MFDA approves COVISHIELD; vaccine meets WHO standards

Maldives Food and Drug Authority (MFDA) on Thursday approved the COVISHIELD vaccine manufactured by India under a special license from AstraZeneca.

Neighbouring India donated 100,000 doses of the COVISHIELD vaccine to the Maldives, which has now been received and stored under appropriate conditions. The government had previously stated that inoculations will only begin after the vaccine is approved both by MFDA and the World Health Organization (WHO).

The Health Emergency Operation Centre (HEOC) said the vaccine was approved for emergency use by MFDA as the vaccine met the standards set by WHO.

Speaking at a press conference held Thursday, Spokesperson of HEOC, Dr. Fathmath Nazla Rafeeq said India has donated large doses of the locally manufactured brand of the Oxford-AstraZeneca vaccine to several countries. Inoculations of the vaccines have already started in Nepal, Bangladesh and Myanmar, said Dr. Nazla. Reports that inoculations will commence in Sri Lanka this Friday have also been received, she added.

According to the Maldives Food and Drug Authority, the approval was granted for emergency use of the COVISHIELD vaccine on January 26th. The approval was issued based on the current circumstance, and only for ‘Restricted Use in Emergency Situations’, said MFDA. MFDA further said that the approval was issued after the technical aspects of the vaccine were reviewed, and based on the recommendation of the National Pharmaceutical Board.

The Health Protection Agency (HPA) has previously stated that any vaccines used for inoculation in the Maldives will be approved by WHO. However, no such approvals have been granted for COVISHIELD by WHO thus far. When asked regarding WHO approval, Dr. Nazla said MFDA issued the approval for the COVISHIELD vaccine after careful consideration, and that the matter was discussed with WHO Regional Office’s Vaccine Safety Experts. The COVISHIELD vaccine meets all standards set by WHO, assured Dr. Nazla.

Some side-effects of the COVISHIELD vaccine include swelling, pain and itching at the injection site, fever and lethargy, headache and nausea as well as joint and muscle pain.

Speaking on possible side effects of the vaccine, Dr. Mohamed Ali from HEOC said the authorities will be prepared for any complications that may arise from receiving the vaccine. When a nation-wide vaccine program is initiated, specially trained health workers will be on site in each island, and the situation will be closely monitored, said the doctor. All vaccines have side-effects, he added.