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Advising the Central Drug Standard Control Organisation (CDSCO), the Subject Expert Committee (SEC) has allowed US pharma giant Johnson & Johnson (J&J) to conduct clinical trials on adolescents for its two dose Covid-19 vaccine, subject to certain conditions, according to a report in Business Standard. It said that the firm should first submit the interim safety data from part 1 of the study before the committee, 28 days after the vaccination. And, only after the review, the second part of the study may be initiated.
Under the primary end-point, the SEC has asked the company to monitor adverse events closely, including Multisystem Inflammatory Syndrome in Children (MIS-C), post the first and the second vaccine dose for 42 days to three months.
Background
Last year, J&J had started trials globally for a two day regimen of its vaccine. In April 2021, the firm expanded the study to include adolescents in the age group between 12-17.
Later, J&J in August, to seek permission for conducting trials on adolescents it said that is fully committed to facilitating equitable access to its Covid-19 vaccine globally and recognise the unmet needs of the children.
It also said that in order to achieve herd immunity, vaccine trials must be on children and it is imperative that the clinical trials keep moving forward. The US based pharma giant has an Indian manufacturing partner called Hyderabad based Biological E.
J&J also got an Emergency Use Authorisation (EUA) from CDSCO for its single shot Covid-19 vaccine. During the phase 3 clinical trial, the vaccine had showed 85% efficacy in preventing severe disease across all regions.