With vaccine supply not an issue Bhutan now focuses on safety and implementation

With India explicitly committing to meet Bhutan’s vaccine needs for 533,000 eligible people and other arrangements in the pipeline, it is becoming clearer now that the main challenge of getting the COVID-19 vaccine is largely resolved.

This now leaves two issues at hand for Bhutan. One is the safety of the vaccine or vaccines and their side effects on a Bhutanese population and the other is on how the mass roll out will happen. 

The ‘Dana’ cover

The Prime Minister Dasho (Dr) Lotay Tshering on 18th January said that apart from the inauspicious month of ‘Dana’ from February 14th to March 13th and the aim to vaccinate 533,000 eligible Bhutanese in one go, the delay till March 14th will allow Bhutan ‘to learn from experiences, possible side effects and lessons of other countries who have rolled out the vaccination programs.’

The Prime Minister also said that Bhutan can afford to wait as Bhutan does not have a massive community spread and high deaths like other countries.

Foreign Minister Dr Tandi Dorji said that Bhutan has its own regulations and no vaccines have been approved yet.

The Foreign Minister said that any COVID-19 vaccine will have to first get regulatory approval to be used in Bhutan and on this front the Ministry of Health and the Drug Regulatory Authority (DRA) will work together to ensure that Bhutan approves and gets the right type of vaccines.

For an extra layer of assurance, the minister said that the Covishield vaccine (Oxford-AstraZeneca) will first be given to around 50 to 100 volunteer front liners to see the impact of the vaccine and how Bhutanese react to it.

He said some Bhutanese who are travelling out will also get the vaccine.

Though no government official has explicitly said it, there is a cautious approach at the senior levels of the government on the mass vaccination of all Bhutanese.

Given that all the available vaccines have all been developed in a record time with long term impact not yet known the government would like to have as much  information as possible on all the risks and impacts before the final green signal.

In that sense even the inauspicious month of ‘Dana’ for all purposes is for the government to buy time to get more information given that no past mass vaccination programs have been guided by such astrological signs.

DRA to vet the vaccines

The Drug Regulatory Authority (DRA) which regulates the use of all drugs and vaccines in Bhutan has been tasked with looking at the side effects and safety of the vaccine.

With most Bhutanese likely to get the Covishield vaccine (Oxford-AstraZeneca) and 150,000 doses already entering the country the main focus of DRA is currently on this vaccine.

The DRA Director Wangdi Gyeltshen said around five to six of his officers are collecting information on a daily basis on the safety, efficacy and side effects of the Oxford-AstraZeneca from across the world.

He said his agency is also studying the position papers of regulatory authorities of countries which have allowed the mass vaccination of Oxford-AstraZeneca vaccine like UK and India.

The Director said that in line with provisions in the Medicines Act and Rules and Regulations the DRA has already set up a guidance document on Emergency Authorization Use (EAU) procedure for Bhutan.

He said since it is an emergency the normal process of registering a vaccine and other paperwork cannot be followed and hence the EAU system has been put in place.

The decision to grant the Emergency Use Authorization (EUA) of COVID-19 vaccines is contingent to the COVID-19 vaccine being listed by the WHO for Emergency Use; or if the COVID-19 vaccine should be approved for emergency use by the Stringent Regulatory Authorities (SRA) as designated by the WHO.

The Director said that the Oxford-AstraZeneca vaccine has not yet been granted Emergency Authorization Use by WHO but the WHO is studying the vaccine and it is expected sometime by the end of January.

He said that the UK which falls under the category of Stringent Regulatory Authorities (SRA) of WHO has already given EUA and it fulfills the condition even without the WHO EUA.

The Director, however, said that the ‘Dana month’ delay gives the DRA time to wait for the WHO EUA and study its position paper before giving EUA in Bhutan for mass vaccination of its population.

This means that while 150,000 doses of the Oxford-AstraZeneca vaccine are in the country they cannot be used for mass vaccination without approval from DRA.

The EUA does not mean that the vaccine is registered but is being allowed due to an emergency, and its use can be withdrawn by the DRA if there are any adverse events.

The DRA under the post marketing surveillance after the vaccine is given will study its impact and at the same it will also be responsible for strictly monitoring the cold-chain storage infrastructure and systems for the vaccine.

In the case of the Covishield vaccine manufactured in India the DRA’s has a requirement for two more additional documents to give any EUA since the vaccine is being manufactured based on technology transfer and permission to manufacture the Oxford-AstraZeneca vaccine in the Serum Institute of India (SII).

The documents are first a declaration from the manufacturer confirming the manufacture of COVID-19 vaccine is based on the technology transfer and all manufacturing processes have been validated and comparable with the vaccine approved by the Stringent Regulatory Authorities.

Secondly a declaration from the manufacturer that the composition of vaccine per dose is the same as that of the principle manufacturer regardless of the trade name.

The DRA has asked for SII to send in these two documents as well before any EUA is given.

The Director said that SII is a global vaccine manufacturer with a very good track record.

He said that Bhutan will mainly have to rely on international data on the quality, safety and efficacy of vaccines as Bhutan does not have the capacity to look into these by itself.

The DRA recently had a meeting with the National Immunization and Technical Advisory Group (NITAG) which is a technical body to advise on the vaccines and Vaccines Preventable Disease Program (VPDP) under the Ministry of Health on the use of vaccines and their roll out.

The aim is to have all procedures and systems in place before the mass roll out happens.

The DRA as the regulatory body is looking at the MoH’s manpower, cold chain storage to store the vaccines and will conduct checks on the storage of the vaccine at the right temperature of 2 to 8 degrees which is the storage temperature of normal vaccines.

