Current Affairs

Issue

US drug maker Moderna has said it is applying for emergency use authorization for its Covid-19 vaccine.

 

Background

Serum Institute of India was also planning to apply for emergency authorization for its AstraZeneca Oxford vaccine.

 

Details

• Vaccines medicines and even diagnostic tests require approval from a regulatory authority before they can be administered. In India Central Drug Standard Control Organisation (CDSCO) is the main authority.

• For vaccines and medicines, approval is granted after an assessment of their safety and effectiveness, based on data from trials.

• In emergency situations, regulatory authorities along the world have developed mechanism to grant permission to use if there is sufficient evidence to suggest the medicinal product is safe and effective.

• In US, the FDA grants permission for emergency use authorisation only if the potential benefits outweigh the risks from the medicine.

• For that, the vaccine must show effectiveness for more than 50% during its final phase of trail to be eligible for emergency use.

• In India drug regulations do not have provisions for emergency use authorisation and the process of receiving one is not clearly defined.

• Any company planning to launch a vaccine tested elsewhere has to conduct trials on local Indian population to show its effectiveness.

• Even after approval of vaccine, citizens cannot be forced to take the vaccine. They must be told the possible drawback before administering the vaccine.