Locally manufactured Johnson & Johnson vaccine could be available for use in India only by the fourth quarter of 2021, The Economic Times has reported.
Though the process of transfer of technology by J&J to Indian vaccine maker Biological E has been initiated, it could take another 4-5 months for all the required processes to be completed and full-fledged manufacturing of the vaccines to begin in India, the paper has reported citing sources.
The COVID-19 vaccine developed US healthcare giant, has already been approved in United States, the European Union and other nations including Thailand and South Africa.
Johnson & Johnson’s one-shot vaccine is ‘safe and effective’ against COVID-19 infection, US regulator earlier said. The vaccine was 72% effective in a US clinical trial, the USFDA mentioned. There were no COVID-19 related deaths in the vaccinated group, according to USFDA.
The Indian government waived the requirement to conduct bridging trial studies before granting emergency use authorisation to foreign-made vaccines that have been approved by regulatory bodies of United States, Europe, Japan or United Kingdom, considered among the most stringent globally.
As per the new norms, these vaccines can be imported into the country in ready-to-use vials or `fill and use’ form. However, such vaccines would have to be subjected to post-approval parallel studies in the Indian population, with the first 100 beneficiaries being assessed for seven days for safety before being allowed a full-fledged rollout under the immunisation programme.
Recently, CDC and the U.S. Food and Drug Administration (FDA) recommend use of Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine resume in the United States, after a temporary pause.
Reports of adverse events following the use of J&J/Janssen vaccine suggest an increased risk of a rare adverse event called thrombosis with thrombocytopenia syndrome (TTS). Nearly all reports of this serious condition, which involves blood clots with low platelets, have been in adult women younger than 50 years old.
A review of all available data showed that the J&J/Janssen COVID-19 Vaccine’s known and potential benefits outweigh its known and potential risks, says the CDC.