Given that the Oxford-AstraZeneca vaccine can be stored in normal temperatures like other vaccines this vaccine can be delivered up to the BHU, Out Reach Clinics (ORC) and even chiwog level for mass vaccination.

The MoH will also be conducting a small training for its staff on injecting the Oxford-AstraZeneca vaccine as it is a new vaccine.

The DRA is also studying the Pfizer vaccine as the PM mentioned that Pfizer may be able to give 100,000 doses of the vaccine to Bhutan.

In the case for Pfizer the same EUA approach will be followed and it is easier as the WHO has already given it an EUA apart from the European Union.

NITEG and roll out

The head of NITEG Dr Mimi Lhamu said that other countries including India are conducting mass vaccinations which will be observed for any issues like safety, efficacy etc.

She said that the NITEG has developed the vaccine deployment strategy which tackles everything from the priority population to cold chain logistics.

Dr Mimi said that in the case of the Oxford-AstraZeneca vaccine the storage temperature means that it can reach all areas. She said that the traditional vaccination program and the experience gained with the recent flu vaccination program for the whole nation will be helpful.

She said that Bhutan already has a system to monitor adverse side effects from vaccines which is why when people (normally children) are given vaccines they are told to wait for at least 30 minutes before going home.

She said the same system will come into play once vaccines are given and any adverse events will be recorded and uploaded.

Dr Mimi said that Bhutan will also be using the Uppsala Monitoring Centre (UMC) data under the WHO where countries upload and reports adverse effects of medicines and vaccines. This is the world’s largest repository of such information.

She said that the vaccine deployment strategy plan is a dynamic plan in its fourth or fifth version. She said NITEG had recommended for mass vaccination to be done within two weeks.

The government’s target is to do it within a week.

She said that in terms of giving the injection it would be a health staff who would do it but another five or six people would be required to do the non-medical work like guiding people and registration.

Dr Mimi said in the case of Pfizer, vaccination will be a bigger challenge as it has to be stored in temperatures of minus 70 degrees centigrade.

Currently only the Royal Center of Diseases Control has coolers large enough to store them in numbers and the JDWNRH has some smaller ones.

The government will have to procure more of such freezers for the vaccine. In the case of the Pfizer vaccine once it is opened it has to be used within five days so theoretically one can use it to inject people in non-urban areas but the transportation will have to be quick and vaccination done immediately.

She said for the Pfizer vaccine it will have to be done with 2 to 3 days very fast and when things are done at such speed then errors are possible.

TAG says vaccine is safe

The Technical Advisory Group (TAG) of the Ministry of Health said it is important to note that Bhutan is not the first country to be using the AstraZeneca vaccine as India has already rolled out a mass inoculation drive and the UK has also used it for its vaccination programs; furthermore, the vaccine has undergone major safety checks as it has passed all the three phases of the clinical trials and has proven to be safe for mass usage.

 In terms of the side effects TAG said Bhutan has no experience of vaccinating anyone for preventing COVID-19 thus far. It said that all side effects reported from other countries will most probably be similar to the Bhutanese population. TAG said the manufacturer claimed side effects or those reported side effects from different countries are easily retrievable from the internet from various sources.  

 In response to a question on precautions to be taken while administering the vaccine if there are side effects the TAG said, “Our health workers will be cautious while injecting the vaccine. After injection, they will be kept for at least 30 minutes for observation. Our health team will be ready with basic equipment and medicines to manage the adverse reaction if it occurs.  We also have a system for reporting and recording such adverse reactions to take appropriate actions (2121/112).”

 TAG said that in addition to the above, they have already made inclusion and exclusion criteria for the vaccines in line with the recommendations from the developers and manufacturers of the vaccine.

TAG said to ensure that all safety checks are in place, MoH will not be inoculating individuals below 18 years of age, pregnant and lactating mothers, and those suffering from very severe illnesses; however, this doesn’t mean that they will not be inoculating those with certain comorbidities.

The exclusion criteria are based on the findings of the clinical trials and inline with the recommendations from the manufacturers and authorities who have authorized them for emergency use.

TAG recommend that identified groups take the vaccine, however it is purely upon one’s discretion to take the vaccine or not. 

 TAG said that to ensure vaccination will be done within a week a detailed vaccination plan has been already developed by the Ministry including the deployment of health staff and logistics like transportation and other requirements. To make the distribution of vaccines faster and smoother, MoH will also be using helicopter services to reach the vaccines to far flung areas.

Foreign Minister clears the air on the vaccine

The Foreign Minister said that the Oxford-AstraZeneca is tested well and approved by regulatory agencies. He said so far the side effects stated are quite common with no serious side effects.

The minister said that people who have to careful are those with known conditions like allergies to the vaccines components, immune compromised people, people taking steroid medicines for a long time etc.

He said the example of 13 people dying in Norway after getting the Pfizer vaccine needs to be pit in proper context as these were all 80 years plus people who are also infirm and vulnerable to other causes too. He said in most of the vaccine related deaths the causes are due to some pre-existing condition and not the vaccine.

Lyonpo said that if the remaining 400,000 doses come before the Dana then the first shot can be given to the whole population before the Dana with the second dose to be given after the Dana.

The minister said that 2,400 medical staff are required to give the vaccines but Bhutan already has around 5,000 medical staff.

He said that for those taking or not taking the vaccine there will be an agreement to be signed outlining all the information. For those not taking the vaccine the agreement will state that they will be accountable in case they get the disease and spread it to others.

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