Express News Service
NEW DELHI: The Covid-19 vaccine developed by Pfizer-BioNtech is set to become the first jab against the disease globally to move from emergency-use authorisation to full-approval stage after it submitted more data to US drug regulator from the late-stage clinical trials and ongoing vaccinations.
This mRNA-based vaccine was the first against Covid-19 to receive restricted use authorisation in the UK followed by the US in December last year. In India, the pharma giant’s negotiations with the government to launch the vaccine are still stuck over the issue of indemnity.
Full approval to the vaccine will mean the vaccine-maker can advertise directly to people and ensure its availability even after the pandemic ends. But most importantly, it is likely to help persuade those who are hesitant about getting vaccinated until the US Food and Drug Administrator fully gives approval to the shot.
Also, this approval could pave the way for new vaccine requirements by public and private organisations which may make it mandatory for employees or service receivers to be vaccinated. So far, almost in all countries, shots against the coronavirus are largely voluntary—a primary reason why a large population is still unvaccinated.
Once it obtains the full licensure, Pfizer-BioNTech is also planning to apply to the USFDA for the approval of a third dose as booster shot. The US government last week had announced that fully vaccinated adults should prepare to get booster shots eight months after they received their second doses, beginning September 20.
This came after new evidence emerged suggesting that the protection offered by the mRNA vaccine may wane after a few months. Back home, sources in the Central Drug Standard Control Organisation said that as of now the vaccines being used in India’s inoculation drive are nowhere near the full approval.
“For complete licensure, vaccine makers need to submit far more details, particularly on safety aspects and emerging issues such as side effects post vaccinations,” said a CDSCO official. “However, we do not really see that happening in near future as for vaccine makers the priority now is to focus on scaling up the supplies to meet the need of vaccinations.”
