Covid vaccine: Panel wants more safety data, puts permission on hold
New Delhi: It seems the wait for COVID-19 vaccine may get a little longer as the proposals of the Serum Institute of India and Bharat Biotech to get permission for emergency use of vaccines were not cleared by the expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday.
According to sources, the experts' panel has "put on hold" the request of both the vaccine manufacturers citing lack of safety and efficacy data for COVID-19 vaccine candidates.
"The proposals of both the vaccine manufacturers have not been rejected as they are still under consideration," the sources affirmed.
However, sources said, the proposal of the Pfizer Inc — Indian arm of US pharmaceutical firm — was not taken up for deliberation on Wednesday as the firm has sought more time for making the presentation before the committee.
As per the sources, the subject expert committee (SEC) of the CDSCO has asked Serum Institute to provide updated safety data of phase-2 and phase-3 clinical trials in India, immunogenicity data from the clinical trial in the UK and India. The Serum Institute has also been told to submit the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA), the sources said.
In case of Bharat Biotech, the sources said, the expert committee has asked the firm to provide the safety and efficacy data from the ongoing phase-3 clinical trial in the country to consider the proposal.
Meanwhile, the Union Health Ministry has issued a denial after certain media reports started claiming that the drugs regulator had "rejected" emergency use authorisation to the two vaccines.
In a related development, a team of 64 ambassadors and high commissioners visited the Bharat Biotech facility at Genome Valley, Hyderabad on Wednesday to learn more about their work to establish a safe and efficacious vaccine against COVID-19.
The delegation was led by the Ministry of External Affairs comprising high commissioners and government representatives from Asia, Africa, Europe, North America, South America, and Oceania.
On the vaccine storage front, India is not at a much better place as the country has 85,634 equipment for storage of vaccine at about 28,947 cold chain points across the country.
The Bharat Biotech had applied for emergency use authorisation for its vaccine Covaxin on December 7, while Serum Institute had sought the permission for its Covishield vaccine on December 6 and Pfizer had applied for EUA for its vaccine on December 4.
