Johnson & Johnson’s vaccine 79% effective in real-world study, but uncertainty over India getting access to it

Johnson & Johnson’s SARS Cov-2 vaccine Janssen showed an effectiveness of 79 % for Covid-19 infections and 81% for Covid-19-related hospitalisations in real world settings in the United States. In the US, in states which had high incidence of Delta Variant, J&J vaccine effectiveness was 78% for infections and 85% for hospitalization, J&J has revealed.

In the pre-print released on medRxiv on September 14, the paper states that the vaccine effectiveness for COVID-19 was higher (83%) in individuals less than 50 years and lower (64%) in immunocompromised patients. The recently-released paper has not been peer reviewed and no public health experts have released any critiques of it. The study from non-randomised data across US showed high and stable vaccine effectiveness of Janssen over time before the Delta variant emerged to when the Delta variant was dominant.

The objective of the real world study was assess the effectiveness of Janssen vaccine (Ad26.COV2.S) in preventing COVID infections and COVID-related hospitalisations in clinical practice, the longer-term stability of its protective effect and effectiveness against Delta variants. This study was funded by Janssen R&D.

The J&J real world study included 3,90,000 people who received the Johnson & Johnson COVID-19 vaccine versus approximately 1.52 million unvaccinated people matched on age, sex, time, three-digit zip code, and co-morbidities and predictors for COVID-19 infection severity conducted from March 2021 to July 2021. The study observed sustained and stable vaccine effectiveness starting 14 days after vaccination to a maximum of 152 days after vaccination.

The company analysed patient-level claims data from March 1, 2020, through July 31, 2021, submitted to insurance companies by US providers of inpatient, outpatient, pharmacy, and laboratory services, and aggregated by HealthVerity, a company which works with healthcare data.

The data from the real world evidence matched with the Phase 3 ensemble trial which was a randomised, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in adults 18 years old and older. The trial showed that there was 75% overall efficacy against severe/critical COVID-19, across all age cohorts and all countries included in the study.

J&J vaccine for Indians

J&J vaccine effectiveness paper comes amidst source-based reports that India could get as many as 4.35 crore doses J&J vaccine doses from October 2021 onwards of the 60 crore doses being manufactured at the Kothur plant in Telangana. However, the Union government has remained silent on the matter and J&J has not committed publicly to supply any of their vaccines to India either. Biological E Managing Director Mahima Datla had claimed that though her company is producing 4 crore J&J doses every month, she does not know where they are headed to.

According to the minutes of a meeting released by Central Drugs Standard Control Organisation (CDSCO), Janssen Pharmaceu­ticals got the approval for the import on August 6 and on Aug­ust 18, 2021 and J&J’s local partner, Biological E, got the CDSCO’s permission to ma­n­ufacture J&J vaccine in India. But it is not clear if at least some of these vaccines will be available for Indian citizens or the entire batch will be dispatched to the United States.

This is even as the Indian government had stated in an affidavit in the Supreme Court in June that 135 crore doses would be required to completely vaccinate the remaining population in the country between August to December 2021. The government included 30 crore Biological E sub unit vaccine doses, 5 crore Zydus Cadila DNA vaccine doses and 10 crore doses of Sputnik V doses in the 135 crore vaccine doses, but neither Bio E sub unit vaccine or the Zydus Cadilla vaccine have been made available to the citizens as of September. Additionally, only 13% of Indians have been fully vaccinated amidst a prevailing vaccine shortage in the country.

A few days ago, on September 16, 2021, several civil society organisations, including some based in India, had written to Johnson & Johnson and the US government underlining that the 60 crore doses being manufactured in India should not go to the European Union or the US, but sent where they are most needed. The civil society groups asserted that the vaccines are most needed in India and the African continent and that any J&J vaccine doses made in India be supplied on priority to the Indian government, the African Union, and the COVAX Facility, a global philanthropic initiative to get vaccines to the poorest countries in the world.