NEED FOR EARLY DECISIONS FOR APPROVAL OF FOREIGN VACCINES
NEED FOR EARLY DECISIONS FOR APPROVAL OF FOREIGN VACCINES
Nikunja Bihari Sahu
In view of augmenting the shortfall
of Coronavirus vaccines in the country at a time when the second wave of the pandemic
sweeping the world , the government is considering emergency approvals to some known
foreign vaccines for entry into Indian market . Accordingly, vaccines cleared for use in the US, the UK, the EU and Japan
or under WHO’s emergency use listing will get fast-track approval in India potentially
boosting the country’s pandemic response and to fulfill its commitment of ‘Vaccine
for All’ programme. If everything goes well, three vaccine companies such as
Pfizer, Moderna , Johnson & Johnson may enter into Indian market very soon for emergency use.
As per the recent recommendation of the National Expert Group on Vaccine
Administration for Covid-19 (NEGVAC), the vaccines approved by the reputed
Regulatory authorities of the world may be included in the country's
vaccination programme skipping the local clinical trial phases and only
adhering to the Bridging clinical trials as per the provisions of the Second
Schedule of the New Drugs and Clinical Trial Rules- 2019. As a pre-condition, the first 100 beneficiaries of such foreign vaccines shall be
assessed for seven days of observation for safety outcomes before further
immunisation takes place within the country.
Though India was the fastest in
the world to vaccine 100 million people, concerns have been mounting whether
there are adequate supplies in the country to meet the requirements of its vast
population. While the daily production of the two Indian
vaccines is around 25 lakh doses, the daily demand for vaccines in the country
is around 32 lakhs. An estimated 85 crore doses of the Russian vaccine is
expected to roll out per year once the production starts and the vaccine has
been found to be 91.6% effective against symptomatic COVID-19 patients. Hence,
the approval to the Russian vaccine is going to be a game changer in the Indian
scenario and expected to bridge the gap of vaccine production and demand in the
country in days to come.
However, the government has been late enough to decide giving approvals to the entry of foreign vaccines in India and that to at a time when the country is facing acute shortage of vaccines and many of the inoculation centres in rural India are facing the risk of closure due to non supply of doses. As per instance, the American Pfizer company had approached India for approval since last December and even the Company was ready to supply the Cold Box to store the vaccine at -70 degrees C. But the Indian government denied approval at that time on the ground of the non-feasibility of this low temperature conditions in Indian conditions to keep its cold chain going. Now, the question is whether a monitoring of only 7 days in the post vaccination period to a limited number of people is sufficient to judge the safety of these vaccines in a surging pandemic situation. Similarly, the decision in favour of the Russian vaccine also appears to be sluggish although 59 countries around the world had already accorded emergency approvals since its introduction in last August in view of its high efficacy rate of around 92% (in contrast to Covaxine 82% and Covieshield 80%) and for the fact that its storage is quite easy at 2 to 8 degrees C making very much suitable for Indian supply chain conditions. An early decision in this regard by the government might have prevented the worsening situation prevailing today.
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