Although Nepal’s national drug regulatory authority on Friday granted emergency use approval to Covaxin, the Covid-19 vaccine developed by an Indian private company, authorities are unsure when and if the vaccine will come to Nepal.

The cost could be the prohibitive factor for Nepal, according to officials at the Health Ministry.

“It is not clear yet about the export price of the Covaxin, but I have heard it is around $16 per dose,” Dr Shyam Raj Upreti, coordinator of the Covid-19 vaccine advisory committee, told the Post. “If so we have to pay three fold the price of Covishield, which we cannot afford.”

The government had last month bought Covishield, developed by the University of Oxford and the British-Swedish pharmaceutical giant AstraZeneca, at $4 per dose.

But since then the government’s efforts to procure additional doses of Covishield from its Indian manufacturer have failed as the company has not responded to the Nepal government.

According to officials at the Health Ministry, Serum Institute of India, the manufacturer of Covishield, has said it is unable to sell the vaccine at that price and has been asking for $5.5 per dose besides the commission for its agent.

The government has allocated a budget of Rs48 billion to vaccinate 52 percent of the population with an estimate of $10 per dose which includes costs for management and administering of the vaccines. Those below the age of 15, who account for 28 percent of the population, cannot be vaccinated and vaccines for 20 percent of the population will come as grant from the COVAX facility.

Covaxin, developed by Bharat Biotech, became the third Covid-19 vaccine to be approved by Nepal’s authorities although it had applied for approval together with Covishield and BBIBP-CorV vaccine, developed by China’s Sinopharm, on January 13.

While Covishield got emergency approval two days later on January 15, approval for BBIBP-CorV was granted on February 17.

Friday’s approval of Covaxin by the drug advisory committee of the Department of Drug Administration comes after review of vaccine trial data that was provided to Nepali authorities after the application for emergency approval.

“After reviewing interim data of the third-phase trial, the committee has decided to give emergency use authorisation in Nepal,” an official at the department told the Post, asking not to be named.

Nepal became only the third country in the world to provide emergency use authorisation for Covaxin after India and Zimbabwe, according to the Reuters.

Emergency use authorisation is granted for some drugs and vaccines by authorities during a declared emergency when officials can make a judgment that the drug is worth releasing—even without all the evidence that would fully establish its effectiveness and safety. Such a decision is taken when there’s enough evidence to suggest that patients have benefited from the drug/vaccine.

India's regulators gave the vaccine an emergency approval in January while the third phase of the trial was still under way, sparking scepticism and questions from experts.

Like the Covishield, Covaxin too can be stored at 2 to 8 degrees Celsius, which the country’s existing storage facility supports.

India has been providing the vaccine free of cost to its population from state-run health facilities and has set the ceiling price at Indian Rs250 (equivalent to Rs400) per dose in private hospitals and clinics.

However, it is not clear what would be the price of Covaxin for export, according to Upreti.

The Bharat Biotech’s production capacity is low compared to the Serum Institute of India and the vaccine has been pre-booked by dozens of countries, Upreti added.

According to Dr Samir Kumar Adhikari, joint spokesperson for the Health Ministry, granting emergency use authorisation doesn't mean that the government has decided to procure Covaxin.

Covaxin has an efficacy rate of 81 percent, preliminary data from its phase 3 trial shows, according to the BBC.

Covishield has an efficacy rate of 63.9 percent and BBIBP-CorV 79 percent .

Friday’s approval of Covaxin comes amid uncertainties about the supply of Covid-19 vaccine.

Nepal launched its vaccination drive on January 27 with one million doses of Covishield it received from India under grant assistance.

Of the 2 million doses for which Nepal signed a deal with the Serum Institute of India, one million doses have already arrived and the remaining half is expected to arrive soon. Nepal has also received 348,000 doses of vaccine under the COVAX facility.

So far, over 1.7 million people have taken the first shot in the first and second phases of the vaccination campaign. During the first phase of the vaccination drive, 438,879 people were vaccinated between January 27 and March 4 while over 1.25 million people took the first jab in the second phase, in which people over 65 were given the vaccine, from March 7 to March 15.

The government says it has around 600,000 doses in its stock. Those who have received the first shot would be administered the booster shot from April 20 to April 24 with this existing stock and the one million doses that the Serum Institute is yet to deliver.

Besides, according to an official at the Department of Health Services, the COVAX facility has said it will supply an additional 600,000 doses of Covishield within March.

“Exact date of delivery is not known, but we are told that additional 600,000 doses of Covishield will be supplied within March,” the official said, asking not to be named.

China has also donated 800,000 doses of the Covid-19 vaccine but that is yet to arrive. According to reports, the Nepal government will have to transport the vaccines from China.

Officials say that they are working to bring them to Nepal.

The government has currently suspended the vaccination drive with no plans to resume it immediately as it is struggling to acquire vaccines.

Adhikari, the joint spokesperson, said that the ministry will make plans to resume the immunisation drive, only after it gets the vaccine.

He, however, said that registration of more vaccines in the country is a good thing in itself, as the government will have more options.

“The monopoly of a particular company will end, more competition will happen, which will ultimately benefit the people and the country,” Adhikari said. “Emergency use authorisation has been given by meeting all the requirements.”