The US Food and Drug Administration last week recommended a booster dose of Janssen vaccine developed and manufactured by Johnson & Johnson.

The booster dose of the vaccine, authorised for use on people above 18 years old, has been recommended to be administered at least two months after the first dose.

The Vaccines and Related Biological Products Advisory Committee of the federal drug regulator of the US voted 19-0 to recommend the extra dose for all recipients of the Janssen vaccine, according to CNN.

With the new recommendation, there are now concerns if over 1.5 million people in Nepal who have received the Janssen vaccine should be considered “fully” immunised. Until the US Food and Drug Administration’s recommendation, Janssen was considered a single-shot vaccine.

Nepal received 1,534,850 doses of the Johnson and Johnson vaccine on July 12 from the United States through COVAX, an international vaccine sharing scheme backed by the United Nations.

The government of Nepal had administered the Janssen vaccines to people between 50 and 54 years of age. People with disabilities, refugees residing in Nepal, health workers and sanitation workers too were administered the vaccine. Other recipients of the vaccine were migrant workers and students going abroad.

“We are aware of the FDA recommendation, but we have not taken any decision regarding the booster dose,” said Dr Samir Kumar Adhikari, joint spokesperson for the Ministry of Health and Population. “We have been told that Janssen is a single-shot vaccine and we still believe in it.”

The vaccine manufacturer Johnson & Johnson says studies have shown booster shots given after two to six months of the first shot can provide 94 percent protection against symptomatic Covid-19 infection.

However, members of the Vaccines and Related Biological Products Advisory Committee said that various studies suggested real-world efficacy of Johnson & Johnson vaccine was anywhere between 50 and 68 percent.

“I am not aware of the recommendation for a second dose of the Janssen vaccine,” Sagar Dahal, chief of the National Immunisation Programme, told the Post. “Since I am not aware I am not in a position to comment.”

When the doses were shipped to Nepal, Janssen was the only vaccine authorised globally that required a single dose. When Nepal received Janssen doses, since there was no recommendation for a booster shot, all of the over 1.5 million doses were used.

If the FDA accepts the expert committee’s decision, which it is expected to do, the Centers for Disease Control will then outline which specific groups should receive the additional dose, according to the Time magazine.

As the Johnson & Johnson vaccine doses were shipped by the United States through COVAX, meaning the jabs were provided under grant assistance, the Health Ministry doesn't have any plan to purchase additional doses from the manufacturing company.

“Earlier we had tried to buy the jabs but we could not,” said an official at the Health Ministry requesting anonymity because he was not authorised to speak to the media. “When we did not see any possibility of buying the [Janssen] vaccine immediately, we dropped the plan.”

After India expressed its inability to export vaccines and COVAX communicated delays in supply in April, Nepal made a move to buy Johnson & Johnson and Moderna vaccines.

But both American vaccine manufacturing firms ruled out the possibility of selling the shots to Nepal before 2022 due to supply constraints and other reasons.

Nepal had in the third week of April reached out to Johnson & Johnson to buy 5 million doses.

Public health experts say Covid-19 has actually left the entire scientific community confused with new situations evolving over the months and the research has continued on the vaccines and their doses as well. In this context, according to the experts, it would be better if authorities pull out all the stops to secure additional doses of Janssen vaccine as well so that booster doses could be given to those who have taken first shots.

“Efforts should be made at the earliest to secure additional doses, as we have to keep our population safe,” Dr Anup Subedee, an infectious disease expert, told the Post. “Chances of not getting the vaccine will increase if we wait until the last moment to make a decision.”

As soon as the FDA accepts the expert panel’s advice, the demand for the Janssen vaccine is surely going to soar.

There, however, is another concern. The Health Ministry does not know the whereabouts of the people who took the Janssen vaccine. Thousands of people who received the jabs were migrant workers and students who have already left the country.

“We are not in position to identify the people within the country, who all have received the Johnson & Johnson vaccine,” said an official at the Department of Health Services who also requested anonymity.

Nepal so far has received 18,857,590 doses of Vero Cell, AstraZeneca (including India-made Covishield) and Janssen vaccines in total.

The government has purchased 12 million doses—10 million doses of Vero Cell from China and 2 million doses of Covishield from India.

The rest were provided under grant assistance by various countries and the COVAX facility.

COVAX, which has committed to providing 13 million doses, sufficient to inoculate 20 percent of Nepal’s 30 million population, has so far directly provided only 348,000 Covishield doses.

As many as 3,497,490 doses (1,534,850 doses of Janssen and 1,614,740 doses of AstraZeneca) were supplied to Nepal by the United States and Japan through COVAX.

COVAX, created to ensure vaccines for poor countries, however, has faced a setback due to a ban on vaccine exports by India. The facility was largely relying on the Serum Institute of India, the world’s largest vaccine manufacturer by volume.

Though India last month announced that it would resume exports of Covid-19 vaccines from October to COVAX, and to neighbouring countries, Reuters reported on Tuesday that the world’s largest vaccine maker has delayed committing supplies to the global vaccine-sharing effort.

Nepal launched its vaccination drive against Covid-19 on January 27.

As of Thursday, according to the Health Ministry, 6,500,463 people have been fully vaccinated. The number includes those over 1.5 million people who took Janssen as fully vaccinated.

Nepal needs to vaccinate around 78 percent of its 30 million population—or around 25 million people—as per the government’s new plan to also inoculate those between 12 and 18 years of age. The government earlier had planned to vaccinate only those aged 15 years and above.

Since around 4-5 million people are said to be living abroad, the government needs to vaccinate around 19-20 million people.

“Along with making efforts to secure Janssen doses, time has also come to purchase additional doses of other vaccines to inoculate all eligible populations,” said Subedee, the infectious disease expert.