On Tuesday, the Ministry of Health gave an official explanation on the Drugs Controller General of India not approving the emergency use of the Pfizer vaccine till now. On December 4, 2020, Pfizer India became the first firm in India to seek emergency use authorization for its COVID-19 vaccine. In its application to the DCGI, it reportedly sought permission to import the vaccine for sale and distribution besides a waiver of clinical trials on the Indian population.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan stated that Pfizer had failed to appear before the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation despite being invited thrice. As per reports, the company had requested more time to submit additional data. At the same time, Bhushan clarified that the SEC was willing to give a fair hearing to Pfizer.
The Pfizer vaccine uses a new technology that packs messenger RNA inside tiny fat droplets to instruct cells to make the spike protein. Having shown 95% efficacy in its final trials, it has already been approved by the US, the UK, the European Union and Bahrain. However, questions have been raised about this vaccine's viability in countries such as India as it needs to be stored at -70°C.
Union Health Secretary Rajesh Bhushan remarked, "Pfizer so far has been given three opportunities after their application by the Subject Expert Committee of the CDSCO. But they have not appeared before the Subject Expert Committee. And the Subject Expert Committee, to the best of our knowledge, willing to listen to their presentation."
In a big breakthrough in India's fight against COVID-19, the DCGI accepted the recommendations of the Subject Expert Committee of the CDSCO, paving way for the approval of COVISHIELD and COVAXIN. Manufactured by the Serum Institute of India with technology transfer from Oxford University-AstraZeneca, COVISHIELD is a Recombinant Chimpanzee Adenovirus vector vaccine with its overall efficacy at 70.42%. 50 million doses of this vaccine are ready.
On the other hand, COVAXIN is a Whole Virion Inactivated Corona Virus Vaccine developed by Bharat Biotech in collaboration with ICMR and NIV. As part of its phase 3 trials, 22,500 participants have been vaccinated across the country so far. However, it has been approved in "public interest" in the clinical trial mode so that there can be more options for vaccination in case of infection by mutant strains. Both the vaccines have to be stored between 2-8 degrees celsius.