Updated 26 April 2021
In spite of the vaccination effort of India being in full swing with thousands of Covishield and Covaxin doses being administered across the country by the minute, most states are reporting short supplies. However, the case count is escalating aggressively and claiming over 2,000 lives every single day. In a bid to ramp up the supply of vaccines and restore balance to some extent in this tense, second-wave situation, the country has paved the way for foreign vaccines.
Johnson & Johnson’s Janssen vaccine is one such elixir that India is eyeing. Many countries, including the US, UK, Canada, South Africa as well as the European Union and African Union have placed multi-million orders for the Janssen jabs. After being first approved in Bahrain, the vaccine also got authorized for emergency use in the United States, Canada, several European countries, and Columbia.
So when will the vaccine get a thumbs up from the Indian authorities? When will it be available in India? Read on to find out.
About the Johnson & Johnson vaccine
Johnson & Johnson’s Janssen COVID-19 Vaccine comprises a single dose injected into the muscle.
As of now, it is suitable only for people aged 18 and above. The pharmaceutical giant, however, is looking at the safety and efficacy of the vaccine for teenagers aged 12 to 17, with clinical trials consisting of adolescents in this age group well underway.
The vaccine is expected to remain stable for two years at -4°F (-20°C), and a maximum of three months at routine refrigeration at temperatures of 36-46°F (2 to 8°C). It is compatible with standard vaccine storage and distribution channels, and hence, can be transported to even remote areas with ease.
The J&J vaccine is less fussy than the standard two-dose vaccines as it eliminates the need of keeping track of people given the first dose and scheduling the second dose accordingly, and also, is far more convenient to store and distribute. This has certainly given it an edge over other front-running vaccines like Pfizer, AstraZeneca, and Moderna.
Johnson and Johnson will be collaborating with Merck & Co. to produce the drug substance, formulate and fill vials of the vaccine.
How does the J&J vaccine work?
Among the available COVID-19 vaccines currently, there are four distinct types, namely, whole virus (this can again be a weakened form or inactivated coronavirus), protein subunit, nucleic acid (RNA or DNA), and viral vector.
The Johnson & Johnson vaccine falls into the viral vector category. The company leverages its proprietary AdVac® vaccine platform, which it had previously used for its Ebola, Zika, RSV, and HIV vaccines. A common cold virus, known as adenovirus-26, is genetically engineered such that it can infect cells, but can’t replicate. The genetic instructions are carried through the weakened virus into the arm cells, where they construct a replica of the coronavirus spike. This triggers the immune system to recognize and respond to the real coronavirus.
How effective is the J&J Vaccine?
Across the different countries where clinical trials were conducted, the J&J vaccine was found to be 66.1% effective. This number goes up in the United States, where it has an efficacy of 72%.
On the flip side, the efficacy rate drops to 57% in South Africa, where 95% of the cases studied in trials involved the new variant. In spite of the low efficacy, the vaccine was 89% effective at preventing the severe disease from the South African strain.
Overall, the vaccine is 85% effective against severe disease, preventing deaths completely and hospitalizations after a period of at least 28 days. As of 5 February, the placebo group saw 193 cases and 7 COVID-related deaths 28 days after vaccination, whereas there were only 66 cases and not a single death in the vaccine group.
Though J&J’s statistics don’t stack up well against Pfizer and Moderna which have 94% and 95% efficacy rates, respectively, experts say that they can’t be compared head-to-head, owing to the testing design differences.
Are there any side effects?
A few commonly observed side effects include injection site reactions such as pain, redness of the skin, and swelling, and general effects like headache, feeling very tired, muscle aches, nausea, and fever.
In rare cases, the vaccine may cause an allergic reaction, resulting in difficulty in breathing, swelling of your face and throat, fast heartbeat, rashes, dizziness, and weakness. It is therefore advisable to stay at the vaccination centre an hour or so after getting the shot, so that medical help will be available immediately if need be.
The company suggests that you let your vaccination provider know about your medical conditions before being given the shot, especially if you:
- have any allergies
- have a fever
- have a bleeding disorder or are on a blood thinner
- are immunocompromised or are on a medicine that affects your immune system
- are pregnant or plan to become pregnant
- are breastfeeding, or
- have received another COVID-19 vaccine
The J&J vaccine is still being studied in clinical trials, so if you observe any serious side effects that don’t go away, it is best to contact your physician or the nearest hospital.
In mid-April, the United States Centers for Disease Control and Prevention (CDC) and the United States Food and Drug Administration (FDA) had abruptly stopped the vaccine administration in the country, after fatal cases of blood-clotting surfaced. However, on 24 April, this temporary ban was lifted by the two authorities, thus reinstating the vaccine’s safety for all.
Latest news of Johnson & Johnson Vaccine in India
Johnson & Johnson plans to start bridging clinical trials in India and will be applying to the Central Drugs Standard Control Organisation (CDSCO) very soon for permission. Such trials will serve the purpose of demonstrating the safety and immunogenicity of the vaccine and will consist of only around 1000 participants.
The company has partnered with Biological E, a privately-held biopharmaceutical based in Hyderabad, to boost its manufacturing capabilities in India. With the tech-transfer from the former, Biological E will be contract-manufacturing around 600 million doses of the Janssen vaccine every year.
India expects to receive the J&J vaccine for “fill and finish” by June or July 2021. Fill and finish, that is filling the vials and syringes with the vaccine, sealing them and packaging them for shipment, is the last rung in the ladder of the manufacturing process.
What is the price of the J&J vaccine in India?
Though details about the exact pricing of the Janssen vaccine in India are yet to emerge, speculations suggest that each dose will cost around INR 730.
It is important to note that the vaccination is free of charge in government hospitals so far. Will the J&J jabs adhere to this? Only time will tell.