Russian Direct Investment Fund (RDIF), a sovereign wealth fund in Russia has allied Dr Reddy’s Laboratories (DRL), the Hyderabad-based drug manufacturer to cooperate on clinical trials and distribution of Sputnik V vaccine in India. This arrangement claims to deliver the vaccine for general use probably beginning late 2020.
After obtaining regulatory approvals from
DCGI (Drug Controller General of India) for conducting trials in India, DRL
will receive 100 million doses of the Covid19 vaccine — developed by the
Gemaleya National Center of Epidemiology and Microbiology (Moscow, Russia). The
results of the early phases (Phase 1 and 2) of trials with the vaccine were
recently published in Lancet in September 2020, while both India and Russia
were laying the groundwork to pursue further trials and production of the
vaccine in India. The Indian Council of Medical Research (ICMR) expresses that
Russia has a good track record in development of vaccines.
Sputnik V is based on proven vaccine
against adenovirus – the common cold. The vaccine is expected to provide
immunity from SARS-CoV-2 (agent responsible for Covid19), for up to two years,
according to the Russian health ministry. Findings of phase I/II trial of this
vaccine, involving 76 healthy volunteers (aged 18-60 years), which used
recombinant adenovirus type 26 and type 5 vector (rAd26-S and rAd5-S), suggests
that 85% of participants had detectable antibodies at 14 days after first dose,
leaping up to 100% by day 21, after the boosting dose. The findings are
published in The Lancet, a renowned peer-reviewed journal in the field of
medicine.
Competitors in the field
Meanwhile, AstraZeneca or Oxford
vaccine (AZD1222) is also in Phase-3 trials which has partnered India’s Serum
Institute to produce it and has secured its position among the leaders in race
for public use, even after recent unfortunate pause in its trials due to
alleged side effects. DCGI has now revoked its earlier suspension on Oxford
Covid-19 vaccine, allowing to continue phase two and three trial and put
certain conditions like extra care during screening, close monitoring for
adverse events during follow-up.
There are two other Indian vaccines
that are being developed and are in Phase I and II stage trials and have shown
no significant side-effects yet.
Zydus Cadila is working on ZyCoV-D,
has completed phase I and II clinical trials. ZyCoV-D utilises technology based
on Plasmid DNA translating into viral protein. Bharat Biotech Limited has
developed COVAXIN, in collaboration with the Indian Council of Medical Research
(ICMR) – National Institute of Virology (NIV). COVAXIN is an inactivated
vaccine with alum as adjuvant.
Globally around 321 vaccine candidates
are in development as either confirmed
projects in clinical trials or in early-stage "exploratory" or
"preclinical" development, as of September 2020. Out of these
only seven vaccines are in phase III clinical trial. The WHO also implemented
an access to COVID‑19 Tools Accelerator for coordinating global vaccine development, a program
called "COVAX" in collaboration with Global Alliance for
Vaccines and Immunisation (GAVI) and the Coalition for Epidemic
Preparedness Innovations (CEPI). COVAX
has the goal to accelerate the development and manufacturing of COVID-19
vaccines, and to assure that access to licensed vaccines is equitably provided
to all countries.
Its very comforting to see that multinational companies are doing their
utmost to find the answer to this pandemic, but it will be crucial to maintain
patient safety. The last thing we need after a pandemic is a global havoc due
to adverse events arising from the very cure we are trying to find.
It's great that the united effort from all stake holders has expedited the entire process of vaccine development not seen previously in the history of human civilization. Hope the vaccine has strong and sustained immune response against the virus with the minimum side effects.
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