MedicineIndia's first single - dose vaccine; the J&J vaccine, how it works...

India’s first single – dose vaccine; the J&J vaccine, how it works and controversies around it

On 7th August, India’s Health Minister, Mansukh Mandaviya announced India’s approval of Johnson & Johnson’s single-dose Covid-19 vaccine for emergency use, in a tweet.

The tweet read, “India expands its vaccine basket! Johnson and Johnson’s COVID-19 vaccine is given approval for Emergency Use in India.”

The American pharmaceutical company had applied for emergency use approval of its vaccine to the Central Drug Standard Control Organisation (CDSCO) on August 5.

J&J vaccine can be a COVID-19 vaccination milestone for India

With the threat of a potential third wave of the pandemic, the approval of the single-dose vaccine seems to be a milestone as the central government has now granted Emergency Use Authorisation (EUA) to a total of five COVID-19 vaccines. 

The J&J vaccine is currently the only single dose vaccine. The vaccine can be a lifesaver for people who may be hard to reach or who are otherwise unlikely to get a second dose.

Also, the Johnson & Johnson vaccine can be refrigerated for up to three months at normal temperatures, unlike all Indian vaccines, which have to be stored at 2-8 degrees Celsius. This would allow the government to send these stocks to rural parts of the country where the cold chain may not be well developed.

Johnson and Johnson company’s statement

In a statement, Johnson & Johnson India spokesperson said, “We are pleased to let you know that on 7th August 2021, the Government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson Covid-19 single-dose vaccine in India.” 

“This is an important step forward in accelerating the availability of our Covid-19 vaccine to help end the pandemic,” read the statement issued by Johnson & Johnson. 

The EUA submission was based on “topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial,” a company statement said. 

The shot will be brought to India through a supply agreement with homegrown vaccine maker Biological E Limited, J&J had said.

South African Study on the J&J vaccine

Data from a clinical trial in South Africa shows that a single dose of the Johnson and Johnson vaccine is highly effective in preventing severe illness and death from the Delta and Beta variants of the coronavirus.

The South African study ‘Sisonke’, found that the J&J vaccine has an efficacy of up to 71% against hospitalization from the Delta variant, 67% against hospitalization from the Beta variant, and up to 96% against death. The data, however, has not yet been peer-reviewed or published in a scientific journal.

The vaccine also showed protection against Covid-19 related hospitalisation and death, beginning 28 days after vaccination. 

Dr Linda-Gail Bekker, co-lead of the study had said, and director of the Desmond Tutu H.I.V. Centre at the University of Cape Town was quoted saying, “We believe this vaccine is doing what it was designed to do, which was to stop people going to the hospital and stop them ending in I.C.U’s and dying.” 

The results suggest that people who have received one dose of the Johnson & Johnson vaccine don’t need a booster shot, Dr Bekker added.

How the J&J vaccine works

Unlike its US counterparts, Moderna and Pfizer vaccines, the Johnson & Johnson vaccine does not use messenger RNA (mRNA) to help the body build its defences against the virus.

The vaccine is an adenovector vaccine like the Oxford-AstraZeneca vaccine. In this case, the gene of the coronavirus’ signature spike protein is added to an adenovirus, a common virus that causes colds or flu-like symptoms, which when introduced into the body, delivers the instructions that teach human cells to make the spike protein. That causes the immune system to react by making antibodies to attack the spike protein. 

According to the Strategic Advisory Group of Experts of WHO, the single dose (0.5 ml) Janssen Ad26.CoV2.S vaccine should be administered intramuscularly. Further, there should be an interval of 14 days before the administration of this vaccine and any other vaccine against other health conditions.

J&J vaccine was being worked on over a decade before the COVID-19 outbreak

A history of the vaccine shows that its central formula was in the making over a decade before the outbreak of the COVID-19 virus.

Dan Barouch, a virologist at the Beth Israel Deaconess Medical Center, and his team had been developing a “vector” for the last decade and a half, as per which a part of a pathogen’s genetic code would be introduced into human cells. Once there, it would trigger the cells to create pieces of the pathogen for the body’s immune system to identify and attack.

Numerous controversies around the J&J vaccine

On 13 April, the US government had paused the administration of the J&J vaccine to investigate a few cases linked to rare blood clots. Some people had experienced blood clots after receiving the vaccine. All the cases emerged within two weeks of vaccination. But on 23 April, US health officials lifted the pause after scientific advisers decided the vaccine’s benefits outweigh the risks.

South Africa, too, had paused the administration of the vaccines because of the U.S. investigation. South African researchers, too had recorded two cases of the rare clotting disorder associated with the Johnson & Johnson vaccine in the trial, but both participants later made a complete recovery. 

Another U.S. study released in July led to the belief that the J&J shot produced relatively low levels of antibodies against Delta. In defence, J&J said that analysis had examined only one aspect of protection and didn’t consider long-lasting responses among immune cells stimulated by the vaccine.

Earlier, social media posts had claimed that the vaccine contains aborted fetal DNA as an ingredient, to which the Roman Catholic Archdiocese of New Orleans released a statement calling it “morally compromised”. It was later clarified that while the vaccine used lab-replicated fetal cells during its production process, the vaccine itself does not contain any fetal cells.

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