The Central Drugs Standard Control Organisation (CDSCO) has sought more data from Serum Institute of India (SII) and Bharat Biotech in order to clear their COVID-19 vaccine candidates for emergency use in the country, sources said on December 9.
Applications seeking emergency use authorisation for Oxford-
"Both proposals were not considered due to inadequate safety and efficiency data available currently. Both the companies have been asked for more data," the sources said.
"Both Bharat Biotech and SII will need to come back again to the SEC with more data, trial information, and documents," the sources added.
Bharat Biotech declined to comment, while SII hasn't responded to messages from Moneycontrol seeking comment on the drug regulator's decision.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The CDSCO expert panel took the decision in its meeting held on December 9 to review the applications of Pfizer, SII, and Bharat Biotech.
"It is standard practice for the government to hold several meetings. The process is expected to go on for one or two weeks," NDTV quoted sources in SII as saying.
Pune-based SII and Hyderabad-based Bharat Biotech had applied for emergency use authorisation (EUA) of their respective vaccine candidates on December 6 and 7, respectively.
The Indian arm of the US pharmaceutical giant Pfizer on December 4 sought approval for its vaccine from the drug regulator after the firm secured clearance in the UK and Bahrain.The UK became the first country in the world to began immunizing its citizens against the viral disease when it rolled out Pfizer's vaccine on December 8.