In India, the Covid-19 vaccine makers Serum Institute of India and Bharat Biotech were asked to submit more data on Covishield and Covaxin respectively. The Subject Expert Committee has sought additional data on their Covid-19 vaccine candidates before they are granted emergency use authorisation for the shots.
Pune-based Serum Institute is recommended by committee to submit an updated safety data of phases 2 and 3 clinical trials in the country, including immunogenicity data from the clinical trial in the UK and India and the outcome of the assessment of the UK medicine regulator.
Hyderabad firm Bharat Biotech has been asked to present the safety and efficacy data from the ongoing Phase 3 clinical trials in the country for further consideration.
Also, Pfizer has applied for emergency use authorisation for its vaccine, but it has requested for more time for making a presentation before the committee.
Pune-based Gennova Biopharmaceuticals have also been granted conditional permission for human clinical trials. In collaboration with HDT, USA, the firm has developed an mRNA vaccine candidate (HGCO19).
The Drug Controller General of India has approved the recommendations of SEC on the proposal submitted by the firm regarding the permission to conduct Phase 1 and 2 clinical trials, and granted the conditional permission on Wednesday as reported by news agency PTI.
Meanwhile, Britain’s first Covid-19 vaccine rollout hit serious problems as the medicines regulator on Wednesday issued a warning for those with a serious allergy to vaccines, medicines or food should not get the Pfizer-BioNTech Covid-19 vaccine.
Britain began its mass inoculation programme on Tuesday, prioritizing elderly and frontline health workers as part of global drive.The warning came a day after two reports of anaphylaxis and one report of a possible allergic reaction were reported since rollout began.
Anyone with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer jab, said Britain’s Medicines and Healthcare Products Regulatory Chief Executive June Raine in a statement.
The fuller guidance was issued after consulting experts on allergies warning about the vaccine shot. MHRA’s investigation has been supported by Pfizer and BioNTech.
Even after the UK ‘s warning on Pfizer shot, Canada on Wednesday approved the Covid-19 vaccine and said the first dose will be administered across the country starting next week.Every Canadian will be inoculated by as early as the end of September. After Bahrain and Britain, Canada will be the third country to give the go-ahead to the Pfizer BioNTech vaccine.