVI support to end in 2020
The pneumococcal vaccine provided through India’s national immunisation progamme has been supported by GAVI. However, India will stop receiving support from GAVI this year. The only way for India to continue providing pneumococcal vaccine in the immunisation programme and to roll it out in other States is by using an inexpensive vaccine.
The low-cost vaccine from Serum has come at the most appropriate time for millions of children in India. Pneumonia is one of the leading causes of deaths in children under five years. In 2018, 1,27,000 deaths due to pneumonia were reported from India, the second highest in the world.