DRA identifies major blotches in vaccination programs

Covid-19 vaccine recipients waiting in line during the second dose

DRA has found several lapses in compliance and implementation of Covid-19 vaccination program guidelines for health workers



Even as the government delivered the herculean task of achieving Covid-19 immunization in record time on the world stage, the Drug Regulatory Authority (DRA) in a report to the Ministry of Health (MoH) has underlined major hiccups in the vaccination campaigns.

The surveillance report on “regulatory cycle and oversight of Covid-19 vaccination campaigns in Bhutan” outlines the critical aspects observed at each stage of the vaccine regulatory cycle starting from the grant of the emergency use authorization (EUA) to vaccine waste management.

Finding glaring gaps, DRA expresses concern about the absence of its representative in the technical advisory groups (TAG), reluctance to seek regulatory advice, and a poor communication channel between the health ministry and DRA as a leading cause of the lapses.

With most of the committee members from the same professionals, although the committees’ mandates are intrinsically different, the report pointed out the lack of a clear coordinating mechanism among the multiple technical committees/advisory groups in the health system.

Lack of awareness of regulatory requirements by the stakeholders, explicit instructions from the committees or relevant stakeholders, and inadequate resources at the field, among others, have also caused loopholes in the vaccination programs.

According to the report, the ministry submitted incomplete documents along with the applications for EUA, import, and lot release which might delay the timely distribution of vaccines. 

Besides, it also found non-compliance to EUA conditions issued by the DRA such as vaccination of pregnant and lactating women, ineligible population, and interchangeability and reverse interchangeability of vaccines.

Despite import authorization being required before the import of the vaccine, the report noted it imported a few vaccines without import authorization from the DRA.

While a few vaccination sites encountered damaged vaccine vials which could have resulted from improper transportation, temperature monitoring devices were also not available during transportation of vaccines to the districts and at some of the vaccination sites. And a backup power generator was also not available in a few centers.

Given the negligence of the personnel involved in screening, Bhutan Vaccine System (BVS) encountered lapses such as improper screening and system errors leading to vaccination of ineligible populations.

And it also found the absence of precautions to prevent the vaccine mix-up at some vaccination sites having over one type of vaccine and reports of quality defects of the syringes from the centers leading to inaccurate dose adjustment and dose delivery.

In the absence of constant monitoring by supervisors and relevant authorities, and proper collaboration and coordination, it noticed the absence of life-saving equipment and drugs in the adverse event following immunization (AEFI) kit such as oxygen cylinder, salbutamol respirator, and dexamethasone that could lead to risks of untimely intervention in case of serious AEFIs.

This has also caused improper set up of AEFI kits for ready use posing a risk of delay in the delivery of life-saving services and inadequate safety signal detection that could compromise the safety of the vaccine.

While noting coordination issues among stakeholders, the report stated that vaccination wastes were not segregated in a few centers and not treated as infectious waste posing a risk of infections, and few centers were found to have mixed the packaging materials with the syringes in the syringe disposal plastic.


During the monitoring, several observations were recorded and analyzed for recommendations and further corrections to serve as a reference for the management of any new vaccine imported in the future. 

On this front, DRA recommended involving its representative in technical committees for vaccines, developing a clear coordination pathway among the committees assigning respective terms of references, devising structured plans for vaccine deployment in consultation with the relevant stakeholders including the regulatory bodies.

It also recommended strengthening communication on the regulatory requirements, and coordination and collaboration among relevant stakeholders to assess the quality of syringes before their distribution and for vaccine waste management.

Given the inadequate training on guidelines or protocols of health officials, it recommends training them on the vaccination practices, system, and associated guidelines, and sensitizing on the importance of AEFI kit and mandate to make it available during the vaccination and also enhancing regulatory capacity.

The recommendations also include prioritizing budget allocation for future vaccines deployment and inoculation, system strengthening of regulatory autonomy, periodic surveillance and monitoring of vaccines, reinforcing the need for cold chain equipment such as temperature monitoring devices or backup power or refrigerator in all the vaccination centers, among others.

In addition, it recommended the health ministry consider using the particular syringe – to be used during vaccination – during health workers’ training and reinforce the implementation of national guidelines for infection control and medical waste management.

And it is also recommended health workers periodically review the status of AEFI kits specifically on the list of kits and shelf life of kits while the ministry and regulatory body streamline AEFI reporting systems.

However, the report highlighted that despite the challenges, the country successfully carried out vaccinations of the majority eligible population with united efforts and cooperation from all relevant agencies and stakeholders.

Meanwhile, this surveillance report covered 220 vaccination sites in 17 districts during the first vaccination campaign and 214 sites in 18 districts during the second campaign, involving 21 DRA officials.