The World Health Organisation (WHO) and the competent authority in Bhutan — Drug Regulatory Authority (DRA) — have authorised Oxford vaccine for emergency use.
DRA authorised the emergency use for Covishield vaccine manufactured by Serum Institute of India last month.
The authorisation was based on a recommendation from the drugs technical advisory committee and chairperson of the Bhutan medicine board.
The Oxford vaccine, locally manufactured in India under the name Covishield, is the first vaccine against SARS-CoV-2 virus to be authorised in Bhutan. The country received its first batch of 150,000 doses of Covishield vaccine on January 20 this year.
WHO, on February 15, also listed two versions of the Oxford vaccine for emergency use, giving the green light for these vaccines to be rolled out globally through the COVAX Facility. The versions include the vaccine produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.
The Oxford vaccine is the second to receive the emergency use authorisation (EUA) from WHO after the global health body approved the emergency use of Pfizer vaccine in December last year.
The government plans to inoculate the entire eligible population (533,000) through a nationwide vaccination campaign. However, to do so, the country would still require over 380,000 doses of the vaccine.
Given that the current vaccines are administered in two doses; the first 533,000 vaccines would cover only the first dose. Around 1.2 million doses of vaccine would be required to cover the entire eligible population (both the doses).
In the meantime, as the government waits for the additional doses, it has plans to use the 150,000 Covishield vaccines for Bhutanese travelling outside and referral patients.
With both WHO and local authority, DRA, granting EUA to Covishield vaccine, the government could now start the inoculation among the selected groups, as planned, before the mass vaccination begins.
It was learnt that besides Dana (inauspicious month) that began from February 14 until March 13, the government has been waiting for the EUA from WHO to start the vaccination programme for the selective groups.
Mass vaccination vs phase-wise inoculation
Bhutanese doctors practising and studying abroad suggested that the government should stick to its initial plan of administering the vaccine in phases.
These doctors have received the Oxford vaccine and they say that there were several side effects associated with the jab. Although not life-threatening, the doctors said they have personally experienced the side effects of the vaccine.
The concern with a nationwide vaccination programme, according to the doctors could overburden the health facilities in the country. “What if a large number of people get sick at once and all require hospitalisation?” a doctor said. However, he said, it would be wise to get vaccinated. “Something is better than nothing.”
Prime Minister Dr Lotay Tshering has earlier said that the reason some vaccines receive the EUA was because they had passed all the three phases of the clinical trials.
In terms of safety, Lyonchhen has said that no major side effects were recorded among the authorised vaccines. “And definitely there are no life-threatening side effects from the vaccine that have received the EUA.”
However, he said, there would be some local side effects, which is an innate quality of any other vaccine. He added that, when a vaccine is administered, reactions such as swelling on the point of the injection, fatigue, and fever among others are bound to happen. “But these aren’t side effects. This is an indication of your body’s immune system reacting to the vaccine, which is expected.”
The government, which initially planned for a phase-wise vaccination programme, decided on a mass campaign later to ensure the same level of immune protection for all, if vaccinated over the same time.
Mass vaccination, which is to be carried out within a period of seven days, also ensured logistical advantages over spreading the vaccine rollout over months, stretching the government’s manpower and other resources, besides time.
Meanwhile, the health ministry has initiated an online registration for Covid-19 vaccination programme on February 21.
Upon the completion of registration, the ministry will plan the vaccination centres accordingly. Health officials said that everyone in the country above the age of 15 years should register themselves through the online portal.
The ministry has also carried out an online survey to receive feedback from the public on the Covid-19 vaccines. The survey report is yet to be made public.